Evidence Report/Technology Assessment 

Number 125 

Manifestations and Management of Chronic Insomnia 

in Adults 

Prepared for: 

Agency for Healthcare Research and Quality 

U.S. Department of Health and Human Services 

540 Gaither Road 

Rockville, MD 20850 

www.ahrq.gov 

Contract No. C400000021

Prepared by: 

University of Alberta Evidence-based Practice Center 

Edmonton, Alberta, Canada 

Investigators: 

Nina Buscemi, PhD

Ben Vandermeer, MSc 

Carol Friesen, MA, MLIS 

Liza Bialy, BSc 

Michelle Tubman, BSc 

Maria Ospina, MSc 

Terry P. Klassen, MD, MSc, FRCPC 

Manisha Witmans, MD, FRCPC, Dip. ABSM 

AHRQ Publication No. 05-E021-2 

June 2005
This report may be used, in whole or in part, as the basis for development of clinical practice 

guidelines and other quality enhancement tools, or a basis for reimbursement and coverage 

policies. AHRQ or U.S. Department of Health and Human Services endorsement of such 

derivative products may not be stated or implied. 

AHRQ is the lead Federal agency charged with supporting research designed to improve the 

quality of health care, reduce its cost, address patient safety and medical errors, and broaden access 

to essential services. AHRQ sponsors and conducts research that provides evidence-based 

information on health care outcomes; quality; and cost, use, and access. The information helps 

health care decisionmakers—patients and clinicians, health system leaders, and policymakers—

make more informed decisions and improve the quality of health care services. 
ii

This document is in the public domain and may be used and reprinted without permission except 

those copyrighted materials noted for which further reproduction is prohibited without the 

specific permission of copyright holders. 

Suggested Citation: 

Buscemi N, Vandermeer B, Friesen C, Bialy L, Tubman M, Ospina M, Klassen TP, Witmans M. 

Manifestations and Management of Chronic Insomnia in Adults. Evidence Report/Technology 

Assessment No. 125. (Prepared by the University of Alberta Evidence-based Practice Center, 

under Contract No. C400000021.) AHRQ Publication No. 05-E021-2. Rockville, MD: Agency 

for Healthcare Research and Quality. June 2005. 
iii

Preface 

 The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-Based 

Practice Centers (EPCs), sponsors the development of evidence reports and technology 

assessments to assist public- and private-sector organizations in their efforts to improve the 

quality of health care in the United States. This report was requested and funded by the Office of 

Medical Applications of Research (OMAR), National Institutes of Health (NIH). The reports and 

assessments provide organizations with comprehensive, science-based information on common, 

costly medical conditions and new health care technologies. The EPCs systematically review the 

relevant scientific literature on topics assigned to them by AHRQ and conduct additional 

analyses when appropriate prior to developing their reports and assessments. 

 To bring the broadest range of experts into the development of evidence reports and health 

technology assessments, AHRQ encourages the EPCs to form partnerships and enter into 

collaborations with other medical and research organizations. The EPCs work with these partner 

organizations to ensure that the evidence reports and technology assessments they produce will 

become building blocks for health care quality improvement projects throughout the Nation. The 

reports undergo peer review prior to their release. 

 AHRQ expects that the EPC evidence reports and technology assessments will inform 

individual health plans, providers, and purchasers as well as the health care system as a whole by 

providing important information to help improve health care quality. 

 We welcome comments on this evidence report. They may be sent by mail to the Task Order 

Officer named below at: Agency for Healthcare Research and Quality, 540 Gaither Road, 

Rockville, MD 20850, or by email to epc@ahrq.gov. 

Carolyn M. Clancy, M.D. Jean Slutsky, P.A., M.S.P.H. 

Director Director, Center for Outcomes and Evidence 

Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality 

The authors of this report are responsible for its content. Statements in the report should 

not be construed as endorsement by the Agency for Healthcare Research and Quality or the 

U.S. Department of Health and Human Services of a particular drug, device, test, treatment, 

or other clinical service. 

Ernestine W. Murray, B.S.N., R.N., M.A.S. 

EPC Program Task Order Officer 

Agency for Healthcare Research and Quality 

Kenneth S. Fink, M.D., M.G.A., M.P.H. 

Director, EPC Program 

Agency for Healthcare Research and Quality 

Barnett S. Kramer, M.P.H., M.D. 

Director 

Office of Medical Applications of Research
iv

Acknowledgments 

We are grateful to members of the technical expert panel for providing input on the direction 

of the review. The members of the panel include J. Todd Arnedt, Ph.D., Richard Bootzin, Ph.D., 

Irvin Mayers, M.D., Parameswaran Nair, M.D., Ph.D., Larry Pawluk, M.D., and Arthur 

Spielman, Ph.D. 

We thank the NIH Office of Medical Applications of Research for their support of this work. 

We are grateful to the Agency for Healthcare Research and Quality for granting the contract for 

this work and the Task Order Officer, CAPT Tina Murray, for facilitating the process. We also 

thank Alan I. Leshner, Ph.D., for his input on the direction of the review and for chairing the preconference panel meeting for the State-of-the-Science Conference on the “Manifestations and 

Management of Chronic Insomnia in Adults.” 
v

Structured Abstract 

Context: Approximately 40 to 70 million Americans are affected by either intermittent or 

chronic sleep problems, representing approximately 20 percent of the population. 

 

Objectives: To conduct a systematic review of (1) the prevalence, natural history, incidence, 

risk factors and consequences of chronic insomnia in adults and (2) the efficacy and safety of 

treatments used in the management of chronic insomnia in adults.

Data Sources: A systematic search of twenty-one electronic databases was conducted. We 

searched MEDLINE®, EMBASE, CINAHL®, Ovid MEDLINE In-Process & Other Non-Indexed 

Citations, Ovid OLDMEDLINE®, PsycINFO®, EBM Reviews-Cochrane Central Register of 

Controlled Trials, International Pharmaceutical Abstracts, AMED (Allied and Complementary 

Medicine), HealthSTAR/Ovid Healthstar, EBM Reviews-Cochrane Database of Systematic 

Reviews (CDSR), ACP Journal Club (ACPJC), Database of Abstracts of Reviews of Effects 

(DARE), Science Citation Index ExpandedTM, Biological Abstracts, Cochrane Complementary 

Medicine Field Registry, CAB Abstracts, SIGLE, OCLC Proceedings First, Dissertation 

Abstracts, Alt HealthWatch, NLM Gateway and PubMed®. 

Study Selection: Cohort, case-control and cross-sectional studies were eligible for questions on 

manifestations of chronic insomnia. Randomized controlled trials were eligible for the question 

on management of chronic insomnia. 

 

Quality Assessment: One of three instruments was used to assess the quality of studies relevant 

to the manifestations of chronic insomnia. The Jadad Scale was used to assess the quality of 

studies relevant to the management of chronic insomnia. The concealment of treatment 

allocation was also assessed in the latter studies. 

 

Data Analysis: Data were analyzed both qualitatively and quantitatively. The Random Effects 

Model was used for quantitative analyses. 

Main Results: The interquartile range of prevalence of chronic insomnia varied from 8.5-24.3 

percent across high quality studies of general populations, to 19.8-53.7 percent across moderate 

quality studies of outpatient populations, to 27.8-43.0 percent across moderate quality studies of 

clinical populations. Sleep onset latency (SOL) was significantly decreased by benzodiazepines 

(Mean Difference (MD): -16.5, 95% Confidence Interval (CI): [-20.5, -12.5]), nonbenzodiazepines (MD: -18.1, 95% CI: [-22.5, -13.7]), antidepressants (MD: -7.4, 95% CI: [-10.5, 

-4.4]) and melatonin (MD: -8.3, 95% CI: [-14.5, -2.0]). All of the preceding interventions, 

except melatonin, had a significantly higher risk of harm compared to placebo: benzodiazepines 

(Risk Difference [RD]: 0.15, 95% CI: [0.10, 0.20]), non-benzodiazepines (RD 0.05, 95% CI: 

[0.01, 0.09]), antidepressants (RD: 0.09, 95% CI: [0.01, 0.18]) and melatonin (RD: 0.09, 95% 

CI: [-0.11, 0.29]). Wakefulness after sleep onset (WASO) was not significantly reduced by 

melatonin (MD: -9.7, 95% CI: [-33.6, 14.3]). SOL was significantly decreased by relaxation 

therapy with short-term treatment (less than 4 weeks) (MD: -22.0, 95% CI: [-41.0, -2.9]); 

however, WASO was not significantly reduced by relaxation therapy (MD: -1.6, 95% CI: [-14.1, 
vi

10.8]). WASO was significantly decreased by cognitive/behavioral therapy (MD: -18.2, 95% CI: 

[-30.4, -6.0]); however, SOL was not significantly reduced by cognitive/behavioral therapy (MD: 

-4.6, 95% CI: -9.8, 0.6). 

Main Conclusions 

• There is evidence that chronic insomnia is associated with older age, female gender, present 

or past psychiatric illness and psychological problems, medical conditions and poor general 

health, increased healthcare utilization, lower quality of life and social relationships, 

socioeconomic status (marital separation, unemployment, poorer working conditions and 

lower social status), and decrements in memory, mood and cognitive function. 

• There is evidence that benzodiazepines and non-benzodiazepines are effective in the 

management of chronic insomnia. There is some evidence that antidepressants are effective 

in the management of chronic insomnia: more research is required in this area. There is 

evidence that benzodiazepines, non-benzodiazepines and antidepressants pose a risk of harm. 

• There is some evidence that melatonin is effective in the management of chronic insomnia in 

subsets of the chronic insomnia population, and there is no evidence that melatonin poses a 

risk of harm. However, more research is required in this area, given that the results are based 

on a small number of studies. 

• There is evidence that relaxation therapy and cognitive/behavioral therapy are effective in the 

management of chronic insomnia in subsets of the chronic insomnia population. 

• There is evidence that benzodiazepines have a greater risk of harm than nonbenzodiazepines. 
Contents 

Evidence Report.............................................................................................................................1 

Chapter 1. Introduction ...................................................................................................................3 

Prevalence of Insomnia....................................................................................................................3 

Risk Factors for Insomnia................................................................................................................3 

Consequences of Insomnia ..............................................................................................................4 

Management of Insomnia ................................................................................................................4 

Objectives ........................................................................................................................................6 

Analytic Approach...........................................................................................................................6 

Etiology and Population at Risk ..................................................................................................6 

Consequences, Morbidities, Co-morbidities, and Public Health Burden ....................................6 

Treatment .....................................................................................................................................7 

Future Direction...........................................................................................................................7 

Chapter 2. Methods.........................................................................................................................9 

Overview..........................................................................................................................................9 

Literature Search..........................................................................................................................9 

Development of Inclusion Criteria.............................................................................................10 

Study Selection ..........................................................................................................................12 

Assessment of Study Quality.....................................................................................................13 

Data Extraction ..........................................................................................................................13 

Data Analysis.............................................................................................................................14 

Chapter 3. Results.........................................................................................................................19 

Literature Review...........................................................................................................................19 

Data Synthesis................................................................................................................................19 

How is chronic insomnia defined, diagnosed and classified, and what is known about its 

etiology?.....................................................................................................................................19 

What are the prevalence, natural history, incidence and risk factors for chronic insomnia? ....24 

What are the consequences, morbidities, co-morbidities and public health burden associated 

with chronic insomnia? ..............................................................................................................24 

What treatments are used for the management of chronic insomnia in adults and what is the 

evidence regarding their safety, efficacy and effectiveness?.....................................................28 

What are the important future directions for insomnia-related research?..................................39 

Chapter 4. Discussion .................................................................................................................115 

Prevalence, Natural History, Incidence and Factors Associated with Chronic Insomnia .......115 

Efficacy and Safety of Treatments for Chronic Insomnia .......................................................116 

Limitations of the Review and Future Research......................................................................120 

Conclusions..............................................................................................................................121 

References and Included Studies.................................................................................................123 

References................................................................................................................................123 

Included Studies.......................................................................................................................127 

vii
viii

Flow Diagrams 

Flow Diagram 1. Analytic framework............................................................................................8 

Flow Diagram 2. Study retrieval and selection.............................................................................40 

Tables 

Table 1. Databases searched .......................................................................................................17 

Table 2. Subject headings and keywords used in searches.........................................................18 

Table 3a. Prevalence of chronic insomnia in adults: general population .....................................41 

Table 3b. Prevalence of chronic insomnia in adults: outpatients of general practice...................47 

Table 4. Natural history of chronic insomnia in adults...............................................................51 

Table 5. Factors associated with chronic insomnia in adults......................................................52 

Table 6. Sleep onset latency: benzodiazepines versus placebo ..................................................68 

Table 7. Other outcomes: benzodiazepines versus placebo........................................................70 

Table 8. Sleep onset latency: non-benzodiazepines versus placebo...........................................71 

Table 9. Other outcomes: non-benzodiazepines versus placebo ................................................72 

Table 10. Sleep onset latency: antidepressants versus placebo ....................................................73 

Table 11. Other outcomes: antidepressants versus placebo..........................................................74 

Table 12. All outcomes: L-trytophan versus placebo ...................................................................75 

Table 13. All outcomes: melatonin versus placebo ......................................................................76 

Table 14. All outcomes: valerian versus placebo .........................................................................77 

Table 15. Sleep onset latency: relaxation therapy versus placebo................................................78 

Table 17. Sleep onset latency: cognitive/behavioral therapy versus placebo...............................80 

Table 18. Other outcomes: cognitive/behavioral therapy versus placebo ....................................81 

Table 19. Sleep onset latency: indirect comparisons of main pharmacological treatment 

 categories ..............................................................................................................................82 

Table 20. Adverse events: indirect comparisons of main pharmacological treatment categories83 

Table 21. All outcomes: barbiturates versus placebo ...................................................................84 

Table 22. All outcomes: hormones versus placebo ......................................................................85 

Table 23. All outcomes: alcohol versus placebo ..........................................................................86 

Table 24. All outcomes: low energy emission therapy versus placebo ........................................87 

Table 25. All outcomes: relaxation therapy and cognitive/behavioral therapy versus placebo....88 

Table 26. All outcomes: relaxation therapy and cognitive/behavioral therapy versus relaxation 

 therapy...................................................................................................................................89 

Table 27. All outcomes: relaxation therapy and cognitive/behavioral therapy versus 

 cognitive/behavioral therapy.................................................................................................90 

Table 28. All outcomes: relaxation therapy and cognitive/behavioral therapy versus 

benzodiazepines .............................................................................................................................91 

Table 29. All outcomes: benzodiazepine and cognitive/behavioral therapy versus placebo........92 

Table 31. All outcomes: benzodiazepine and cognitive/behavioral therapy versus 

 cognitive/behavioral therapy.................................................................................................94 

Table 33. All outcomes: cognitive/behavioral therapy and modafinil versus cognitive/behavioral 

 therapy...................................................................................................................................96 

Table 34. All outcomes: cognitive/behavioral therapy and modafinil versus modafinil..............97 
ix

Figures 

Figure 1. Meta graph: Sleep onset latency: benzodiazepines versus placebo...............................98 

Figure 2. Funnel Plot: Sleep onset latency: benzodiazepines versus placebo ..............................99 

Figure 3. Meta graph: Wakefulness After Sleep Onset: benzodiazepines versus placebo .........100 

Figure 4. Meta graph: Sleep Onset Latency: non-benzodiazepines versus placebo...................101 

Figure 5. Funnel Plot: Sleep Onset Latency: non-benzodiazepines versus placebo...................102 

Figure 6. Meta graph: Wakefulness After Sleep Onset: non-benzodiazepines versus placebo..103 

Figure 7. Meta graph: Sleep Onset Latency: antidepressants versus placebo ............................104 

Figure 8. Meta graph: Wakefulness After Sleep Onset: antidepressants versus placebo ...........105 

Figure 9. Meta graph: Sleep Onset Latency: complementary and alternative care 

 versus placebo..................................................................................................................106 

Figure 10. Funnel Plot: Sleep Onset Latency: melatonin versus placebo...................................107 

Figure 11. Meta graph: Wakefulness After Sleep Onset: complementary and alternative care 

 versus placebo....................................................................................................................108 

Figure 11. Meta graph: Wakefulness After Sleep Onset: complementary and alternative care 

 versus placebo....................................................................................................................108 

Figure 12. Meta graph: Sleep Onset Latency: relaxation therapy versus placebo......................109 

Figure 13. Funnel Plot: Sleep Onset Latency: relaxation therapy versus placebo......................110 

Figure 14. Meta graph: Wakefulness After Sleep Onset: relaxation therapy versus placebo.....111 

Figure 15. Meta graph: Sleep Onset Latency: cognitive/behavioral therapy versus placebo.....112 

Figure 16. Funnel Plot: Sleep Onset Latency: cognitive/behavioral therapy versus placebo.....113 

Figure 17. Meta graph: Wakefulness After Sleep Onset: cognitive/behavioral therapy versus 

 placebo ...............................................................................................................................114 

Appendices 

Appendix A: Exact Search Strings 

Appendix B: Data Extraction and Quality Assessment Forms 

Appendix C: Evidence Tables 

Appendix D: Technical Expert Panel 

Appendix E: Excluded Studies 

The Appendices and Evidence Tables cited in this report are provided electronically at 

http://www.ahrq.gov/clinic/tp/insomntp.htm
Prevalence of Insomnia

Insomnia, or inability to sleep, is the most

commonly reported sleep problem in the

industrialized world.1 Estimates suggest that

between 40 and 70 million Americans are

affected by either intermittent or chronic sleep

problems, representing approximately 20 percent

of the population.2 The Sleep in America Poll,

conducted by the National Sleep Foundation,

revealed that almost 50 percent of people

surveyed had complaints of frequent insomnia,

but only 6 percent were formally diagnosed.3

Moreover, approximately, 30 to 35 percent of

respondents complained of nightly insomnia.3

The most prevalent symptoms of insomnia,

experienced at least a few nights a week by

people with insomnia, include waking up feeling

unrefreshed (34 percent) and being awake often

during the night (32 percent).3 The symptoms

of difficulty falling asleep and waking up too

early are less common, but still experienced at

least a few nights a week by about one-fourth of

adults with insomnia (23 to 24 percent).3

Risk Factors for Insomnia

Although some risk factors and etiologies of

insomnia have been identified, the nature of the

relationships has not been fully elucidated. Some

risk factors for insomnia that have emerged from

data related to insomnia include female gender3

and old age.4 Additional risks factors include less

education, unemployment, separation or divorce,

and medical illness.1 Insomnia may be primary

or secondary to other sleep problems and may be

associated with a number of co-morbidities. An

association has been found between insomnia

and psychiatric (depression and anxiety) and

psychological disorders.4 There is increasing

evidence that chronic insomnia may predispose

individuals to the development of psychiatric

disorders.5-6 Persistent insomnia increases the risk

of depression, substance abuse, and anxiety

disorders. Environmental factors such as

irregular sleep schedules, use of caffeine or other

stimulants, co-morbid medical conditions,

and/or shift work may also predispose vulnerable

individuals to insomnia. 

Consequences of Insomnia

Insomnia has significant direct and indirect

effects on the health and wellness of affected

individuals. Insomnia has been correlated with

frequent use of medical services,7-8 chronic health

problems, 9-10 increased drug use,7-8 and perceived

poor health,11 and has been associated with

medical problems including heart disease,12

hypertension,13 and musculoskeletal problems.12

The daytime consequences of chronic insomnia

often include increased healthcare utilization,

increased risk of depression,14 poor memory,

reduced concentration, poor work performance,

and perceived or real risk of failure at work.15

The economic implications of insomnia and

Evidence Report/Technology Assessment

Number 125

Manifestations and Management of Chronic

Insomnia in Adults

Summary

Authors: Buscemi N, Vandermeer B, Friesen C, Bialy L, Tubman M, Ospina M, 

Klassen TP, Witmans M

Agency for Healthcare Research and Quality

Advancing Excellence in Health Care • www.ahrq.gov

Agency for Healthcare Research and Quality Evidence-Based

Practice
2

associated morbidity have been described.7,3 The direct costs of

insomnia (insomnia treatments, healthcare services, hospital

and nursing home care) are estimated to be nearly $14

billion.16-17 The indirect costs of insomnia, such as time lost

from work and loss of productivity, are estimated to be nearly

$28 billion. A National Sleep Foundation survey found that

lost productivity from insomnia alone was over $18 billion. 

Management of Insomnia

Management of acute insomnia has traditionally involved

pharmacotherapy. The use of such agents is common practice

for both acute and chronic insomnia, despite the fact that the

Food and Drug Administration (FDA) has approved none of

them for chronic insomnia. Another medication, eszopiclone

(Lunesta), was recently approved by the FDA for treatment of

insomnia, but the duration of use is not explicitly stated. An

estimated 0.5 percent of the population takes sedative

medications for insomnia for more than 1 year.3 More than 1

in 10 people (11 percent) report using prescription (6 percent)

and/or over-the-counter (OTC) medications (6 percent), at

least a few nights a month, to help them sleep, according to a

Sleep in America Poll.3 Individuals reporting symptoms of

medical conditions are more likely to take sleep aids, both

prescription and OTC medications. For example, 14 percent

of people with symptoms of depression report using

prescription medication, and 12 percent of people with

symptoms of depression report using OTC sleep aids.3

Medications commonly used to treat insomnia include

sedating antidepressants,18 antihistamines, anticholinergics,

benzodiazepines, and non-benzodiazepine hypnotics. A side

effect of all hypnotics is to reduce slow wave sleep. Other side

effects of concern are possible daytime residual effects related

to sedation, rebound insomnia, and tolerance, along with

minor side effects specific to each drug class. Many questions

and challenges related to pharmacological therapy for chronic

insomnia remains, such as the appropriate treatment for

different types of primary and secondary insomnia, and the

long-term side effects and daytime consequences of

pharmacotherapy. The evidence for management of chronic

insomnia with pharmacotherapy has not been systematically

evaluated. 

Cognitive/behavioral therapy has been recognized as a valid

and successful treatment approach for insomnia. Cognitive/

behavioral therapy can include any combination of sleep

restriction, sleep hygiene, stimulus control, paradoxical

intention, and cognitive restructuring. Many of these

commonly used clinical tools have not undergone rigorous

testing to determine their efficacy and long-term safety. The

efficacy of these treatments has been evaluated in some

studies,4,19 but differences in the definition of insomnia and

outcome measures make it difficult to compare study results. 

In summary, insomnia is a common complaint with

significant consequences. Significant advancements have been

made in sleep research over the past three decades, yet many

questions related to the treatment of chronic insomnia remain.

Our goal was to review the evidence and state of research in

the area of chronic insomnia.

Objectives

The objectives of this report are to conduct a systematic

review of (1) the prevalence, natural history, incidence, risk

factors, and consequences of chronic insomnia in adults and

(2) the efficacy and safety of treatments used in the

management of chronic insomnia in adults. A population was

considered to suffer from chronic insomnia if the sleep

disturbance persisted for at least 4 weeks, regardless of severity

of symptoms. 

Methods

Literature Search

The research librarian, in collaboration with the TEP

(Technical Expert Panel), developed and implemented search

strategies designed to identify relevant evidence for key

questions of the review. A systematic search of 21 electronic

databases was conducted. We searched MEDLINE®,

EMBASE, CINAHL®, Ovid MEDLINE® In-Process &

Other Non-Indexed Citations, Ovid OLDMEDLINE®,

PsycINFO®, EBM Reviews-Cochrane Central Register of

Controlled Trials, International Pharmaceutical Abstracts,

AMED (Allied and Complementary Medicine) ,

HealthSTAR/Ovid Healthstar, EBM Reviews-Cochrane

Database of Systematic Reviews (CDSR), ACP Journal Club

(ACPJC), Database of Abstracts of Reviews of Effects

(DARE), Science Citation Index ExpandedTM, Biological

Abstracts, Cochrane Complementary Medicine Field Registry,

CAB Abstracts, SIGLE, OCLC Proceedings First, Dissertation

Abstracts, Alt HealthWatch, NLM Gateway, and PubMed®.

Most of the searches were limited to humans, and no age

restrictions were applied to any of the searches. 

For Question 1, which relates to the definition,

classification, diagnosis, and aetiology of chronic insomnia in

adults, we searched for narrative and systematic reviews, book
chapters, diagnostic manuals and standards of practice

parameters, and applied English-language restrictions. For

Question 2, which relates to the prevalence, natural history,

incidence, and risk factors for chronic insomnia in adults, and

Question 3, which relates to the consequences, morbidities,

co-morbidities and public health burden associated with

chronic insomnia in adults, we searched for observational

studies, encompassing a range of designs including crosssectional, case-control, and cohort studies, and applied

English-language restrictions. For Question 4, which relates to

the treatments for chronic insomnia in adults, and the

evidence regarding their safety, efficacy, and effectiveness, we

searched for randomized controlled trials, and no language

restrictions were applied. 

Inclusion Criteria

We did not develop formal inclusion criteria for the

question pertaining to the definition, classification, diagnosis,

and etiology of chronic insomnia (Question 1), nor for the

question pertaining to the future direction of insomnia-related

research (Question 5). The former question was answered by

providing an overview of the literature, and the latter question

was answered by assessing the limitations in the evidence for

the other questions of the review.

Inclusion criteria were developed for three questions of the

review (Questions 2-4). Question-specific inclusion criteria

appear below. In the interest of clarity, questions 2 and 3 will

be referred to as the questions on manifestations of chronic

insomnia, while question 4 will be referred to as the question

on management of chronic insomnia.

2. What are the prevalence, natural history, incidence,

and risk factors for chronic insomnia? Specific risk

factors of interest include age, gender, race/ethnicity,

psychiatric illness and psychological problems, medical

disease, socioeconomic status, and shift work.

A study was considered to be relevant to the portion of

Question 2 pertaining to the prevalence, natural history, and

incidence of chronic insomnia, if it met the following criteria:

• The report was written in English

• Participants were at least 15 years old

• It examined chronic insomnia

• It had a cross-sectional or cohort design

• It assessed the prevalence, natural history, or incidence

of chronic insomnia

A study was considered to be relevant to the portion of

Question 2 pertaining to risk factors for chronic insomnia, if it

met the first three criteria listed above as well as the following:

• It had a cohort, case-control, or cross-sectional design

• It assessed one of the risk factors of interest

3. What are the consequences, morbidities, comorbidities, and public health burden associated with

chronic insomnia? Specific outcomes of interest include

healthcare utilization, psychiatric illness, absenteeism,

work performance, accidents, falls in the elderly, quality

of life and social relationships, memory, cognitive

function, mood, and direct and indirect costs.

A study was considered to be relevant to this question of the

review, if it met the first three criteria outlined for Question 2 as

well as the following:

• It had a cohort or cross-sectional design

• It assessed one of the consequences of interest

For Questions 2 and 3, a study was considered to examine

chronic insomnia if this condition was defined as a sleep

disturbance of four weeks or more or the report explicitly

mentioned that chronic sleep disturbance was examined.

4. What treatments are used for the management of

chronic insomnia and what is the evidence regarding

their safety, efficacy, and effectiveness? Specific

treatments of interest include prescription medication,

over-the-counter medication, alcohol, behavioral therapy,

combination therapy, and complementary and alternative

care.

A study was considered to be relevant to this question of the

review, if it met the following criteria:

• The report was written in English

• Participants were at least 15 years old, and the

majority were at least 18 years old

• Participants suffered from chronic insomnia

• Participants were randomized to intervention or

placebo

• Participants and assessors were blind to treatment

received

• It assessed at least one of the following outcomes,

listed in order of importance in deriving conclusions

of the review:

• sleep onset latency

• wakefulness after sleep onset 

• sleep efficiency

• total sleep time

3
4

• sleep quality

• quality of life

Sleep onset latency was defined as the amount of time

between the participant laying down to sleep and the onset of

sleep; wakefulness after sleep onset was defined as the amount

of time spent awake in bed following the attainment of sleep;

sleep efficiency was defined as the amount of time spent asleep

as a percentage of the total time spent in bed; and total sleep

time was defined as the total time spent asleep while in bed.

Sleep onset latency and wakefulness after sleep onset were

given the highest priority in deriving conclusions from the

review, since they were considered the best indices of sleep

initiation and sleep maintenance, respectively. However,

subgroup analyses were conducted only on data relevant to

sleep onset latency, since this outcome was the most highly

reported outcome across studies.

If the majority of participants met one of the following

criteria, the study population was considered to suffer from

chronic insomnia:

• Participants suffered from a sleep disturbance of four

weeks or more.

• Participants were described as having a chronic/longstanding/persistent sleep disturbance.

• Participants were selected from a sleep disorders clinic.

In the case of combination therapy, the combined treatment

could be compared to either placebo or single treatment.

We acknowledged the fact that double-blinding is often not

feasible in studies of psychological treatments by not requiring

double-blinding in these studies for inclusion in the review.

The placebo treatment for relaxation therapy and cognitive/

behavioral therapy was minimal treatment, such as sleep

hygiene recommendations or minimal instruction. We

required that the placebo resemble the intervention of the

study except that it was known to produce either no effect or

only a minimal effect. 

Study Selection

In the first stage of study selection, two reviewers screened

the titles and abstracts of all potentially relevant articles,

independently. Each reviewer noted the titles and abstracts

that were potentially relevant to the review, and these articles

were retrieved. In the second stage of study selection, two

reviewers appraised the potentially relevant articles,

independently, using pre-determined, question-specific,

inclusion criteria. Disagreements between reviewers were

resolved by discussion and consensus. The rate of

disagreement between reviewers and the primary reason for

exclusion of potentially relevant articles were noted.

Data Extraction

Data relevant to study design, population, interventions,

and outcomes were extracted from studies, as appropriate,

using standardized data extraction forms. A trained reviewer

extracted relevant data, and a second reviewer verified the data

extracted for accuracy and completeness.

Assessment of Study Quality 

The quality of studies relevant to the questions on

manifestations of chronic insomnia was assessed using one of

three instruments; studies on prevalence and incidence were

assessed using a scale designed specifically for this purpose.20

All other studies relevant to manifestations of chronic

insomnia were assessed using one of two Newcastle-Ottawa

scales (unpublished), each scale specific to either cohort or

case-control studies.

The quality of studies relevant to management of chronic

insomnia was assessed using the Jadad scale.21 The

concealment of allocation of participants to treatment groups

was also assessed.22

Data Analysis

Data relevant to manifestations of chronic insomnia were

analyzed qualitatively, while data relevant to management of

chronic insomnia were analyzed quantitatively.

Manifestations of Chronic Insomnia

For the questions on prevalence, natural history, incidence,

risk factors, and consequences of chronic insomnia, data

relevant to each variable were analyzed separately, except for

data relevant to potential risk factors and potential

consequences of chronic insomnia, which were analyzed

together as associated factors of chronic insomnia. The data

were synthesized to provide a description of the methods and

results of the studies relevant to a given variable. 

Management of Chronic Insomnia

For continuous outcomes (e.g., sleep onset latency and sleep

efficiency), studies were combined using a mean difference

(MD), with the exception of sleep quality and quality of life,

where studies were combined using a standardized mean

difference (SMD). Dichotomous outcomes (i.e., safety

outcomes) were combined using a risk difference (RD). A
number needed to harm (NNH) was also reported for any

safety outcomes that were found to be statistically significant.

The Inverse Variance Method23 was used to weight the studies.

An efficacy estimate, with corresponding 95% confidence

interval, was computed for each outcome. All meta-analyses

were performed using a Random Effects Model.24

For some outcomes (sleep onset latency and number of

adverse events), treatment categories were compared indirectly,

via their relationship to placebo. Differences of differences

with 95% confidence intervals (CI) were computed. 

All estimates of efficacy were assessed for heterogeneity

using the I-squared statistic.25 For our primary outcome (sleep

onset latency), heterogeneity was explored in subgroup and

sensitivity analyses using a number of variables (treatment,

presence/absence of psychiatric illness, length of treatment,

age, gender and study quality). Deeks’ chi-square statistic26

was used to test for significant heterogeneity reduction in

partitioned subgroups.

We tested for publication bias visually using the Funnel

Plot27 and quantitatively using the Rank Correlation Test,28 the

Graphical Test,29 and the Trim and Fill Method.30

Main Results

Prevalence of Chronic Insomnia

In general populations: Interquartile Range (IQR): 8.5-

24.3 percent. There was evidence of an association between

female gender and chronic insomnia.

• In clinical populations: IQR: 27.8-43.0 percent.

• In outpatients of general practice: IQR: 19.8-53.7

percent.

• The majority of studies were either of moderate or high

quality.

Natural History of Chronic Insomnia

• Only one study provided evidence on natural history of

chronic insomnia: the remission rate was 13.1 percent

after a 4-month followup period in a population suffering

from insomnia for 1 month or more.

• The study was of moderate quality.

Incidence of Chronic Insomnia

• No studies were identified that provided evidence on

incidence of chronic insomnia.

Factors Associated with Chronic

Insomnia

Potential Risk Factors

• Age. Eleven studies found evidence of an association

between age and chronic insomnia, whereas seven studies

found no evidence of an association between these

variables. Of the studies that found an association, all,

except one,31 found evidence that chronic insomnia is

associated with older age. 

• Gender. Eleven studies found evidence of an association

between gender and chronic insomnia, while seven

studies found no evidence of an association between these

variables. All of the studies that found evidence of an

association between gender and chronic insomnia, found

evidence that chronic insomnia is associated with female

gender.

• Race/ethnicity. Two studies found evidence of an

association between ethnicity and chronic insomnia,32-33

while one study found no evidence of an association

between these variables.34 Bixler et al. found evidence

that chronic insomnia is associated with being a nonCaucasian minority, and Riedel et al. found evidence that

chronic insomnia is associated with being White.

• Psychiatric illness and psychological problems. Thirtyeight studies found evidence of an association between

present or past psychiatric illness or psychological

problems and chronic insomnia. Seven studies did not

find evidence of an association between these variables. 

• Medical conditions. Twelve studies found evidence of an

association between medical conditions or poor general

health and chronic insomnia, while one study35 did not

find evidence of an association between these variables. 

• Socioeconomic status. Six studies found evidence of an

association between socioeconomic status and chronic

insomnia. Nine studies did not find evidence of an

association between these variables. 

• Shift work. Only 2 studies provided evidence regarding

the relationship between shift-work and chronic

insomnia.31,36 The study by Kageyama et al. provided

evidence that chronic insomnia is associated with three or

less night shifts per month within the preceding three

months in hospital nurses. The study by Martikainen et

al. found no evidence of an association between shift

work and chronic insomnia.

5
Potential Consequences

• Healthcare utilization. Five studies provided evidence of

an association between increased healthcare utilization

and chronic insomnia. One study did not find evidence

of an association between chronic insomnia and

undergoing medical treatment in hospital nurses.31

• Absenteeism and work performance. Only two studies

provided evidence regarding the relationship between

work performance or absenteeism and chronic

insomnia;37-38 both studies found evidence of an

association between chronic insomnia and absenteeism.

The study by Zammit et al. also found evidence of an

association between chronic insomnia and impaired work

performance.

• Quality of life and quality of social relationships. Five

studies examined the relationship between either quality

of life (from a global perspective) or quality of social

relationships and chronic insomnia. All studies found

evidence of an association between chronic insomnia and

either lower quality of life or lower quality of social

relationships; one of these studies found evidence that

both quality of life and quality of social relationships are

impaired in chronic insomniacs.39

• Memory, cognitive function, and mood. Fifteen studies

found evidence of an association between decrements in

memory, mood or cognitive function and chronic

insomnia. One study40 found evidence of increased recall

of presentations made just before sleep onset in chronic

insomniacs. Eleven studies found no evidence of an

association between mood, memory, or cognitive function

and chronic insomnia. 

We did not identify any studies that provided data relevant

to the relationship between accidents or falls in the elderly and

chronic insomnia or direct and indirect costs of the disorder.

The majority of studies were of either moderate or high

quality.

Efficacy and Safety of the Six Main

Categories of Interventions Identified in

the Literature

The efficacy estimates are provided as mean differences

(MDs) in the effect of intervention and placebo on sleep onset

latency (SOL) or wakefulness after sleep onset (WASO). The

safety estimates are provided as risk differences (RDs) between

intervention and placebo.

• Benzodiazepines. MD (SOL): -16.5, 95% CI: (-20.5, -

12.5); MD (WASO): -23.1, 95% CI: (-35.7, -10.5); RD:

0.15, 95% CI: (0.10, 0.20); number needed to harm was

eight.

• Non-benzodiazepines. MD (SOL): -18.1, 95% CI: (-

22.5, -13.7); MD (WASO): -12.6, 95% CI: (-23.0, -2.3);

RD: 0.05, 95% CI: (0.01, 0.09); number needed to

harm was 20.

• Antidepressants. MD (SOL): -7.4, 95% CI (-10.5, -4.4);

MD (WASO): -11.4, 95% CI: (-16.2, -6.6); RD: 0.09,

95% CI (0.01, 0.18); number needed to harm was 12.

• L-Tryptophan. MD (SOL): -11.0, 95% CI: (-33.0,

11.1)

• Melatonin. MD (SOL): -8.3, 95% CI: (-14.5, -2.0);

MD (WASO): -9.7, 95% CI: (-33.6, 14.3); RD: 0.09,

95% CI: (-0.11, 0.29)

• Valerian. MD (SOL): -1.3, 95% CI: (-21.4, 18.9); MD

(WASO): -8.4, 95% CI: (-15.9, -1.0); RD: -0.06, 95%

CI: (-0.48, 0.35) 

• Relaxation therapy. MD (SOL): -14.6, 95% CI: (-29.3,

0.2); MD (WASO): -1.6, 95% CI: (-14.1, 10.8). No

adverse event data was provided.

• Cognitive/behavioral therapy. MD (SOL): -4.6, 95%

CI: (-9.8, 0.6); MD (WASO): -18.2, 95% CI: (-30.4, -

6.0). No adverse event data was provided.

Most studies were of moderate or high quality.

Discussion

Prevalence, Natural History, Incidence, and

Factors Associated with Chronic Insomnia

The interquartile range of prevalence varied from 8.5-24.3

percent across high-quality studies of general populations, to

19.8-53.7 percent across moderate-quality studies of

outpatient populations, to 27.8-43.0 percent across moderatequality studies of clinical populations. Therefore, the

prevalence estimates for chronic insomnia in outpatient and

clinical populations appear to be significantly higher than

those for the general population, a finding that is consistent

with evidence of an association between chronic insomnia and

6
medical conditions, poor general health, and increased

healthcare utilization. 

Only one study provided data on the natural history of

chronic insomnia; the remission rate was 13.1 percent after a

4-month followup. More research is necessary to determine

the course of chronic insomnia in various populations. We did

not identify any studies that provided evidence regarding the

incidence of chronic insomnia; more research is needed in this

area as well.

We found evidence to suggest that chronic insomnia is

associated with older age, female gender, present or past

psychiatric illness and psychological problems, medical

conditions and poor general health, increased healthcare

utilization, lower quality of life and social relationships,

socioeconomic status (marital separation, unemployment,

poorer working conditions, and lower social status), and

decrements in memory, mood, and cognitive function. Some

of the factors that are thought to contribute to insomnia in the

elderly include multiple medical problems, polypharmacy, and

environmental factors such as absence of zeitgebers

(time/schedule cues).11,41 Similarly, factors such as stress,

pregnancy, menopause, medical conditions, and complex

home life may explain the higher prevalence of insomnia in

females. 

Efficacy and Safety of Treatments for

Chronic Insomnia

The interventions for chronic insomnia that were

investigated in included studies may be categorized as either

benzodiazepines, non-benzodiazepines, antidepressants,

complementary and alternative care (L-tryptophan, melatonin

and valerian), relaxation therapy, cognitive/behavioral therapy,

barbiturates, hormone therapy, alcohol, low energy emission

therapy, and combination therapy. The majority of studies

were classified under the first six categories of the preceding

list. 

The review provides evidence that benzodiazepines and

non-benzodiazepines are effective treatments for chronic

insomnia. There is some evidence that antidepressants are

effective treatments for chronic insomnia, although more

research is required in this area. The review provides some

evidence that melatonin is effective in subsets of the chronic

insomnia population; however, more research is required in

this area. There is also evidence that relaxation therapy and

cognitive/behavioral therapy are effective treatments in subsets

of the chronic insomnia population. There were too few

studies of L-tryptophan and valerian to draw conclusions

regarding the efficacy of these treatments in the management

of chronic insomnia: additional large-scale, randomized trials

are needed. Additional large-scale, randomized trials are also

needed in the area of relaxation therapy and cognitive/

behavioral therapy in the management of chronic insomnia to

determine the efficacy of these interventions across subsets of

the chronic insomnia population. The reduction in sleep

onset latency by benzodiazepines and non-benzodiazepines was

significantly greater than that for antidepressants and

melatonin, based on indirect comparisons. However, it should

be noted that there were significantly fewer studies of

antidepressants and melatonin compared to benzodiazepines

and non-benzodiazepines, and additional large-scale,

randomized trials of the former interventions are needed

before firm conclusions can be drawn regarding the relative

efficacy of these interventions. 

The benzodiazepines, non-benzodiazepines, and

antidepressants had a significantly greater risk of harm than

placebo, while melatonin did not. There were too few studies

of L-tryptophan to draw conclusions regarding the safety of

this intervention. Although there was no evidence that

valerian poses a risk of harm, this result was based on only

three studies of relatively small sample size. Therefore, more

studies are needed before firm conclusions can be drawn

regarding the safety of valerian. The risk for benzodiazepines

was significantly greater than for non-benzodiazepines, based

on indirect comparisons. Indeed, benzodiazepine use has been

shown to increase the risk of injury in the elderly,42 and there is

pharmacologic evidence that the non-benzodiazepines have a

better side-effect profile than the benzodiazepines.43-44 Studies

of relaxation therapy and cognitive/behavioral therapy did not

provide adverse event data. 

There was substantial heterogeneity in the pooled estimate

for SOL for benzodiazepines, non-benzodiazepines, Ltryptophan, valerian, and relaxation therapy. Similarly, there

was substantial heterogeneity in the pooled estimate for

WASO for benzodiazepines, non-benzodiazepines, melatonin,

and cognitive/behavioral therapy. The heterogeneity was often

due to differences in the magnitude of the point estimate and

confidence interval across studies, rather than differences in the

directionality of the effect. The exceptions are for estimates of

the efficacy of relaxation therapy with respect to SOL and the

efficacy of melatonin with respect to WASO. The

heterogeneity in the pooled estimates for SOL was explored in

7
8

sensitivity and sub-group analyses. The results indicate that

heterogeneity in the pooled estimate for SOL for relaxation

therapy is at least partially due to type of relaxation therapy,

length of treatment, age and gender distribution of the study

population, and study quality. 

There was strong evidence of publication bias in the pooled

estimates for SOL for the benzodiazepine and nonbenzodiazepine categories of intervention. This finding

suggests that the true estimate of efficacy is lower than the

estimate calculated in the current analysis.

We identified a small sample of studies examining the

efficacy of combination treatments in the management of

chronic insomnia; some of these studies compared a

combination of treatments with placebo, while others

compared them with single treatment. Many comparisons did

not have data for our primary outcome, sleep onset latency,

and the majority of results were non-significant. The latter

finding may reflect the low power of these analyses. None of

the studies provided data on adverse events. We identified

only one study that compared the efficacy of a combined

pharmacological and psychological treatment with these

treatments administered sequentially. The research agenda for

the management of chronic insomnia should include an

evaluation of the efficacy and safety of combination treatments

and sequential treatments.

Our results relating to relaxation therapy and

cognitive/behavioral therapy are somewhat at odds with three

meta-analyses reviewing the efficacy of psychological

treatments in the management of chronic insomnia.45-47 The

difference in the findings may relate to key differences in the

conduct of the reviews. First, we restricted our meta-analysis

to a review of placebo-controlled, randomized trials and

accounted for placebo effects in our estimations of efficacy.

Other meta-analyses have included non-controlled studies, and

for these studies, have not accounted for placebo/control

effects in their estimation of efficacy. Second, we used clearly

defined criteria for chronic insomnia; however, for some

studies the criteria for insomnia was not clear. Third, we

separated predominantly cognitive/behavioral approaches from

predominantly relaxation approaches in management of

insomnia, resulting in distinct meta-analyses for each category

of intervention. These interventions have been grouped under

the broader heading of psychological/non-pharmacological

treatments in other reviews. 

Conclusions

• There is evidence that the prevalence of chronic insomnia

in outpatient and clinical populations is larger than in the

general population.

• There is evidence that chronic insomnia is associated with

older age, female gender, present or past psychiatric illness

and psychological problems, medical conditions and poor

general health, increased healthcare utilization, lower

quality of life and social relationships, socioeconomic

status (marital separation, unemployment, poorer

working conditions and lower social status), and

decrements in memory, mood, and cognitive function.

• Additional studies are needed to determine the incidence

and natural history of chronic insomnia in adults.

Similarly, additional studies are needed to explore the

relationship between chronic insomnia and race/ethnicity,

shift work, absenteeism, work performance, accidents,

falls in the elderly, and the direct and indirect costs of the

disorder. It is necessary that longitudinal studies be

undertaken to explore the risk factors and consequences

of chronic insomnia.

• There is evidence that benzodiazepines and nonbenzodiazepines are effective in the management of

chronic insomnia. There is some evidence that

antidepressants are effective in the management of

chronic insomnia: more research is required in this area.

There is evidence that benzodiazepines, nonbenzodiazepines, and antidepressants pose a risk of harm.

• There is some evidence that melatonin is effective in the

management of chronic insomnia in subsets of the

chronic insomnia population, and there is no evidence

that melatonin poses a risk of harm. However, more

research is required in this area given that the results are

based on a small number of studies. Similarly, additional

large-scale, randomized trials are needed to determine the

efficacy of melatonin across subsets of the chronic

insomnia population. There is insufficient evidence to

conclude on the efficacy and safety of L-tryptophan and

valerian in the management of chronic insomnia.

Additional large-scale, randomized trials are needed in

these areas.

• There is evidence that relaxation therapy and

cognitive/behavioral therapy are effective in the

management of chronic insomnia in subsets of the
chronic insomnia population. Additional large-scale,

randomized trials are needed to determine their efficacy

across subsets of the chronic insomnia population.

• There is evidence that benzodiazepines have a greater risk

of harm than non-benzodiazepines.

• There is insufficient evidence to conclude whether there

are differences between the short- and long-term efficacy

and safety of the various categories of interventions in the

management of chronic insomnia; additional long-term

studies are needed.

• There is insufficient evidence regarding the efficacy and

safety of combined treatments of pharmacological and

psychological interventions, and sequential treatments, in

the management of chronic insomnia; additional studies

are needed in these areas.

Availability of the Full Report

The full evidence report from which this summary was

taken was prepared for the Agency for Healthcare Research

and Quality (AHRQ) by the University of Alberta Evidencebased Practice Center, under Contract No. C400000021. It is

expected to be available in June 2005. At that time, printed

copies may be obtained free of charge from the AHRQ

Publications Clearinghouse by calling 800-358-9295.

Requesters should ask for Evidence Report/Technology

Assessment No. 125, Manifestations and Management of

Chronic Insomnia in Adults. In addition, Internet users will be

able to access the report and this summary online through

AHRQ’s Web site at www.ahrq.gov.

Suggested Citation

Buscemi N, Vandermeer B, Friesen C, Bialy L, Tubman M,

Ospina M, Klassen TP, Witmans M. Manifestations and

Management of Chronic Insomnia in Adults. Summary,

Evidence Report/Technology Assessment No. 125. (Prepared

by the University of Alberta Evidence-based Practice Center,

under Contract No. C400000021.) AHRQ Publication No.

05-E021-1. Rockville, MD: Agency for Healthcare Research

and Quality. June 2005.

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www.ahrq.gov

AHRQ Pub. No. 05-E021-1

June 2005

ISSN 1530-440X
Evidence Report 

3 

Chapter 1. Introduction 

Prevalence of Insomnia 

Insomnia, or inability to sleep, is the most commonly reported sleep problem in the 

industrialized world.1

 Estimates suggest that between 40-70 million Americans are affected by 

either intermittent or chronic sleep problems, representing approximately 20 percent of the 

population.2

 The Sleep in America Poll, conducted by the National Sleep Foundation, revealed 

that almost 50 percent of people surveyed had complaints of frequent insomnia, but only 6 

percent were formally diagnosed.3

 Moreover, approximately, 30-35 percent of respondents 

complained of nightly insomnia.3

 The most prevalent symptoms of insomnia, experienced at 

least a few nights a week by people with insomnia, include waking up feeling un-refreshed (34 

percent) and being awake often during the night (32 percent).3

 The symptoms of difficulty 

falling asleep and waking up too early are less common, but still experienced at least a few 

nights a week by about one-fourth of adults with insomnia (23-24 percent).3

 The reported 

prevalence rates of insomnia vary in epidemiological studies based on the definitions and 

methods used to define insomnia. Earlier studies report prevalences of 5-35 percent.1

 The 

prevalence rate decreases to 10-15 percent for severe insomnia, when more stringent criteria are 

used.1

 The duration of insomnia is often classified as being transient, short-term or chronic. 

Chronic insomnia implies that insomnia is either persistent or recurrent. Definitions of chronic 

insomnia vary, ranging from greater than one month to greater than 6 months. Unfortunately, 

there is no standard definition of chronic insomnia used in studies. 

There is emerging evidence that short-term sleep deprivation, under strict experimental 

conditions, is associated with a variety of adverse physiological and cognitive effects. 

Decrements in memory, concentration and executive function have been reported. There is also 

an increased risk of injury and accidents. Physiological effects resulting from sleep deprivation 

include hypertension, activation of the sympathetic nervous system, altered glucose metabolism 

and increased inflammatory markers. Sleep deprivation is associated with excessive sleepiness. 

Acute insomnia, however, may not equate to sleep deprivation. There is no evidence to suggest 

that patients with insomnia experience similar changes. Furthermore, it is not yet clear from the 

evidence what the physiological consequences of chronic insomnia are or if there is a process of 

adaptation that occurs in individuals with chronic insomnia. Thus, further research is needed in 

the area of chronic insomnia to determine what impact chronic insomnia has on health. 

 

Risk Factors for Insomnia 

Although some risk factors and etiologies of insomnia have been identified, the nature of the 

relationships has not been fully elucidated. Some risk factors for insomnia that have emerged 

from data related to insomnia include female gender 3

 and old age.4 Additional risks factors 

include less education, unemployment, separation or divorce and medical illness.1

 Insomnia may 

be primary or secondary to other sleep problems, and may be associated with a number of comorbidities. An association has been found between insomnia and psychiatric (depression and 

anxiety) and psychological disorders.4

 There is increasing evidence that chronic insomnia may 

predispose individuals to the development of psychiatric disorders.5-6 Persistent insomnia 

increases the risk of depression, substance abuse and anxiety disorders. Environmental factors 
4 

such as irregular sleep schedules, use of caffeine or other stimulants, co-morbid medical 

conditions and/or shift-work may also predispose vulnerable individuals to insomnia. We 

speculate that genetic predisposition to insomnia and environmental factors are likely involved in 

the development and maintenance of insomnia, and differences in the relative exposure to these 

influences may explain differences in the manifestation of this disorder among affected 

individuals.

Consequences of Insomnia 

Insomnia has significant direct and indirect effects on the health and wellness of affected 

individuals. Insomnia has been correlated with frequent use of medical services,7-8 chronic 

health problems,9-10 increased drug use,7-8 perceived poor health,11 and associated with medical 

problems including heart disease,12 hypertension13 and musculoskeletal problems.12 One study 

reported associations between insomnia and medical problems, and found that individuals with 

insomnia were more likely to have hypertension (59 percent), night time heartburn (62 percent) 

and depression (74 percent).3

 The daytime consequences of chronic insomnia often include 

increased healthcare utilization, increased risk of depression,14 poor memory, reduced 

concentration, poor work performance and perceived or real risk of failure at work.15 The 

economic implications of insomnia and associated morbidity have been described.3;7 The direct 

costs of insomnia (insomnia treatments, healthcare services, hospital and nursing home care) are 

estimated to be nearly $14 billion.16-17 The indirect costs of insomnia, such as time lost from 

work and loss of productivity, are estimated to be nearly $28 billion. A National Sleep 

Foundation survey found that lost productivity from insomnia, alone, was over $18 billion. 

Another estimate of total costs of insomnia has reported amounts totaling almost $100 billion.18 

This estimate is based on a high prevalence of insomnia, in the range of 33 percent, and the costs 

are related to sleepiness rather than insomnia. The data related to costs of chronic insomnia 

cannot be fully understood because of the impact insomnia has on many aspects of life. 

Nevertheless, insomnia, in its various forms, does result in substantial burden for affected 

individuals. 

Management of Insomnia 

Management of acute insomnia has traditionally involved pharmacotherapy. The use of such 

agents is common practice for both acute and chronic insomnia, despite the fact that the Food 

and Drug Administration (FDA) has approved none of them for chronic insomnia. Another 

medication, eszopiclone (Lunesta), was recently approved by the FDA for treatment of insomnia, 

but the duration of use is not explicitly stated. An estimated 0.5 percent of the population takes 

sedative medications for insomnia for more than one year.3

 More than one in ten people (11 

percent) report using prescription (6 percent) and/or over-the-counter (OTC) medications (6 

percent), at least a few nights a month, to help them sleep, according to a Sleep in America Poll.3

 

Individuals reporting symptoms of medical conditions are more likely to take sleep aids, both 

prescription and OTC medications. For example, 14 percent of people with symptoms of 

depression report using prescription medication, and 12 percent of people with symptoms of 

depression report using OTC sleep aids.3

 Medications commonly used to treat insomnia include 

sedating antidepressants,19 antihistamines, anticholinergics, benzodiazepines and non-
5 

benzodiazepine hypnotics. A side effect of all hypnotics is to reduce slow wave sleep. Other 

side effects of concern are possible daytime residual effects related to sedation, rebound 

insomnia and tolerance, along with minor side effects specific to each drug class. Many 

questions and challenges related to pharmacological therapy for chronic insomnia remains, such 

as the appropriate treatment for different types of primary and secondary insomnia, and the longterm side effects and daytime consequences of pharmacotherapy. The evidence for management 

of chronic insomnia with pharmacotherapy has not been systematically evaluated. 

Cognitive/behavioral therapy has been recognised as a valid and successful treatment 

approach for insomnia. Cognitive/behavioral therapy can include any combination of sleep 

restriction, sleep hygiene, stimulus control, paradoxical intention and cognitive restructuring. 

Brief descriptions of these techniques are provided here. 

Sleep restriction therapy involves limiting the amount of time in bed. The affected individual 

spends only the amount of time in bed that he/she sleeps, thus sleep may be restricted to 6 hours 

for an insomniac that spends 8 hours in bed. The purpose of the exercise is to improve the sleep 

efficiency progressively until the desired sleep duration is achieved, without prolonged sleep 

latency or maintenance insomnia. 

Sleep hygiene instructions or education involves addressing environmental factors and health 

practices that may be counterproductive to sleep. It involves education about sleep patterns and 

the impact of health habits related to sleep. For example, alcohol consumed in the evening may 

help sleep onset, but promotes sleep maintenance insomnia during the night as the alcohol level 

declines. 

Stimulus control therapy involves instructions aimed at curtailing sleep maladaptive 

behaviors and altering sleep-wake schedules. The instructions include: 1) going to bed when 

sleepy; 2) no other activities, besides sleep and sex, should be undertaken in the bed and 

bedroom; 3) get out of bed when unable to sleep for 15-20 minutes and return only if sleepy; 4) 

the daily wake-up time should be the same irrespective of how much sleep was obtained the 

previous night; 5) no naps allowed during the day. 

Paradoxical intention is a technique that involves having the patient with insomnia stay 

awake, which is the most feared activity. The premise is that performance anxiety related to 

sleep would be alleviated if the patient stops trying to sleep and instead genuinely attempts to 

stay awake. 

Cognitive restructuring can involve cognitive behavioral therapy targeted at an individual’s 

unique perpetuating factors for insomnia. 

Sleep non-suppression involves allowing oneself to think about whatever comes to mind, 

without any restrictions, as one gets to bed. The mind is allowed to go free, without the 

individual attempting to control his/her thoughts. This approach is thought to counteract the 

negative effects of thought suppression that often accompanies insomnia. 

Relaxation therapy may or may not be a part of cognitive behavioral therapy. Different 

forms of relaxation therapy are designed to reduce somatic tension or cognitive arousals. 

Relaxation therapy may focus on somatic tension such as autogenic training, progressive muscle 

relaxation, or biofeedback, or may focus on the cognitive component such as intrusive thoughts 

that prevent sleep. 

Many of these commonly used clinical tools have not undergone rigorous testing to 

determine their efficacy and long-term safety. The efficacy of these treatments has been 

evaluated in some studies,4;20 but differences in the definition of insomnia and outcome measures 

make it difficult to compare study results. 
6 

In summary, insomnia is a common complaint with significant consequences. Significant 

advancements have been made in sleep research over the past three decades, yet many questions 

related to the treatment of chronic insomnia remain. Our goal was to review the evidence and 

state of research in the area of chronic insomnia. 

Objectives 

To conduct a systematic review of (1) the prevalence, natural history, incidence, risk factors 

and consequences of chronic insomnia in adults and (2) the efficacy and safety of treatments 

used in the management of chronic insomnia in adults. A population was considered to suffer 

from chronic insomnia if the sleep disturbance persisted for at least 4 weeks, regardless of 

severity of symptoms. 

Analytic Approach 

The analytic framework outlining the approach to the review is depicted in Flow Diagram 1. 

The specific questions addressed in the review appear below. 

Etiology and Population at Risk 

The following questions pertain to the clinical definition and etiology of chronic insomnia in 

adults, as well as the population at risk of the disorder. 

1. How is chronic insomnia defined, diagnosed and classified, and what is known about its 

etiology? 

2. What are the prevalence, natural history, incidence, and risk factors for chronic 

insomnia? Specific risk factors of interest include: 

• Age 

• Gender 

• Race/ethnicity 

• Psychiatric illness and psychological problems 

• Medical disease 

• Socioeconomic status 

• Shift-work 

Consequences, Morbidities, Co-morbidities, and Public Health Burden 

The following question pertains to the clinical, social and economic consequences of chronic 

insomnia in adults. 

3. What are the consequences, morbidities, co-morbidities, and public health burden 

associated with chronic insomnia? Specific outcomes of interest include: 

• Healthcare utilization 

• Risk of developing psychiatric disease 
7 

• Absenteeism, work performance 

• Accidents 

• Falls in the elderly 

• Quality of life, social relationships 

• Memory, cognitive function, mood 

• Direct and indirect costs 

Treatment 

The following question pertains to the benefits and harms of treatments used in the 

management of chronic insomnia in adults. 

4. What treatments are used in the management of chronic insomnia and what is the 

evidence regarding their safety, efficacy, and effectiveness? Specific treatments of 

interest include: 

• Prescription medication 

• Over the counter medication 

• Alcohol 

• Behavioral therapy 

• Combination of therapies 

• Complementary and alternative care 

Future Direction 

The answer to the following question is based on the evidence for the preceding questions. 

5. What are important future directions for insomnia-related research? 
8 

Flow Diagram 1. Analytic framework 

Aetiology and 

Population at Risk 

Screening for 

Treatment Treatment

Morbidity of 

Treatment

Intermediate and 

Surrogate Outcomes Medical 

Benefits

4 1

4

Consequences 

Morbidities 

Co-morbidities 

and Public Health Burden 

3

 2

Future Direction

5

5 5

5

4
9 

Chapter 2. Methods 

Overview 

The systematic review involved a number of steps: 

• Literature Search 

• Development of Inclusion Criteria 

• Study Selection 

• Data Extraction 

• Assessment of Study Quality 

• Data Analysis 

Literature Search 

The research librarian, in collaboration with the TEP (Technical Expert Panel), developed 

and implemented search strategies designed to identify relevant evidence for key questions of the 

review. A systematic search of 21 electronic databases was conducted. Table 1 outlines the 

electronic databases that were searched. Table 2 outlines the subject headings and keywords that 

were used in the search. Appendix A♦ contains details of the search strategy. Most of the 

searches were limited to humans, and no age restrictions were applied to any of the searches. 

For Question 1, which relates to the definition, classification, diagnosis, and etiology of 

chronic insomnia in adults, we searched for narrative and systematic reviews, book chapters, 

diagnostic manuals and standards of practice parameters, and applied English-language 

restrictions. For Question 2, which relates to the prevalence, natural history, incidence, and risk 

factors for chronic insomnia in adults, and Question 3, which relates to the consequences, 

morbidities, co-morbidities and public health burden associated with chronic insomnia in adults, 

we searched for observational studies, encompassing a range of designs including crosssectional, case-control, and cohort studies, and applied English-language restrictions. For 

Question 4, which relates to the treatments for chronic insomnia in adults, and the evidence 

regarding their safety, efficacy, and effectiveness, we searched for randomized controlled trials, 

and no language restrictions were applied. We did not apply language restrictions to searches for 

Question 4, since a portion of this question involves a review of complementary and alternative 

medicine (CAM), and there is evidence to suggest that studies of some CAM topics are often 

initially published in non-English languages, and many of these are not published in English.21

We searched electronic resources that specialize in CAM, including AMED (Allied and 

Complementary Medicine), Alt HealthWatch, and Cochrane Complementary Medicine Field 

Registry. In order to systematically search for the different types of studies required for each 

question, it was useful to refer to: the highly sensitive search strategy for identifying reports of 

randomized controlled trials in MEDLINE® from the Cochrane Reviewer’s Handbook 

(Appendix 5b)22; search strategies for diagnosis, etiology, natural history and morbidities from 

PDQ Evidence-based Principles and Practice23; and the search strategy for systematic reviews in 

MEDLINE® from the Alberta Research Centre for Child Health Evidence.24 Searches were also 

 

♦ The Appendices and Evidence Tables cited in this report are provided electronically at 

http://www.ahrq.gov/clinic/tp/insomntp.htm. 
10 

conducted in databases that index grey literature, including SIGLE (System for Information on 

Grey Literature in Europe), OCLC Proceedings First, Dissertation Abstracts and the NLM 

Gateway (searched specifically for meeting abstracts). 

No hand searching was conducted for this review, given that the key journals pertaining to 

chronic insomnia, such as Sleep and Sleep Medicine Reviews, are indexed in MEDLINE. 

Development of Inclusion Criteria 

We did not develop formal inclusion criteria for the question pertaining to the definition, 

classification, diagnosis and etiology of chronic insomnia, nor for the question pertaining to the 

future direction of insomnia-related research. The former question was answered by providing 

an overview of the literature, and the latter question was answered by assessing the limitations in 

the evidence for the other questions of the review. 

Inclusion criteria were developed for three questions of the review. Question-specific 

inclusion criteria appear below. The questions have been numbered according the numbering 

system outlined in the Introduction of this report. In the interest of clarity, questions 2 and 3 will 

be referred to as the questions on manifestations of chronic insomnia, while question 4 will be 

referred to as the question on management of chronic insomnia. 

 

2. What are the prevalence, natural history, incidence and risk factors for chronic 

insomnia? Specific risk factors of interest include age, gender, race/ethnicity, psychiatric 

illness and psychological problems, medical disease, socioeconomic status and shift-work. 

A study was considered to be relevant to the portion of Question 2 pertaining to the 

prevalence, natural history and incidence of chronic insomnia, if it met the following criteria: 

• the report was written in English 

• participants were at least 15 years old 

• it examined chronic insomnia 

• it had a cross-sectional or cohort design 

• it assessed the prevalence, natural history or incidence of chronic insomnia 

A study was considered to be relevant to the portion of Question 2 pertaining to risk factors 

for chronic insomnia, if it met the following criteria: 

• the report was written in English 

• participants were at least 15 years old 

• it examined chronic insomnia 

• it had a cohort, case-control, or cross-sectional design 

• it assessed one of the risk factors of interest 

3. What are the consequences, morbidities, co-morbidities, and public health burden 

associated with chronic insomnia? Specific outcomes of interest include healthcare 

utilization, psychiatric illness, absenteeism, work performance, accidents, falls in the elderly, 

quality of life and social relationships, memory, cognitive function, mood, direct and indirect 

costs.
11 

A study was considered to be relevant to this question of the review, if it met the following 

criteria: 

• the report was written in English 

• participants were at least 15 years old 

• it examined chronic insomnia 

• it had a cohort or cross-sectional design 

• it assessed one of the consequences of interest 

For Questions 2 and 3, a study was considered to examine chronic insomnia if this condition 

was defined as a sleep disturbance of four weeks or more, or the report explicitly mentioned that 

chronic sleep disturbance was examined. 

4. What treatments are used for the management of chronic insomnia and what is the 

evidence regarding their safety, efficacy, and effectiveness? Specific treatments of 

interest include prescription medication, over the counter medication, alcohol, behavioral 

therapy, combination therapy and complementary and alternative care. 

A study was considered to be relevant to this question of the review, if it met the following 

criteria. 

 

• the report was written in English 

• participants were at least 15 years old, and the majority were at least 18 years old 

• participants suffered from chronic insomnia 

• participants were randomized to intervention or placebo 

• participants and assessors were blind to treatment received 

• it assessed at least one of the following outcomes, listed in order of importance in 

deriving conclusions of the review: 

• sleep onset latency 

• wakefulness after sleep onset 

• sleep efficiency 

• total sleep time 

• sleep quality 

• quality of life 

Sleep onset latency was defined as the amount of time between the participant laying down 

to sleep and the onset of sleep; wakefulness after sleep onset was defined as the amount of time 

spent awake in bed following the attainment of sleep; sleep efficiency was defined as the amount 

of time spent asleep as a percentage of the total time spent in bed; and total sleep time was 

defined as the total time spent asleep while in bed. We used broad definitions of sleep outcomes 

in this review. For example, sleep onset latency could be defined as time to sleep, time to stage 1 

sleep, time to stage 2 sleep or latency to persistent sleep. We believe that it was acceptable to 

combine studies with differing definitions of sleep onset latency in the analysis, since differences 

in the magnitude of estimations across definitions would be accounted for by subtraction of 
12 

placebo effects from treatment effects. Although it could be argued that these definitions are 

significantly different, the optimal definition of sleep onset latency has not yet been determined. 

Nonetheless, differences between polysomnography, sleep diary and actigraphy definitions of 

sleep onset latency were explored indirectly through sub-group analyses. 

Sleep onset latency and wakefulness after sleep onset were given the highest priority in 

deriving conclusions of the review, since they were considered the best indices of sleep initiation 

and sleep maintenance, respectively. However, sub-group analyses were conducted only on data 

relevant to sleep onset latency, since this outcome was the most highly reported outcome across 

studies. 

If the majority of participants met one of the following criteria, the study population was 

considered to suffer from chronic insomnia: 

• participants suffered from a sleep disturbance of 4 weeks or more 

• participants were described as having a chronic/long-standing/persistent sleep disturbance 

• participants were selected from a sleep disorders clinic 

The 4-week cut-point for chronic insomnia was considered long enough to eliminate studies 

involving transient insomnia, and short enough to include studies involving persistent insomnia. 

In the case of combination therapy, the combined treatment could be compared to either 

placebo or single treatment. 

We acknowledged the fact that double-blinding is often not feasible in studies of 

psychological treatments by not requiring double-blinding in these studies for inclusion in the 

review. The placebo treatment for relaxation therapy and cognitive/behavioral therapy was 

minimal treatment, such as sleep hygiene recommendations or minimal instruction. We required 

a placebo control and randomization of participants to intervention groups in order to account for 

potential confounders in the analysis. That is, we wanted to control for potential improvements 

in insomnia symptoms that may occur during the natural course of observation, irrespective of 

treatment effects, and for systematic differences in the experimental and control groups. 

Given that placebo for psychological treatment is variable and not standardized across 

studies, we restricted our analysis to a particular type of placebo such that our results could be 

put in some context i.e. the efficacy of psychological treatment could be judged against a 

particular type of comparator. We required that the placebo resemble the intervention of the 

study except that it was known to produce either no effect or only a minimal effect. Thus, 

component controls or attention-placebo were considered appropriate if they were thought to 

have at most a minimal effect. A waiting-list or measurement control was considered inadequate 

because no intervention was provided. A pill-placebo was considered inadequate because it did 

not resemble the experimental intervention, which did not involve administration of a pill. 

Study Selection 

The research librarian provided three databases containing the titles and abstracts of 

potentially relevant articles of the review; one database was relevant to the question on the 

definition and etiology of chronic insomnia, another database was relevant to the questions on 

manifestations of chronic insomnia, and another database was relevant to the question on 

management of chronic insomnia. In the first stage of study selection, two reviewers screened 

the titles and abstracts of all potentially relevant articles, independently. Each reviewer noted the 
13 

titles and abstracts that were potentially relevant to the review, and these articles were retrieved. 

In the second stage of study selection, two reviewers appraised the potentially relevant articles, 

independently, using pre-determined, question-specific, inclusion criteria. Disagreements 

between reviewers were resolved by discussion and consensus. The rate of disagreement 

between reviewers and the primary reason for exclusion of potentially relevant articles were 

noted. 

Assessment of Study Quality 

 

The quality of studies relevant to the questions on manifestations of chronic insomnia was 

assessed using one of three instruments; studies on prevalence and incidence were assessed using 

a scale designed specifically for this purpose.25 This scale assesses bias in sample selection, 

sampling frame, sample size, outcomes and their assessment, response rate, confidence intervals 

and sub-group analysis, and sample description. The maximum score is eight. A priori, it was 

established that a score of zero to two would be considered low quality, a score of three to five 

would be considered moderate quality and a score of six to eight would be considered high 

quality. All other studies relevant to manifestations of chronic insomnia were assessed using one 

of two Newcastle-Ottawa scales (unpublished), each scale specific to either cohort or casecontrol studies. The scale specific to cohort studies assesses bias in the selection of exposed and 

non-exposed cohorts, ascertainment of exposure, presence of outcomes at the start of the study, 

comparability of cohorts based on design or analysis, outcome assessment, and length and 

adequacy of follow-up. The scale specific to case-control studies assesses bias in the definition, 

selection, comparability, ascertainment of exposure, and non-response rate for both cases and 

controls, and how these groups compare on these items. The maximum score for the NewcastleOttawa scales is nine. A priori, it was established that a score of zero to two would be 

considered low quality, a score of three to five would be considered moderate quality and a score 

of six to nine would be considered high quality. 

The quality of studies relevant to management of chronic insomnia was assessed using the 

Jadad scale.26 This scale assesses bias in sample selection, outcome assessment, data analysis, 

and appropriateness of randomization and blinding methods. The maximum score is five. A 

priori, it was established that a score of zero to one would be considered low quality, a score of 

two to three would be considered moderate quality and a score of four to five would be 

considered high quality. The concealment of allocation of participants to treatment groups was 

also assessed.27 Allocation was considered adequate, inadequate or unclear. 

Appendix B contains the quality assessment tools used in this review. 

Data Extraction 

The following data were extracted for studies relevant to manifestations of chronic insomnia, 

as applicable: first author and year of publication, site, objectives, design, time-frame, intended 

sample size, response and follow-up rates, type of participants, definition of comparison groups, 

participants’ gender, age, and ethnicity, and participants’ co-morbid conditions at entry. For the 

question on prevalence, incidence, natural history and risk factors for chronic insomnia, 

additional data extracted included setting, sampling frame and method of sampling, data 

collection method, prevalence, incidence and natural history parameters. We did not identify 

studies with designs that would support the categorization of outcomes as either risk factors or 
14 

consequences of chronic insomnia; therefore, data relevant to potential risk factors and potential 

consequences of chronic insomnia were extracted, and these outcomes were referred to as 

associated factors of chronic insomnia. 

The following data were extracted for studies relevant to management of chronic insomnia: 

first author and year of publication, funding source and role of funding organization, design, 

whether an intent-to-treat analysis was conducted, number of participants enrolled and their 

distribution by gender, participants’ age, number of withdrawals and reasons for withdrawal, 

duration of insomnia, participants’ co-morbid conditions at entry, methods used to assess 

outcomes, details of the intervention, such as frequency and duration of treatment and timing and 

route of delivery, number of participants allocated to treatment groups and number analyzed in 

each group, length of follow-up, patient preference, and data relevant to sleep onset latency, 

wakefulness after sleep onset, sleep efficiency, total sleep time, sleep quality, quality of life and 

adverse events. A trained reviewer extracted relevant data, and a second reviewer verified the 

data extracted for accuracy and completeness. 

Appendix B contains data extraction forms for the questions on manifestations and 

management of chronic insomnia. 

The information gathered by data extraction was used to generate Evidence Tables. 

Appendix C contains these tables. 

Data Analysis

Data relevant to manifestations of chronic insomnia were analyzed qualitatively, while data 

relevant to management of chronic insomnia were analyzed quantitatively. 

Manifestations of chronic insomnia. For the questions on prevalence, natural history, 

incidence, risk factors and consequences of chronic insomnia, data relevant to each variable were 

analyzed separately, except for data relevant to potential risk factors and potential consequences 

of chronic insomnia, which were analyzed together as associated factors of chronic insomnia. 

The key features of all studies providing information on prevalence, natural history, incidence or 

associated factors of chronic insomnia were summarized in tables, such that data relevant to each 

variable appeared in a separate table. The information on prevalence was divided into three 

tables, one for prevalence in the general population, one for prevalence in outpatients of general 

practice and one for prevalence in clinical populations.

The following information was included in the tables on prevalence: first author and year of 

publication, study quality, study design, sampling frame, sampling method, response/follow-up 

rate, method of data collection, type of participants, duration of sleep complaints and definition 

of cases and comparison groups, gender distribution of sample, age distribution of sample, and 

prevalence estimates. The following information was included in the table on natural history: 

first author and year of publication, study quality, study design, time frame for the study, 

response/follow-up rate, type of participants, duration of sleep complaints, gender distribution of 

sample, age distribution of sample, and natural history estimates. The following information was 

included in the table on associated factors for chronic insomnia: author and year of publication, 

study quality, study design, type of participants, duration of sleep complaints, gender distribution 

of sample, age distribution of sample, response/follow-up rate, and a qualitative summary of the 

findings of the study. The qualitative summary of results was derived by consolidating 
15 

information available in the results and conclusions of relevant studies. We did not identify 

information relevant to the incidence of chronic insomnia. 

The data provided in the tables were synthesized to provide a description of the methods and 

results of the studies relevant to a given variable. In the analysis of prevalence of chronic 

insomnia, a range, median and interquartile range were provided for each population (general, 

outpatient and clinical), separately for high and moderate quality studies, where appropriate. In 

the analysis of associated factors of chronic insomnia, the qualitative summary of findings were 

summarized in terms of the studies that did or did not find an association between chronic 

insomnia and the various factors of interest. 

Management of chronic insomnia. A priori, the drug interventions were categorized according 

to drug class i.e. benzodiazepines, non-benzodiazepines and antidepressants. It was considered 

acceptable to combine different drugs of the same category in a meta-analysis, based on similar 

mechanisms of action. For psychological interventions, it was considered acceptable to combine 

predominantly cognitive approaches in a meta-analysis, and also to combine predominantly 

relaxation approaches in a meta-analysis; however, it was considered unacceptable to combine 

these two types of psychological approaches in a meta-analysis, since they were considered too 

different in their modes of action. Relaxation techniques address somatized tension, and 

different forms of this type of therapy (progressive relaxation and group relaxation) were 

considered similar enough to be pooled. However, cognitive therapy addressing the cognitive 

aspects of insomnia was not thought to be equivalent to relaxation therapy because it targets 

different aspects of insomnia, and was considered separately. A few interventions (e.g. Ltryptophan, melatonin and valerian) were categorized under the heading of “complementary and 

alternative care”; however, separate meta-analyses were presented for these interventions. We 

did not combine these interventions in a meta-analysis, given their distinct modes of action. 

For continuous outcomes (i.e. sleep onset latency, sleep efficiency), studies were combined 

using a Mean Difference (MD), with the exception of sleep quality and quality of life, where 

studies were combined using a Standardized Mean Difference (SMD). Dichotomous outcomes 

(i.e. safety outcomes) were combined using a Risk Difference. A number needed to harm (NNH) 

was also reported for any safety outcomes that were found to be statistically significant. The 

Inverse Variance Method28 was used to weight the studies. An efficacy estimate, with 

corresponding 95% Confidence Interval (CI), was computed for each outcome. For interpreting 

estimates calculated using the SMD, we used the generalization of 0.2 as small, 0.5 as moderate, 

and 0.8 as large.29

We were usually able to calculate the efficacy estimates for each study exactly (i.e. mean 

difference, standardized mean difference, risk difference), but occasionally, estimates had to be 

made by extracting from graphs or using medians. Standard errors of the differences were 

calculated exactly from available data (i.e. individual patient data or exact P-values), whenever 

possible. For studies with a parallel design, this calculation was usually accomplished with the 

standard formula for variance of difference of independent variables: var(A-B) = var(A) + 

var(B). For studies with a crossover design, the standard error was estimated using the formula 

for variance of difference of dependant variables: var(A-B) = var(A) + var(B) -

2ρ(var(A)var(B))1⁄2 and using a correlation estimate of 0.5. In cases where exact values could not 

be obtained, standard errors were estimated using conservative P-values (i.e. p < 0.05), ranges, 

inter-quartile ranges, and extracting from graphs. As a last resort, an average of standard 

deviations of other studies was used to impute standard deviations of a study. 
16 

For studies with a parallel design, change from baseline data were used if available, 

otherwise final data were used. For studies with a crossover design, final data were always used. 

When continuous data were presented for multiple conditions, which we wished to combine, a 

new mean and standard deviation were computed. 

All meta-analyses were performed using a Random Effects Model. Bailey30 suggests that the 

Random Effects Model is more appropriate when making recommendations for management and 

treatment of the next given patient. 

For some outcomes (sleep onset latency and number of adverse events), treatment categories 

were compared indirectly, via their relationship to placebo. Differences of differences with 95% 

CI were computed. Indirect comparisons were not made between pharmacological and 

psychological treatments for the following reasons (1) although our inclusion criteria required 

blinding for drug and complementary and alternative care, this criteria was omitted for 

psychological treatments (2) the placebo intervention was considered to have no effect for drug 

and complementary and alternative treatments, while it may have had minimal effect for 

psychological treatments (3) the pool of participants for psychological interventions was much 

smaller than for either the benzodiazepines, non-benzodiazepines or antidepressants. Thus, only 

indirect comparisons between non-psychological intervention categories and between 

psychological intervention categories were made. 

 All estimates of efficacy were assessed for heterogeneity using the I-squared statistic.31 

Based on this statistic, heterogeneity for each outcome was classified as negligible (I2 = 0 

percent), minimal (I2 < 20 percent), moderate (20 percent < I2 < 50 percent), or substantial (I2 > 

50 percent). This measure of heterogeneity describes the degree of variation in the efficacy 

estimates among studies. For our primary outcome (sleep onset latency), heterogeneity was 

explored in sub-group analyses using a number of variables. The following variables were 

targeted a priori and explored in sub-group analyses: treatment sub-group (i.e. type of drug or 

therapy), presence or absence of psychiatric illness (as defined in the study inclusion criteria), 

length of treatment (short-term and long-term, defined as less than or equal to 4 weeks and 

greater than 4 weeks, respectively), age (adult and elderly defined as the majority of patients 15-

65 years or greater than 65 years, respectively) and gender (male and female). Method of 

measurement of sleep outcomes (polysomnography, sleep diary actigraphy) was analyzed posthoc in a sub-group analysis based on comments from peer reviewers. Study quality (low, 

moderate and high quality defined as Jadad scores of 0-1, 2-3 and 4-5, respectively) was also 

explored in a sensitivity analysis. Deeks’ chi-square statistic 32 was used to test for significant 

heterogeneity reduction in partitioned sub-groups. 

Publication bias is the publication of studies based on the nature and direction of results. We 

tested for publication bias visually using the Funnel Plot33 and quantitatively using the Rank 

Correlation Test,34 the Graphical Test,35 and the Trim and Fill Method.36 
17 

Table 1. Databases searched 

Database Platform Dates of Search 

MEDLINE® Ovid Version: rel9.1.0 1966 to September Week 1 2004 

EMBASE Ovid Version: rel9.1.0 1988 to 2004 Week 37 

CINAHL Ovid Version: rel9.1.0 1982 to September Week 2 2004 

Ovid MEDLINE In-Process & 

Other Non-Indexed Citations Ovid Version: rel9.1.0 September 14, 2004 

Ovid OLDMEDLINE(R) ® Ovid Version: rel9.1.0 1951 to 1965 – Searched 

September 15, 2004 

PsycINFO® Ovid Version: rel9.1.0 1872 to September Week 1 2004 

EBM Reviews - Cochrane Central 

Register of Controlled Trials Ovid Version: rel9.1.0 2nd Quarter 2004, Searched 

September 15, 2004 

International Pharmaceutical 

Abstracts Ovid Version: rel9.1.0 1970 to August 2004 

AMED (Allied and 

Complementary Medicine)

Ovid Version: rel9.1.0 1985 to September 2004 

HealthSTAR/Ovid Healthstar Ovid Version: rel9.1.0 1975 to August 2004 

EBM Reviews – Cochrane 

Database of Systematic Reviews 

(CDSR) ; ACP Journal Club 

(ACPJC) ; Database of Abstracts 

of Reviews of Effects (DARE) 

Ovid Version: rel9.1.0 

2nd Quarter 2004 (CDSR); 1991 

to March/April 2004 (ACPJC); 2nd

Quarter 2004 (DARE); Searched 

September 15, 2004 

Science Citation Index 

Expanded® ISI Web of Knowledge 1945-September 2004, Searched 

September 17, 2004 

Biological Abstracts WebSPIRS from SilverPlatter, Version 4.3 1969-September 17, 2004 

Cochrane Complementary 

Medicine Field Registry 

Reference Web Poster 2001, ISI 

ResearchSoft 1950-September 20, 2004 

CAB Abstracts WebSPIRS from SilverPlatter, Version 4.3 1973-September 18, 2004 

SIGLE FIZ Karlsruhe – Version Interhost 3000 1980-September 18, 2004 

OCLC Proceedings First OCLC FirstSearch 1993-September 18, 2004 

Dissertation Abstracts ProQuest 1980-September 18, 2004 

Alt HealthWatch EBSCOhost 1990-September 18, 2004 

NLM Gateway U.S. National Library of Medicine - 

http://gateway.nlm.nih.gov/gw/Cmd 1950-September 18, 2004 

PubMed U.S. National Library of Medicine 1950-September 20, 2004 
18 

Table 2. Subject headings and keywords used in searches 

Terms used for Questions 1-4 Additional Terms used for Question 4 

Insomnia Time zone change 

Sleep Initiation and Maintenance Disorders Jet lag 

Sleep onset delay ------- 

Sleep onset latency ------- 

DIMS ------- 

Disorder of initiating and maintaining sleep ------- 

Early awakening ------- 

Sleeplessness ------- 

Agrypnia ------- 

Hyposomnia ------- 
19 

Chapter 3. Results 

Literature Review 

The database searches resulted in 16,991 references of potentially relevant articles. One 

thousand two hundred studies were evaluated for inclusion in the review; 528 studies were 

potentially relevant to prevalence, natural history, incidence, risk factors and consequences of 

chronic insomnia, and 672 studies were potentially relevant to efficacy and safety of treatments 

used in the management of chronic insomnia. The application of inclusion criteria resulted in 79 

studies included and 449 studies excluded for the questions on manifestations of chronic 

insomnia, and 116 studies included and 556 studies excluded for the question on management of 

chronic insomnia. 

The primary reasons for exclusion of studies potentially relevant to manifestations of chronic 

insomnia were as follows: (1) the study was reported in a language other than English (n=9), (2) 

the report was a review (n=38), (3) the study was not relevant to the review topic (n=71), (4) the 

study was a case report (n=9), (5) the study did not have a control group (n=47), (6) the study did 

not examine an adult population (n=8), (7) the study population did not have chronic insomnia as 

defined in this report (n=208), (8) the study did not report on any of the outcomes of this review 

(n=58), and (9) data relevant to the study outcomes were not adequately reported (n=1). The 

primary reasons for exclusion of studies potentially relevant to the management of chronic 

insomnia were as follows: (1) the study was reported in a language other than English (n=27), 

(2) the report was a review/commentary/practice parameter (n=32), (3) the study report was a 

duplicate publication (n=3), (4) the study did not examine an adult population (n=17), (5) the 

study population did not suffer from chronic insomnia as defined in this report (n=221), (6) the 

study was not a randomized controlled trial (n=160), (7) the study did not have a placebo arm 

(n=48), (8) the study was not double-blind (n=15), (9) the study did not report on any of the 

outcomes of this review (n=16), and (10) data relevant to the study outcomes were not 

adequately reported (n=15). 

The rate of disagreement between reviewers for inclusion/exclusion of studies was 61/528 

(11.6 percent) for the questions on manifestations of chronic insomnia and 53/672 (7.9 percent) 

for the question on management of chronic insomnia. The primary reason for disagreement 

between reviewers was oversight of study details, such that reviewers erred on the side of overinclusion. Therefore, consensus often resulted in exclusion of studies: for the questions on 

manifestations of chronic insomnia, 18 disagreements resulted in inclusion and 43 disagreements 

resulted in exclusion, and for the question on management of chronic insomnia, eight 

disagreements resulted in inclusion and 45 disagreements resulted in exclusion. 

Flow Diagram 2 outlines study retrieval and selection for the review. 

Data Synthesis 

How is chronic insomnia defined, diagnosed and classified, and what 

is known about its etiology? 

There is lack of consensus regarding the “ideal” definition of insomnia and what constitutes 

chronic insomnia. The threshold of clinically significant sleep disturbance is not established, nor 
20 

has the morbidity resulting from insomnia been well studied. It is a matter of debate as to which 

definition of insomnia encompasses the problem as it would appear in a clinical and/or research 

setting, and whether the definition of chronic insomnia should be distinct. As a result, many 

variations in the definition of insomnia exist, especially for research purposes. We reviewed 

multiple sources to define, diagnose and classify chronic insomnia, including the Principles and 

Practice of Sleep Medicine textbook,15 diagnostic manuals (International Classification of Sleep 

Disorders-Revised (ICSD-R) and Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. 

(DSM-IV)),37-38 and standards of practice published by the American Academy of Sleep 

Medicine.1;39

Definition of chronic insomnia

The International Classification of Sleep Disorders Manual. The International Classification of 

Sleep Disorders Manual is a comprehensive diagnostic manual, which is used as a reference 

among sleep researchers and physicians for sleep disorders in adults. The manual outlines a 

highly specific system for diagnosis and classification of insomnia, and includes over 40 

diagnoses that may involve a complaint of insomnia. The International Classification of Sleep 

Disorders defines insomnia as difficulty in initiating and/or maintaining sleep or non-restorative 

sleep after a habitual sleep episode.37 The ICSD-R further differentiates insomnia based on 

severity of symptoms that impact daytime functioning. Mild insomnia is often associated with a 

feeling of restlessness, irritability, mild anxiety, daytime fatigue and tiredness, without evidence 

of social or occupational impairment. In contrast, moderate insomnia is accompanied by either 

mild or moderate impairment of social and occupational functioning. Moderate insomnia is 

always associated with feelings of restlessness, irritability, anxiety, daytime fatigue and 

tiredness. Severe insomnia is associated with symptoms similar to moderate insomnia, with 

severe impairment of social and/or occupational functioning. The duration of the insomnia is 

usually classified as acute (< 4 weeks), sub-acute (> 4 weeks but < 6 months) or chronic (> 6 

months). Investigators have not consistently adhered to this classification scheme to determine 

severity and duration of insomnia in study populations, thus the definition of insomnia across 

studies varies. This classification scheme has coding for insomnia secondary to psychiatric 

conditions, substance abuse as well as medical and sleep disorders. The ICSD-R has been 

revised, and another edition of the ICSD (ICSD2) is in press for publication. This revised coding 

manual will replace the current ICSD-R. 

International Statistical Classification of Diseases and Related Health Problems 10th Revision 

(ICD-10). The World Health Organization-supported definition for nonorganic insomnia is a 

condition of unsatisfactory quantity and/or quality of sleep, which persists for a considerable 

period of time, including difficulty falling asleep, difficulty staying asleep, or early final 

wakening. It also states that insomnia is a common symptom of many mental and physical 

disorders, and should be classified here in addition to the basic disorder only if it dominates the 

clinical picture. The duration of insomnia is not specified.

Diagnostic and Statistical Manual of Mental Disorders. In contrast to the definition of insomnia 

in the ICSD-R, in the DSM-IV, insomnia is not subcategorized, but rather referred to as primary 

insomnia,38 implying that insomnia is not caused or significantly influenced by a psychiatric 

disorder. Insomnia caused or associated with psychiatric illness is classified separately. The 
21 

duration of insomnia is listed as being longer than one month. Chronic insomnia is not defined 

in the DSM nosology. 

American Academy of Sleep Medicine: Standards of Practice. The standards of practice 

published by the American Academy of Sleep Medicine defines insomnia as a complaint of 

unsatisfactory sleep, which may involve difficulty initiating sleep, frequent or lengthy 

awakenings, early awakening, inadequate total sleep time or poor quality of sleep, impacting 

daytime functioning.1

 The daytime dysfunction may include any of the following: change in 

alertness, energy, cognitive function, behavior or emotional state. This definition of insomnia 

allows for subjective diagnosis in a clinical setting based on the patients’ history, without the aid 

of polysomnography. Although short-term insomnia is generally considered to last less than 

three months, the time frame for chronic insomnia is not explicitly stated in the standards of 

practice statement. 

Classification of insomnia 

The International Classification of Sleep Disorders Manual. A clinically relevant classification 

of insomnia is outlined in the ICSD-R, 2001.37 According to the ICSD-R, the different 

categories of insomnia include: psychophysiological insomnia, sleep state misperception, 

idiopathic insomnia, as well as insomnia secondary to other medical conditions or sleep 

disorders. Acute and chronic insomnia are not classified separately; however, insomnia is 

considered to be chronic if the symptoms last for more than six months. A brief overview of the 

ICSD-R categories follows: 

 

A. Psychophysiological insomnia, also known as conditioned or learned insomnia, is a 

disorder of somatized tension and learned sleep preventing associations that result in a 

complaint of insomnia and associated decreased functioning during wakefulness.37 

Continued problems in somatized tension and maladaptive learned sleep-preventing 

associations can worsen insomnia, creating a vicious cycle by perpetuating the initial 

problem. One must search for precipitating, predisposing and perpetuating factors for 

insomnia. A hallmark of this diagnosis is the individual’s fixation with his/her sleep 

problem. This diagnosis cannot be made in the context of other medical or psychiatric 

disorders. Associated features include perceived decrement in daytime mood and 

functioning, without overt sleepiness. The true prevalence of psychophysiological 

insomnia in the general population is not known, although approximately 15 percent of 

patients referred to a sleep disorders clinic suffer from this type of insomnia.37 

Diagnostic criteria for psychophysiological insomnia include: 

a) A combination of a complaint of insomnia and a complaint of decreased 

functioning during wakefulness. 

b) Indications of learned sleep-preventing associations such as trying too hard to 

sleep, or increased arousal in the bedroom (concern and worry about sleep). 

c) Evidence of somatized tension. 

d) Polysomnography may show increased sleep latency, reduced sleep efficiency and 

increased number and/or duration of awakenings during the sleep period. 

e) No other medical condition accounts for the sleep disturbance. 
22 

The diagnosis of psychophysiological insomnia requires that criteria a) and b) are satisfied. 

B. Sleep state misperception, or pseudo insomnia, is a subjective complaint of problems 

initiating or maintaining sleep without objective findings to support the complaint. There 

is no psychopathology per se associated with this disorder. The afflicted individual 

honestly has complaints of insomnia and decreased daytime functioning, without 

objective data to support the claim. Although the exact prevalence of this disorder is not 

known, this group accounts for approximately 5 percent of individuals with complaints of 

insomnia. Diagnostic criteria for sleep state misperception include: 

a) complaint of insomnia. 

b) sleep quality and quantity are normal. 

c) polysomnography shows normal sleep latency, sleep duration and awakenings 

during the sleep period. 

The diagnosis of sleep state misperception requires that criteria a) and b) are satisfied. 

C. Idiopathic Insomnia is defined as a life-long inability to obtain adequate sleep and may be 

related to abnormalities in the neurological systems affecting the sleep-wake cycle. The 

exact prevalence of this disorder is not known, but it is thought to be rare. Diagnostic 

criteria for idiopathic insomnia include: 

a) Complaint of insomnia with decreased functioning. 

b) Insomnia is life-long and may begin in early childhood. 

c) Insomnia is relentless and does not vary. 

d) Polysomnography shows increased sleep latency, decreased sleep efficiency and 

multiple awakenings during the night. 

e) No other medical illness or disease explains the early onset of insomnia. 

The diagnosis of idiopathic insomnia requires that criteria a), b), and d) are satisfied. 

Proposed classification for insomnia. A more recent article considers a novel method for 

classifying insomnia for research purposes.40 The authors propose research diagnostic criteria 

for Insomnia Disorder, Primary Insomnia, Insomnia due to a Mental Disorder, Paradoxical 

Insomnia and Psychophysiological Insomnia. The main differences between this classification 

scheme and that of ICDS-R, 2001, is that the criteria are more precise and the duration of 

symptoms must be more than one month for all categories. This classification scheme does not 

define a subcategory of chronic insomnia. This classification scheme was developed to allow for 

clear categorization of insomniacs within a study population, and thus avoid the study of a 

heterogeneous population. Based on a review of the literature, acute, situational or transient 

insomnia is considered to be different from chronic insomnia. It is not clear whether there are 

distinct differences in the nature of insomnia that lasts for more than 1 month, but less than 6 

months versus insomnia lasting for more than 6 months. 
23 

Diagnosis and assessment of insomnia. Different evaluation methods have evolved to identify 

individuals with insomnia. Diagnosis of insomnia is made in the context of a clinical history 

based on any of the aforementioned criteria or definitions. There are semi-structured or 

structured interviews available for diagnosing insomnia [i.e., Insomnia Interview Schedule and 

Duke Structured Sleep Inventory (the latter is currently being evaluated in a large-scale study)]. 

Sleep diaries/logs, sleep histories, actigraphy, ambulatory monitoring, and in-home 

polysomnography are often used to assess sleep parameters. The most commonly used measure 

for evaluation of insomnia is self-reported questionnaires. The use of objective tools, such as 

polysomnography or multiple sleep latency tests for the diagnosis of insomnia are not 

recommended.41-43 Sleep diaries are essential for identifying sleep onset and sleep maintenance 

difficulties; however, the reporting of sleep onset latency by diary is subjective. Scientists have 

tried to evaluate more objective measures for measuring sleep disturbances in patients with 

insomnia, but currently available tools have limitations (polysomnography and unattended home 

studies), and are most commonly used to diagnose sleep disorders other than insomnia. 

Moreover, these methods are cumbersome and costly. Actigraph monitors are small watch-like 

devices that are worn on the wrist and are used to record movement; they can be useful adjuncts 

for gathering data from individuals with sleep complaints; however, these devices are not 

indicated for the routine diagnosis of any sleep disorder.39 There is currently no biomarker of 

insomnia, which makes objective diagnosis of insomnia more difficult. Research in the area of 

insomnia has recently been directed towards identifying specific hormones or neurotransmitters 

that may be involved in this disorder.15 Various research groups are studying the link between 

specific electroencephalogram findings and insomnia. A less commonly used diagnostic tool for 

insomnia, position emission tomography imaging, has been used to evaluate brain metabolism 

and its role in insomnia.44 Insomnia is a clinical diagnosis and the lack of a research model for 

insomnia makes it difficult to target appropriate therapy for this disorder and evaluate treatment 

outcomes. 

Etiology of insomnia. Despite significant advances in sleep medicine over the past 50 years, 

much less is known about the cause of insomnia, its natural history, and its consequences than 

the treatments available for insomnia. Recent studies have demonstrated an increased metabolic 

rate in patients with insomnia,45 suggesting that sleep difficulties may at least partially have a 

physiological basis. It is also speculated that patients with insomnia are more aroused than 

people without insomnia;46 however, this theory is difficult to prove, given that the 

neurotransmitters involved in arousal are unknown. Advances in molecular genetics have shed 

light on the potential role of genetics in sleep disorders. Indeed, a familial etiology of this 

disorder has been postulated. A recent study concluded that more than 33 percent of patients 

with insomnia had a family history of insomnia.47 A similar study estimated a family history of 

insomnia among first-degree relatives of people suffering from insomnia to be 48.8 percent, 

compared to 23.5 percent among first-degree relatives of people who did not suffer from 

insomnia.48 The familial aggregates of insomnia have led researchers to investigate the genetic 

basis of insomnia, but no specific gene has been implicated. 

Certain populations, including the elderly, psychiatric patients, and those suffering from 

chronic pain are known to have more chronic sleep maintenance problems.1;49 A strong link has 

been found between insomnia and depression.50 The directionality of the association has not 

been fully elucidated, but the association appears to be strong.1
24 

Environmental factors, such as irregular sleep schedules, use of caffeine or other stimulants, 

co-morbid medical conditions, and/or shift-work may also predispose vulnerable individuals to 

insomnia.1

 Genetic predisposition, in addition to environmental factors, are likely involved in 

the development and maintenance of insomnia, and differences in the relative exposure to these 

influences may explain differences in the manifestation of this disorder across affected 

individuals. 

What are the prevalence, natural history, incidence and risk factors 

for chronic insomnia? 

What are the consequences, morbidities, co-morbidities and public 

health burden associated with chronic insomnia? 

Prevalence. A description of key features of studies relevant to prevalence of chronic insomnia 

is provided in Tables 3a (prevalence in general population), 3b (prevalence in outpatients of 

general practice) and 3c (prevalence in clinical populations), and additional information on each 

study is provided in Evidence Table C-1♦. The evidence provided in Tables 3a, b and c is 

summarized here. 

Forty-one studies provided evidence regarding the prevalence of chronic insomnia in adults; 

38/41 studies were cross-sectional studies, one study was a cross-sectional case-control study 

and compared the prevalence of chronic insomnia in bipolar subjects and healthy controls,51 one 

study had both cross-sectional and case-control components,52 and one study had both crosssectional and cohort components.53 Seventeen studies were considered of high quality, 19 

studies were considered of moderate quality and five studies were considered of low quality. 

Twenty-four studies described the sampling frame; most studies used census data, phone lists 

or patients presenting to a health clinic. Thirty-four studies described the sampling method; 21 

studies used a random method, while the majority of the remaining studies used a non-random 

method, and a minority of studies investigated entire populations. Twenty-seven studies 

provided a response or follow-up rate. The rate ranged from 25-100 percent; slightly more than 

half of the studies had a rate greater than 80 percent. All studies except one 54 clearly described 

the method of data collection; 19 studies used self-reported questionnaires, 12 studies used faceto-face interviews and 10 studies used phone interviews. One of these studies 55 used both selfreported questionnaires and phone interviews. Of the studies that described the method of data 

collection, slightly more than half used a validated method. The criteria used to establish the 

duration of chronic insomnia ranged from one month to one year; most of the studies required 

that participants suffer from insomnia symptoms for at least one month. Most studies reported 

the gender distribution of the population; the majority of studies used mixed gender populations 

and a minority of studies used all-female populations. All studies provided an estimate of the 

age of the population; the age of the populations ranged from 18 to 98 years, based on studies 

that provided a range. 

Twenty-six studies investigated general populations (Table 3a), eight studies investigated 

populations of outpatients from general practice (Table 3b), and eight studies investigated 

clinical populations (Table 3c). For high quality studies investigating general populations, the 

 

♦ The Appendices and Evidence Tables cited in this report are provided electronically at 

http://www.ahrq.gov/clinic/tp/insomntp.htm. 
25 

prevalence of chronic insomnia ranged from 5-45 percent, and the median was 17.6 percent. The 

interquartile range was 8.5-24.3 percent. For moderate quality studies investigating general 

populations, the prevalence of chronic insomnia ranged from 7.5-42.5 percent, and the median 

was 15.3. The interquartile range was 11.2-29.2 percent. 

We did not identify any high quality studies investigating the prevalence of chronic insomnia 

in outpatients of general practice. For moderate quality studies investigating this population, the 

prevalence of chronic insomnia ranged from 11.7-63.7 percent, and the median was 38.4 percent. 

The interquartile range was 19.8-53.7 percent. 

We identified only one high quality study investigating clinical populations, and it compared 

the prevalence of chronic insomnia in patients with Bipolar I disorder and a non-psychiatric 

population.56 One hundred percent of participants in the psychiatric group reported a longstanding sleep disturbance, while 21 percent of participants in the non-psychiatric group reported 

such a disorder. For moderate quality studies investigating clinical populations, the prevalence 

of chronic insomnia ranged from 26-51.3 percent, with a median of 33.5 percent. The 

interquartile range was 27.8-43 percent. The disorders of the clinical populations investigated 

were Parkinson’s Disease, brain injury, diabetes, stroke, Bipolar I disorder, migraines, blood 

disorders and metastatic breast cancer. 

Natural history. A description of key features of the study relevant to natural history is 

provided in Table 4, and additional information on this study is provided in Evidence Table C-1. 

The evidence provided in Table 4 is summarized here. 

Only one study was identified that provided evidence regarding the natural history of chronic 

insomnia,53 and it was of moderate quality. In this prospective cohort study, the participants 

consisted of outpatients from general hospitals with sleep complaints lasting for at least one 

month. The population was of mixed gender and had an age range of 18-65 years. At a fourmonth follow-up, the prevalence of chronic insomnia was reduced from 100 percent to 86.9 

percent, providing a remission rate of 13.1 percent. The follow-up rate was 42.2 percent. 

Incidence. We did not identify any studies that provided evidence on the incidence of chronic 

insomnia in adults. 

Associated factors. The majority of studies identified did not have designs that would support 

the categorization of an associated factor of chronic insomnia as either a risk factor or 

consequence of the disorder, such as longitudinal cohort studies. Most studies that examined the 

risk factors and consequences of interest were either of a cross-sectional or cross-sectional casecontrol design. Thus, we do not report on risk factors and consequences of chronic insomnia per 

se, rather we report on associated factors. For simplicity, we separate the results relevant to the 

various factors according to their categorization in the relevant question of the review, such that 

potential risk factors are reported separately from potential consequences. 

A description of key features of the studies relevant to associated factors is provided in Table 

5, and additional information for each study is provided in Evidence Table C-1. The evidence 

provided in Table 5 is summarized here. 

Sixty-seven studies provided evidence regarding the association between various factors and 

chronic insomnia in adults; 30/67 studies were cross-sectional studies and 37/67 studies were 

cross-sectional case-control studies. The cross-sectional case-control studies compared chronic 

insomniacs (cases) and normal sleepers (control) on various factors to determine whether these 
26 

factors are associated with chronic insomnia. Similarly, the cross-sectional studies examined the 

relationship of various factors and chronic insomnia by comparing chronic insomniacs and 

normal sleepers within a given population. Twenty-three studies were considered of high 

quality, 30 studies were considered of moderate quality and 14 studies were considered of low 

quality. 

The criteria for chronic insomnia varied widely across studies and it was explicitly reported 

for most studies. The duration of sleep disturbance required to meet the criteria for chronic 

insomnia ranged from one month to 5 years, although the majority of studies required symptoms 

to be present for one or 6 months. Most studies reported the gender distribution of the 

population; the majority of populations were of mixed gender, and a minority of populations 

were all-female. The age of participants was reported for most studies, and ranged from 18 to 98 

years, based on studies that provided a range. A number of studies (37/67) did not report the 

response/follow-up rate for the study. Of those that reported the response/follow-up rate, it 

ranged from 37.6-100 percent. The majority of studies had a rate of 80 percent or more. 

Potential risk factors 

Age. Eleven studies found evidence of an association between age and chronic insomnia, while 

seven studies found no evidence of an association between these variables. Of the studies that 

found an association, all, except one,57 found evidence that chronic insomnia is associated with 

older age. Kageyama et al. found evidence that chronic insomnia is associated with age 24 years 

or less. 

Gender. Eleven studies found evidence of an association between gender and chronic insomnia, 

while seven studies found no evidence of an association between these variables. All of the 

studies that found evidence of an association between gender and chronic insomnia, found 

evidence that chronic insomnia is associated with female gender. 

Race/ethnicity. Two studies found evidence of an association between ethnicity and chronic 

insomnia,58-59 while one study found no evidence of an association between these variables.60

Bixler et al. found evidence that chronic insomnia is associated with being a non-Caucasian 

minority, and Riedel et al. found evidence that chronic insomnia is associated with being White. 

Psychiatric illness and psychological problems. Thirty-eight studies found evidence of an 

association between present or past psychiatric illness or psychological problems and chronic 

insomnia. Cumulatively, chronic insomnia was found to be associated with anxiety, depression, 

tension, loneliness, neuroticism, worry, rumination, psychological distress, nervousness, 

obsessive compulsiveness, maladaptive perfectionism, impulsivity, phobia, paranoid ideation, 

psychoticism and hypochondrial concerns. Seven studies did not find evidence of an association 

between one or more of the following conditions and chronic insomnia: neurological problems, 

anxiety, depression, tension and confusion. 

Medical conditions. Twelve studies found evidence of an association between medical 

conditions or poor general health and chronic insomnia, while one study57 did not find evidence 

of an association between these variables. 
27 

Socioeconomic status. Six studies found evidence of an association between socioeconomic 

status and chronic insomnia. Cumulatively, chronic insomnia was found to be associated with 

marital separation, divorce or death of a spouse, unemployment, exposure to poorer working 

conditions and lower social status. Moreover, chronic insomnia was found to be associated with 

both lower and higher education. Nine studies did not find evidence of an association between 

one or more of the following factors and chronic insomnia: education, employment and marital 

status. 

Shift-work. Only two studies provided evidence regarding the relationship between shift-work 

and chronic insomnia.57-61 The study by Kageyama et al. provided evidence that chronic 

insomnia is associated with three or less night shifts per month within the preceding three 

months in hospital nurses. The study by Martikainen et al. found no evidence of an association 

between shift-work and chronic insomnia. 

Potential consequences 

Healthcare utilization. Five studies provided evidence of an association between increased 

healthcare utilization and chronic insomnia. Cumulatively, chronic insomnia was found to be 

associated with hospitalization, visits to neurology and psychiatric departments and undergoing 

medical treatment. One study did not find evidence of an association between chronic insomnia 

and undergoing medical treatment in hospital nurses.57 

Absenteeism and work performance. Only two studies provided evidence regarding the 

relationship between work performance or absenteeism and chronic insomnia;62-63 both studies 

found evidence of an association between chronic insomnia and absenteeism. The study by 

Zammit et al. also found evidence of an association between chronic insomnia and impaired 

work performance. 

Quality of life and quality of social relationships. Five studies examined the relationship 

between either quality of life or quality of social relationships and chronic insomnia. All studies 

found evidence of an association between chronic insomnia and either lower quality of life or 

lower quality of social relationships; one of these studies found evidence that both quality of life 

and quality of social relationships are impaired in chronic insomniacs.64 Lower quality of social 

relationships was reported as receiving less support from colleagues and conflicts with relatives. 

Memory, cognitive function and mood. Fifteen studies found evidence of an association between 

decrements in memory, mood or cognitive function and chronic insomnia. Cumulatively, the 

measures of cognitive function were cognitive fatigue, sensory acuity, perceptual/motor skills, 

reaction time, psychosocial function, concentration, psychomotor function, attention, alertness, 

mental acuity, reasoning, problem-solving ability and mental reactivity. One study65 found 

evidence of increased recall of presentations made just before sleep onset in chronic insomniacs. 

Eleven studies found no evidence of an association between mood, memory or cognitive function 

and chronic insomnia. Cumulatively, the measures of cognitive function were vigilance, proofreading, reaction time, motor performance, concentration, divided attention, recent memory, 

audio/verbal patterns, psychomotor function, words heard and repeated, free recall, alertness and 

concentration. 
28 

We did not identify any studies that provided data relevant to the relationship between 

accidents or falls in the elderly and chronic insomnia, nor did we find evidence on the direct and 

indirect costs associated with the disorder. 

What treatments are used for the management of chronic insomnia in 

adults and what is the evidence regarding their safety, efficacy and 

effectiveness? 

One hundred and sixteen studies were relevant to the management of chronic insomnia; 34 

studies were considered of high quality, 68 studies were considered of moderate quality and 14 

studies were considered of low quality. All studies were described as randomized, while only 91 

studies were described as double-blind. Seventy-eight studies provided a description of 

withdrawals and dropouts. Only nine studies described an appropriate method to generate the 

sequence of randomization, and 41 studies described an appropriate method of double-blinding. 

All other studies did not describe the method to generate the sequence of randomization, or the 

method of double-blinding. Only nine studies had adequate concealment of treatment allocation; 

for the remaining 107 studies, the adequacy of concealment was unclear. One hundred and four 

studies reported on sleep onset latency and only 33 studies reported on wakefulness after sleep 

onset, the outcomes of highest priority in this review. Regarding the other outcomes of interest 

in this review, 33 studies reported on sleep efficiency, 71 studies reported on total sleep time, 66 

studies reported on sleep quality and only one study reported on quality of life. 

Only 51 studies provided information on source of funding; 38 studies received private 

funding, 10 studies received government funding, two studies received academic funding, and 

one study received foundation funding. The majority of studies did not provide information on 

the role of the funding organization; however, only two out of 38 studies that reported receiving 

private funding explicitly stated that the funding organization was involved in data analysis 

and/or research design and selection of investigators. 

The majority of studies had a parallel design. For studies in which there was a discrepancy 

between the number of participants enrolled and analyzed, it was often unclear whether an 

intent-to-treat analysis had been conducted. The majority of studies used sleep diary to assess 

sleep outcomes, and a number used both sleep diary and polysomnography to assess outcomes. 

Of the 111 studies that reported a treatment length, it ranged from one day to six months, with a 

median of three weeks. Of the 25 studies that reported a follow-up period, it ranged from one 

week to three years, with a median of 6 months. 

The duration of chronic insomnia suffered by participants ranged from two months to 51 

years, based on the 54 studies that provided a range. The age range of the population was 15-95 

years, based on the 84 studies that provided a range; only two studies included participants under 

the age of 18 years old. Of the 111 studies that reported on the gender distribution of the 

population, 102 studies had a mixed gender population, while five studies had an all-female 

population and four studies had an all-male population. The inclusion criteria of nine studies 

were designed to select individuals with a psychiatric illness, including individuals with 

depression, dysthymic disorder, dementia, schizophrenia, personality disorder, myocolonus, 

anxiety disorders, Pick's disease, alcoholic psychoses, Huntington chorea, and cerebral laceration 

and contusion. 

The studies were categorized according to intervention: benzodiazepines (n=51), nonbenzodiazepines (n=36), antidepressants (n=7), complementary and alternative care (n=14), 
29 

relaxation therapy (n=15), cognitive/behavioral therapy (n=18), alcohol (n=1), barbiturates 

(n=2), hormones (n=1) and LEET therapy (n=1). Complementary and alternative care had two 

studies on L-tryptophan, 8 studies on melatonin and 4 studies on valerian. A number of studies 

fell under the general category of combination treatment (n=8). A given study could be relevant 

to more than one category. The number of participants analyzed in the efficacy analysis (sleep 

onset latency only) was as follows: benzodiazepines (n=1858), non-benzodiazepines (n=4169), 

antidepressants (n=298), L-tryptophan (n=47), melatonin (n=103), valerian (n=51), relaxation 

therapy (n=384), cognitive/behavioral therapy (n=276), alcohol (n=11), barbiturates (n=93), 

hormones (n=49) and LEET therapy (n=97). The number of participants analyzed in the safety 

analysis was as follows: benzodiazepines (n=3800), non-benzodiazepines (n=5485), 

antidepressants (n=288), complementary and alternative care (n=87), relaxation therapy (n=0), 

cognitive/behavioral therapy (n=0), alcohol (n=0), barbiturates (n=48), hormones (n=0) and 

LEET therapy (n=0). 

Benzodiazepines 

Sleep onset latency. Meta-analysis of the 32 studies that compared the effects of 

benzodiazepines and placebo on sleep onset latency (SOL) showed a statistically significant, 

albeit modest, difference of 16.5 minutes in favour of benzodiazepines (Figure 1). While there 

was substantial heterogeneity among the studies, all but two studies had a point estimate that 

favoured benzodiazepines. The heterogeneity was due more to different estimates of how 

effective the drugs were than as to whether or not they were superior to placebo. The study 

estimates ranged from about 65 minutes improvement in SOL to no difference.

Table 6 lists all of the sub-group analyses conducted for sleep onset latency. Nine different 

types of benzodiazepines were examined by the studies. With the exception of nitrazolam 

(which had a significantly higher estimate than all other drugs except flunitrazepam, flurazepam, 

and triazolam, but was examined by only one study) all drug types had SOL estimates between 

24 and 10 minutes. The four studies that examined patients with a psychiatric illness showed a 

mean SOL difference of about 26 minutes, 10 minutes more than the remainder of the studies 

that had patients without a psychiatric illness (not statistically significant). The two studies that 

had results for long-term treatment showed a nearly identical estimate to those with results for 

short-term treatment. Similarly, age had little impact on SOL, with a 19-minute difference for 

elderly patients compared to a 15-minute difference for adult patients. There were only three 

studies that examined solely male patients and only one study that examined solely female 

patients. These studies were not very different from each other or the remaining studies. 

Finally, subdividing the studies by method of measurement of outcomes showed that those 

studies that used a sleep diary to measure SOL had a significantly greater efficacy estimate than 

those that used polysomnography (about 18 minutes compared to 7 minutes). The sub-groups of 

drug type, psychiatric illness, age and method of measurement had a Deeks’ chi-square P-value 

less than 0.05, indicating that heterogeneity was significantly reduced by the sub-group. 

Analysis of the studies by quality revealed that the high quality studies showed a slightly 

stronger estimate of SOL difference (19 minutes) than the moderate quality studies (14 minutes) 

(there were no low quality studies). Although the difference is not statistically significant, 

Deeks’ chi-square shows that this sub-grouping significantly reduced heterogeneity. 

Although both Begg’s (P-value = 0.81) and Duval’s (no studies added) tests indicated no 

publication bias non-parametrically, Egger’s test (p-value < 0.001) showed significant 
30 

asymmetry in the funnel plot. This finding is also confirmed by a visual inspection of the funnel 

plot (Figure 2). The finding may indicate that the efficacy estimate given by the meta-analysis 

may in fact overestimate true efficacy, due to possible unpublished studies with non-significant 

results. 

Wakefulness after sleep onset. Only eight benzodiazepine studies reported data on wakefulness 

after sleep onset (WASO). They revealed an average 23-minute improvement in WASO in the 

benzodiazepine patients as compared to the placebo patients (Figure 3). This result was 

statistically significant. Although there was substantial heterogeneity in this estimate, seven of 

the eight studies showed a point estimate that favoured treatment. 

Other efficacy outcomes. Three other estimates of efficacy were measured, and the results can 

be viewed in Table 7. All outcomes showed statistically significant results that favoured 

benzodiazepines over placebo. Benzodiazepines increased sleep efficiency over placebo by an 

average of 6.3 percent and increased total sleep time by an average of 39 minutes. Sleep quality 

also showed a large difference between the groups with the benzodiazepines group having a 

standard mean difference (SMD) that was 0.8 standard deviations larger than placebo. 

Heterogeneity was negligible for sleep efficiency, substantial for total sleep time, and moderate 

for sleep quality. 

Safety. The benzodiazepines showed a significantly greater proportion of adverse events than 

did placebo, although the meta-analysis showed substantial heterogeneity (Table 7). The risk 

difference estimates had a range of (0.01, 0.30) and an interquartile range of (0.08, 0.22) across 

interventions. The pooled risk-difference of 0.15 translates into a number needed to harm of 

seven patients (95% CI: 5, 10). 

The most commonly reported adverse events of benzodiazepine use were somnolence (n=27 

studies), headache (n=18), dizziness (n=16), nausea (n=11) and fatigue (n=11). There were no 

reports of falls, injury or death. 

Non-benzodiazepines 

Sleep onset latency. Twenty-nine studies on non-benzodiazepines showed a statistically 

significant difference of about 18 minutes in sleep onset latency compared to placebo (Figure 4). 

This difference is similar to the one reported for benzodiazepines. Again, similar to 

benzodiazepines, there was substantial heterogeneity among the studies, but all studies had a 

point estimate that favoured non-benzodiazepines. The study estimates ranged from about 67 

minutes improvement to 4 minutes improvement in SOL. 

The results for the sub-group analyses for sleep onset latency can be viewed in Table 8. Four 

different types of non-benzodiazepines were examined by the studies. The four different drugs 

examined ranged in their efficacy from a 31-minute improvement (zopiclone) to a 13-minute 

improvement (zolpidem). Deeks’ chi-square test showed that this sub-grouping resulted in a 

significant reduction in heterogeneity. All of the other sub-groups examined did not show 

significant reductions in heterogeneity. For psychiatric illness, only one study had patients with 

such an illness, and that study showed a significantly shorter improvement in SOL. For length of 

treatment, the short-term and long-term studies had nearly identical improvements, as did the 

studies for adult and elderly patients. For gender, there was one study that examined an all-male 
31 

population and one study that examined an all-female population. Although the results differed 

from the overall average (less effective for males and much more effective for females), there 

was not enough data to draw any firm conclusions (no statistically significant differences). 

Finally, the studies that used polysomnography to estimate sleep onset latency were not different 

from those that used a sleep diary. 

The high quality studies had an SOL estimate (30 minutes) that was significantly greater than 

the estimate for moderate quality studies (14 minutes) (there were no low quality studies), as was 

the case with the benzodiazepines. However, this sub-grouping did not significantly reduce 

heterogeneity. 

Only Duval’s test (no studies added in the trim and fill) showed no evidence of publication 

bias. Begg’s (P-value = 0.01) and Egger’s (P-value = 0.01) tests both showed evidence of funnel 

plot asymmetry, as did a visual examination of the plot (Figure 5). This finding suggests a 

possible overestimation of the efficacy in terms of SOL of non-benzodiazepines in our metaanalysis. 

Wakefulness after sleep onset. Nine studies reported on WASO comparing non-benzodiazepines 

to placebo. The studies found that non-benzodiazepines decreased WASO by an average of 

about 13 minutes, which was statistically significant. Heterogeneity was substantial, caused 

mostly by one study, whose estimate was very different from the others (Figure 6). 

Other efficacy outcomes. Four other estimates of efficacy were measured, and their results can 

be viewed in Table 9. All outcomes showed statistically significant results that favoured nonbenzodiazepines over placebo. Sleep efficiency was increased in non-benzodiazepines by about 

6 percent, while total sleep time was increased by about 28 minutes. Both sleep quality and 

quality of life showed moderate improvements in non-benzodiazepines compared to placebo 

with SMDs of 0.48 and 0.45, respectively. Heterogeneity was negligible for sleep efficiency, 

moderate for total sleep time, and substantial for sleep quality. 

Safety. The non-benzodiazepines showed a significantly greater proportion of adverse events 

than did placebo, although the meta-analysis showed substantial heterogeneity (Table 9). The 

risk-difference had a range of (0.00, 0.15) and an interquartile range of (0.05, 0.08) across 

interventions. The pooled risk-difference of 0.05 translates into a number needed to harm of 20 

patients (95% CI: 11, 100). 

The most commonly reported adverse events of non-benzodiazepine use were headache 

(n=16 studies), dizziness (n=14), nausea (n=13) and somnolence (n=13). Accidental injury was 

reported in only one study, although there was no difference in the frequency of this event 

between experimental and control groups. 

Antidepressants 

Sleep onset latency. There were six studies that examined the effect of antidepressants (doxepin, 

pivagabine, trazodone and trimipramine) on sleep onset latency. They showed a small but 

statistically significant difference of about 7 minutes in sleep onset latency compared to placebo 

(Figure 7). The heterogeneity in this estimate was minimal and all six studies had an estimate 

that favoured the drug. The study estimates ranged from about 17 minutes improvement in SOL 

to no difference. 
32 

The results of sub-group analyses for sleep onset latency can be viewed in Table 10. All six 

studies were of mixed gender and featured only adults, so no sub-group analysis on gender or 

age was performed. Of the comparisons that were made, none significantly reduced 

heterogeneity, despite some marked differences in point estimates. This finding was mainly due 

to the low number of studies: most categories had a sub-group of only one study and method of 

measurement had a sub-group of only two studies. None of the differences in point estimates 

were statistically significant. 

The one high quality study had an SOL estimate (17 minutes) that was higher than the 

estimate for the moderate quality studies (7 minutes) (there were no low quality studies). This 

sub-grouping did not significantly reduce heterogeneity, and the difference between estimates 

was not significant. 

Since only six studies were included in this analysis, there were too few studies to perform 

any meaningful tests of publication bias. 

Wakefulness after sleep onset. Three studies reported on WASO comparing antidepressants 

(doxepin and trazodone) to placebo. The studies found that antidepressants decreased WASO by 

an average of about 11 minutes, which was statistically significant. Heterogeneity was 

negligible (Figure 8). 

Other efficacy outcomes. Three other estimates of efficacy were measured (no studies included 

an analysis of quality of life), and their results can be viewed in Table 11. All outcomes showed 

statistically significant results that favoured antidepressants over placebo. Sleep efficiency was 

increased in the antidepressant group by about 13.8 percent, while total sleep time was increased 

by about 53.1 minutes. Sleep quality showed a moderate increase for antidepressants of about 

0.63 on the SMD scale. Heterogeneity was negligible for sleep efficiency and substantial for 

both total sleep time and sleep quality.

Safety. The antidepressants showed a significantly greater proportion of adverse events than 

placebo, and the meta-analysis showed negligible heterogeneity (Table 11). The risk-difference 

had a range of (-0.07, 0.13) and an interquartile range of (0.01, 0.11). The pooled risk-difference 

of 0.09 translates into a number needed to harm of 11 patients (95% CI: 6, 100). 

The most commonly reported adverse events with antidepressant use were somnolence (n=4), 

headache (n=3), dizziness (n=3), and nausea (n=3). There were no reports of falls, injury or 

death. 

Complementary and alternative care 

There were three different types of complementary and alternative therapies observed in our 

included studies: L-tryptophan, melatonin, and valerian. These three substances were considered 

too different clinically to combine, and thus their results will be considered separately. 

L-tryptophan

Sleep onset latency. Only two studies reported data for l-trytophan versus placebo and the results 

for sleep onset latency can be seen in Figure 9. The two studies showed an average reduction in 

SOL of 11 minutes, but the result was not significant, and the heterogeneity between the two 
33 

studies was substantial. There were too few studies to do any meaningful tests for publication 

bias. No other outcomes of interest were reported for L-tryptophan (Table 12). The two studies 

used different methods to measure sleep onset latency. The study that used polysomnography 

showed a significant effect of L-tryptophan (-20.1 minutes; 95% CI: -33.6, -6.6), while the study 

that used sleep diary did not (2.9 minutes; 95% CI: -21.6, 27.4). However, the difference 

between the two studies was not statistically significant. 

Melatonin

Sleep onset latency. There were 8 studies on melatonin that examined sleep onset latency. 

Similar to the antidepressants, this category of intervention showed a small but statistically 

significant difference of about 8 minutes in sleep onset latency compared to placebo (Figure 9). 

The heterogeneity in this estimate was moderate, and all but two of the studies had an estimate 

that favoured the drug. The study estimates ranged from about 20 minutes improvement in SOL 

to 10 minutes detriment. When the eight studies were grouped by method of measurement, some 

differences in efficacy estimates were observed among the groups. The estimate for 

polysomnography (-3.6 minutes; 95% CI: -8.8, 1.6) was significantly different from the estimate 

for actigraphy (-16.7 minutes; 95% CI: -25.0, -8.3). Neither estimate was significantly different 

from the estimate for sleep diary (5.1 minutes; 95% CI: -20.0, 30.2). 

No publication bias was immediately apparent from the funnel plot (Figure 10), and both 

Begg’s test (P-value = 0.90) and Egger’s test (P-value = 0.21) did not show significant 

asymmetry. However, Duval’s trim and fill test did add one study to the meta-analysis and 

slightly increased the efficacy estimate (-8.7 minutes; 95% CI: -14.9, -2.5). 

Wakefulness after sleep onset. Five studies reported on WASO comparing melatonin to placebo. 

The studies found that melatonin decreased WASO by an average of about 10 minutes, but this 

difference was not statistically significant. Heterogeneity was substantial, with two studies 

indicating a significant effect in favour of melatonin, while the other three studies all had 

estimates on the side of the null favouring placebo (Figure 11). 

Other efficacy outcomes. Three other estimates of efficacy were measured for melatonin versus 

placebo (no studies included an analysis of quality of life), and their results can be viewed in 

Table 13. None of the three outcomes showed statistically significant results. The point 

estimates for sleep efficiency and total sleep time were 3 percent and 6 minutes, respectively. 

Sleep quality had a small efficacy difference of 0.3 standard deviations. Heterogeneity was 

substantial for both sleep efficiency and total sleep time, while it was negligible for sleep quality. 

Safety. The melatonin studies did not show any significant difference in number of adverse 

events versus placebo (Table 13), with an estimated risk difference of 0.09. Heterogeneity 

among studies was moderate. 

Valerian

Sleep onset latency. There were three studies on valerian that examined sleep onset latency. The 

studies showed a small average difference between valerian and placebo (1 minute), which was 

not statistically significant (Figure 9). The heterogeneity in this estimate was substantial with 
34 

two studies favouring valerian and the third being well on the side of placebo. The study 

estimates ranged from about 17 minutes improvement in SOL to 23 minutes detriment. There 

were too few studies to do any meaningful tests for publication bias. When the studies were 

grouped by method of measurement, differences among groups were observed. The estimate for 

polysomnography (9.5 minutes; -11.3, 30.3) was significantly different from the estimate for 

sleep diary (-16.0 minutes; 95% CI: -29.5, -2.5). 

Wakefulness after sleep onset. Only one study reported on WASO comparing melatonin to 

placebo, but it did find a difference of 8 minutes between the groups, which favoured valerian 

and was statistically significant (Figure 11). 

Other efficacy outcomes. Three other estimates of efficacy were measured for valerian versus 

placebo (no studies included an analysis of quality of life), and their results can be viewed in 

Table 14. None of the three outcomes showed statistically significant results. The point 

estimates for sleep efficiency and sleep onset latency were very small at 0.1 percent and 1 

minute, respectively. Sleep quality had a large efficacy difference of 1.38 standard deviations, 

but, as mentioned, it was not statistically significant. Heterogeneity was negligible for sleep 

efficiency and substantial for sleep quality. 

Safety. The valerian studies did not show any significant difference in number of adverse events 

versus placebo (Table 14), with an estimated risk difference of -0.06, which actually favoured 

valerian. Heterogeneity among studies was substantial. 

Relaxation therapy 

Sleep onset latency. There were 13 studies on relaxation therapy that examined sleep onset 

latency. Meta-analysis showed a pooled difference of 15 minutes favouring therapy over 

placebo (Figure 12). This result was not statistically significant. The heterogeneity in this 

estimate was extremely high (I2

: 96 percent), although all but three of the studies had an estimate 

that favoured the drug. The study estimates ranged from about 60 minutes improvement in SOL 

to 14 minutes detriment. 

The results for sub-group analyses for sleep onset latency in relaxation therapy can be viewed 

in Table 15. All 13 studies analysed patients without psychiatric illnesses and used sleep diary to 

measure SOL, so no sub-group analyses on these variables were performed. The other four subgroups examined yielded highly significant reductions in heterogeneity. Despite this finding, 

many of the individual sub-groups had very high heterogeneity. Subdividing by type of 

relaxation therapy, efficacy estimates ranged from 60 minutes improvement to 5 minutes 

improvement. Only breathing training, group relaxation, and hypnotic relaxation showed 

statistically significant efficacy despite each sub-group containing only one trial. The short-term 

effects of relaxation therapy on SOL proved significantly greater than the long-term effects (22 

minutes improvement versus 2 minutes detriment). There was only one study of elderly patients, 

and it showed no improvement in sleep onset latency compared to the studies on adults, which 

showed an improvement of 16 minutes. This difference was not significant. Finally, one study 

had only female participants (there were no studies of all-male populations), and it had a lower 

efficacy than the remainder of the studies (6 minutes compared to 16 minutes). This difference 

was non-significant. 
35 

The moderate quality studies had a slightly higher (but not significantly higher) efficacy 

estimate than the low quality studies (18 minutes compared to 9 minutes) (there were no high 

quality studies). This sub-grouping significantly reduced heterogeneity. 

No publication bias was immediately apparent from the funnel plot (Figure 13). Both 

Egger’s test (P-value = 0.49) and Duval’s trim and fill (no studies added) did not show 

significant asymmetry. However, Begg’s test did show some evidence of asymmetry (P-value = 

0.004). This finding is somewhat surprising considering that Begg’s test is usually the most 

conservative test (i.e. it is unusual to have a significant Begg P-value and a non-significant Egger 

P-value). 

Wakefulness after sleep onset. Only three studies reported on WASO comparing relaxation 

therapy to placebo. Their combined efficacy estimate was very small (-2 minutes) and favoured 

relaxation therapy (Figure 14). The result was not statistically significant. Heterogeneity was 

minimal. 

Other efficacy outcomes. Three other estimates of efficacy were measured for relaxation therapy 

versus placebo (no studies included an analysis of quality of life), and their results can be viewed 

in Table 16. Only total sleep time showed a statistically significant result, with an average 

improvement in the relaxation group of 23 minutes. Sleep efficiency had an estimate of 0.4 

percent, while sleep quality showed a small estimate of 0.4 standard deviations. Neither estimate 

was statistically significant. Heterogeneity was negligible for sleep efficiency and total sleep 

time, but was substantial for sleep quality. 

Safety. None of the trials of this category reported on adverse events. 

Cognitive/behavioral therapy

Sleep onset latency. There were nine studies on cognitive/behavioral therapy (CBT) that 

examined sleep onset latency. Meta-analysis showed a pooled difference of 5 minutes favouring 

therapy over placebo (Figure 15). This result was not statistically significant. The heterogeneity 

in this estimate was minimal, although three of the nine studies had an estimate that favoured 

placebo. The study estimates ranged from about 30 minutes improvement in SOL to 19 minutes 

detriment. 

The results of sub-group analyses for sleep onset latency in CBT can be viewed in Table 17. 

All nine studies were of mixed gender, analysed patients without psychiatric illnesses and used 

sleep diary to measure SOL, so no sub-group analyses on gender, psychiatric illness or method 

of measurement were performed. Of the three sub-groups examined, none showed significant 

reduction in heterogeneity. Subdividing by type of intervention, stimulus control and thought 

non-suppression had slightly higher estimates than multi-component CBT, paradoxical intention, 

and sleep compression, but the differences were not significant. Similarly, the short-term and 

long- term differences were comparable. There was only one study that examined elderly 

participants, and its efficacy estimate was not very different from the adult studies. 

The low quality studies had a slightly higher efficacy estimate than the moderate quality 

studies (8 minutes compared to 1 minute), but the difference was not statistically significant 

(there were no high quality studies). This sub-grouping did not significantly reduce 

heterogeneity. 
36 

There was no evidence of publication bias. The funnel plot did not appear to be asymmetric 

(Figure 16), and Begg’s (P-value = 0.53), Egger’s (P-value = 0.37) and Duval’s (no studies 

added) tests all confirmed this finding. 

Wakefulness after sleep onset. Eight studies reported on WASO comparing CBT to placebo. 

Their combined efficacy estimate showed that CBT improved WASO by an average of 18 

minutes (Figure 17). The result was statistically significant, although heterogeneity was 

substantial. Despite the high heterogeneity, all but one study showed a result that favoured CBT. 

Other efficacy outcomes. Three other estimates of efficacy were measured for CBT versus 

placebo (no studies included an analysis of quality of life), and their results can be viewed in 

Table 18. Both sleep efficiency and sleep quality showed statistically significant improvements 

for CBT over placebo. Sleep efficiency improved by an average of 6 percent, while sleep quality 

showed an improvement of 0.38 standard deviations. Total sleep time showed no difference. 

Heterogeneity was negligible for sleep quality, but substantial for both the sleep efficiency and 

total sleep time estimates. 

Safety. None of the CBT trials reported on adverse events. 

Indirect comparisons 

Efficacy. Table 19 shows the results of the pair-wise indirect comparisons of sleep onset latency 

for each of the four pharmacological treatment categories: benzodiazepines, nonbenzodiazepines, antidepressants, and complementary and alternative care, the latter divided into 

L-tryptophan, melatonin, and valerian. Both benzodiazepines and non-benzodiazepines proved 

significantly more efficacious than antidepressants and melatonin. None of the other 

comparisons showed significant differences. Comparing the two non-pharmacological treatment 

categories (relaxation therapy and cognitive/behavioral therapy) also showed no significant 

difference (-10 min.; 95% CI: -25.7, 5.7). 

Safety. Table 20 shows the results of indirect comparisons of adverse events for the four main 

pharmacological treatment categories that provided relevant data: benzodiazepines, nonbenzodiazepines, antidepressants and complementary and alternative care, the latter divided into 

melatonin and valerian (there was no safety data for L-tryptophan). The only significant 

comparison is that of benzodiazepines and non-benzodiazepines, where the latter treatment 

category was found to be significantly safer than the former in terms of number of adverse 

events. Note that despite the fact that valerian had the lowest point estimate, the larger 

confidence interval prevented a meaningful comparison of its safety relative to the other 

treatment categories. 

Other treatments

There were some studies that examined treatments that did not fall under any of the 

preceding six treatment categories. They are outlined here.
37 

Barbiturates. There were two trials that examined barbiturates versus placebo. Four different 

types of barbiturates were examined in the trials: glutethimide, methyprylon, phenobarbitol and 

secobarbitol. 

Only two outcomes (sleep onset latency and adverse events) were analysed in the two trials. 

The results can be viewed in Table 21. Neither SOL nor number of adverse events differed 

significantly from placebo in the meta-analyses. 

Hormones. One trial examined the efficacy of two different hormones (climodein and estradiol) 

in women with a diagnosis of insomnia related to post-menopausal syndrome. Four outcomes 

(sleep onset latency, sleep efficiency, total sleep time, and sleep quality) were examined (Table 

22). Sleep efficiency and sleep quality showed a statistically significant improvement (5 percent 

and 22 minutes respectively) with the hormones, while sleep onset latency and total sleep time 

showed an improvement that was not significant. 

Alcohol. One trial examined the efficacy of ethanol versus placebo. The three outcomes 

examined (sleep onset latency, WASO, and sleep efficiency) had non-significant differences 

between treatment and placebo (Table 23). All three efficacy estimates favoured placebo, 

although the differences were not significant. 

Low energy emission therapy. One study compared the effect of low energy emission therapy 

(LEET) with placebo for insomniacs. The results for the four efficacy (sleep onset latency, 

WASO, sleep efficiency, and total sleep time) and one safety outcome can be viewed in Table 

24. Statistically significant improvements in both sleep efficiency and total sleep time (11 

percent and 56 minutes, respectively) were found. The estimates for sleep onset latency and 

WASO were not significant, but did favour the LEET intervention. There was also no evidence 

that adverse events were higher for LEET than for placebo. 

Combination treatments 

This section will outline the results of eight trials that employed various combinations of the 

above treatments. Unlike all other sections of this review, we did not limit ourselves to 

comparing these treatments to placebo. All comparisons within the trials were examined. Ten 

different comparisons resulted and are outline below. The combination therapy in each case is 

always considered to be the “treatment arm.” 

Relaxation therapy and cognitive behavioral therapy versus placebo. There were four studies 

included in a meta-analysis of a combined relaxation therapy and CBT treatment versus placebo. 

The results for four outcomes (SOL, WASO, total sleep time, and sleep quality) can be viewed in 

Table 25. Although all estimates favoured treatment, only the result for sleep onset latency 

proved statistically significant, with an estimated improvement of about 22 minutes. 

Interestingly, this is nearly identical to the sum of the calculated effect from the meta-analyses of 

each of these interventions alone. 

Relaxation therapy and cognitive behavioral therapy versus relaxation therapy. Two studies 

compared relaxation therapy and CBT treatment with relaxation therapy alone. Table 26 

contains the results for the four reported outcomes (SOL, WASO, total sleep time, and sleep 
38 

quality). None of the results were statistically significant with only sleep onset latency favouring 

the combined treatment. The other three outcomes showed an efficacy estimate that favoured 

relaxation alone, although as mentioned, none were significant. 

Relaxation therapy and cognitive behavioral therapy versus cognitive behavioral therapy. Two 

studies compared relaxation therapy and CBT treatment with CBT alone. None of the results for 

the four outcomes (SOL, WASO, total sleep time, and sleep quality) were statistically significant 

(Table 27). Two of the outcomes (SOL and sleep quality) favoured the combined treatment, 

while the other two outcomes (WASO and total sleep time) favoured CBT alone. 

Relaxation therapy and cognitive behavioral therapy versus benzodiazepine. One study 

compared relaxation therapy and CBT versus a benzodiazepine. The results for SOL, WASO, 

and sleep quality can be viewed in Table 28. All three outcomes favoured the benzodiazepine 

over the combined treatment. The difference was not significant for SOL or WASO, but it was 

significant for sleep quality (a large difference of about 1.5 SDs). 

Benzodiazepine and cognitive behavioral therapy versus placebo. Table 29 lists the results for 

the four outcomes (SOL, WASO, sleep efficiency, and total sleep time) that were reported in 

comparisons of benzodiazepine and CBT versus placebo. Two studies were meta-analysed. All 

four outcomes favoured the combined treatment, and the difference was significant for sleep 

efficiency (13 percent improvement). 

Benzodiazepine and cognitive behavioral therapy versus benzodiazepine. One study compared 

the combined treatment of a benzodiazepine and CBT versus the benzodiazepine alone. The 

results for three outcomes (WASO, sleep efficiency and total sleep time) can be viewed in Table 

30. The result for sleep efficiency was statistically significant in favour of the combined 

treatment (7 percent improvement). WASO favoured the combined treatment but not 

significantly. Total sleep time favoured the benzodiazepine alone, but the difference was not 

significant. 

Benzodiazepine and cognitive behavioral therapy versus cognitive behavioral therapy. The 

comparison of a benzodiazepine and CBT versus CBT alone was available through one study. 

The results of the three outcomes (WASO, sleep efficiency, and total sleep time) can be viewed 

in Table 31. None of the results were significant and all had relatively small efficacy estimates. 

Non-benzodiazepine and cognitive behavioral therapy taken in combination versus the same two 

treatments taken sequentially. One study examined the difference between the effects of a nonbenzodiazepine taken simultaneously with CBT versus the same two treatments taken 

sequentially. The results for the two outcomes examined (sleep efficiency and total sleep time) 

can be viewed in Table 32. Neither result was significant. 

Cognitive behavioral therapy and modafinil versus cognitive behavioral therapy. One study 

compared CBT combined with the stimulant modafinil versus CBT alone. Results for the three 

reported outcomes (SOL, WASO, and total sleep time) can be viewed in Table 33. None of the 

results are significant, and all three efficacy estimates favour CBT alone over the combined 

treatment. 
39 

Cognitive behavioral therapy and modafinil versus modafinil. CBT and modafinil was 

compared to modafinil alone in one study. The results of the three outcomes examined (SOL, 

WASO, and total sleep time) can be viewed in Table 34. All outcomes favoured the combined 

treatment, but none of them were significant. 

What are the important future directions for insomnia-related 

research? 

The response to this question appears under “Limitations and Future Research” in the 

Discussion section of the Evidence Report. 
40 

Flow Diagram 2. Study retrieval and selection 

References identified from 

database searches 

n=16,991

Studies potentially relevant to 

questions on manifestations of 

chronic insomnia 

n= 528

Studies potentially relevant to 

question on management of 

chronic insomnia 

n= 672

Included in review 

n=79 

Excluded from 

review 

n=449 

Included in review

n=116 

Excluded from 

review 

n=556 

Studies assessed for potential 

inclusion in the review 

n=1200
41 

Table 3a. Prevalence of chronic insomnia in adults: general population Author / Year Quality (score) 

Study Design 

Sampling Frame / Method 

Method Of Data Collection 

Participants Duration of Sleep 

Complaints, Definition of Cases and Comparison Groups 

Gender Age 

(years) 

ResRatFolRat

Ancoli-Israel, S / 1999 Moderate (3/8) 

Crosssectional Phone list/ random Phone interview 

(nonvalidated) 

General population 

Sleep complaints on a frequent basis; population referred to as “chronic” insomniacs. 

Not specified 

Range: 18-65 

51.

Bixler, EO / 1979 Moderate (3/8) 

Crosssectional Census data/ 

random

Face-to face interview (nonvalidated) 

General population 

Current or past sleep disorders; prevalence reported for “long-term” insomniacs. 

Male: 44% Female:56% 

Over 18 Not 

spe

Bixler, EO / 2002 Moderate (3/8) 

Crosssectional Phone list/ random Self- reported Qu 

(nonvalidated) 

General population 

Sleep complaint for at least one year. 

Male: 42.6% Female:57.4%

Over 20 66.

Broman, JE / 1996 High (6/8) 

Crosssectional Population register/ 

random 

Selfreported Qu (validated) 

General population 

Sleep complaints during the last three months. 

Male: 46.9% Female:53.1%

Range: 20-64 

68% 

Hajak, G / 2001 High (6/8) - cross sectional  High (7/9)  - case control 

Crosssectional and CaseControl (matched) 

Census data/ random 

Face-to face interview (nonvalidated) 

Crosssectional: 

General population Casecontrol:: Cases: severe insomnia Controls: normal sleepers 

Cross-sectional: 

Insomnia disorders during the previous month (DSM-III-R and DSM-IV criteria). Severe insomniacs had sleep complaints during the previous month. Case-control: Cases: 

Severe insomniacs as defined above. Controls: No sleep complaints. 

Crosssectional: Male:46.8% Female:53.1% 

Over 18 Not 

spe
42 

Table 3a. Prevalence of chronic insomnia in adults: general population (continued) Author / Year Quality (score) 

Study Design 

Sampling Frame / Method 

Method Of Data Collection 

Participants Duration of Sleep 

Complaints, Definition of Cases and Comparison Groups 

Gender Age 

(years) 

ResRatFolRat

Hetta, J / 1999 Low (0/8) 

Crosssectional Not specified/ 

non-random (quota method) 

Not clearly specified 

General population 

Sleep complaints over the past month (DSMIII-R criteria modified). 

Not specified 

Over 18 25% 

Hidalgo, MP / 2002 Moderate (5/8) 

Crosssectional Not specified Self- reported Qu 

(validated) 

Medical students 

Sleep complaints for at least one month during the past year. 

Male: 58.2% Female:41.8%

Range: 18-35 

Not spe

Kageyama, T / 1997 Moderate (6/8) 

Crosssectional Residential registration 

information/ random sample of some districts, recruitment at block meetings in others

Self-admin Qu (nonvalidated) 

Adult women living in urban areas 

Sleep complaints for at least one month (ICD10 and DSM-IV criteria). 

All women Range: 

20-80 

Varbetdist51-

Kageyama, T / 2001 Moderate (5/8) 

Crosssectional Not specified Self-admin Qu (nonvalidated) Hospital nurses Sleep complaints for at least one month. Not specified Range: 24-59 Not spe

Kawada, T / 2003 High (6/8) 

Crosssectional Map/ Not specified Self- reported Qu 

(nonvalidated) 

Women from the general population 

Sleep complaint for at least one month (ICD10 and DSM-IV criteria). 

All female Range: 

20-80 

50.
43 

Table 3a. Prevalence of chronic insomnia in adults: general population (continued) Author / Year Quality (score) 

Study Design 

Sampling Frame / Method 

Method Of Data Collection 

Participants Duration of Sleep 

Complaints, Definition of Cases and Comparison Groups 

Gender Age 

(years) 

ResRatFolRat

Leger, D / 2000 High (6/8) 

Crosssectional Census data/ 

random

Face-to face interview (nonvalidated) 

General population 

Sleep complaint for at least a month (DSM-IV criteria). "Severe insomnia" considered as "chronic insomnia" if sleep complaints were over a four-month period. 

Male: 47% Female:53%

Over 18 85.

Martikainen, K / 2003 Moderate (5/8) 

Crosssectional Not specified / 

random 

Selfreported Qu (nonvalidated) 

General population 

Sleep complaints during the previous three months. 

Male:42.2% Female:57.8%

Range: 41-55 

52.

Millar, A / 2004 High (6/9) 

Cross sectional case-control 

Not applicable 

Selfreported Qu (validated), sleep laboratory investigations 

Cases: remitted Bipolar I disorder subjects Controls: healthy subjects

Cases: DSM-IV criteria for Bipolar I disorder. Controls: No psychiatric disorders.

Cases:

Male: 8 Female: 11 Controls:

Male: 8 Female: 11

Cases: range:26-68 Controls: range: 27-67 

Cas59.(folConNot spe

Ohayon, MM / 2002 High (8/8) 

Crosssectional Phone list/ random Phone interview 

(validated) 

General population 

Insomnia complaints during the last year (DSM-IV criteria). 

Male: 48.2% Female:51.8%

Over 15 89.
44 

Table 3a. Prevalence of chronic insomnia in adults: general population (continued) Author / Year Quality (score) 

Study Design 

Sampling Frame / Method 

Method Of Data Collection 

Participants Duration of Sleep 

Complaints, Definition of Cases and Comparison Groups 

Gender Age 

(years) 

ResRatFolRat

Ohayon, MM / 2002 High (8/8) 

Crosssectional Census data/ 

random

Phone interview (validated) 

General population 

Chronic insomnia diagnosed according to DSM-IV criteria. 

Male: 48.2% Female:51.8% 

Over 18 78.

Ohayon, MM / 1997 High (8/8) 

Crosssectional Census data/ 

random

Phone interview (validated) 

General population 

Insomnia complaints for at least one month. 

Male: 47.9% Female:52.1% 

Over 15 80.

Ohayon, MM / 2003 High (7/8) 

Crosssectional Census data/ 

random

Phone interview (validated) 

General population 

Insomnia complaints for more than six months. 

Male: 47.9% Female:52.1%

Over 15 78.

Ohayon, MM / 2000 High (7/8) 

Crosssectional Census data/ 

random 

Computerized phone interview (validated) 

General population 

Diagnoses of chronic sleep disorders according to DSM-IV criteria. 

Male: 49.2% Female: 50.8%

Range: 19 -24 

Not spe

Ohayon, MM / 2001 High (7/8) 

Crosssectional Census data/ 

random 

Phone interview (validated) 

General population 

Chronic insomnia defined by both DSM-IV and ICSD criteria. 

Male:49.5% Female:50.5%

Range: 19-24 

Not spe
45 

Table 3a. Prevalence of chronic insomnia in adults: general population (continued) Author / Year Quality (score) 

Study Design 

Sampling Frame / Method 

Method Of Data Collection 

Participants Duration of Sleep 

Complaints, Definition of Cases and Comparison Groups 

Gender Age 

(years) 

ResRatFolRat

Ohayon, MM / 2001 High (8/8) 

Crosssectional Census data/ 

random

Telephone interview (validated) 

General population 

Sleep complaints for at least a month (DSM-IV criteria). 

Male: 49% Female: 51% 

Over 15 All 

couexcGe(68parrate or hOve81.

Ohayon, MM / 2002 High (8/8) 

Crosssectional Phone lists/ random Telephone interview 

(validated) 

General population 

Chronic insomnia diagnosed according to ICSD and DSM-IV criteria. 

Male:49.5% Female:50.5%

Range: 15-90 

91.

Riedel, BW / 2004 High (6/8) 

Crosssectional Not specified/ 

random 

Selfreported Qu (validated) 

General population 

Sleep complaints for at least six months (ICSD criteria). 

Male: 49.3% Female:50.7% - 390/769

Range: 20-98 

43.

Rocha, FL / 2002 High (7/8) 

Crosssectional Census data/ whole 

population studied 

Face-toface interview (validated) 

Elderly from the general population 

Sleep complaints during the last month. 

Male: 38.9% Female:61.1%

Over 60 87% 

Rocha, FL / 2002 High (7/8) 

Crosssectional Census data/ 

random

Face-toface interview (validated) 

General population 

Sleep complaints in the last month. 

Male: 44.3% Female:55.7%

Over 18 87.

Taylor, DJ / 2003 High (6/8) 

Crosssectional Three-digit telephone 

prefixes/ random digit dialling 

Sleep diaries and self-admin Qu 

General population 

Sleep complaints for at least six months. 

Male: 49.4% Female: 50.6% 

Range: 20-98 

49% 
46 

Table 3a. Prevalence of chronic insomnia in adults: general population (continued) Author / Year Quality (score) 

Study Design 

Sampling Frame / Method 

Method Of Data Collection 

Participants Duration of Sleep 

Complaints, Definition of Cases and Comparison Groups 

Gender Age 

(years) 

ResRatFolRat

Yeo, BKL / 1996 Moderate (3/8) 

Crosssectional House registers/ 

random 

Face-to face interview (nonvalidated) 

General population 

Sleep complaint for the past year. 

Male:50% Female:50%

Range: 15-55 

Not spe

Abbreviations: CI = confidence interval; DSM-III-R = Diagnostic and Statistical Manual of Mental Disorders, Third Edition, Revised; DSM-I

Statistical Manual of Mental Disorders, Fourth Edition; ICSD = International Classification of Sleep Disorders; MSK = musculoskeletal injury

rehab = rehabilitation; SCI = spinal cord injury; TBI = traumatic brain injury 
47 

Table 3b. Prevalence of chronic insomnia in adults: outpatients of general practice Author / Year Quality (score) 

Study Design 

Sampling Frame / Method 

Method Of Data Collection 

Participants Duration of Sleep 

Complaints, Definition of Cases and Comparison Groups 

Gender Age 

(years) 

ResRatFolRat

Hohagen, F / 1993 Moderate (4/8) 

Crosssectional Not specified/ 

non-random (consecutive) 

Selfreported Qu (nonvalidated) 

Outpatients from general practices 

Insomnia disorders during the last month (DSM-III-R criteria). 

Male:44.7% Female:55.3%

Range: 18-65 

97.

Hohagen, F / 1994 Moderate (4/8) 

Crosssectional Not specified / 

non-random (consecutive) 

Selfreported Qu (nonvalidated) 

Elderly outpatients from general practices 

Sleep complaints (mild, moderate, and severe) for at least one month (DSM-III-R criteria). 

Male: 28% Female:72% 

Over 65 97.

Hohagen, F / 1994 Moderate (4/8) 

Crosssectional and prospective cohort 

Not specified/ non-random (consecutive) 

Selfreported Qu (nonvalidated) 

Outpatients from general practices 

Sleep complaints for at least one month. 

Crosssectional: 

Male:44.7% Female:55.3% Cohort:Male: 60.4%. Female: 39.6% 

Range: 18-65 

Cro

sec97.Coh

42.(fol

Ishigooka, J / 1999 Moderate (5/8) 

Crosssectional Not specified Self- reported Qu 

(nonvalidated) 

Outpatients from general hospitals 

Long-term insomnia defined as sleep complaints for more than one month. 

Male: 41.9% Female:58.1%

Range: 15-65 

88.
48 

Table 3b. Prevalence of chronic insomnia in adults: outpatients of general practice (continued) Author / Year Quality (score) 

Study Design 

Sampling Frame / Method 

Method Of Data Collection 

Participants Duration of Sleep 

Complaints, Definition of Cases and Comparison Groups 

Gender Age 

(years) 

ResRatFolRat

Kappler, C / 2003 Low (2/8) 

Crosssectional Not specified Self- reported Qu 

(nonvalidated) 

Outpatients from general practices 

Diagnosis of chronic insomnia (moderate and severe) according to DSM-III-R criteria. 

Male:49.9% Female:50.1% 

Range: 18-65 

37.

Ohayon, MM / 1999 Moderate (5/8) 

Crosssectional Not specified/ 

non-random

Face-toface clinical interview (validated) 

Outpatients from general practices 

Chronic sleep disorders diagnosed according to DSM-IV criteria. 

Male: 44.5% Female:55.5%

Over 15 Not 

spe

Scochat, T / 1999 Low (1/8) 

Crosssectional All patients presenting 

to participating family medicine clinics/ all asked to participate

Selfadministration Qu (nonvalidated) 

Patients consulting their primary care physician 

Normal sleepers: no sleep complaints; Occasional insomniacs: sleep complaints on an occasional basis. Chronic insomniacs: sleep complaints on a frequent basis; chronic insomniacs defined as such. 

Male:42% Female:58%

Range: 18-87 

Not spe

Terzano, MG / 2004 Moderate (4/8) 

Crosssectional List of general 

practitioner patients/ non-random 

Face-toface clinical interview (nonvalidated) 

Patients presenting to their general practitioner for medical problems other than sleep disorders 

Sleep complaints for at least one month. 

Male:39.1% Female:60.9%

Over 18 Not 

spe

Abbreviations: CI = confidence interval; DSM-III-R = Diagnostic and Statistical Manual of Mental Disorders, Third Edition, Revised; DSM-I

Statistical Manual of Mental Disorders, Fourth Edition; ICSD = International Classification of Sleep Disorders; MSK = musculoskeletal injury

rehab = rehabilitation; SCI = spinal cord injury; TBI = traumatic brain injury 
49 

Table 3c. Prevalence of chronic insomnia in adults: clinical population Author / Year Quality (score) 

Study Design 

Sampling Frame / Method 

Method Of Data Collection 

Participants Duration of Sleep 

Complaints, Definition of Cases and Comparison Groups 

Gender Age 

(years) 

ResRatFolRat

Braga-Neto, P / 2004 Low (2/8) 

Crosssectional Not specified/ 

non-random (consecutive) 

Face-toface clinical interview (nonvalidated) 

Patients with Parkinson's Disease 

Sleep complaints over the last month. 

Male:64% Female:36%

Range: 34-86 

Not spe

Fichtenberg, NL / 2002 Moderate (4/8) 

Crosssectional Patients enrolled in 

outpatient rehab. clinics/ nonrandom (consecutive)

Selfreported Qu (validated), sleep diaries, clinical interview 

Rehabilitation patients (TBI, SCI, MSK) 

DSM-IV criteria TBI: Male: 

56% Female: 44%. SCI:

Male: 76% Female: 24%. MSK:

Male: 20% Female: 80% 

TBI:mean±SD:36.5±14.5 SCI:mean±SD:38.2±13.5 MSK:mean±SD:47.3±12.2

100

Han, SY / 2002 Low (2/8) 

Crosssectional Not specified Self- reported Qu 

(nonvalidated) 

Diabetic haemodialysis patients 

Sleep complaints for at least two months (DSMIV criteria modified). 

Male:61% Female:39%

Range: 27-78 

Not spe

Leppavuori, A / 2002 Moderate (4/8) 

Crosssectional Not specified / 

non-random (consecutive) 

Face-toface clinical interview (validated) 

Stroke patients 

Insomnia complaints for at least one month (DSM-IV criteria). 

Male: 50.9% Female:49.1% 

Range: 55-85 

Not spe
50 

Table 3c. Prevalence of chronic insomnia in adults: clinical population (continued) Author / Year Quality (score) 

Study Design 

Sampling Frame / Method 

Method Of Data Collection 

Participants Duration of Sleep 

Complaints, Definition of Cases and Comparison Groups 

Gender Age 

(years) 

ResRatFolRat

Millar, A / 2004 High (6/9) 

Cross sectional case-control 

Not applicable 

Selfreported Qu (validated), sleep laboratory investigations 

Cases: remitted Bipolar I disorder subjects Controls: healthy subjects

Cases: DSM-IV criteria for Bipolar I disorder. Controls: No psychiatric disorders.

Cases:

Male: 8 Female: 11 Controls:

Male: 8 Female: 11

Cases: range:26-68 Controls: range: 27-67 

Cas59.(folConNot spe

Robbins, L / 1995 Moderate (4/8) 

Retrospective crosssectional Long-term patients of headache 

clinic/ random 

Face-toface interview 

Patients with migraines 

Chronic insomnia assessed by qualitative judgement of the neurologist and patient. 

Male:20.4% Female:79.6%

Range: 18-60 

100

Sabbatini, M / 2002 Moderate (3/8) 

Crosssectional Not specified Face-to- face 

interview (nonvalidated) 

Haemodialysis patients Sleep complaints for at least one month. Male: 55.5% 

Female:44.5%

Mean±SD: 61.0±14.4 

Not spe

Savard, J / 2001 Moderate (4/8) 

Crosssectional Not specified/ 

nonrandom (consecutive)

Selfreported Qu (nonvalidated) and phone interview (validated) 

Women with metastatic breast cancer 

Insomnia symptoms, insomnia syndrome and chronic insomnia syndrome defined by sleep complaints for at least six months (DSMIV criteria). 

All female Range: 

28-90 

88% 

Abbreviations: CI = confidence interval; DSM-III-R = Diagnostic and Statistical Manual of Mental Disorders, Third Edition, Revised; DSM-I

Statistical Manual of Mental Disorders, Fourth Edition; ICSD = International Classification of Sleep Disorders; MSK = musculoskeletal injury

rehab = rehabilitation; SCI = spinal cord injury; TBI = traumatic brain injury 
51 

Table 4. Natural history of chronic insomnia in adults 

Author/Year Quality (Score) 

Study Design 

Time Frame 

Response Rate / Follow-up Rate 

Participants Duration Of Sleep 

Complaints 

Gender Age (years

Hohagen, F / 1994 Moderate (4/8) 

Crosssectional and prospective cohort 

Four months 

Response rate (cross-sectional): 97.9% Follow-up rate (cohort): 42.2% 

Outpatients from general practices 

Sleep complaints for at least one month 

Cross-sectional: Male: 44.7% 

Female: 55.3% 

Cohort: Male: 60.4% 

Female: 39.6%. 

Range:18-65 

Abbreviations: CI = confidence interval 
52 

Table 5. Factors associated with chronic insomnia in adults 

Author / Year Quality (Score) 

Study Design 

Participants Duration of Sleep 

Complaints 

Gender Age (years) Response / 

Follow-up Rate 

Bastien, CH / 2003 Moderate (5/9) 

Crosssectional case-control (unmatched) 

Cases: chronic insomniacs Controls: normal sleepers

Cases: insomnia complaint for at least six months (ICSD-10 and DSM-IV criteria combined) Controls: no sleep complaints

Cases: chronic insomniacs using benzodiazepines: Male: 10, Female: 10. 

Drug-free insomniacs: Male: 9, Female: 11 

Controls: Male: 11, 

Female: 9.

Cases and controls: Over 55

Not specified 

Bixler, EO / 2002 Moderate (3/8) 

Crosssectional General population Insomnia complaint for at least one year Male: 42.6% Female: 57.4% Over 20 66.6% 

Bixler, EO / 1979 Moderate (3/8) 

Crosssectional General population Current or past sleep disorders; results 

provided for chronic insomniacs 

Male: 44% 

Female: 56%

Over 18 Not specified 

Bliwise, NG / 1992 Low (1/9) 

Crosssectional case-control (unmatched) 

Cases: poor sleepers Controls: good sleepers

Cases: sleepcomplaint for at least five years Controls: no sleep complaints

All women Cases: 

mean ± SD: 68.4 ± 8.7, range: 49-82 Controls: mean ± SD: 67.5 ± 9.9, range: 52-95

Not specified 

Bonnet, MH / 1995 High (7/9) 

Crosssectional case-control (matched) 

Cases: chronic insomniacs Controls: normal sleepers

Cases: sleep complaints for at least one year Controls: no sleep complaints

Not specified Cases: 

range: 18-50 Controls:range: 18-50 

Cases: 50% Controls: 50% 

Braga-Neto, P / 2004 Low (2/8) 

Crosssectional Parkinson's Disease 

patients 

Sleep complaints over the last month 

Male: 64% 

Female: 36%

Range: 34-86 

Not specified 
53 

Table 5. Factors associated with chronic insomnia in adults (continued) Author / Year Quality (Score) 

Study Design 

Participants Duration of Sleep 

Complaints 

Gender Age (years) Response / 

Follow-up Rate 

Broman, JE / 1996 High (6/8) 

Crosssectional General population Sleep complaints during the last three months Male: 46.9% Female: 53.1% Range: 20- 64 68% 

Broman, JE / 1992 Moderate (5/9) 

Crosssectional case-control (matched) 

Cases: persistent primary insomniacs Controls: normal sleepers

Cases: persistent sleep complaints Controls: no sleep complaints

Cases: Male: 5, 

Female: 15 

Controls: Male: 5, 

Female: 15

Cases: mean ± SD: 45.8 ± 11.5 Controls: mean ± SD: 45.0 ± 10.2

Not specified 

Chambers, MJ / 1993 Low (1/9) 

Crosssectional case-control (unmatched) 

Cases: chronic insomniacs referred to a sleep clinic Controls: good sleepers

Cases: sleep complaints for at least six months (ASDA criteria) Controls: no sleep complaints

Cases: Male: 35.5%, 

Female: 64.5% 

Controls: Male: 40%, 

Female: 60%

Cases: mean ± SD: 47.5 ± 10.9 Controls: mean ± SD: 45.9 ± 16.0

Not specified 

Coursey, RD / 1975 High (7/9) 

Crosssectional case-control (matched) 

Cases:chronic insomniacsControls:normal sleepers

Cases: sleep complaints for at least two years Controls: no sleep complaints 

Cases: Male: 13, 

Female: 5 

Controls: Male: 13, 

Female: 5

Cases and controls: mean ± SD: 44.7 ± 16.8

Not specified 

Crenshaw, MC / 1999 Moderate (3/9) 

Crosssectional case-control (agematched) 

Cases:insomniacs Controls: normal sleepers

Cases: history of insomnia complaints for ≥ 6 months Controls: no sleep complaints

Cases: Male: 50% 

Female: 50% 

Controls: Male: 50%, 

Female: 50%

Cases:mean ± SD: 67.7 ± 4.8 Controls:mean ± SD: 67.5 ± 5.7

Not specified 
54 

Table 5. Factors associated with chronic insomnia in adults (continued) Author / Year Quality (Score) 

Study Design 

Participants Duration of Sleep 

Complaints 

Gender Age (years) Response / 

Follow-up Rate 

Dorsey, CM / 1997 Low (2/9) 

Crosssectional case-control (unmatched) 

Cases: chronic insomniacs (subjective and objective) Controls: normal sleepers

Cases: sleep complaints > 6 months Controls: no sleep complaints

Male: 17 

Female: 14

Cases and controls: range: 18-25

Not specified 

Edinger, JD / 2000 High (8/9) 

Crosssectional case-control (matched) 

Cases: persistent primary insomniacs Controls: normal sleepers

Cases: sleep complaints > 6 months (DSM-IV criteria) Controls: no sleep complaints

Cases: Male: 32, 

Female: 32 

Controls: Male: 30, 

Female: 31

Cases and controls:

range: 40-79

Cases: 100% (64/64); Controls: 95.3% (61/64) 

Edinger, JD / 2000 Moderate (4/9) 

Crosssectional case-control (age and gendermatched) 

Cases:insomniacs Controls: normal sleepers

Cases: history of 

insomnia complaints for ≥ 6 months 

Controls: no sleep complaints 

Cases: Male: 44.4%, 

Female: 55.6% 

Controls: Male: 48.4% 

Female: 51.6%

Cases and controls:range: 40-79

Cases: 84.4%

Controls: 96.9%

Hajak, G / 2001 High (6/8)  - cross-sectional High (7/9)  - case control 

Crosssectional and casecontrol (matched) 

Crosssectional: General population Casecontrol:

Cases:severe insomniacs Controls:normal sleepers 

Cross-sectional: 

Insomnia disorders during the previous month (DSM-III-R and DSM-IV criteria). Severe insomnia: Sleep complaints during the previous month. Case-control: Cases: 

severe insomnia as defined above Controls: no sleep complaints 

Cross-sectional:Male: 46.8% 

Female: 53.1% 

Over 18 Not specified 
55 

Table 5. Factors associated with chronic insomnia in adults (continued) Author / Year Quality (Score) 

Study Design 

Participants Duration of Sleep 

Complaints 

Gender Age (years) Response / 

Follow-up Rate 

Han, SY / 2002 Low (2/8) 

Crosssectional Diabetic haemodialysis 

patients 

Sleep complaints for at least two months (DSMIV criteria modified) 

Male: 61% 

Female: 39%

Range: 27-78 

Not specified 

Harvey, AG / 2003 Moderate (3/9) 

Crosssectional case-control (unmatched) 

Cases: insomniacs Controls: normal sleepers

Cases: sleep complaints for at least one month (DSM-IV criteria) Controls: no sleep complaints

Cases: Male: 40% 

Female: 60% 

Controls: Male: 36.7% 

Female: 63.3%

Cases: mean ± SD: 20.4 ± 4.7 Controls: mean ± SD: 22.3 ± 8.9

Not specified 

Hauri, PJ / 1997 High (7/9) 

Crosssectional case-control (matched) 

Cases: chronic insomniacs Controls: normal sleepers

Cases: sleep complaints for at leastsix months Controls: no sleep complaints

Cases: Male: 7, 

Female: 19 

Controls: Male: 7, 

Female: 19

Cases and controls: mean ± SD: 47.7 ± 11.8

Not specified 

Healey, ES / 1981 High (8/9) 

Crosssectional case-control (matched) 

Cases: chronic insomniacs Controls: normal sleepers

Cases: sleep complaints within the previous eight years; defined as “chronic” insomniacs Controls: no sleep complaints

Cases: Male: 9, 

Female: 22 

Controls: Male: 9, 

Female: 22

Cases:range: 19-63 Controls: range: 18-63

Not specified 

Hidalgo, MP / 2002 Moderate (5/8) 

Crosssectional Medical students Sleep complaints for at least one month during 

the past year 

Male: 58.2% 

Female: 41.8%

Range: 18-35 

Not specified 
56 

Table 5. Factors associated with chronic insomnia in adults (continued) Author / Year Quality (Score) 

Study Design 

Participants Duration of Sleep 

Complaints 

Gender Age (years) Response / 

Follow-up Rate 

Hohagen, F / 1994 Moderate (4/8) 

Crosssectional Elderly outpatients 

from general practices 

Sleep complaints for at least one month (DSMIII-R criteria) 

Male: 28% 

Female: 72%

Over 65 97.5% 

Hohagen, F / 1993 Moderate (4/8) 

Crosssectional Outpatients from general 

practices 

Sleep complaints during the past month (DSMIII-R criteria) 

Male: 44.7% 

Female: 55.3%

Range: 18-65 

97.9%. 

Ishigooka, J / 1999 Moderate (5/8) 

Crosssectional Outpatients from general 

hospitals 

Sleep complaints for more than 1 month 

Male: 41.9% 

Female: 58.1%

Range: 15-65 

88.3% 

Kageyama, T / 2001 Moderate (5/8) 

Crosssectional Hospital nurses Sleep complaints for at least one month Not specified Range: 24- 59 Not specified 
57 

Table 5. Factors associated with chronic insomnia in adults (continued) Author / Year Quality (Score) 

Study Design 

Participants Duration of Sleep 

Complaints 

Gender Age (years) Response / 

Follow-up Rate 

Kageyama, T / 1997 High (6/8) 

Crosssectional Adult women living in 

urban areas 

Sleep complaints for at least one month (ICD10 and DSM-IV criteria) 

All women Range: 20-

80 

Varied between district 51-59% 

Kales, JD / 1984 Low (1/9) 

Crosssectional case-control (unmatched) 

Cases: 100 

patients with sleep complaints for at least one year, + 114 insomniacs (appropriate data was available) Controls: normal sleepers

Cases: sleep 

complaints for at least one year Controls: no sleepcomplaints

Cases: Male: 41.1% 

Female: 58.9% 

Controls: Male: 41% 

Female: 59%

Cases: mean: 43.1 Controls: mean ± SD: 48.2 ± 1.5 range: 24-80

Cases: not 

specified Controls: 94%

Kales, AK / 1983 Moderate (4/9) 

Crosssectional case-control 

Cases: chronic insomniacs Controls: normal sleepers

Cases: defined as

“chronic” insomniacs Controls: no sleep complaints

Cases: Male: 41% 

Female: 59% 

Controls: Male: 41%. 

Female: 59%

Cases: mean ± SD: 43.1 ± 0.9 range: 18-84 Controls: mean ± SD: 40.9 ± 1.5 range: 19-74

Cases: 93% 

Controls: 97%
58 

Table 5. Factors associated with chronic insomnia in adults (continued) Author / Year Quality (Score) 

Study Design 

Participants Duration of Sleep 

Complaints 

Gender Age (years) Response / 

Follow-up Rate 

Kales, A / 1982 Low (2/9) 

Crosssectional case-control (unmatched) 

Cases: chronic insomniacs Controls: normal sleepers

Cases: sleep complaints > 6 months Controls: no sleep complaints

Cases: Male: 82, 

Female: 118 

Controls: Male: 41, 

Female: 59

Cases:range: 18-78 Controls:range: 18-74

Not specified 

Kappler, C / 2003 Low (2/8) 

Crosssectional Outpatients from general 

practices 

Insomnia disorders diagnosed according to DSM-III-R criteria 

Male: 49.9% 

Female: 50.1% 

Range: 18-65 

37.6% 

Kawada, T / 2003 High (6/8) 

Crosssectional Women from the general 

population 

Sleep complaints for at least one month (ICD10 and DSM-IV criteria) 

All female Range: 20-

80 

50.4% 

Leger, D / 2000 High (6/8) 

Crosssectional General population Sleep complaints for at least one month (DSMIV criteria). 

Sleep complaints over a four-month period was considered "severe insomnia". 

Male: 47% 

Female: 53%

Over 18 85.2% 
59 

Table 5. Factors associated with chronic insomnia in adults (continued) Author / Year Quality (Score) 

Study Design 

Participants Duration of Sleep 

Complaints 

Gender Age (years) Response / 

Follow-up Rate 

Leppavuori, A / 2002 Moderate (4/8) 

Crosssectional Stroke patients Insomnia complaints for at least one month 

(DSM-IV criteria) 

Male: 50.9% 

Female: 49.1%

Range: 55-85 

Not specified 

Levitt, H / 2004 Low (2/9)  - case control  Low (0/9)  - cross sectional 

Crosssectional and casecontrol (agematched) 

Cases: insomniacsControls: normal sleepers

Cases: primary insomnia diagnosed according to DSM-IV criteria Controls: no sleep complaints

Cases: Male: 14.3% 

Female: 85.7% 

Controls: Male: 12.5% 

Female: 87.5% 

Cases: mean ± SD: 24.1 ± 3.4 range: 20-30 Controls: mean ± SD: 23.3 ± 1.9 range: 20-30

100% 

Lichstein, KL / 2001 Moderate (5/9) 

Crosssectional case-control (unmatched) 

Cases: primary or secondary insomniacs Controls: normal sleepers 

Cases: sleep complaints of at least six months (ASDA criteria) Controls: no 

sleep complaints

Cases: Primary insomnia: Male: 24, 

Female: 58 

Secondary insomnia: Male: 23, Female: 23 

Controls: Male: 26, 

Female: 35

Cases and controls: Over 58 

Not specified 

Linzmayer, L / 2002 Low (1/9) 

Crosssectional case-control (unmatched) 

Cases: nonorganic insomniacs associated with different mental disorders Controls:normal sleepers

Cases: Group A: nonorganic insomnia: ICSD classification of psychophysiological insomnia, DSM-IV classification of primary insomnia. All other cases had insomnia plus a concomitant mental disorder. Controls: no sleep complaints

Cases: Female: 51.1% 

Male: 48.9% 

Range: 22-63 

Not specified 
60 

Table 5. Factors associated with chronic insomnia in adults (continued) Author / Year Quality (Score) 

Study Design 

Participants Duration of Sleep 

Complaints 

Gender Age (years) Response / 

Follow-up Rate 

Lundh, LG / 1997 Moderate (5/9) 

Crosssectional case-control (matched) 

Cases: persistent insomnia Controls: normal sleepers

Cases: long-standing problems with insomnia Controls: no sleep complaints

Cases: Male: 4, 

Female: 16 

Controls: Male: 4, 

Female: 16

Cases and controls: range: 20-65 Cases mean ± SD: 46.5 ± 11.3 Controls mean ± SD: 45.5 ± 11.1

Not specified 

Martikainen, K / 2003 Moderate (5/8) 

Crosssectional General population Sleep complaints during the previous three 

months 

Male: 42.2% 

Female: 57.8%

Range: 41-55 

52.6% 

Mendelson, WB / 1984 Moderate (4/9) 

Crosssectional case-control (matched) 

Cases: insomniacs Controls: normal sleepers

Cases: sleep complaints for at least one year Controls: no sleep complaints

Cases: Male: 1, 

Female: 9 

Controls: Male: 1, 

Female: 9

Cases and controls: range: 22-44 

Not specified 

Niemcewicz, S / 2001 Low (2/9) 

Case-control (matched for gender, age, and education) 

Cases: primary insomniacs recruited from sleep disorder clinic. Controls: normal sleepers

Cases: primary insomnia diagnosed according to DSM-IV criteria Controls: no sleep complaints

Cases: Male: 44%, 

Female: 56% 

Controls: Male: 44%, 

Female: 56% 

Mean ± SD: 40.8 ± 11.3 Range: 21-55 

100% 

Ohayon, MM / 2003 High (7/8) 

Crosssectional General population Sleep complaints > 6 months Male: 47.9% Female: 52.1% Over 15 78.6% 
61 

Table 5. Factors associated with chronic insomnia in adults (continued) Author / Year Quality (Score) 

Study Design 

Participants Duration of Sleep 

Complaints 

Gender Age (years) Response / 

Follow-up Rate 

Ohayon, MM / 2002 High (8/8) 

Crosssectional General population Chronic insomnia diagnosed according to 

ICSD and DSM-IV criteria 

Male: 49.5% 

Female: 50.5%

Range: 15-90 

91.4% 

Ohayon, MM / 2002 High (8/8) 

Crosssectional General population Sleep complaints during the past year (DSM-IV 

criteria) 

Male: 48.2% 

Female: 51.8%

Over 15 89.4% 

Ohayon, MM / 2001 High (8/8) 

Crosssectional General population Chronic Insomnia diagnosed according to 

DSM-IV criteria 

Male: 47.9% 

Female: 52.1%

Over 15 78% 

Pallesen, S / 2002 High (7/9) 

Crosssectional case-control (matched) 

Cases: chronic primary insomniacs Controls: 1) normal sleepers, 2) community sample

Cases: chronic primary insomnia diagnosed according to DSM-IV criteria Controls: 1) no sleep complaints, 2) community sample

Cases: Male: 11, 

Female: 49. 

Controls: Good sleepers: Male: 9, 

Female: 32 

Community: Male: 19, 

Female: 41

Cases:range: 60-84 Controls: Good sleepers: 63-83; Community: 60-86 

Cases: not specified Controls: Good sleepers: not specified Community: 82.6%. 

Pavlova, M / 2001 Moderate (4/9) 

Crosssectional case-control (unmatched) 

Cases: primary insomniacs Controls: normal sleepers

Cases: primary Insomnia diagnosed according to DSM-IV criteria Controls: no sleep complaints

Not specified Cases: 

mean ± SD: 45.9 ± 14 Controls: mean ± SD: 44.6 ± 15

Not specified 
62 

Table 5. Factors associated with chronic insomnia in adults (continued) Author / Year Quality (Score) 

Study Design 

Participants Duration of Sleep 

Complaints 

Gender Age (years) Response / 

Follow-up Rate 

Perlis, ML / 2001 Moderate (5/9) 

Crosssectional case-control (matched for age, sex, and body mass) 

Cases:insomniacs Controls:good sleepers

Cases:psychophysiologic insomnia for ≥ 6 months 

(ICSD criteria) Controls: no sleep complaints

Cases: Male: 50%, 

Female: 50% 

Controls: Male: 40%, 

Female: 60%

Cases:mean ± SD: 30.6 ± 8.9 Controls:mean ± SD: 32.3 ± 11.5

Not specified 

Riedel, BW / 2004 High (6/8) 

Crosssectional General population Sleep complaints for at least six months (ICSD 

criteria) 

Male: 49.3% 

Female: 50.7%

Range: 20-98 

43.4% 

Rocha, FL / 2002 High (7/8) 

Crosssectional Elderly from the general 

population 

Sleep complaint during the last 30 days 

Male: 38.9%

Female: 61.1%

Over 60 87% 

Rocha, FL / 2002 High (7/8) 

Crosssectional General population Sleep complaints in the last month Male: 44.3% Female: 55.7% Over 18 87.3% 
63 

Table 5. Factors associated with chronic insomnia in adults (continued) Author / Year Quality (Score) 

Study Design 

Participants Duration of Sleep 

Complaints 

Gender Age (years) Response / 

Follow-up Rate 

Roth, T / 1999 Moderate (3/8) 

Crosssectional General population Sleep complaints on a frequent basis; defined 

as “chronic” insomniacs 

Not specified Range: 18-

65 

51.2% 

Sabbatini, M / 2002 Moderate (3/8) 

Crosssectional Haemo- dialysis 

patients 

Sleep complaints for at least one month 

Male: 55.5% 

Female: 44.5%

Mean ± SD: 61.0 ± 14.4 

Not specified 

Saletu-Zyhlarz, G / 1997 Low (1/9) 

Crosssectional case-control (unmatched) 

Cases: nonorganic 

insomniacs with concomitant generalized anxiety disorder (ICD-10) Controls: normal sleepers

Cases: sleep complaint 

for at least one month Controls: no sleep complaints

Cases: Male: 43.2%, 

Female: 56.8% 

Controls: Male: 45.5%, 

Female: 54.5%

Cases: mean ± SD: 43.2 ±11.7 range: 24-65 Controls: mean ± SD: 43.0 ±11.7 range: 24-65

Cases: 100% Controls: 77.3%

Savard, J / 2001 Moderate (4/8) 

Crosssectional Women with metastatic 

breast cancer 

Insomnia symptoms, insomnia syndrome and chronic insomnia syndrome with sleep complaints for at least six months (DSM-IV criteria) 

All female Range: 28-

90 

88% 
64 

Table 5. Factors associated with chronic insomnia in adults (continued) Author / Year Quality (Score) 

Study Design 

Participants Duration of Sleep 

Complaints 

Gender Age (years) Response / 

Follow-up Rate 

SchneiderHelmert, D / 1987 High (7/9) 

Crosssectional case-control (matched) 

Cases:chronic insomniacs referred to a sleep clinicControls:normal sleepers

Cases: persistent psychophysiological insomnia diagnosed by ASDC criteria Controls: no sleep complaints 

Cases: Male: 7, 

Female: 9 

Controls: Male: 7, 

Female: 9

Cases: range: 32-61 Controls: range: 28-61 

Not specified 

Shochat, T / 1999 Low (1/8) 

Crosssectional Patients consulting 

their primary care physician 

Occasionalinsomniacs: sleep complaints on an occasional basis Chronic insomniacs: sleep complaints on a frequent basis; defined as “chronic” insomniacs Normal Sleepers: no sleep complaints 

Male: 42% 

Female: 58% 

Range: 18-87 

Not specified 

Seidel, WF / 1984 High (6/9) 

Crosssectional case-control (matched) 

Cases: chronic insomniacs Controls: normal sleepers

Cases: sleep complaints for at least three months (ASDC criteria) Controls: no 

sleep complaints

Cases: Male: 15, 

Female: 23 

Controls: Male: 15, 

Female: 23

Cases and controls: mean ± SD: 29 ± 5 

Not specified 

Sharpley, AL / 1997 Moderate (5/9) 

Crosssectional case-control (gender matched) 

Cases: insomniacs Controls:normal sleepers

Cases: primary insomnia diagnosed according to DSM-II-R diagnosis Controls: no sleep complaint

Cases: Male: 50% 

Female: 50% 

Controls: Male: 50% 

Female: 50%

Cases: mean ± SD: 54.7 ± 40-69 Controls: mean ± SD: 53.9 ± 40-68

100% both groups 
65 

Table 5. Factors associated with chronic insomnia in adults (continued) Author / Year Quality (Score) 

Study Design 

Participants Duration of Sleep 

Complaints 

Gender Age (years) Response / 

Follow-up Rate 

Shaver, JLF / 2002 High (6/9) 

Crosssectional case-control (unmatched) 

Cases:Psycho physiologictype insomniacs and subjectiveonly type insomniacs Controls:normal sleepers

Cases: sleep complaints for at least three months Controls: no sleep complaints

All women Cases: PPtype 

insomnia: mean ± SD: 46.7 ± 3.3, SO-type insomnia: mean ± SD: 46.1 ± 4.4 Controls:mean ± SD: 44.4 ± 3.5

Not specified 

Sugerman, JL / 1985 High (6/9) 

Crosssectional case-control (matched) 

Cases: insomniacs Controls: normal sleepers

Cases: sleep complaints for at least six months Controls: no sleep complaints

Cases: 1) Objective insomnia: Male: 2, 

Female: 6 

2) Subjective insomnia: Male: 2, 

Female: 6 

Controls: Male: 2, 

Female: 6

Cases and controls: range: 21-55

Not specified 

Taylor, DJ / 2003 High (6/8) 

Crosssectional Community volunteers Sleep complaints for at least six months Male: 49.4% Female: 50.6% Range: 20- 98 49% 

Terzano, MG / 2004 Moderate (4/8) 

Crosssectional Patients presenting to 

their GP for medical problems other than sleep disorders 

Sleep complaints for at least one month 

Male: 39.1% 

Female: 60.9%

Over 18 Not specified 
66 

Table 5. Factors associated with chronic insomnia in adults (continued) Author / Year Quality (Score) 

Study Design 

Participants Duration of Sleep 

Complaints 

Gender Age (years) Response / 

Follow-up Rate 

Vgontzas, AN / 1995 Low (2/9) 

Crosssectional case-control (unmatched) 

Cases: insomniacs from the community and a sleep clinic Controls:normal sleepers from the community

Cases: sleep complaints for more than six months Controls: no sleep complaints

Cases: Male: 49.9% 

Female: 50.1% 

Controls:Male: 41.3% 

Female: 58.7%

Cases:range: 18-86 Controls: range: 16-80 

Not specified 

Vignola, A / 2000 Moderate (5/9) 

Crosssectional case-control (unmatched) 

Cases: chronic insomniacs (using or not benzodiazepines) Controls: normal sleepers

Cases: sleep complaints > 6 months Controls: no sleep complaints

Cases: Chronic insomnia using benzodiazepines: Male: 10, Female: 10. Drug-free insomnia: Male: 9, Female: 11 

Controls: Male: 11, 

Female: 9

Cases and Controls: Over 55

Not specified 

Vincent, NK / 2000 Moderate (4/9) 

Crosssectional case-control (unmatched) 

Cases: chronic insomniacs from the community Controls: normal sleepers

Cases: sleep complaints for at least the previous six months (DSM-IV criteria) Controls: no sleep complaints

Cases: Male: 28%, 

Female: 72% 

Controls: Not specified

Cases: mean ± SD: 46.91±10.04 Controls: mean ± SD: 39.64±11.49

Not specified 

Wang, W / 2001 Moderate (4/9) 

Crosssectional case-control (unmatched) 

Cases: chronic primary insomniacs. Controls: Normal sleepers

Cases: diagnosis of chronic primary insomnia according to DSM-IV criteria Controls: no sleep complaints

Cases: Male: 11, 

Female: 12 

Controls: Male: 9, 

Female: 19

Cases: mean ± SD: 30.2 ± 7.0 Controls: mean ± SD: 27.2 ± 5.0

Cases: 100% Controls: 89.2% 
67 

Table 5. Factors associated with chronic insomnia in adults (continued) Author / Year Quality (Score) 

Study Design 

Participants Duration of Sleep 

Complaints 

Gender Age (years) Response / 

Follow-up Rate 

Yeo, BKL / 1996 Moderate (3/8) 

Crosssectional General population Sleep complaints for the past year Male: 50% Female: 50% Range: 15- 55 Not specified 

Zammit, GK / 1999 Moderate (4/9) 

Crosssectional case-control (unmatched) 

Cases: primary insomniacs Controls: normal sleepers

Cases: sleep complaints for at least one month Controls: no sleep complaints

Cases: Male: 104, 

Female: 157 

Controls: Male: 38, 

Female: 63

Cases: mean ± SD: 44.1 ± 14.04 Controls: mean ± SD: 37.1 ± 12.7

Not specified 

Abbreviations: ASDA = American Sleep Disorders Association; ASDC = Association of Sleep Disorders Centers; DSM-III-R = Diagnosti

Mental Disorders, Third Edition, Revised; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition; GP = general p

International Classification for Disease Version 10; PP = psychophysiologic; SD = standard deviation; SO = subjective only 
68 

Table 6. Sleep onset latency: benzodiazepines versus placebo 

No. of Participants 

Categorization Sub-group No. of studies 

Tr. Pl. 

Point 

Estimate 

(min.) 

95% Confidence 

Interval (min.) Hete

 All Studies 32 1345 961 -16.5 (-20.5, -12.5) Substant

Brotizolam 5 101 92 -10.5 (-16.2, -4.8) NegligEstazolam 3 235 125 -10.2 (-14.5, -5.9) NegligFlunitrazepam 2 49 30 -23.6 (-62.8, 15.6) SubstantFlurazepam 10 317 215 -23.2 (-34.3, -12.2) SubstantLormetazepam 4 137 112 -14.8 (-21.8, -7.7) MinimaNitrazepam 1 37 19 -47.4 (-76.6, -18.2) Quazepam 3 51 41 -14.2 (-23.7, -4.6) NegligTemazepam 4 128 78 -11.6 (-23.6, 0.4) Substant

Drug Type (*) 

Triazolam 8 290 249 -19.7 (-28.4, -11.0) Substant

Absent 28 1147 803 -15.4 (-19.5, -11.2) Substant

Psychiatric Illness 

Present 4 198 158 -25.8 (-41.7, -9.8) Substant

Short Term 30 1275 898 -16.5 (-20.5, -12.4) Substant

Length of Treatment 

Long Term 2 70 63 -18.5 (-51.3, 14.4) Neglig

Adult 26 999 775 -15.4 (-19.9, -10.9) Substant

Age 

Elderly 6 346 186 -19.2 (-26.6, -11.7) Moderat

Male 3 43 43 -17.0 (-29.5, -4.5) NegligFemale 1 6 6 -10.0 (-19.4, -0.6) 

Gender 

Mixed 28 1296 912 -16.9 (-21.2, -12.6) Substant

PSG 9 181 170 -7.1 (-12.5, -1.7) Substant

Method of Measurement (*) 

Sleep Diary 25 1216 842 -18.3 (-22.0, -12.4) Moderat
69 

Table 6. Sleep onset latency: benzodiazepines versus placebo (continued) 

Categorization Sub-group No. of studies No. of Participants 

Point 

Estimate 

(min.) 

95% Confidence 

Interval (min.) Hete

Moderate 18 648 400 -13.5 (-18.7, -8.3) Substant

Study Quality 

High 14 697 561 -19.2 (-24.7, -13.7) Substant

Abbreviations: min. = minutes; NA = not applicable; No. = number; Pl. = placebo group; PSG = polysomnography; Tr. = treatment gro

*Sum of studies in each group is greater than total studies because some studies are included in multiple groups. 
70 

Table 7. Other outcomes: benzodiazepines versus placebo 

No. of Participants 

Outcome (units) Comparison No. of studies 

Tr. Pl. 

Point Estimate 

(min.) 

95% Confidence 

Interval 

Efficacy Outcomes 

Wakefulness After Sleep Onset (min.) Mean Difference 8 153 137 -23.1 (-35.7, -10.5) Sleep Efficiency (%) Mean Difference 10 187 168 6.3 (4.7, 8.0) Total Sleep Time (min.) Mean Difference 17 416 404 39.1 (27.2, 51.0) Sleep Quality (SD) Standardized Mean Difference 24 1243 857 0.80 (0.66, 0.94) 

Safety Outcomes 

Adverse Events Risk Difference 34 2566 1595 0.15 (0.10, 0.20) Abbreviations: min. = minutes; No. = number; Pl. = placebo group; SD = standard deviation; Tr. = treatment group 
71 

Table 8. Sleep onset latency: non-benzodiazepines versus placebo 

No. of Participants 

Categorization Sub-group No. of studies 

Tr. Pl. 

Point 

Estimate 

(min.) 

95% Confidence 

Interval (min.) Hetero

 All Studies 29 2913 1614 -18.1 (-22.5, -13.7) Substantia

Eszopiclone 1 593 195 -16.7 (-29.4, -4.0) NZaleplon 8 1145 433 -20.1 (-29.8, -10.5) SubstantiaZolpidem 17 997 808 -12.8 (-16.4, -9.1) Minimal 

Drug Type (*) 

Zopiclone 5 178 178 -30.9 (-49.4, -12.4) Substantia

Absent 28 2837 1534 -18.7 (-23.2, -14.2) Substantia

Psychiatric Illness 

Present 1 76 80 -3.7 (-16.1, 8.7) N

Short Term 24 2591 1338 -18.4 (-23.4, -13.4) Substantia

Length of Treatment (*) 

Long Term 6 915 471 -16.8 (-25.1, -8.6) Moderate 

Adult 26 2520 1355 -18.7 (-23.9, -13.5) Substantia

Age 

Elderly 3 393 259 -16.1 (-21.2, -10.9) Negligib

Male 1 12 12 -10.3 (-36.6, 16.0) NFemale 1 6 6 -34.8 (-84.6, 15.0) N

Gender 

Mixed 27 2895 1596 -18.2 (-22.7, -13.6) Substantia

PSG 9 278 185 -16.7 (-24.3, -9.0) Moderate 

Method of Measurement (*) 

Sleep Diary 24 2809 1543 -18.5 (-23.4, -13.6) Substantia

Moderate 20 2462 1219 -14.1 (-16.9, -11.3) Negligib

Study Quality 

High 9 451 395 -29.7 (-43.7, -15.6) Substantia

Abbreviations: min. = minutes; NA = not applicable; No. = number; Pl. = placebo group; PSG = polysomnography; Tr. = treatment gro

*Sum of studies in each group is greater than total studies because some studies are included in multiple groups. 
72 

Table 9. Other outcomes: non-benzodiazepines versus placebo 

No. of Participants 

Outcome (units) Comparison No. of studies 

Tr. Pl. 

Point Estimate 95% Confidence Interval 

Efficacy Outcomes 

Wakefulness After Sleep Onset (min.) Mean Difference 9 950 552 -12.6 (-23.0, -2.3) Sleep Efficiency (%) Mean Difference 7 172 115 5.9 (3.7, 8.0) Total Sleep Time (min.) Mean Difference 23 2505 1247 28.0 (21.3, 34.6) Sleep Quality (SD) Standardized Mean Difference 20 2818 1554 0.48 (0.37, 0.59) Quality of Life (SD) Standardized Mean Difference 1 231 227 0.45 (0.27, 0.64) 

Safety Outcomes 

Adverse Events Risk Difference 21 3718 1951 0.05 (0.01, 0.09) Abbreviations: min. = minutes; NA = not applicable; No. = number; Pl. = placebo group; SD = standard deviation; Tr. = treatment grou
73 

Table 10. Sleep onset latency: antidepressants versus placebo 

No. of Participants 

Categorization Sub-group No. of studies 

Tr. Pl. 

Point 

Estimate 

(min.) 

95% Confidence 

Interval (min.) Hetero

All Studies 6 159 166 -7.4 (-10.5, -4.4) Minimal 

Doxepin 3 40 40 -6.7 (-10.7, -2.6) Moderate Trazodone 2 100 108 -12.2 (-22.3, -2.2) Negligib

Drug Type 

Trimipramine 1 19 18 -15.4 (-36.8, 6.0) N

Absent 5 152 159 -7.2 (-10.3, -4.1) Minimal 

Psychiatric Illness 

Present 1 7 7 -17.4 (-36.8, 2.0) N

Short Term 6 159 166 -7.8 (-10.2, -5.4) Negligib

Length of Treatment (*) 

Long Term 1 10 10 -4.4 (-7.7, -1.1) N

PSG 4 59 59 -7.0 (-10.7, -3.3) Moderate 

Method of Measurement 

Sleep Diary 2 100 108 -12.2 (-22.3, -2.2) Negligib

Moderate 5 152 159 -7.2 (-10.3, -4.1) Minimal 

Study Quality 

High 1 7 7 -17.4 (-36.8, 2.0) N

Abbreviations: min. = minutes; NA = not applicable; No. = number; Pl. = placebo group; PSG = polysomnography; Tr. = treatment gro

*Sum of studies in each group is greater than total studies because some studies are included in multiple groups. 
74 

Table 11. Other outcomes: antidepressants versus placebo 

No. of Participants 

Outcome (units) Comparison No. of studies 

Tr. Pl. 

Point 

Estimate 

95% Confidence 

Interval 

Efficacy Outcomes 

Wakefulness After Sleep Onset (min.) Mean Difference 3 123 131 -11.4 (-16.2, -6.6) NSleep Efficiency (%) Mean Difference 4 59 58 13.8 (9.6, 18.0) NTotal Sleep Time (min.) Mean Difference 5 66 65 53.1 (2.8, 103.5) SubSleep Quality (SD) Standardized Mean Difference 3 162 169 0.63 (0.27, 0.99) Sub

Safety Outcomes 

Adverse Events Risk Difference 3 143 145 0.09 (0.01, 0.18) NAbbreviations: min. = minutes; No. = number; Pl. = placebo group; SD = standard deviations; Tr. = treatment group 
75 

Table 12. All outcomes: L-trytophan versus placebo 

No. of Participants 

Outcome (units) Comparison No. of studies 

Tr. Pl. 

Point 

Estimate 

95% Confidence 

Interval 

Efficacy Outcomes 

Sleep Onset Latency (min.) Mean Difference 2 47 41 -11.0 (-33.0, 11.1) Abbreviations: min. = minutes; No. = number; Pl. = placebo group; Tr. = treatment group 
76 

Table 13. All outcomes: melatonin versus placebo 

No. of Participants 

Outcome (units) Comparison No. of studies 

Tr. Pl. 

Point 

Estimate 

95% Confidence 

Interval 

Efficacy Outcomes 

Sleep Onset Latency (min.) Mean Difference 8 103 103 -8.3 (-14.5, -2.0) Wakefulness After Sleep Onset (min.) Mean Difference 5 68 68 -9.7 (-33.6, 14.3) Sleep Efficiency (%) Mean Difference 8 121 121 3.3 (-0.4, 6.9) Total Sleep Time (min.) Mean Difference 7 95 95 5.8 (-13.2, 24.8) Sleep Quality (SD) Standardized Mean Difference 3 35 35 0.25 (-0.22, 0.73) 

Safety Outcomes 

Adverse Events Risk Difference 2 27 27 0.09 (-0.11, 0.29) Abbreviations: min. = minutes; No. = number; Pl. = placebo group; SD = standard deviation; Tr. = treatment group 
77 

Table 14. All outcomes: valerian versus placebo 

No. of Participants 

Outcome (units) Comparison No. of studies 

Tr. Pl. 

Point 

Estimate 

95% Confidence 

Interval 

Efficacy Outcomes 

Sleep Onset Latency (min.) Mean Difference 3 51 50 -1.3 (-21.4, 18.9) Wakefulness After Sleep Onset (min.) Mean Difference 1 10 9 -8.4 (-15.9, -1.0) Sleep Efficiency (%) Mean Difference 2 26 25 -0.1 (-3.4, 3.2) Total Sleep Time (min.) Mean Difference 1 10 9 0.8 (-50.6, 52.2) Sleep Quality (SD) Standardized Mean Difference 3 50 49 1.38 (-0.49, 3.25) 

Safety Outcomes 

Adverse Events Risk Difference 3 51 50 -0.06 (-0.48, 0.35) Abbreviations: min. = minutes; NA = not applicable; No. = number; Pl. = placebo group; SD = standard deviation; Tr. = treatment grou
78 

Table 15. Sleep onset latency: relaxation therapy versus placebo 

No. of Participants 

Categorization Sub-group No. of studies 

Tr. Pl. 

Point 

Estimate 

(min.) 

95% Confidence 

Interval (min.) Heteroge

All Studies 13 199 185 -14.6 (-29.3, 0.2) Substantial (

Autogenic Training 1 8 4 -27.0 (-126.2, 72.2) NA Breathing Training 1 23 23 -60.0 (-64.5, -55.5) NA EMG Feedback Training 3 27 27 -5.3 (-28.4, 17.8) Substantial (Group 1 14 14 -5.5 (-10.8, -0.2) NA Hypnotic 1 15 15 -16.3 (-24.3, -8.3) NA Progressive 5 61 55 -15.7 (-39.2, 7.8) Moderate (I

Relaxation Description(*) 

Relaxation 4 51 47 -5.3 (-17.3, 6.8) Substantial (

Short Term 9 124 114 -22.0 (-41.0, -2.9) Substantial (

Length of Treatment 

Long Term 4 75 71 1.9 (-6.7, 10.6) Minimal (I2

Adult 12 172 162 -15.9 (-31.5, -0.3) Substantial (

Age 

Elderly 1 27 23 -0.2 (-10.4, 10.0) NA 

Female 1 14 14 -5.5 (-10.8, -0.2) NA Gender 

Mixed 12 185 171 -15.5 (-32.0, 0.9) Substantial (

Low 8 101 94 -9.1 (-16.0, -2.2) Substantial (

Study Quality 

Moderate 5 98 91 -17.6 (-54.2, 19.0) Substantial (

Abbreviations: EMG = electromyographic; min. = minutes; NA = not applicable; No. = number; Pl. = placebo group; Tr. = treatment gr

*Sum of studies in each group is greater than total studies because some studies are included in multiple groups. 
79 

Table 16. Other outcomes: relaxation therapy versus placebo 

No. of Participants 

Outcome (units) Comparison No. of studies 

Tr. Pl. 

Point 

Estimate 

95% Confidence 

Interval 

Efficacy Outcomes 

Wakefulness After Sleep Onset (min.) Mean Difference 3 60 57 -1.6 (-14.1, 10.8) Sleep Efficiency (%) Mean Difference 2 50 47 0.4 (-3.7, 4.6) Total Sleep Time (min.) Mean Difference 3 60 57 23.0 (2.7, 43.4) Sleep Quality (SD) Standardized Mean Difference 3 50 47 0.37 (-0.49, 1.24) SAbbreviations: min. = minutes; No. = number; Pl. = placebo group; SD = standard deviation; Tr. = treatment group 
80 

Table 17. Sleep onset latency: cognitive/behavioral therapy versus placebo 

No. of Participants 

Categorization Sub-group No. of studies 

Tr. Pl. 

Point 

Estimate 

(min.) 

95% Confidence 

Interval (min.) Heteroge

All Studies 9 152 124 -4.6 (-9.8, 0.6) Minimal (I2: 

Multicomponent CBT 

2 20 19 -2.6 (-15.4, 10.2) Moderate (I2: 

Paradoxical Intention 3 37 23 -3.7 (-28.7, 21.3) Moderate (I2: Sleep Compression 1 24 23 -0.8 (-13.7, 12.1) NA Stimulus Control 4 58 46 -7.3 (-18.3, 3.7) Moderate (I2: 

Cognitive Behavioral Therapy Type (*) 

NonSuppression 1 13 13 -9.7 (-24.2, 4.8) NA 

Short Term 7 99 87 -4.3 (-10.4, 1.8) Minimal (I2: 

Length of Treatment 

Long Term 2 53 37 -8.5 (-24.7, 7.8) Moderate (I2: 

Adult 8 128 101 -5.3 (-11.4, 0.7) Minimal (I2: 

Age 

Elderly 1 24 23 -0.8 (-13.7, 12.1) NA 

Low 5 60 62 -8.1 (-14.6, -1.6) Negligible (

Study Quality 

Moderate 4 92 62 -1.2 (-7.8, 5.5) Minimal (I2: 

Abbreviations: min. = minutes; NA = not applicable; No. = number; Pl. = placebo group; Tr. = treatment group 

*Sum of studies in each group is greater than total studies because some studies are included in multiple groups. 
81 

Table 18. Other outcomes: cognitive/behavioral therapy versus placebo 

No. of Participants 

Outcome (units) Comparison No. of studies 

Tr. Pl. 

Point 

Estimate 

95% Confidence 

Interval 

Efficacy Outcomes 

Wakefulness After Sleep Onset (min.) Mean Difference 8 128 120 -18.2 (-30.4, -6.0) SSleep Efficiency (%) Mean Difference 4 75 74 5.5 (1.2, 9.9) STotal Sleep Time (min.) Mean Difference 5 85 84 0.7 (-28.1, 29.5) SSleep Quality (SD) Standardized Mean Difference 6 94 95 0.38 (0.09, 0.67) Abbreviations: min. = minutes; No. = number; Pl. = placebo group; SD = standard deviation; Tr. = treatment group 
82 

Table 19. Sleep onset latency: indirect comparisons of main pharmacological treatment categories 

Comparison Difference in SOL (min.) 95% Confidence Interval (min.) Difference Favours: Sig

BNZ versus NBNZ 1.6 (-4.3, 7.5) NBNZ BNZ versus ADP -9.1 (-14.1, -4.1) BNZ BNZ versus LT -5.5 (-28.0, 17.0) BNZ BNZ versus MLT -8.2 (-15.7, -0.7) BNZ BNZ versus VAL -15.2 (-35.8, 5.4) BNZ NBNZ versus ADP -10.7 (-16.0, -5.4) NBNZ NBNZ versus LT -7.1 (-29.6, 15.4) NBNZ NBNZ versus MLT -9.8 (-17.5, -2.1) NBNZ NBNZ versus VAL -16.8 (-37.5, 3.9) NBNZ ADP versus LT 3.6 (-18.7, 25.9) LT ADP versus MLT 0.9 (-6.1, 7.9) MLT ADP versus VAL -6.1 (-26.5, 14.3) ADP LT versus MLT -2.7 (-25.7, 20.3) LT LT versus VAL -9.7 (-39.6, 20.2) LT MLT versus VAL -7.0 (-28.2, 14.2) MLT Abbreviations: ADP = antidepressants; BNZ = benzodiazepines; LT = L-tryptophan; min. = minutes; MLT = melatonin; NBNZ = non-b

sleep onset latency; VAL = valerian 
83 

Table 20. Adverse events: indirect comparisons of main pharmacological treatment categories 

Comparison Difference in risk difference 95% Confidence Interval Difference Favors: 

S

BNZ versus NBNZ 0.10 (0.04, 0.16) NBNZ BNZ versus ADP 0.06 (-0.04, 0.16) ADP BNZ versus MLT 0.06 (-0.15, 0.27) MLT BNZ versus VAL 0.21 (-0.20, 0.62) VAL NBNZ versus ADP -0.04 (-0.14, 0.06) NBNZ NBNZ versus MLT -0.04 (-0.24, 0.16) NBNZ NBNZ versus VAL 0.11 (-0.30, 0.52) VAL ADP versus MLT 0.00 (-0.22, 0.22) neither ADP versus VAL 0.15 (-0.27, 0.57) VAL  MLT versus VAL 0.15 (-0.31, 0.61) VAL Abbreviations: ADP = antidepressants; BNZ = benzodiazepines; MLT = melatonin; NBNZ = non-benzodiazepines; VAL = valerian
84 

Table 21. All outcomes: barbiturates versus placebo 

No. of Participants 

Outcome (units) Comparison No. of studies 

Tr. Pl. 

Point Estimate 95% Confidence Interv

Efficacy Outcomes 

Sleep Onset Latency (min.) Mean Difference 2 166 71 -4.5 (-14.2, 5.2) 

Safety Outcomes 

Adverse Events Risk Difference 1 144 48 0.02 (-0.10, 0.15) Abbreviations: min. = minutes; NA = not applicable; No. = number; Pl. = placebo group; Tr. = treatment group 
85 

Table 22. All outcomes: hormones versus placebo 

No. of Participants 

Outcome (units) Comparison No. of studies 

Tr. Pl. 

Point Estimate 95% Confidence Interval 

Efficacy Outcomes 

Sleep Onset Latency (min.) Mean Difference 1 33 16 -6.9 (-17.3, 3.6) Sleep Efficiency (%) Mean Difference 1 33 16 5.0 (0.3, 9.7) Total Sleep Time (min.) Mean Difference 1 33 16 21.9 (-0.2, 44.1) Sleep Quality (SD) Standardized Mean Difference 1 33 16 0.83 (0.21, 1.45) Abbreviations: min. = minutes; NA = not applicable; No. = number; Pl. = placebo group; SD = standard deviations; Tr. = treatment gro
86 

Table 23. All outcomes: alcohol versus placebo 

No. of Participants 

Outcome (units) Comparison No. of studies 

Tr. Pl. 

Point Estimate 95% Confidence Interval 

Efficacy Outcomes 

Sleep Onset Latency (min.) Mean Difference 1 11 11 4.7 (-7.5, 16.9) Wakefulness After Sleep Onset (min.) Mean Difference 1 11 11 11.3 (-9.1, 31.7) Sleep Efficiency (%) Standardized Mean Difference 1 11 11 -3.4 (-8.7, 1.9) Abbreviations: min. = minutes; NA = not applicable; No. = number; Pl. = placebo group; Tr. = treatment group 
87 

Table 24. All outcomes: low energy emission therapy versus placebo 

No. of Participants 

Outcome (units) Comparison No. of studies 

Tr. Pl. 

Point Estimate 95% Confidence Interval 

Efficacy Outcomes 

Sleep Onset Latency (min.) Mean Difference 1 49 48 -15.6 (-32.1, 0.9) Wakefulness After Sleep Onset (min.) Mean Difference 1 49 48 -23.5 (-50.0, 3.0) Sleep Efficiency (%) Mean Difference 1 49 48 10.5 (4.2, 16.8) Total Sleep Time (min.) Mean Difference 1 49 48 56.0 (21.7, 90.3) 

Safety Outcomes 

Adverse Events Risk Difference 1 49 48 0.04 (-0.11, 0.18) Abbreviations: min. = minutes; NA = not applicable; No. = number; Pl. = placebo group; SD = standard deviation; Tr. = treatment grou
88 

Table 25. All outcomes: relaxation therapy and cognitive/behavioral therapy versus placebo 

No. of Participants 

Outcome (units) Comparison No. of studies 

Com. Pl. 

Point Estimate 95% Confidence Interval 

Sleep Onset Latency (min.) Mean Difference 4 45 46 -21.5 (-42.2, -0.8) Wakefulness After Sleep Onset (min.) Mean Difference 2 23 26 -7.6 (-26.3, 11.1) Total Sleep Time (min.) Mean Difference 1 10 10 24.0 (-15.8, 63.8) Sleep Quality (SD) Standardized Mean Difference 2 23 26 0.69 (-0.34, 1.73) Abbreviations: Com. = combined treatment group; min. = minutes; NA = not applicable; No. = number; Pl. = placebo group; SD = stan
89 

Table 26. All outcomes: relaxation therapy and cognitive/behavioral therapy versus relaxation therapy 

No. of Participants 

Outcome (units) Comparison No. of studies 

Com. Rel. 

Point Estimate 95% Confidence Interval 

Sleep Onset Latency (min.) Mean Difference 2 18 16 -9.2 (-37.9, 19.5) Wakefulness After Sleep Onset (min.) Mean Difference 1 10 10 8.3 (-24.8, 41.4) Total Sleep Time (min.) Mean Difference 1 10 10 -12.0 (-44.9, 20.9) Sleep Quality (SD) Standardized Mean Difference 1 10 10 -0.08 (-0.95, 0.80) Abbreviations: Com. = combined treatment group; min. = minutes; NA = not applicable; No. = number; Rel. = relaxation group; SD = s
90 

Table 27. All outcomes: relaxation therapy and cognitive/behavioral therapy versus cognitive/behavioral therapy 

No. of Participants 

Outcome (units) Comparison No. of studies 

Com. CBT 

Point Estimate 95% Confidence Interval 

Sleep Onset Latency (min.) Mean Difference 2 23 24 -4.6 (-20.7, 11.5) Wakefulness After Sleep Onset (min.) Mean Difference 2 23 24 5.1 (-12.0, 22.2) Total Sleep Time (min.) Mean Difference 1 10 10 -24 (-84.8, 36.8) Sleep Quality (SD) Standardized Mean Difference 2 23 24 0.20 (-0.38, 0.77) Abbreviations: CBT = cognitive behavioral therapy group; Com. = combined treatment group; min. = minutes; NA = not applicable; No

standard deviation 
91 

Table 28. All outcomes: relaxation therapy and cognitive/behavioral therapy versus benzodiazepines 

No. of Participants 

Outcome (units) Comparison No. of studies 

Com. Ben. 

Point Estimate 95% Confidence Interval 

Sleep Onset Latency (min.) Mean Difference 1 13 10 8.3 (-16.4, 33.0) Wakefulness After Sleep Onset (min.) Mean Difference 1 13 10 7.3 (-12.5, 27.1) Sleep Quality (SD) Standardized Mean Difference 1 13 10 -1.51 (-2.46, -0.55) Abbreviations: Ben. = benzodiazepine group; Com. = combined treatment group; min. = minutes; NA = not applicable; No. = number; 
92 

Table 29. All outcomes: benzodiazepine and cognitive/behavioral therapy versus placebo 

No. of Participants 

Outcome (units) Comparison No. of studies 

Com. Pl. 

Point Estimate 95% Confidence Interval 

Sleep Onset Latency (min.) Mean Difference 1 8 7 -5.5 (-18.0, 7.0) Wakefulness After Sleep Onset (min.) Mean Difference 1 19 18 -32.1 (-54.1, -10.2) Sleep Efficiency (%) Mean Difference 1 19 18 12.8 (6.3, 19.3) Total Sleep Time (min.) Mean Difference 2 27 25 23.2 (-2.3, 48.8) Abbreviations: Com. = combined treatment group; min. = minutes; NA = not applicable; No. = number; Pl. = placebo group
93 

Table 30. All outcomes: benzodiazepine and cognitive/behavioral therapy versus benzodiazepine 

No. of Participants 

Outcome (units) Comparison No. of studies 

Com. CBT 

Point 

Estimate 

95% Confidence 

Interval 

Wakefulness After Sleep Onset (min.) Mean Difference 1 19 17 -15.5 (-37.1, 6.1) Sleep Efficiency (%) Mean Difference 1 19 17 6.8 (0.3, 13.3) Total Sleep Time (min.) Mean Difference 1 19 17 -13.3 (-45.3, 18.7) Abbreviations: CBT = cognitive behavioral therapy group; Com. = combined treatment group; min. = minutes; NA = not applicable; No
94 

Table 31. All outcomes: benzodiazepine and cognitive/behavioral therapy versus cognitive/behavioral therapy 

No. of Participants 

Outcome (units) Comparison No. of studies 

Com. Ben. 

Point Estimate 95% Confidence Interval 

Wakefulness After Sleep Onset (min.) Mean Difference 1 19 18 -10.1 (-34.6, 14.4) Sleep Efficiency (%) Mean Difference 1 19 18 3.1 (-3.4, 9.6) Total Sleep Time (min.) Mean Difference 1 19 18 7.0 (-23.8, 37.8) Abbreviations: Ben. = benzodiazepine group; Com. = combined treatment group; min. = minutes; NA = not applicable; No. = number 
95 

Table 32. All outcomes: non-benzodiazepine and cognitive/behavioral therapy (in combination) versus non-benzodiazepine antherapy (sequential) 

No. of Participants 

Outcome (units) Comparison No. of studies 

Com. Seq. 

Point Estimate 95% Confidence Interval 

Sleep Efficiency (%) Mean Difference 1 2 2 4.0 (-23.4, 31.4) Total Sleep Time (min.) Mean Difference 1 2 2 -25.8 (-169.9, 118.3) Abbreviations: Com. = combined treatment group; min. = minutes; NA = not applicable; No. = number; Seq. = sequential treatment gr
96 

Table 33. All outcomes: cognitive/behavioral therapy and modafinil versus cognitive/behavioral therapy 

No. of Participants 

Outcome (units) Comparison No. of studies 

Com. CBT 

Point Estimate 95% Confidence Interval 

Sleep Onset Latency (min.) Mean Difference 1 10 9 3.6 (-13.5, 20.7) Wakefulness After Sleep Onset (min.) Mean Difference 1 10 9 2.0 (-28.4, 32.4) Total Sleep Time (min.) Mean Difference 1 10 9 -7.0 (-69.3, 55.3) Abbreviations: CBT = cognitive behavioral therapy group; Com. = combined treatment group; min. = minutes; NA = not applicable; No
97 

Table 34. All outcomes: cognitive/behavioral therapy and modafinil versus modafinil 

No. of Participants 

Outcome (units) Comparison No. of studies 

Com. Mod. 

Point Estimate 95% Confidence Interval 

Sleep Onset Latency (min.) Mean Difference 1 10 8 -2.0 (-29.2, 25.2) Wakefulness After Sleep Onset (min.) Mean Difference 1 10 8 -25.4 (-61.1, 10.3) Total Sleep Time (min.) Mean Difference 1 10 8 15.8 (-29.5, 61.1) Abbreviations: Com. = combined treatment group; min. = minutes; Mod. = modafinil group; NA = not applicable; No. = number 
98 

Figure 1. Meta graph: Sleep onset latency: benzodiazepines versus placebo 

 
99 

Figure 2. Funnel Plot: Sleep onset latency: benzodiazepines versus placebo 

 

SE 
100 

Figure 3. Meta graph: Wakefulness After Sleep Onset: benzodiazepines versus placebo 

 
101 

Figure 4. Meta graph: Sleep Onset Latency: non-benzodiazepines versus placebo 
102 

Figure 5. Funnel Plot: Sleep Onset Latency: non-benzodiazepines versus placebo 

 

SE 
103 

Figure 6. Meta graph: Wakefulness After Sleep Onset: non-benzodiazepines versus placebo 

 
104 

Figure 7. Meta graph: Sleep Onset Latency: antidepressants versus placebo 
105 

Figure 8. Meta graph: Wakefulness After Sleep Onset: antidepressants versus placebo 
106 

Figure 9. Meta graph: Sleep Onset Latency: complementary and alternative care versus placebo 
107 

Figure 10. Funnel Plot: Sleep Onset Latency: melatonin versus placebo 

 

SE 
108 

Figure 11. Meta graph: Wakefulness After Sleep Onset: complementary and alternative care versus placebo 
109 

Figure 12. Meta graph: Sleep Onset Latency: relaxation therapy versus placebo 
110 

Figure 13. Funnel Plot: Sleep Onset Latency: relaxation therapy versus placebo 

 

 

SE 
111 

Figure 14. Meta graph: Wakefulness After Sleep Onset: relaxation therapy versus placebo 
112 

Figure 15. Meta graph: Sleep Onset Latency: cognitive/behavioral therapy versus placebo 
113 

Figure 16. Funnel Plot: Sleep Onset Latency: cognitive/behavioral therapy versus placebo 

SE 
114 

Figure 17. Meta graph: Wakefulness After Sleep Onset: cognitive/behavioral therapy versus placebo 
115 

Chapter 4. Discussion 

Our inclusion criteria for age allowed for the inclusion of studies in the review for which 

participants between the ages of 15 and 18 years were eligible. This decision was in agreement 

with our aim to conduct a comprehensive review of the literature, since we would have otherwise 

excluded predominantly adult studies based on the possibility that their populations included a 

sub-population of adolescents. Only 10 out of 79 studies relevant to the manifestations of 

chronic insomnia explicitly stated that individuals under the age of 18 years were eligible for the 

study, and only two out of 116 studies relevant to the management of chronic insomnia explicitly 

stated that individuals under the age of 18 years were eligible for the study. Given the low 

number of included studies for which adolescents were eligible for inclusion, it is reasonable to 

assume that the findings of the review apply to adults. 

We reviewed only English-language reports. The inclusion of non-English language reports 

in systematic reviews has been shown to increase treatment estimates in reviews of 

complementary and alternative medicine (CAM).66 This effect is thought to occur due to the 

presence of publication bias in CAM literature, such that studies with negative CAM findings are 

more likely to be published in English-language journals, and studies with positive CAM 

findings are more likely to be published in non-English language journals.66 However, we found 

no evidence of publication bias by three out of four tests conducted for studies on melatonin. 

There were not enough studies on L-tryptophan and valerian to conduct meaningful tests of 

publication bias for these interventions. Only seven non-English language reports were 

identified that were potentially relevant to this category of intervention, and given that the 

inclusion rate for the question on management of chronic insomnia was approximately 15 

percent, only one study would likely have been relevant to the review. Given the relatively small 

sample sizes of the studies identified for this category of intervention, it is unlikely that the 

addition of one study to this category would have considerably affected treatment estimates. 

Prevalence, Natural History, Incidence and Factors 

Associated with Chronic Insomnia 

The range of prevalence of chronic insomnia in the three categories of populations analyzed 

was wide. This variability may be due to the cumulative effect of variation in a number of 

factors across studies such as the sampling frame and method of sampling, the response rate, 

whether the method of data collection was validated, the criteria for chronic insomnia, the age 

distribution of the population, and the presence of psychological or psychiatric problems in the 

population. Indeed, the criteria for the duration of insomnia varied across studies from one 

month to one year and the severity of chronic insomnia varied across these populations as well. 

The interquartile range of prevalence varied from 8.5-24.3 percent across high quality studies of 

general populations, to 19.8-53.7 percent across moderate quality studies of outpatient 

populations, to 27.8-43.0 percent across moderate quality studies of clinical populations. 

Therefore, the prevalence estimates for chronic insomnia in outpatient and clinical populations 

appear to be significantly higher than for the general population, a finding that is consistent with 

evidence of an association between chronic insomnia and medical conditions, poor general 

health and increased healthcare utilization. Although we identified a number of high quality 

studies examining a general population, we did not identify any high quality studies examining 
116 

outpatients of general practice and only one examining clinical populations, suggesting that high 

quality studies investigating the prevalence of chronic insomnia in outpatients of general practice 

and clinical populations are needed. 

Only one study provided data on the natural history of chronic insomnia; the remission rate 

was 13.1 percent after a four-month follow-up. More research is necessary to determine the 

course of chronic insomnia in various populations. We did not identify any studies that provided 

evidence regarding the incidence of chronic insomnia; more research is needed in this area as 

well. 

The majority of studies identified did not have designs that would support the categorization 

of associated factors of chronic insomnia as risk factors or consequences of the disorder. That is, 

most identified studies had designs in which both chronic insomnia and a factor of interest were 

assessed in a population at the same point in time. It is necessary that longitudinal cohort studies 

be conducted to elucidate the relationship between chronic insomnia and its associated factors. 

We found evidence to suggest that chronic insomnia is associated with older age, female gender, 

present or past psychiatric illness and psychological problems, medical conditions and poor 

general health, increased healthcare utilization, lower quality of life and social relationships, 

socioeconomic status (marital separation, unemployment, poorer working conditions and lower 

social status), and decrements in memory, mood and cognitive function. Some of the factors that 

are thought to contribute to insomnia in the elderly include multiple medical problems, 

polypharmacy and environmental factors, such as absence of zeitgebers (time/schedule cues).50;67

Similarly, factors such as stress, pregnancy, menopause, medical conditions and complex home 

life may explain the higher prevalence of insomnia in females.68 It is noteworthy that there were 

studies that did not find evidence of an association between these factors and chronic insomnia. 

One of the reasons for this finding may be the different methods of data analysis employed in 

these studies; some studies performed multivariate analyses, while others performed univariate 

analyses. Other factors that may explain this finding are the age and gender distribution of the 

population, the response rate, and the duration of insomnia. Similarly, studies showing a lack of 

association between variables may have been underpowered. The relationship between chronic 

insomnia and race/ethnicity, shift-work, and absenteeism and work performance is not clear; 

there were too few studies examining these relationships to arrive at any conclusions. We did 

not identify any studies that examined the relationship between chronic insomnia and accidents 

or falls in the elderly. There was also no evidence regarding the direct and indirect costs of the 

disorder. Research in these areas is required. 

Efficacy and Safety of Treatments for Chronic Insomnia 

The interventions for chronic insomnia that were investigated in included studies may be 

categorized as either benzodiazepines, non-benzodiazepines, antidepressants, complementary 

and alternative care (L-tryptophan, melatonin and valerian), relaxation therapy, 

cognitive/behavioral therapy, barbiturates, hormone therapy, alcohol, low energy emission 

therapy and combination therapy. The majority of studies were classified under the first six 

categories of the preceding list. The discussion of results relevant to the management of chronic 

insomnia is focused on the results as they pertain to the primary and secondary outcomes of this 

review, sleep onset latency (SOL) and wakefulness after sleep onset (WASO); however, any 

major discrepancies between the estimates for these outcomes and other outcomes will be 

discussed. 
117 

The benzodiazepines, non-benzodiazepines, antidepressants and melatonin significantly 

decreased SOL. L-tryptophan, valerian, relaxation therapy and cognitive/behavioral therapy 

reduced SOL, but the results were not statistically significant. Although the overall SOL 

estimate for relaxation therapy was not significantly different from placebo, when only shortterm studies were analyzed, the effect became statistically significant in favour of relaxation 

therapy. The benzodiazepines, non-benzodiazepines and antidepressants significantly reduced 

WASO. Melatonin decreased WASO, but the result was not statistically significant. Melatonin 

had a non-significant effect on sleep efficiency, total sleep time and sleep quality. The studies on 

L-tryptophan did not report on any other outcomes besides SOL, and only one study on valerian 

provided data on WASO; valerian significantly reduced WASO in this study. Valerian did not 

have a significant effect on sleep efficiency, total sleep time or sleep quality. Relaxation therapy 

reduced WASO, but the result was not significant; however, this intervention significantly 

increased total sleep time (no significant effect on sleep efficiency or sleep quality). 

Cognitive/behavioral therapy significantly reduced WASO, and significantly increased sleep 

efficiency and sleep quality (no significant effect on total sleep time). The review provides 

evidence that benzodiazepines and non-benzodiazepines are effective treatments for chronic 

insomnia. The review provides some evidence that antidepressants are effective treatments for 

chronic insomnia, although more research is required in this area. There is some evidence that 

melatonin is an effective treatment for subsets of the chronic insomnia population, although more 

research is required in this area as well. The review provides evidence that relaxation therapy 

and cognitive/behavioral therapy are effective treatments in subsets of the chronic insomnia 

population. There were too few studies of L-tryptophan and valerian to draw conclusions 

regarding the efficacy of these treatments in the management of chronic insomnia: additional 

large-scale, randomized trials are needed. Additional large-scale, randomized trials are also 

needed in the area of relaxation therapy and cognitive/behavioral therapy in the management of 

chronic insomnia, in order to determine the efficacy of these interventions across subsets of the 

chronic insomnia population. The reduction in sleep onset latency by benzodiazepines and nonbenzodiazepines was significantly greater than for antidepressants and melatonin, based on 

indirect comparisons. However, it should be noted that there were significantly fewer studies of 

antidepressants and melatonin compared to benzodiazepines and non-benzodiazepines, and 

additional large-scale, randomized trials of the former interventions are needed before firm 

conclusions can be drawn regarding the relative efficacy of these interventions. 

The benzodiazepines, non-benzodiazepines and antidepressants had a significantly greater 

risk of harm than placebo, while melatonin did not. There were too few studies of L-tryptophan 

to draw conclusions regarding the safety of this intervention. Although there was no evidence 

that valerian poses a risk of harm, this result was based on only three studies of relatively small 

sample size. Therefore, more studies are needed before firm conclusions can be drawn regarding 

the safety of valerian. The risk for benzodiazepines was significantly greater than for nonbenzodiazepines, based on indirect comparisons. Indeed, benzodiazepine use has been shown to 

increase the risk of injury in the elderly,69 and there is pharmacologic evidence that the nonbenzodiazepines have a better side-effect profile than the benzodiazepines.70-71 Studies of 

relaxation therapy and cognitive/behavioral therapy did not provide adverse event data. 

We did not aim to conduct a head-to-head comparison between pharmacological and nonpharmacological treatments for chronic insomnia, in which case we would have required 

randomized, controlled trials, which directly compare these interventions, in order to control for 

systematic differences between control and experimental groups. An indirect comparison 
118 

between these categories of interventions is not presented here for the following reasons: (1) 

although our inclusion criteria required blinding for drug and CAM treatments, this criteria was 

omitted for psychological treatments; (2) the placebo intervention was considered to have no 

effect for drug and CAM treatments, while it may have had minimal effect for psychological 

treatments; (3) the pool of participants for psychological interventions was much smaller than for 

either the benzodiazepines, non-benzodiazepines or antidepressants. Thus, only indirect 

comparisons between non-psychological intervention categories and between psychological 

interventions were made. 

There was substantial heterogeneity in the pooled estimate for SOL for benzodiazepines, 

non-benzodiazepines, L-tryptophan, valerian and relaxation therapy. Similarly, there was 

substantial heterogeneity in the pooled estimate for WASO for benzodiazepines, nonbenzodiazepines, melatonin and cognitive/behavioral therapy. The heterogeneity was often due 

to differences in the magnitude of the point estimate and confidence interval across studies, 

rather than differences in the directionality of the effect. The exceptions are for estimates of the 

efficacy of relaxation therapy with respect to SOL and the efficacy of melatonin with respect to 

WASO. The heterogeneity in the pooled estimates for SOL was explored in sensitivity and subgroup analyses. The results indicate that heterogeneity in the pooled estimate for SOL for 

relaxation therapy is at least partially due to type of relaxation therapy, length of treatment, age 

and gender distribution of the study population, and study quality. 

There was strong evidence of publication bias in the pooled estimates for SOL for the 

benzodiazepine and non-benzodiazepine categories of intervention. This finding suggests that 

the true estimate of efficacy is lower than the estimate calculated in the current analysis. 

The results of sub-group analyses of SOL were varied. The efficacy of non-benzodiazepines 

was greater in participants without a psychiatric illness relative to those with such a disorder. 

This finding may reflect the strong, poorly understood, complex relationship between 

psychological or psychiatric disorders and insomnia,4

 which necessitates individualized 

treatment of insomnia for people suffering from these psychological or psychiatric disorders. 

The efficacy of relaxation therapy was greater with short-term treatment compared to long-term 

treatment. There were no salient differences in the design, population, intervention or method of 

measurement of sleep outcomes between short- and long-term studies that could explain the 

differences in effect of relaxation therapy with length of treatment. The possibility exists that the 

subgroup for long-term treatment did not have sufficient power to detect a statistically significant 

difference between relaxation therapy and placebo. There were too few long-term studies of 

cognitive/behavioral therapy to arrive at a conclusion regarding the difference in efficacy of this 

intervention with short- and long-term treatment. There was no evidence to suggest that 

treatment efficacy is affected by age or gender distribution of the population. It is noteworthy 

that many of the sub-group analyses were conducted with very few studies in sub-groupings, and 

some analyses could not be performed at all due to lack of data. Thus, the results of these 

analyses should be interpreted with caution. It is important that future research examine the role 

of factors such as psychiatric illness, length of treatment, age and gender in treatment efficacy in 

chronic insomnia. 

We made an a priori decision to combine summary estimates of outcomes even if they were 

measured by different methods i.e. (polysomnography, actigraphy and sleep diary). We assumed 

that any differences between methods would be cancelled out when absolute differences in the 

effect of treatment and placebo were obtained. This assumption is correct as long as the 

differences in measurement between methods were not correlated with the value of the 
119 

measurement, which is a reasonable assumption in our view. The sub-group analyses based on 

method of measurement produced variable results. Of the six comparisons made between 

polysomnography and sleep diary data, the methods most commonly used in the studies included 

in this review, only two analyses revealed a significant difference between pooled estimates 

(benzodiazepines and valerian); in both cases sleep diary overestimated effects relative to 

polysomnography. However, while four comparisons showed sleep diary to overestimate effects 

relative to polysomnography (benzodiazepines, non-benzodiazepines, antidepressants, and 

valerian), two other comparisons showed polysomnography to overestimate effects relative to 

sleep diary (L-tryptophan and melatonin). These results appear to be inconsistent in terms of the 

direction of a potential bias and cause us to doubt whether any true relationship between 

measurement method and effect estimates exists. It is noteworthy that the direction and 

significance of the estimates were not different between overall and sub-group estimates for the 

benzodiazepine, non-benzodiazepine and antidepressant categories of interventions. Although 

some differences were observed in the directionality and significance of overall and sub-group 

estimates for L-tryptophan, melatonin and valerian, the results may simply reflect the lower 

power of these sub-group analyses: sub-groups contained only one to three studies of small 

sample size. 

There was no evidence of an effect of barbiturates, hormone therapy, alcohol and low energy 

emission therapy on sleep onset latency of chronic insomniacs. The lack of evidence may reflect 

the low number of studies and/or participants encompassed by these categories. It would be 

worthwhile to explore these interventions in future research on chronic insomnia. 

We identified a small sample of studies examining the efficacy of combination treatments in 

the management of chronic insomnia; some of these studies compared a combination of 

treatments with placebo, while others compared them with single treatment. Many comparisons 

did not have data for our primary outcome, sleep onset latency, and the majority of results were 

non-significant. The latter finding may reflect the low power of these analyses. None of the 

studies provided data on adverse events. We identified only one study that compared the 

efficacy of a combined pharmacological and psychological treatment with these treatments 

administered sequentially. The research agenda for the management of chronic insomnia should 

include an evaluation of the efficacy and safety of combination treatments and sequential 

treatments. 

Our results regarding the efficacy of benzodiazepines and non-benzodiazepines in the 

management of chronic insomnia are consistent with those of other meta-analyses.72-74 Our 

results regarding the efficacy of melatonin in subsets of the chronic insomnia population are 

similar to another review.75 Our results regarding the efficacy of relaxation therapy and 

cognitive/behavioral therapy in subsets of the chronic insomnia population are similar to a recent 

meta-analysis reviewing the efficacy of cognitive/behavioral therapy in the management of sleep 

problems in older adults.76 Similar to our meta-analysis, the authors restricted the review to 

randomized, controlled trials. Our results relating to relaxation therapy and cognitive/behavioral 

therapy are somewhat at odds with three meta-analyses reviewing the efficacy of psychological 

treatments in the management of chronic insomnia.74;77-78 The difference in the findings may 

relate to key differences in the conduct of the reviews. First, we restricted our meta-analysis to a 

review of placebo-controlled, randomized trials and accounted for placebo effects in our 

estimations of efficacy. Other meta-analyses have included non-controlled studies, and for these 

studies, have not accounted for placebo/control effects in their estimation of efficacy. Second, 

we used clearly defined criteria for chronic insomnia; however, for some studies the criteria for 
120 

insomnia was not clear. Third, we separated predominantly cognitive/behavioral approaches 

from predominantly relaxation approaches in management of insomnia, resulting in distinct 

meta-analyses for each category of intervention. These interventions have been grouped under 

the broader heading of psychological/non-pharmacological treatments in other reviews. 

Limitations of the Review and Future Research 

Additional high quality studies investigating the prevalence of chronic insomnia in 

outpatients of general practice and clinical populations are needed. Similarly, we found a 

paucity of data on the natural history and incidence of chronic insomnia, which necessitates 

further research in these areas. We did not identify any cohort studies that examined the causal 

relationship between various factors and chronic insomnia; future research should be directed at 

conducting such studies in order to determine the nature of the relationship between chronic 

insomnia and its associated factors. Additional studies are needed to examine the relationship 

between chronic insomnia and race/ethnicity, shift-work, and absenteeism and work 

performance, since few studies in this area exist. Future research should also examine the 

relationship between chronic insomnia and accidents and falls in the elderly, and the direct and 

indirect costs of this disorder, since we did not identify any studies that addressed these issues. 

The pooled estimates of efficacy for antidepressants, CAM therapies, relaxation therapy and 

cognitive/behavioral therapy were based on a small sample size relative to benzodiazepines and 

non-benzodiazepines. It is necessary that additional large-scale, randomized trials be conducted 

before firm conclusions can be drawn regarding their efficacy and safety and how they compare 

to other treatments for chronic insomnia. We found a relatively small number of studies 

examining the long-term efficacy and safety of various interventions for chronic insomnia: more 

long-term studies are needed in order to differentiate the short and long-term efficacy and safety 

of these interventions. It is necessary that an agreed upon criteria be developed to determine 

what constitutes short- and long- term treatment of chronic insomnia. In addition, research 

should be conducted to establish a threshold for a clinically significant treatment effect in the 

management of chronic insomnia, such that statistically significant findings can be put into some 

clinical context. Future research should report on outcomes in addition to SOL, such as WASO, 

in order to determine the efficacy of treatments across subsets of the chronic insomnia 

population; our analysis revealed that studies tend to report SOL much more often than WASO. 

Quality of life outcomes should also be given more attention. It is necessary that future research 

be directed at establishing an agreed upon placebo treatment for psychological treatment that is 

standardized across studies, such that meaningful comparisons can be made across studies of this 

type. Finally, additional studies are necessary to determine the efficacy and safety of combined 

pharmacological and psychological treatments, as well as sequential treatments in the 

management of chronic insomnia. 

Many of the sub-group analyses conducted in this review were based on a small number of 

studies within sub-groupings, and some analyses could not be conducted at all due to lack of 

data. The paucity of data may reflect a need for future research to determine the efficacy and 

safety of treatments for chronic insomnia within specific sub-populations stratified by age, 

gender, and presence or absence of psychiatric illness. There was no evidence of an effect of 

barbiturates, hormone therapy, alcohol and low energy emission therapy on sleep onset latency 

of chronic insomniacs, however, there was a small amount of data in these areas, which prevents 

one from drawing firm conclusions before additional research is conducted. 
121 

A number of the six major categories of interventions for chronic insomnia had substantial 

heterogeneity, suggesting that the studies within these categories were significantly different. In 

some cases, sub-categorization by type of intervention significantly reduced heterogeneity within 

some of these categories. The categorization of interventions into classes is reasonable when the 

goal is to determine the efficacy and safety of a given class of intervention; however, it should be 

noted that although the interventions of a given class may be similar in some respects, they are in 

fact unique. For many interventions within these categories, there were few studies that 

addressed their safety and efficacy, and additional research is required into the efficacy and 

safety of these various interventions of chronic insomnia. 

There was strong evidence of publication bias for the benzodiazepine and nonbenzodiazepine categories, which suggests that the pooled estimates of treatment efficacy may 

be overestimates. 

It is noteworthy that research in the area of bright light therapy and physical exercise in the 

management of insomnia is ongoing; however, we did not identify any studies of these 

interventions that fulfilled our inclusion criteria. 

We restricted our analysis of efficacy and safety to evidence derived from randomizedcontrolled trials in order to provide the least biased estimate of these parameters. However, it 

should be noted that the short follow-up period that generally characterizes these types of studies 

is a limitation when assessing the long-term safety of pharmacological treatments. 

Conclusions 

• There is evidence that the prevalence of chronic insomnia in outpatient and clinical 

populations is larger than in the general population. 

• There is evidence that chronic insomnia is associated with older age, female gender, 

present or past psychiatric illness and psychological problems, medical conditions and 

poor general health, increased healthcare utilization, lower quality of life and social 

relationships, socioeconomic status (marital separation, unemployment, poorer working 

conditions and lower social status), and decrements in memory, mood and cognitive 

function. 

• Additional studies are needed to determine the incidence and natural history of chronic 

insomnia in adults. Similarly, additional studies are needed to explore the relationship 

between chronic insomnia and race/ethnicity, shift-work, absenteeism and work 

performance, accidents, falls in the elderly, and the direct and indirect costs of the 

disorder. It is necessary that longitudinal studies be undertaken to explore the risk factors 

and consequences of chronic insomnia. 

• There is evidence that benzodiazepines and non-benzodiazepines are effective in the 

management of chronic insomnia. There is some evidence that antidepressants are 

effective in the management of chronic insomnia: more research is required in this area. 

There is evidence that benzodiazepines, non-benzodiazepines and antidepressants pose a 

risk of harm. 
122 

• There is some evidence that melatonin is effective in the management of chronic 

insomnia in subsets of the chronic insomnia population, and there is no evidence that 

melatonin poses a risk of harm. However, more research is required in this area, given 

that the results are based on a small number of studies. Similarly, additional large-scale, 

randomized trials are needed to determine the efficacy of melatonin across subsets of the 

chronic insomnia population. There is insufficient evidence to conclude on the efficacy 

and safety of L-tryptophan and valerian in the management of chronic insomnia. 

Additional large-scale, randomized trials are needed in these areas. 

• There is evidence that relaxation therapy and cognitive/behavioral therapy are effective in 

the management of chronic insomnia in subsets of the chronic insomnia population. 

Additional large-scale, randomized trials are needed in order to determine their efficacy 

across subsets of the chronic insomnia population. 

• There is evidence that benzodiazepines have a greater risk of harm than nonbenzodiazepines. 

• There is insufficient evidence to conclude if there are differences between the short-term 

and long-term efficacy and safety of the various categories of interventions in the 

management of chronic insomnia; additional long-term studies are needed. 

• There is insufficient evidence regarding the efficacy and safety of combined treatments of 

pharmacological and psychological interventions, and sequential treatments, in the 

management of chronic insomnia; additional studies are needed in these areas. 
123 

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insomnia. Sleep 2000; 23(8):1087-96. 

 189. Wang RIH, Stockdale SL. Subjective and objective 

method assessing the efficacy of hypnotic 

medications in insomniacs. J Clin Pharmacol 1977; 

17:728-33. 

 190. Wang W, Zhu SZ, Pan LC, et al. Mismatch 

negativity and personality traits in chronic primary 

insomniacs. Funct Neurol 2001; 16(1):3-10. 

 191. Waters WF, Hurry MJ, Binks PG, et al. Behavioral 

and hypnotic treatments for insomnia subtypes. 

Behav Sleep Med 2003; 1(2):81-101. 

 192. Winsauer HJ, O'Hair DE, Valero R. Quazepam: 

short term treatment of insomnia in geriatric 

outpatients. Curr Ther Res 1984; 35:228-34. 
135 

 193. Yeo BK, Perera IS, Kok LP, et al. Insomnia in the 

community. Singapore Med J 1996; 37(3):282-4. 

 194. Zammit GK, Weiner J, Damato N, et al. Quality of 

life in people with insomnia. Sleep 1999; 22(Suppl 

2):S379-85. 

 195. Zhdanova IV, Wurtman RJa, Regan MM, et al. 

Melatonin treatment for age-related insomnia. J 

Clin Endocrinol Metab 2001; 86(10):4727-30
136 
A-1

Appendix A: Exact Search Strings 

Table A-1. MEDLINE® - Ovid Version: rel9.1.0 

Table A-2. EMBASE - Ovid Version: rel9.1.0 

Table A-3. CINAHL® (Cumulative Index to Nursing & Allied Health Literature) - Ovid 

Version: rel9.1.0 

Table A-4. Ovid MEDLINE® In-Process & Other Non-Indexed Citations - Ovid Version: 

rel9.1.0 

Table A-5. Ovid OLDMEDLINE® - Ovid Version: rel9.1.0 

Table A-6. PsycINFO® - Ovid Version: rel9.1.0 

Table A-7. EBM Reviews - Cochrane Central Register of Controlled Trials - Ovid Version: 

rel9.1.0 

Table A-8. International Pharmaceutical Abstracts - Ovid Version: rel9.1.0 

Table A-9. AMED (Allied and Complementary Medicine) - Ovid Version: rel9.1.0 

Table A-10. HealthSTAR/Ovid Healthstar - Ovid Version: rel9.1.0 

Table A-11. EBM Reviews - Cochrane Database of Systematic Reviews (2nd Quarter 2004); 

ACP Journal Club (1991 to March/April 2004); Database of Abstracts of Reviews 

of Effects (2nd Quarter 2004) - Ovid Version: rel9.1.0 

Table A-12. Science Citation Index ExpandedTM -1945-September 2004 - ISI Web of Knowledge 

Table A-13. Biological Abstracts - WebSPIRS from SilverPlatter, Version 4.3 

Table A-14. Cochrane Complementary Medicine Field Registry - Reference Web Poster 2001; 

ISI ResearchSoft 

Table A-15. CAB Abstracts - WebSPIRS from SilverPlatter, Version 4.3 

Table A-16. SIGLE - FIZ Karlsruhe - Version Interhost 3000 

Table A-17. OCLC Proceedings First - OCLC FirstSearch 

Table A-18. Dissertation Abstracts - ProQuest 

Table A-19. Alt HealthWatch - EBSCOhost 

Table A-20. NLM Gateway 

Table A-21. PubMed®
A-2

Table A-1. MEDLINE® - Ovid Version: rel9.1.0 

1966 to September Week 1 2004 

Searched Sept. 15, 2004

1. insomni$.mp. 

2. exp "Sleep Initiation and Maintenance Disorders"/ 

3. (sleep adj initiation adj2 maintenance adj disorder$).mp. 

4. (sleep adj onset adj3 (delay$ or latenc$)).mp. 

5. dims.mp. 

5. (disorder$ adj initiating adj2 maintaining adj sleep).mp. 

6. (early adj2 awaken$).mp. 

7. (sleeplessness or agrypnia$ or hyposomnia$).mp. 

8. or/1-8 

9. "analytic stud$".mp. 

10. exp case-control studies/ or exp retrospective studies/ 

11. exp cohort studies/ or exp longitudinal studies/ or exp follow-up studies/ or exp prospective studies/ or 

comparative study/ or exp Evaluation Studies/ 

12. exp Cross-Sectional Studies/ 

13. exp RISK FACTORS/ or exp RISK/ or exp RISK ASSESSMENT/ 

14. exp Odds Ratio/ 

15. exp CAUSALITY/ 

16. exp Logistic Models/ 

17. exp epidemiologic factors/ or exp age factors/ or exp "bias (epidemiology)"/ or exp comorbidity/ or exp 

"confounding factors (epidemiology)"/ or exp "effect modifiers (epidemiology)"/ or exp observer 

variation/ or exp reproductive history/ or exp sex factors/ 

18. exp morbidity/ or exp incidence/ or exp prevalence/ 

19. (cohort or observational or correlational or non-experimental or "non experimental" or 

nonexperimental or control$ or prospectiv$ or volunteer$ or "case series" or "case-series" or "case 

comparison" or "case-comparison" or "case referent" or "case-referent" or "cross sectional" or "crosssectional" or risk or "relative risk" or causation or causal$ or "odds ratio$" or etiol$ or aetiol$ or 

incidence).mp. 

20. exp prognosis/ or exp medical futility/ or exp treatment outcome/ 

21. exp mortality/ or exp "cause of death"/ or exp fatal outcome/ or exp survival rate/ 

22. exp survival analysis/ or exp disease-free survival/ 

23. exp disease susceptibility/ or exp genetic predisposition to disease/ 

24. exp disease progression/ or exp "Severity of Illness Index"/ 

25. exp Time Factors/ 

26. exp RECURRENCE/ 

27. ("natural history" or "inception cohort" or predict$ or prognos$ or outcome$ or course).mp. 

28. exp "costs and cost analysis"/ or exp "cost allocation"/ or exp cost-benefit analysis/ or exp "cost 

control"/ or exp "cost savings"/ or exp "cost of illness"/ or exp "cost sharing"/ or exp "deductibles and 

coinsurance"/ or exp health care costs/ or exp direct service costs/ or exp drug costs/ or exp employer 

health costs/ or exp hospital costs/ or exp health expenditures/ or exp capital expenditures/ 

29. exp "Quality of Life"/ or exp "Activities of Daily Living"/ 

30. exp "OUTCOME ASSESSMENT (HEALTH CARE)"/ or exp "OUTCOME AND PROCESS 

ASSESSMENT (HEALTH CARE)"/ or exp Health Status Indicators/ or exp Health Status/ or exp 

Questionnaires/ 

31. (cost$ or economic or social or "quality of life" or "life quality" or hrql or well-being or wellbeing or "well 

being" or "outcome adj assessment$" or "health status").mp. 

32. (et or pc or ae or ep or to or ge or ec or in or ut or mo).fs. 

33. or/10-33 

34. animal/ not human/ 

35. 34 not 35 

36. 9 and 36 

37. eng.la. 

38. 37 and 38 

39. insomni$.mp. 

40. exp "Sleep Initiation and Maintenance Disorders"/ 

41. (sleep adj initiation adj2 maintenance adj disorder$).mp. 
A-3

Table A-1. MEDLINE® - Ovid Version: rel9.1.0 (continued)

1966 to September Week 1 2004 

Searched Sept. 15, 2004

42. (sleep adj onset adj3 (delay$ or latenc$)).mp. 

43. dims.mp. 

44. "disorder$ of initiating and maintaining sleep".mp. 

45. (early adj2 awaken$).mp. 

46. (sleeplessness or agrypnia$ or hyposomnia$).mp. 

47. (((time-zone or "time zone") adj2 change$) or "jet lag").mp. 

48. or/40-48 

49. randomized controlled trial.pt. 

50. controlled clinical trial.pt. 

51. randomized controlled trials/ 

52. random allocation/ 

53. double blind method/ 

54. single blind method/ 

55. clinical trial.pt. 

56. exp Clinical Trials/ 

57. (clin$ adj25 trial$).ti,ab. 

58. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).ti,ab. 

59. placebos/ 

60. placebo$.ti,ab. 

61. random$.ti,ab. 

62. research design/ 

63. or/50-63 

64. 64 not 35 

65. 49 and 65 

66. 66 not 39 

67. meta-analysis.pt,sh. 

68. (meta-anal$ or metaanal$).mp. 

69. ((systematic$ adj3 review$) or (systematic$ adj3 overview$)).mp. 

70. ((quantitativ$ adj3 review$) or (quantitativ$ adj3 overview)).mp. 

71. ((methodol$ adj3 review$) or (methodol$ adj3 overview$)).mp. 

72. (integrative research review$ or research integration$).mp. 

73. (quantitativ$ adj (synthes$ or analys$)).mp. 

74. (("evidence based" or evidence-based) adj3 (medicine or guideline$ or recommendation$)).mp. 

75. guideline.pt. 

76. "cochrane database of systematic reviews".mp. 

77. cdsr.mp. 

78. acp journal club.mp. 

79. "health tech$ assess$".mp. 

80. hta.mp. 

81. "evidence based nursing".mp. 

82. "evidence based mental health".mp. 

83. "clinical evidence".mp. 

84. technolog$ assess$.mp. 

85. "evidence report$".mp. 

86. or/68-86 

87. review.pt. or (review or overview$ or reviews or handsearch or "hand search" or hand-search or 

"manual search").mp. 

88. (medline or medlars or pubmed or embase or "index medicus" or cochrane or scisearch or "Web of 

Science" or psychinfo or psycinfo or psychlit or psyclit or cinahl or cinhal or "experta medica" or 

"excerpta medica" or "science citation index" or "sciences citation index" or "biological abstracts" or 

"current contents").mp. 

89. (((electronic or bibliographic) adj3 database$) or "periodical index$").mp. 

90. ((pool$ or combined or combining) adj (data or trials or studies or results)).mp. 

91. (peto or "der simonian" or dersimonian or "fixed effect$" or "treatment outcome$" or "mantel 

haenszel").mp. 
A-4

Table A-1. MEDLINE® - Ovid Version: rel9.1.0 (continued)

1966 to September Week 1 2004

Searched Sept. 15, 2004

92. or/89-92 

93. 88 and 93 

94. 87 or 94 

95. case report.ti,sh. 

96. editorial.ti,pt. 

97. letter.pt. 

98. newspaper article.pt. 

99. comment.pt. 

100. or/96-100 

101. 95 not 101 

102. animal/ not human/ 

103. 102 not 103 

104. eng.la. 

105. 104 and 105 

106. 9 and 106 

107. 107 not (39 or 67) 
A-5

Table A-2. EMBASE - Ovid Version: rel9.1.0

1988 to 2004 Week 37 

Searched September 15, 2004 

1. insomni$.mp. or exp insomnia/ 

2. (sleep adj initiation adj2 maintenance adj disorder$).mp. 

3. (sleep adj onset adj3 (delay$ or latenc$)).mp. 

4. dims.mp. 

5. (disorder$ adj initiating adj2 maintaining adj sleep).mp. 

6. (early adj2 awaken$).mp. 

7. (sleeplessness or agrypnia$ or hyposomnia$).mp. 

8. or/1-7 

9. "analytic stud$".mp. 

10. exp case-control study/ or exp retrospective study/ 

11. exp cohort analysis/ or exp longitudinal study/ or exp prospective study/ or exp Comparative Study/ or 

exp Evaluation/ 

12. (("follow up" or follow-up) adj stud$).mp. 

13. exp GENETIC RISK/ or exp POPULATION RISK/ or exp CORONARY RISK/ or exp HIGH RISK 

PATIENT/ or exp HIGH RISK PREGNANCY/ or exp RISK FACTOR/ or exp CARDIOVASCULAR 

RISK/ or exp RISK ASSESSMENT/ or exp RISK/ or exp HIGH RISK POPULATION/ or exp CANCER 

RISK/ or exp RISK MANAGEMENT/ or exp RISK REDUCTION/ or exp RISK BENEFIT ANALYSIS/ or 

exp INFECTION RISK/ or exp RECURRENCE RISK/ 

14. causality.mp. 

15. (Logistic adj Model$).mp. or exp Statistical Model/ 

16. exp COMORBIDITY/ or exp Onset Age/ or exp Observer Variation/ or exp Sex Difference/ 

17. exp epidemiology/ or exp incidence/ or exp morbidity/ or exp mortality/ or prevalence/ 

18. (cohort or control$ or correlational or non-experimental or "non experimental" or nonexperimental or 

prospectiv$ or volunteer$ or "case series" or "case-series" or "case comparison" or "casecomparison" or "case referent" or "case-referent" or "cross sectional" or "cross-sectional" or risk or 

"relative risk" or causation or causal$ or "odds ratio$" or etiol$ or aetiol$ or incidence).mp. 

19. exp prognosis/ or medical futility.mp. or exp treatment outcome/ 

20. exp "cause of death"/ or exp fatality/ or exp survival rate/ 

21. exp SURVIVAL RATE/ or exp SURVIVAL/ or exp SURVIVAL TIME/ 

22. exp Disease Predisposition/ or exp Genetic Predisposition/ 

23. exp Disease Course/ or "Severity of illness index".mp. 

24. exp Recurrent Disease/ or exp Disease Severity/ or exp Chronic Disease/ 

25. ("natural history" or "inception cohort" or predict$ or prognos$ or outcome$ or course).mp. 

26. exp "HOSPITAL COST"/ or exp "COST EFFECTIVENESS ANALYSIS"/ or exp "COST UTILITY 

ANALYSIS"/ or exp "ENERGY COST"/ or exp "COST CONTROL"/ or exp "DRUG COST"/ or exp 

"COST BENEFIT ANALYSIS"/ or exp "COST MINIMIZATION ANALYSIS"/ or exp "COST"/ or exp 

"HEALTH CARE COST"/ or exp "COST OF ILLNESS"/ 

27. exp "Quality of Life"/ or exp Daily Life Activity/ 

28. exp Health Status/ or exp Follow Up/ or exp Questionnaire/ or exp Outcomes Research/ or exp 

Health Care Quality/ 

29. (cost$ or economic or social or "quality of life" or Hrql or "life quality" or well-being or wellbeing or 

"well being" or "outcome adj assessment$" or "health status").mp. 

30. ((human or "daily living") adj2 activit$).mp. 

31. (et or pc or ae or ep or to or ge or ec or in or ut or mo).fs. 

32. or/9-31 

33. limit 32 to human/ 

34. Nonhuman/ 

35. 33 not 34 

36. 8 and 35 

37. eng.la. 

38. 36 and 37 

39. insomni$.mp. or exp insomnia/ 

40. (sleep adj initiation adj2 maintenance adj disorder$).mp. 

41. (sleep adj onset adj3 (delay$ or latenc$)).mp. 

42. dims.mp. 
A-6

Table A-2. EMBASE - Ovid Version: rel9.1.0 (continued)

1988 to 2004 Week 37 

Searched September 15, 2004 

43. (disorder$ adj initiating adj2 maintaining adj sleep).mp. 

44. (early adj2 awaken$).mp. 

45. (sleeplessness or agrypnia$ or hyposomnia$).mp. 

46. exp Jet Lag/ 

47. (((time-zone or "time zone") adj2 change$) or "jet lag").mp. 

48. or/39-47 

49. Randomized Controlled Trial/ 

50. exp Randomization/ 

51. Double Blind Procedure/ 

52. Single Blind Procedure/ 

53. Clinical Trial/ 

54. (clin$ adj25 trial$).mp. 

55. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).mp. 

56. exp Placebo/ 

57. (placebo$ or random$).mp. 

58. exp Methodology/ 

59. or/49-58 

60. limit 59 to human/ 

61. 60 not 34 

62. 48 and 61 

63. 62 not 38 

64. meta-analysis.sh. 

65. (meta-anal$ or metaanal$).mp. 

66. ((systematic$ adj3 review$) or (systematic$ adj3 overview$)).mp. 

67. ((quantitativ$ adj3 review$) or (quantitativ$ adj3 overview)).mp. 

68. ((methodol$ adj3 review$) or (methodol$ adj3 overview$)).mp. 

69. (integrative research review$ or research integration$).mp. 

70. (quantitativ$ adj (synthes$ or analys$)).mp. 

71. (("evidence based" or evidence-based) adj3 (medicine or guideline$ or recommendation$)).mp. 

72. "cochrane database of systematic reviews".mp. 

73. cdsr.mp. 

74. acp journal club.mp. 

75. "health tech$ assess$".mp. 

76. hta.mp. 

77. "evidence based nursing".mp. 

78. "evidence based mental health".mp. 

79. "clinical evidence".mp. 

80. technolog$ assess$.mp. 

81. "evidence report$".mp. 

82. or/64-81 

83. review.pt. or (review or overview$ or reviews or handsearch or "hand search" or hand-search or 

"manual search").mp. 

84. (medline or medlars or pubmed or embase or "index medicus" or cochrane or scisearch or "Web of 

Science" or psychinfo or psycinfo or psychlit or psyclit or cinahl or cinhal or "experta medica" or 

"excerpta medica" or "science citation index" or "sciences citation index" or "biological abstracts" or 

"current contents").mp. 

85. (((electronic or bibliographic) adj3 database$) or "periodical index$").mp. 

86. ((pool$ or combined or combining) adj (data or trials or studies or results)).mp. 

87. (peto or "der simonian" or dersimonian or "fixed effect$" or "treatment outcome$" or "mantel 

haenszel").mp. 

88. or/84-87 

89. 83 and 88 

90. 82 or 89 

91. case report.ti,sh. 

91. editorial.ti,pt. 

92. letter.pt. 

93. note.pt. 

94. or/91-94 
A-7

Table A-2. EMBASE - Ovid Version: rel9.1.0 (continued)

1988 to 2004 Week 37 

Searched September 15, 2004 

95. 90 not 95 

96. Nonhuman/ not human/ 

97. 96 not 97 

98. eng.la. 

99. 98 and 99 

100. 8 and 100 

101. 101 not (38 or 63) 
A-8

Table A-3. CINAHL® (Cumulative Index to Nursing & Allied Health Literature) - Ovid Version: rel9.1.0

1982 to September Week 2 2004 

Searched September 15, 2004

1. insomni$.mp. or exp INSOMNIA/ 

2. (sleep adj initiation adj2 maintenance adj disorder$).mp. 

3. (sleep adj onset adj3 (delay$ or latenc$)).mp. 

4. dims.mp. 

5. (disorder$ adj initiating adj2 maintaining adj sleep).mp. 

6. (early adj2 awaken$).mp. 

7. (sleeplessness or agrypnia$ or hyposomnia$).mp. 

8. or/1-7 

9. exp Analytic Research/ or (analytic adj (stud$ or research)).mp. 

10. exp Nonexperimental Studies/ or exp Case Control Studies/ or exp Hospital-Based Case Control/ or 

exp Matched Case Control/ or exp Population-Based Case Control/ or exp Correlational Studies/ 

11. exp Prospective Studies/ or exp concurrent prospective studies/ or exp nonconcurrent prospective 

studies/ or exp panel studies/ or exp retrospective panel studies/ or exp revolving panel studies/ or 

exp pseudolongitudinal studies/ 

12. exp Cross Sectional Studies/ 

13. exp RELATIVE RISK/ or exp CARDIOVASCULAR RISK FACTORS/ or exp RISK MANAGEMENT/ or 

exp RISK FACTORS/ or exp FALL RISK ASSESSMENT TOOL/ or exp RISK ASSESSMENT/ 

14. exp Odds Ratio/ or ("relative odd$" or "rate ratio").mp. 

15. exp Causal Attribution/ 

16. exp professional practice, research-based/ or exp medical practice, research-based/ or exp nursing 

practice, research-based/ 

17. exp epidemiological research/ or exp seroprevalence studies/18. exp Age Factors/ or exp "age of 

onset"/ or exp comorbidity/ or exp disease surveillance/ or exp injury pattern/ or exp Sex Factors/ 

18. exp morbidity/ or exp incidence/ or exp prevalence/ 

19. (cohort or comparative or "evaluation stud$" or observational or non-experimental or "non 

experimental" or nonexperimental or control$ or prospectiv$ or volunteer$ or "case series" or "caseseries" or "case comparison" or "case-comparison" or "case referent" or "case-referent" or "cross 

sectional" or "cross-sectional" or risk or "relative risk" or causation or causal$ or "odds ratio$" or etiol$ 

or aetiol$ or incidence).mp. 

20. exp prognosis/ or exp medical futility/ or exp treatment outcomes/ 

21. exp mortality/ or exp "cause of death"/ or exp survival/ 

22. exp survival analysis/ 

23. exp disease susceptibility/ 

24. exp disease progression/ or exp "Severity of Illness Indices"/ 

25. exp Time Factors/ 

26. exp RECURRENCE/ 

27. ("natural history" or "inception cohort" or predict$ or prognos$ or outcome$ or course).mp. 

28. exp "costs and cost analysis"/ or exp "cost benefit analysis"/ or exp "cost control"/ or exp diagnosisrelated groups/ or exp health care costs/ or exp HEALTH FACILITY COSTS/ 

29. exp "Quality of Life"/ or exp "Activities of Daily Living"/ 

30. exp "Outcomes (Health Care)"/ or exp Outcome Assessment/ or exp Health Status/ or exp Health 

Status Indicators/ or exp QUESTIONNAIRES/ 

31. (cost$ or economic or social or "quality of life" or "life quality" or hrql or well-being or wellbeing or "well 

being" or "outcome adj assessment$" or "health status").mp. 

32. (et or pc or ae or ep or to or ge or ec or in or nu or ut or mo).fs. 

33. or/9-33 

34. 8 and 34 

35. limit 35 to English 

36. insomni$.mp. or exp INSOMNIA/ 

37. (sleep adj initiation adj2 maintenance adj disorder$).mp. 

38. (sleep adj onset adj3 (delay$ or latenc$)).mp. 

39. dims.mp. 

40. "disorder$ of initiating and maintaining sleep".mp. 
A-9

Table A-3. CINAHL® (Cumulative Index to Nursing & Allied Health Literature) - Ovid Version: rel9.1.0 

(continued)

1982 to September Week 2 2004 

Searched September 15, 2004

41. (early adj2 awaken$).mp. 

42. (sleeplessness or agrypnia$ or hyposomnia$).mp. 

43. exp Jet Lag Syndrome/ or (((time-zone or "time zone") adj2 change$) or "jet lag").mp. 

44. or/37-44 

45. Random Assignment/ 

46. random sample/ 

47. Crossover Design/ 

48. exp Clinical Trials/ 

49. Double-Blind Studies/ 

50. Single-Blind Studies/ 

51. Control Group/ or Factorial Design/ or Quasi-Experimental Studies/ or Community Trials/ or 

Experimental Studies/ or PRETEST-POSTTEST DESIGN/ or PRETEST-POSTTEST CONTROL 

GROUP DESIGN/ or SOLOMON FOUR-GROUP DESIGN/ 

52. clinical trial.pt. 

53. (clin$ adj25 trial$).ti,ab. 

54. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).ti,ab. 

55. ((clin$ or intervention$ or compar$ or experiment$ or preventive or therapeutic) adj10 trial$).mp. 

56. placebos/ 

57. placebo$.ti,ab. 

58. random$.ti,ab. 

59. Study Design/ 

60. or/46-60 

61. 45 and 61 

62. 62 not 36 

63. meta-analysis.sh. 

64. (meta-anal$ or metaanal$).mp. 

65. ((systematic$ adj3 review$) or (systematic$ adj3 overview$)).mp. 

66. ((quantitativ$ adj3 review$) or (quantitativ$ adj3 overview)).mp. 

67. ((methodol$ adj3 review$) or (methodol$ adj3 overview$)).mp. 

68. (integrative research review$ or research integration$).mp. 

69. (quantitativ$ adj (synthes$ or analys$)).mp. 

70. (("evidence based" or evidence-based) adj3 (medicine or guideline$ or recommendation$)).mp. 

71. guideline$.mp. 

72. "cochrane database of systematic reviews".mp. 

73. cdsr.mp. 

74. acp journal club.mp. 

75. "health tech$ assess$".mp. 

76. hta.mp. 

77. "evidence based nursing".mp. 

78. "evidence based mental health".mp. 

79. "clinical evidence".mp. 

80. technolog$ assess$.mp. 

81. "evidence report$".mp. 

82. or/64-82 

83. review.pt. or (review or overview$ or reviews or handsearch or "hand search" or hand-search or 

"manual search").mp. 

84. (medline or medlars or pubmed or embase or "index medicus" or cochrane or scisearch or "Web of 

Science" or psychinfo or psycinfo or psychlit or psyclit or cinahl or cinhal or "experta medica" or 

"excerpta medica" or "science citation index" or "sciences citation index" or "biological abstracts" or 

"current contents").mp. 

85. (((electronic or bibliographic) adj3 database$) or "periodical index$").mp. 

86. ((pool$ or combined or combining) adj (data or trials or studies or results)).mp. 

87. (peto or "der simonian" or dersimonian or "fixed effect$" or "treatment outcome$" or "mantel 

haenszel").mp. 

88. or/85-88 

89. 84 and 89 

90. 83 or 90 
A-10

Table A-3. CINAHL® (Cumulative Index to Nursing & Allied Health Literature) - Ovid Version: rel9.1.0 

(continued) 

1982 to September Week 2 2004 

Searched September 15, 2004

91. "case report".ti. or "case study".pt. 

92. editorial.ti,pt. 

93. letter.pt. 

94. commentary.pt. 

95. or/92-95 

96. 91 not 96 

97. limit 97 to English 

98. 8 and 98 

99. 99 not (36 or 63) 
A-11

Table A-4. Ovid MEDLINE® In-Process & Other Non-Indexed Citations - Ovid Version: rel9.1.0 

Searched September 14, 2004

1. insomni$.mp. 

2. (sleep adj initiation adj2 maintenance adj disorder$).mp. 

3. (sleep adj onset adj3 (delay$ or latenc$)).mp. 

4. (disorder$ adj initiating adj2 maintaining adj sleep).mp. 

5. (early adj2 awaken$).mp. 

6. (sleeplessness or agrypnia$ or hyposomnia$).mp. 

7. (((time-zone or "time zone") adj2 change$) or "jet lag").mp. 

8. or/1-7 

9. "randomized controlled trial$".mp. 

10. "controlled clinical trial$".mp. 

11. "random allocation".mp. 

12. ("double blind" adj3 method$).mp. 

13. ("single blind" adj3 method$).mp. 

14. (clin$ adj25 trial$).mp. 

15. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).ti,ab. 

16. placebo$.ti,ab. 

17. random$.ti,ab. 

18. "research design$".mp. 

19. "clinical research".mp. 

20. or/9-19 

21. 8 and 20 
A-12

Table A-5. Ovid OLDMEDLINE® - Ovid Version: rel9.1.0 

1951 to 1965 

Searched September 15, 2004 

1. insomni$.mp 

2. (sleep adj initiation adj2 maintenance adj disorder$).mp. 

3. (sleep adj onset adj3 (delay$ or latenc$)).mp. 

4. (disorder$ adj initiating adj2 maintaining adj sleep).mp. 

5. (early adj2 awaken$).mp. 

6. (sleeplessness or agrypnia$ or hyposomnia$).mp. 

7. (((time-zone or "time zone") adj2 change$) or "jet lag").mp. 

8. or/1-7 

9. "randomized controlled trial$".mp. 

10. "controlled clinical trial$".mp. 

11. "random allocation".mp. 

12. ("double blind" adj3 method$).mp. 

13. ("single blind" adj3 method$).mp. 

14. (clin$ adj25 trial$).mp. 

15. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).ti,ab. 

16. placebo$.ti,ab. 

17. random$.ti,ab. 

18. "research design$".mp. 

19. "clinical research".mp. 

20. or/9-19 

21. 8 and 20 
A-13

Table A-6. PsycINFO® - Ovid Version: rel9.1.0 

1872 to September Week 1 2004 

Searched September 15, 2004

1. insomni$.mp. or exp INSOMNIA/ 

2. (sleep adj initiation adj2 maintenance adj disorder$).mp. 

3. (sleep adj onset adj3 (delay$ or latenc$)).mp. 

4. dims.mp. 

5. (disorder$ adj initiating adj2 maintaining adj sleep).mp. 

6. (early adj2 awaken$).mp. 

7. (sleeplessness or agrypnia$ or hyposomnia$).mp. 

8. or/1-7 

9. "analytic stud$".mp. 

10. exp Between Groups Design/ or exp Cohort Analysis/ or exp Followup Studies/ or exp Longitudinal 

Studies/ or exp Repeated Measures/ or empirical methods/ or observation methods/ or exp Causal 

Analysis/ or exp Cohort Analysis/ or exp Content Analysis/ or exp Data Collection/ or exp Self Report/ 

or exp QUESTIONNAIRES/ 

11. prevention/ or exp accident prevention/ or exp preventive medicine/ or exp risk management/ or exp 

risk perception/ 

12. exp EPIDEMIOLOGY/ or exp COMORBIDITY/ 

13. (cohort or observational or correlational or non-experimental or "non experimental" or 

nonexperimental or control$ or prospectiv$ or volunteer$ or "case series" or "case-series" or "case 

comparison" or "case-comparison" or "case referent" or "case-referent" or "cross sectional" or "crosssectional" or risk or "relative risk" or causation or causal$ or "odds ratio$" or etiol$ or aetiol$ or 

incidence).mp. 

14. exp At Risk Populations/ or exp Coronary Prone Behavior/ or exp Age Differences/ or exp Human 

Sex Differences/ or exp PREDISPOSITION/ or exp DISORDERS/ or exp "SUSCEPTIBILITY 

(DISORDERS)"/ 

15. exp ETIOLOGY/ or exp ATTRIBUTION/ 

16. exp PROGNOSIS/ or exp "DEATH AND DYING"/ or exp Disease Course/ or exp Treatment 

Effectiveness Evaluation/ or exp Treatment Outcomes/ or exp Psychotherapeutic Outcomes/ or exp 

"RECOVERY (DISORDERS)"/ or exp "RELAPSE (DISORDERS)"/ or exp "remission (disorders)"/ 

17. (morbidity or prevalence or mortality or "cause of death" or "survival rate" or "disease progression" or 

"time factor$" or "disease free survival" or cure$).mp. 

18. recurrence.mp. 

19. ("natural history" or "inception cohort" or predict$ or prognos$ or outcome$ or course).mp. 

20. "costs and cost analysis"/ or exp health care costs/ or exp Resource Allocation/ 

21. exp "Quality of Life"/ or exp Psychosocial Factors/ or exp Sociocultural Factors/ or exp "Activities of 

Daily Living"/ 

22. (cost$ or economic or social or "quality of life" or "life quality" or hrql or well-being or wellbeing or "well 

being" or "outcome adj assessment$" or "health status").mp. 

23. ("empirical study" or "followup study" or "longitudinal study" or "prospective study").fc. 

24. or/9-23 

25. exp animals/ 

26. 24 not 25 

27. 8 and 26 

28. limit 27 to english language 

29. insomni$.mp. or exp INSOMNIA/ 

30. (sleep adj initiation adj2 maintenance adj disorder$).mp. 

31. (sleep adj onset adj3 (delay$ or latenc$)).mp. 

32. dims.mp. 

33. "disorder$ of initiating and maintaining sleep".mp. 

34. (early adj2 awaken$).mp. 

35. (sleeplessness or agrypnia$ or hyposomnia$).mp. 

36. (((time-zone or "time zone") adj2 change$) or "jet lag").mp. 

37. or/29-36 

38. ("Quantitative Study" or "experimental replication").fc. 

39. exp experimental methods/ or exp experimental design/ or exp quantitative methods/ 
A-14

Table A-6. PsycINFO® - Ovid Version: rel9.1.0 (continued)

1872 to September Week 1 2004

Searched September 15, 2004

40. exp Experiment Controls/ 

41. treatment/ or alternative medicine/ or interdisciplinary treatment approach/ or "medical treatment 

(general)"/ or multimodal treatment approach/ or physical treatment methods/ or preventive medicine/ 

or psychotherapeutic techniques/ or psychotherapy/ or rehabilitation/ or relaxation therapy/ or 

sociotherapy/ 

42. (therapy or treat$).mp. 

43. ((clin$ or intervention$ or compar$ or experiment$ or preventive or therap$) adj25 (trial$ or study or 

studies)).mp. 

44. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).mp. 

45. exp placebo/ 

46. (cross?over or placebo$ or control$ or factorial or sham).mp. 

47. "clinical research".mp. 

48. random$.mp. 

49. or/38-48 

50. 49 not 25 

51. 37 and 50 

52. 51 not 28 
A-15

Table A-7. EBM Reviews - Cochrane Central Register of Controlled Trials - Ovid Version: rel9.1.0 

2nd Quarter 2004 

Searched September 15, 2004

1. insomni$.mp. 

2. exp "Sleep Initiation and Maintenance Disorders"/ 

3. (sleep adj initiation adj2 maintenance adj disorder$).mp. 

4. (sleep adj onset adj3 (delay$ or latenc$)).mp. 

5. dims.mp. 

6. "disorder$ of initiating and maintaining sleep".mp. 

7. (early adj2 awaken$).mp. 

8. (sleeplessness or agrypnia$ or hyposomnia$).mp. 

9. (((time-zone or "time zone") adj2 change$) or "jet lag").mp. 

10. or/1-9 

11. randomized controlled trial.pt. 

12. controlled clinical trial.pt. 

13. randomized controlled trials/ 

14. random allocation/ 

15. double blind method/ 

16. single blind method/ 

17. clinical trial.pt. 

18. exp Clinical Trials/ 

19. (clin$ adj25 trial$).ti,ab. 

20. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).ti,ab. 

21. placebos/ 

22. placebo$.ti,ab. 

23. random$.ti,ab. 

24. research design/ 

25. or/11-24 

26. animal/ 

27. 25 not 26 

28. 10 and 27 
A-16

Table A-8. International Pharmaceutical Abstracts - Ovid Version: rel9.1.0 

1970 to August 2004 

Searched September 15, 2004

1. insomni$.mp. 

2. (sleep adj initiation adj2 maintenance adj disorder$).mp. 

3. (sleep adj onset adj3 (delay$ or latenc$)).mp.4. (disorder$ adj initiating adj2 maintaining adj 

sleep).mp. 

4. (early adj2 awaken$).mp. 

5. (sleeplessness or agrypnia$ or hyposomnia$).mp. 

6. (((time-zone or "time zone") adj2 change$) or "jet lag").mp. 

7. or/1-7 

8. "randomized controlled trial$".mp. 

9. "controlled clinical trial$".mp. 

10. "random allocation".mp. 

11. ("double blind" adj3 method$).mp. 

12. ("single blind" adj3 method$).mp. 

13. (clin$ adj25 trial$).mp. 

14. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).ti,ab. 

15. placebo$.ti,ab. 

16. random$.ti,ab. 

17. "research design$".mp. 

18. "clinical research".mp. 

19. or/9-19 

20. limit 20 to human 

21. 8 and 21 
A-17

Table A-9. AMED (Allied and Complementary Medicine) - Ovid Version: rel9.1.0 

1985 to September 2004 

Searched September 15, 2004

1. insomni$.mp. 

2. exp insomnia/ 

3. (sleep adj onset adj3 (delay$ or latenc$)).mp. 

4. (disorder$ adj initiating adj2 maintaining adj sleep).mp. 

5. (early adj2 awaken$).mp. 

6. (sleeplessness or agrypnia$ or hyposomnia$).mp. 

7. (((time-zone or "time zone") adj2 change$) or "jet lag").mp. 

8. or/1-7 

9. "randomized controlled trial$".mp. 

10. "controlled clinical trial$".mp. 

11. "random allocation".mp. 

12. ("double blind" adj3 method$).mp. 

13. ("single blind" adj3 method$).mp. 

14. (clin$ adj25 trial$).mp. 

15. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).ti,ab. 

16. placebo$.ti,ab. 

17. random$.ti,ab. 

18. "research design$".mp. 

19. "clinical research".mp. 

20. or/9-19 

21. animal/ 

22. 20 not 21 

23. 8 and 22 
A-18

Table A-10. HealthSTAR/Ovid Healthstar - Ovid Version: rel9.1.0 

1975 to August 2004 

Searched September 15, 2004

1. insomni$.mp. 

2. exp "Sleep Initiation and Maintenance Disorders"/ 

3. (sleep adj initiation adj2 maintenance adj disorder$).mp. 

4. (sleep adj onset adj3 (delay$ or latenc$)).mp. 

5. dims.mp. 

6. (disorder$ adj initiating adj2 maintaining adj sleep).mp. 

7. (early adj2 awaken$).mp. 

8. (sleeplessness or agrypnia$ or hyposomnia$).mp. 

9. or/1-8 

10. "analytic stud$".mp. 

11. exp case-control studies/ or exp retrospective studies/ 

12. exp cohort studies/ or exp longitudinal studies/ or exp follow-up studies/ or exp prospective studies/ or 

comparative study/ or exp Evaluation Studies/ 

13. exp Cross-Sectional Studies/ 

14. exp RISK FACTORS/ or exp RISK/ or exp RISK ASSESSMENT/ 

15. exp Odds Ratio/ 

16. exp CAUSALITY/ 

17. exp Logistic Models/ 

18. exp epidemiologic factors/ or exp age factors/ or exp "bias (epidemiology)"/ or exp comorbidity/ or exp 

"confounding factors (epidemiology)"/ or exp "effect modifiers (epidemiology)"/ or exp observer 

variation/ or exp reproductive history/ or exp sex factors/ 

19. exp morbidity/ or exp incidence/ or exp prevalence/ 

19. (cohort or observational or correlational or non-experimental or "non experimental" or 

nonexperimental or control$ or prospectiv$ or volunteer$ or "case series" or "case-series" or "case 

comparison" or "case-comparison" or "case referent" or "case-referent" or "cross sectional" or "crosssectional" or risk or "relative risk" or causation or causal$ or "odds ratio$" or etiol$ or aetiol$ or 

incidence).mp. 

20. exp prognosis/ or exp medical futility/ or exp treatment outcome/ 

21. exp mortality/ or exp "cause of death"/ or exp fatal outcome/ or exp survival rate/ 

22. exp survival analysis/ or exp disease-free survival/ 

23. exp disease susceptibility/ or exp genetic predisposition to disease/ 

24. exp disease progression/ or exp "Severity of Illness Index"/ 

25. exp Time Factors/ 

26. exp RECURRENCE/ 

27. ("natural history" or "inception cohort" or predict$ or prognos$ or outcome$ or course).mp. 

28. exp "costs and cost analysis"/ or exp "cost allocation"/ or exp cost-benefit analysis/ or exp "cost 

control"/ or exp "cost savings"/ or exp "cost of illness"/ or exp "cost sharing"/ or exp "deductibles and 

coinsurance"/ or exp health care costs/ or exp direct service costs/ or exp drug costs/ or exp employer 

health costs/ or exp hospital costs/ or exp health expenditures/ or exp capital expenditures/ 

29. exp "Quality of Life"/ or exp "Activities of Daily Living"/ 

30. exp "OUTCOME ASSESSMENT (HEALTH CARE)"/ or exp "OUTCOME AND PROCESS 

ASSESSMENT (HEALTH CARE)"/ or exp Health Status Indicators/ or exp Health Status/ or exp 

Questionnaires/ 

31. (cost$ or economic or social or "quality of life" or "life quality" or hrql or well-being or wellbeing or "well 

being" or "outcome adj assessment$" or "health status").mp. 

32. (et or pc or ae or ep or to or ge or ec or in or ut or mo).fs. 

33. or/10-33 

34. animal/ not human/ 

35. 34 not 35 

36. 9 and 36 

37. eng.la. 

38. 37 and 38 
A-19

Table A-11. EBM Reviews - Cochrane Database of Systematic Reviews (2nd Quarter 2004); 

ACP Journal Club (1991 to March/April 2004); Database of Abstracts of Reviews of Effects (2nd Quarter 2004) - 

Ovid Version: rel9.1.0 

Searched September 15, 2004

1. insomni$.ti,ab. 

2. (sleep adj initiation adj2 maintenance adj disorder$).mp. 

3. (sleep adj onset adj3 (delay$ or latenc$)).mp. 

4. (early adj2 awaken$).mp. 

5. (sleeplessness or agrypnia$ or hyposomnia$).mp. 

6. or/1-5 
A-20

Table A-12. Science Citation Index ExpandedTM - 1945-September 2004 - ISI Web of Knowledge 

Searched September 17, 2004 

#8 

#7 NOT #5 

DocType=All document types; Language=All languages; Database=SCI-EXPANDED; 

Timespan=1945-2004 

#7 

#6 AND #3 

DocType=All document types; Language=All languages; Database=SCI-EXPANDED; 

Timespan=1945-2004 

#6 

TS=Analytic Stud* OR TS=Case Control Stud* OR TS=Case-Control Stud* OR 

TS=Retrospective Stud* OR TS=Cohort OR TS=Longitudinal OR TS=Follow-up Stud* OR 

TS=Follow up Stud* OR TS=Prospective Stud* OR TS=Comparative Stud* OR TS=Evaluation 

Stud* OR TS=Cross Sectional Stud* OR TS=Cross-sectional Stud* OR TS=Observational 

Stud* OR TS=Questionnaire* 

DocType=All document types; Language=All languages; Database=SCI-EXPANDED; 

Timespan=1945-2004 

#5 

#4 AND #3 

DocType=All document types; Language=All languages; Database=SCI-EXPANDED; 

Timespan=1945-2004 

#4 

TS=Random* OR TS=Placebo* OR TS=Randomized Controlled Trial* OR TS=Controlled 

Clinical Trial* OR TS=Clinical Trial* OR TS=Double Blind Method* OR TS=Single Blind 

Method* 

DocType=All document types; Language=All languages; Database=SCI-EXPANDED; 

Timespan=1945-2004 

#3 

#2 OR #1 

DocType=All document types; Language=All languages; Database=SCI-EXPANDED; 

Timespan=1945-2004 

#2 

TS=Sleeplessness OR TS=Agrypnia* OR TS=Hyposomnia* 

DocType=All document types; Language=All languages; Database=SCI-EXPANDED; 

Timespan=1945-2004 

#1 

TS=Insomni* 

DocType=All document types; Language=All languages; Database=SCI-EXPANDED; 

Timespan=1945-2004 
A-21

Table A-13. Biological Abstracts - WebSPIRS from SilverPlatter, Version 4.3 

Searched September 17, 2004

1. #1 insomni* or sleeplessness or agrypnia* or hyposomnia* 

2. #2 analytic stud* or case control stud* or case-control stud* or retrospective stud* or cohort or 

longitudinal or follow up stud* or follow-up stud* or prospective stud* or comparative stud* or 

evaluation stud* or cross sectional stud* or cross-sectional stud* or observational stud* or 

questionnaire* 

3. #3 #1 and #2 

4. #4 random* or placebo* or randomized controlled trial* or controlled clinical trial* or clinical trial* or 

double blind method* or single blind method 

5. #5 #1 and #4 
A-22

Table A-14. Cochrane Complementary Medicine Field Registry - Reference Web Poster 2001; ISI 

ResearchSoft 

Searched September 20, 2004

1. Insomni or sleeplessness or agrypnia or hyposomnia 
A-23

Table A-15. CAB Abstracts - WebSPIRS from SilverPlatter, Version 4.3

Searched September 18, 2004

1. Insomni* or agrypnia* or hypsomnia* or sleeplessness 

2. Clinical trial* or randomized controlled trial* or random* or cohort or retrospective or prospective or 

volunteer* or questionnaire* 
A-24

Table A-16. SIGLE - FIZ Karlsruhe – Version Interhost 3000

Searched September 18, 2004 

1. Insomnia or sleeplessness 
A-25

Table A-17. OCLC Proceedings First - OCLC FirstSearch

Searched September 18, 2004 

1. Insomnia or insomniacs 
A-26

Table A-18. Dissertation Abstracts – ProQuest

Searched September 18, 2004

1. Insomnia 
A-27

Table A-19. Alt HealthWatch – EBSCOhost

Searched September 18, 2004 

1. Insomnia or insomnia – alternative treatment 
A-28

Table A-20. NLM Gateway

Searched September 18, 2004 

1. Searched for insomnia under Meeting Abstracts 
A-29

Table A-21. PubMed®

Searched September 20, 2004 

1. A search was conducted for the period of Jan. 01, 2004, to Sept. 20, 2004 for “Sleep Initiation and 

Maintenance Disorders” [MeSH] 
Appendix B: Data Extraction and 

Quality Assessment Forms 

Form B-1: Data extraction form for studies on manifestations of chronic insomnia in adults 

Form B-2: Data extraction form for studies on management of chronic insomnia in adults 

Form B-3: Quality assessment form for studies on prevalence or incidence of chronic insomnia 

in adults 

Form B-4: Quality assessment form for cohort studies on manifestations of chronic insomnia in 

adults 

Form B-5: Quality assessment form for case-control studies on manifestations of chronic 

Insomnia in adults 

Form B-6: Quality assessment form for studies on management of chronic insomnia in adults 
B-2

Form B-1: Data extraction form for studies on manifestations of chronic insomnia To be extracted from all studies, except where indicated. 

Record ID Indicate if 

Relevant to 

Prevalence 

Indicate if Relevant 

to Natural History 

Indicate if 

Relevant to 

Incidence 

Indicate if 

Relevant to 

Associated 

Factors 

Reviewer/Date 

Year of 

Publication 

Study Site Study Setting (if 

relevant to 

prevalence) 

Objective(s) Study Design Sampling Frame 

and Method of 

Sampling (if 

relevant to 

prevalence) 

Ti
B-3

To be extracted from all studies, except where indicated. 

Intended Sample 

Size 

Response/Follow-up 

Rate 

Method of Data 

Collection (if 

relevant to 

prevalence) 

Type of 

Participants 

Definition of 

Cases and 

Comparison 

Groups, if 

applicable 

Gender 

Distribution of 

Population 

D

Ethnicity of 

Population 

Co-morbid 

Conditions of 

Population at Entry 

Prevalence of 

Chronic Insomnia 

(if relevant to 

prevalence) 

Incidence of 

Chronic 

Insomnia (if 

relevant to 

incidence) 

Natural History 

of Chronic 

Insomnia (if 

relevant to 

natural history) 

Associated 

Factors of 

Chronic 

Insomnia (if 

relevant to 

associated 

factors) 

S
B-4

Form B-2: Data extraction form for studies on management of 

chronic insomnia in adults 

Study ID: Reviewer Initials: Verifier Initials: 

First Author: 

Title: 

Year of Publication: Language of Publication: Country of Corresponding Author: 

Funding: 

Private Industry ___ Not Specified ___

Government ___

Foundation ___

Internal ___

Other ___

Role of Funding Organization: 

Study Design: Parallel ___ Crossover ___ Unclear ___

Intent to Treat Analysis: Yes ___ No ___ Unclear ___ N/A ___ 

Quality Score: 

Number of Participants Enrolled: 

Number of Males Enrolled: Number of Females Enrolled: 

Age of Participants: 

Withdrawals/Dropouts: Yes ___ No ___ Unclear ___

Overall: 

Treatment Group(s): 

If yes, state 

number of 

withdrawals/ group 

and reasons for 

withdrawal: 

Control Group: 
B-5

Criteria for Insomnia: 

Length of Insomnia: 

Primary Chronic Insomnia: Yes ___

 

No ___

If primary chronic insomnia, list any co-morbid conditions: 

Secondary Chronic Insomnia: Yes ___ No ___

If secondary chronic insomnia, secondary to what condition (if psychiatric, see below)? 

Psychiatric Illness: Yes ___ 

If Yes, specify: 

No ___ 

Method used to Assess Outcomes: 

PSG: ___ 

Actigraphy: ___ 

Diary: ___ 

If different methods were used for different outcomes OR more than one method was used for one or more 

outcomes, please specify: 

Treatment 

Group 

Intervention Frequency 

and Duration 

of Treatment 

Timing Route of 

Delivery 

Number of 

Participants 

Allocated/ 

Analyzed 

Length of 

Follow-up 

1 

2 

3 

4 
B-6

Did participants have a treatment preference? If so, indicate which treatment was preferred and related 

information. 

Treatment 

Group 1 

Treatment 

Group 2 

Treatment 

Group 3 

Treatment 

Group 4 

Interventions 

Sleep Onset 

Latency (SOL) 

Definition of SOL: 

Wakefulness after 

Sleep Onset 

(WASO) 

 

Definition of WASO: 

Sleep Efficiency 

(SE) 

 

Definition of SE: 

Total Sleep Time 

(TST) 

 

Definition of TST: 

Sleep Quality (SQ) 

Definition of SQ: 
B-7

Quality of Life 

(QOL) 

 

Definition of QOL: 

Adverse 

Effects/Events 

 
B-8

Form B-3: Quality assessment form for studies on prevalence or 

incidence of chronic insomnia in adults 

The criteria used to rate studies relevant to the prevalence or incidence of chronic insomnia 

in adults is outlined below (Loney PL, 1998). One point was assigned for each criterion that was 

satisfied. The maximum score was eight. 

1. Random sample or whole population 

2. Unbiased sampling frame (i.e. census data) 

3. Adequate sample size 

4. Measures were the standard 

5. Outcomes measured by unbiased assessors 

6. Adequate response rate (70 percent), refusers described 

7. Confidence intervals, subgroup analysis 

8. Study subjects described
B-9

Form B-4: Quality assessment form for cohort studies on 

manifestations of chronic insomnia in adults (Newcastle-Ottawa 

scale)

Note: A study could be awarded a maximum of one star for each numbered item within the Selection and Outcome 

categories. A maximum of two stars could be awarded for Comparability. Each star was equivalent to one point. The 

maximum score was nine. 

Selection 

1) Representativeness of the exposed cohort

a) truly representative of the average _______________ (describe) in the community ∗

b) somewhat representative of the average ______________ in the community ∗

c) selected group of users e.g. nurses, volunteers 

d) no description of the derivation of the cohort 

2) Selection of the non exposed cohort

a) drawn from the same community as the exposed cohort ∗

b) drawn from a different source 

c) no description of the derivation of the non exposed cohort 

3) Ascertainment of exposure

a) secure record (e.g. surgical records) ∗

b) structured interview ∗

c) written self report 

d) no description 

4) Demonstration that outcome of interest was not present at start of study

a) yes ∗

b) no 

Comparability 

1) Comparability of cohorts on the basis of the design or analysis

a) study controls for _____________ (select the most important factor) ∗

b) study controls for any additional factor ∗ (This criteria could be modified to indicate specific 

control for a second important factor.) 

Outcome 

1) Assessment of outcome

a) independent blind assessment ∗

b) record linkage ∗

c) self report 

d) no description 

2) Was follow-up long enough for outcomes to occur

a) yes (select an adequate follow up period for outcome of interest) ∗

b) no 

3) Adequacy of follow up of cohorts

a) complete follow up - all subjects accounted for ∗

b) subjects lost to follow up unlikely to introduce bias - small number lost - > ____ % (select an 

adequate percent) follow up, or description provided of those lost) ∗

c) follow up rate < ____% (select an adequate percent) and no description of those lost 

d) no statement 
B-10

Form B-5: Quality assessment form for case-control studies on 

manifestations of chronic insomnia in adults (Newcastle-Ottawa 

scale) 

Note: A study could be awarded a maximum of one star for each numbered item within the Selection and Exposure 

categories. A maximum of two stars could be awarded for Comparability. Each star was equivalent to one point. The 

maximum score was nine. 

Selection 

1) Is the case definition adequate?

a) yes, with independent validation ∗

b) yes, e.g. record linkage or based on self reports 

c) no description 

2) Representativeness of the cases

a) consecutive or obviously representative series of cases ∗

b) potential for selection biases or not stated 

3) Selection of Controls

a) community controls ∗

b) hospital controls 

c) no description 

4) Definition of Controls

a) no history of disease (endpoint) ∗

b) no description of source 

Comparability 

1) Comparability of cases and controls on the basis of the design or analysis

a) study controls for _______________ (Select the most important factor.) ∗

b) study controls for any additional factor ∗ (This criteria could be modified to indicate specific 

control for a second important factor.) 

Exposure 

1) Ascertainment of exposure

a) secure record (e.g. surgical records) ∗

b) structured interview where blind to case/control status ∗

c) interview not blinded to case/control status 

d) written self report or medical record only 

e) no description 

2) Same method of ascertainment for cases and controls

a) yes ∗

b) no 

3) Non-Response rate

a) same rate for both groups ∗

b) non respondents described 

c) rate different and no designation 
B-11

Form B-6: Quality assessment form for studies on management of 

chronic insomnia in adults (Jadad scale and allocation concealment 

for quality assessment of RCTs) 

 

Study # _______________ Initials of Assessor: _____ 

 

Part 1 (from Jadad – Controlled Clin Trials 1996; 17:1-12) 

 

1. Was the study described as randomized (this includes the use of words such as 

randomly, random and randomization)? 

Yes = 1 No = 0 

2. Was the study described as double-blind? 

Yes = 1 No = 0 

3. Was there a description of withdrawals and drop-outs? 

Yes = 1 No = 0 

Additional points: Add 1 point if: 

Method to generate the sequence of randomization was described and was 

appropriate (e.g. table of random numbers, computer generated, coin tossing, etc.) 

Method of double-blinding described and appropriate (identical placebo, active 

placebo, dummy) 

Point deduction: Subtract 1 point if: 

Method of randomization described and it was inappropriate (allocated alternately, 

according to date of birth, hospital number, etc.) 

Method of double-blinding described but it was inappropriate (comparison of tablet 

vs. injection with no double dummy) 

OVERALL SCORE (Maximum 5)

Score 

______ 

______ 

______ 

______ 

______ 

-_____ 

-_____ 

 _____ 

Part 2 (from Schulz – JAMA 1995; 273:408-12) 

 

Concealment of treatment allocation:  Adequate 

 Inadequate 

 Unclear 

 

Adequate: e.g. central randomization; numbered/coded containers; drugs prepared by 

pharmacy; serially numbered, opaque, sealed envelopes 

 Inadequate: e.g. alternation, use of case record numbers, dates of birth or day of week; open lists 

 Unclear: Allocation concealment approach not reported or fits neither above category 
Appendix C: Evidence Tables 

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic 

insomnia in adults 

Evidence Table C-1: References

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic 

insomnia in adults 

Evidence Table C-2: References
C-1

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults Abbreviations: adj = adjusted; BAI = Beck Anxiety Inventory; BDI = Beck Depression Inventory; BMI = body mass index; BNZ = benzodiazepine; ChI = chronic insomnia; CI = 

community; CS = case; CT = control group; DSM-IV = Diagnostic and Statistical Manual of mental Disorders, 4th edition; GS = good sleepers; Hx = history; INS = drug-free inso

use insomnia; mo = months; msec = mili-seconds; MSK = musculoskeletal; MMPI = Minnesota Multiphasic Personality Inventory; NA = not applicable; NR = not reported; OR 

statistically significant; QoL = Quality of Life; TBI = traumatic brain injury; VAS = visual analogue scale; yrs = years 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Ancoli-Israel, S / 1999 Moderate (3/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional 18->65 yrs NR NR White:86%(860/1000) Black:8%(80/1000) Hispanic:3%(30/1000) Other:3%(30/1000) 1950 51.2%(1000/1950) 

Prevalence: 

All: (ChI) 9% (90/1000) 95%CI: 7.23-10.77. No prevalence data by gender. >65 group: 20% (37/183) 95%CI:14.20-25.80 Associated Factors: 

Significant Socioeconomic status: (<$50,000/yr vs >$50,000/yr): 42% vs 31%; OR (no insomnia) 0.89; 9

Non-significant Age: (<65 vs >65): 37% vs 44%; OR (no insomnia) 1.33; 95%CI: 0.83-2.14, p=0.29. Race/ethn

38% vs 35%; OR (no insomnia) 1.59; 95%CI: 0.99-2.54, p=0.66; Socioeconomic status: Edu

college): 41% vs 35%; OR (no insomnia) 0.78; 95%CI: 0.54-1.13, p=0.22. 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Bastien, CH / 2003 Moderate (5/9) 

Study Design: 

Age Group: 

GenderFemale: Male:Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol >55 yrs X=62.5± 5.8 

30 30 60 NR 

Associated Factors: 

3 groups: drug-free insomniacs (INS) vs benzodiazepine use insomniacs (INSBZ) vs good sleeSignificant Psychiatric illness and psychological problems: 1) Depression (BDI): INS vs GS: 9.00 ± 4.4INSBZ vs GS: 9.40 ± 7.16 vs 1.75 ± 1.68, p<0.01; 2) Anxiety (BAI): INS vs GS: 9.10 ± 8.38, p<vs 1.20 ± 1.47; (p<0.01). 3) Sleep impairment index: INS vs INSBZ vs GS: 17.9 ± 4.85, 16.85 ± Non-significant INS vs INSBZ vs GS: 61.7 ± 6.43, 62.3 ± 5.89, 63.35 ± 5.15, p=NS. Socioeconomic status: E

13.6 ± 5.15, 11.65 ± 2.76, 13.35 ± 3.67, p=NS. Cognitive function: 1) Folstein Mini-mental Sta

29.1 ± 1.12, 28.75 ± 1.2, 28.85 ± 1.04, p=NS. 2) Vocabulary: INS vs INSBZ vs GS: 12.65 ± 3.8p=NS. Information: INS vs INSBZ vs GS: 10.15 ± 3.51, 10.0 ± 3.01, 11.5 ± 3.40, p=NS. 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Bixler, EO / 2002 Moderate (3/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional > 20 yrs 57.4%(1000/1741) 42.6%(741/1741) NR 1741 66.6%(1160/1741) 

Prevalence: 

Insomnia ≥1 year: 7.5% (131/1741), 95%CI: 6.27-8.73. 

Associated Factors: 

Significant Age: CS vs CT: 50.4 ± 1.0 vs 46.9 ± 0.7 yrs, p=0.02. Gender: M vs F: 5.9% vs 9%; OR=1.6, 95

Race/ethnicity: Non-Caucasian vs Caucasian 12.9% vs 6.6%; OR: 2.1; 95%CI: 1.3-3.2, p<0.0

psychological problems: Depression: adj OR: 5.5; 95%CI: 3.6-8.4, p<0.0001. Medical condi

95%CI: 1.0-6, p<0.02. 2) Hypertension: adj OR: 1.2; 95%CI: 1.1-1.3, p<0.0001. 3) Anemia: adj 

p=0.004. Non-significant None reported 
C-2

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued) 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Bixler, EO / 1979 Moderate (3/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size: Response Rate: 

Cross-sectional > 18 yrs 56%(563/1006) 44%(443/1006) NR 1006 NR 

Prevalence: Life-time prevalence: (Current or past insomnia): 42.5% (428/1006), 95%CI: 39.4-45.5. Curre

(324/1006), 95%CI: 29.3-35.0. Gender: M vs F: 39% (172/443), 95%CI: 34.5-43.5 vs 61% (343

Associated Factors: 

Significant Age: >51yr (higher prevalence) 39.8%, 95%CI: 34.6-45.3, p<0.05. Psychiatric illness and ps

Tension: 29.2%, p<0.01. 2) Depression: 19.4%, p<0.05. 3) Loneliness: 12.9%, p<0.01. Medica

persistent or recurring health problem: 50%, p<0.01. 2) Multiple health problems: 17.3%, p<0.0

past year: 15.7%, p<0.01. Non-significant Gender: reported NS difference. Other factors: Marital/family problems: 17.8%, Alcohol relate

Healthcare utilization: 9.2%, all p=NS.

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Bliwise, NG / 1992 Low (1/9) 

Study Design: 

Age Group (years): GenderFemale: Male: Ethnicity: 

Sample Size:

Response Rate: 

Cross-sectional casecontrol 68.4 ± 8.7, 49-82 (CS) 67.5 ± 9.9, 52-95 (CT) 38 0 NS 38 total 16 (CS) 22 (CT) NR 

Associated Factors: 

Significant Psychiatric illness and psychological problems: (SCL-90-R Revised Symptom Checklist) C0.54 vs 0.26 ± 0.30, p<0.05. 2) Obsessive-compulsive: 1.06 ± 0.48 vs 0.68 ± 0.66, p<0.10. 3) A0.26, p<0.10. 4) Phobic anxiety: 0.15 ± 0.25 vs 0.02 ± 0.05, p<0.05. 8) Paranoid ideation: 0.50 

Psychoticism: 0.31 ± 0.27 vs 0.12 ± 0.23, p<0.05. 6 Geriatric Depression Scale (total score): 8.

p<0.10. Non significant Psychiatric illness and psychological problems: 1) Interpersonal: 0.44 ± 0.33 vs 0.31 ± 0.380.54 ± 0.54; 3) Hostility: 0.33 ± 0.36 vs 0.16 ± 0.17. Other factors: Chronic illness, Psychosoc

Socioeconomic status, Exercise, Alcohol and Caffeine intake all reported p=NS. 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Bonnet, MH / 1995 High (7/9) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional matched case-control 18-50 yrs NR NR NR 40 total 20 (CS) 20 (CT) 50%, 10/20 (CS) 50%, 10/20 (CT) 

Associated Factors: 

SignificantPsychiatric illness and psychological problems: (Profile of Mood States scale): 1) Confusio

2) Tension: 6.0 ± 5.8 vs 4.0 ± 3.8, p<0.05. 3) Depression: 9.0 ± 11.8 vs 4.1 ± 5.3, p<0.05. 4) Vi

p<0.001. Memory and cognitive function: 1) Low results on short-term memory (# words): 5.

Low results on MAST test (# correct): 53.2 ± 24 vs 60.5 ± 19, p<0.001. Non Significant: (cases vs controls): Memory and cognitive function: 1) Proofread lines: 246 ± 71 vs 258 ± 75; 2) Vigilance: 0.88 Psychiatric illness and psychological problems: 1) Fatigue: 5.7± 5.7 vs 3.6 ± 4.3; 2) Anger: scores: Hypochondriasis: 57 ± 13 vs 51 ± 6.6; Psychopathic deviate: 72 ± 12 vs 62 ± 14; M/F: 5± 6.5 vs 56 ± 7.4; Psychasthenia: 58 ± 10 vs 54 ± 6.4; Schizophrenia: 59 ± 12 vs 57 ± 7.1; HypSocial introversion: 52 ± 12 vs 48 ± 9.3, all p=NS. 
C-3

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Braga-Neto. P / 2004 Low (2/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional 34-86 yrs 36% (31/86) 64% (55/86) NR 86 NR 

Co-Morbidity: 

Medically ill (Parkinson's disease). Prevalence: 

One-month prevalence: 53.3% (49/86) (95%CI: 42.8-63.8). No prevalence data by gender. 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Broman, JE / 1996 High (6/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional 20-64 yrs 53.1% (210/396) 46.9% (186/396) NR 583 68% (396/583) 

Prevalence: 

Three-month prevalence: (ChI): 12% (47/396) 95%CI: 8.8-15.2. Associated Factors: 

Groups 1) M vs F; 2) Age: 20-34 (reference group), 35-49 and 50-64 Significant(Basic Nordic Sleep Questionnaire scores) Medical conditions: 1) Personal illness (age): p<0

activities (age): p<0.0001. 2) Having too little time (age): p<0.0001, 3) Watching TV (age): p<0

Relatives' illness (gender): p<0.05, 2) Children's sleeping pattern (age): p<0.0001. Cognitive f

factor (age): p <0.05; Sleepiness (age): p<0.01; Non-Significant (Basic Nordic Sleep Questionnaire scores) Quality of life: Working conditions/hours, low capacity for sleep both p=NS. 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Broman, JE / 1992 Moderate (5/9) 

Study Design: 

Age Group

mean ± SD: GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 45.8 ± 11.5 yrs (CS) 45.0 ± 10.2 yrs (CT) 15 (CS), 15 (CT) 5 (CS), 5 (CT) NR 40 total 20 (CS), 20 (CT) NR 

Associated Factors: 

Significant Psychiatric illness and psychological problems: 1) Mood, anxiety and cognitive performanc

43.4, p<0.01. 2) State anxiety (State-Trait Anxiety Inventory): 39.9 ± 9.5 vs 32.6 ± 7.6, p<0.05. Non-Significant Objective performance: Reaction time dominant hand 1) Speed (ms:) 225.9 ± 42.3 vs 230.1 ± 

vs 54.3 ± 25.4; Word recognition 1) # correct: 19.5 ± 2.6 vs 19.8 ± 2.5; 2) Latency (s): 2.66 ± 1.recognition 1) # correct: 12.9 ± 3.1 vs 12.2 ± 3.1; 2) Latency (s): 3.55 ± 1.46 vs 3.24 ± 1.07; Fin

taps 61.0 ± 7.6 vs 61.7 ± 8.9; 2) Variability 3.9 ± 2.9 vs 4. ± 2.8, all p=NS. Psychiatric illness aVAS for Tension: 47.5 vs 38.5, Excitement 46.4 vs 41.7, Stress 40.9 vs 35.4, Concentration 53(Jenkins Activity scale) all subscales p=NS. 
C-4

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Chambers, MJ / 1993 Low (1/9) 

Study Design: 

Age Group

mean ± SD:GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 47.5 ± 10.9 yrs (CS) 45.9 ± 16.0 yrs (CT) 64.5%, 20/31 (CS) 60%, 21/35 (CT) 35.5%, 11/31 (CS) 40%, 14/35 (CT) NR 66 total 31 (CS), 35 (CT) NR 

Associated Factors: 

Significant Psychiatric illness and psychological problems: Anxiety 1) State anxiety: 39.1 ± 10.3 vs 31anxiety: 44.8 ± 9.8 vs 32.3 ± 7.7, p<0.001. Non-Significant None reported 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Coursey, RD / 1975 High (7/9) 

Study Design: 

Age Group

mean ± SD: GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 44.7 ± 16.8 yrs 5 (CS), 5 (CT) 13 (CS), 13 (CT) NR 36 total 18 (CS), 18 (CT) NR 

Associated Factors: 

SignificantPsychiatric illness and psychological problems: 1) Anxious worriers (Byrne's Repression-S

vs 50.4 ± 20.9, p<0.01; Taylor Manifest Anxiety scale: 22.5 ± 9.5 vs 13.3 ± 11.6, p<0.01; Edwa25.4 ± 6.1 vs 30.1 ± 5.8, p<0.05; Eysenck's Neuroticism scale: 12.1 ± 4.5 vs 5.7 ± 4.6, p<0.001vs 19.8 ± 3.5, p<0.001; Zung's Depression scale: 53.0 ± 11.5 vs 35.7 ± 6.2, p<0.001; MMPI Ps

vs 25.94 ± 3.75, p<0.01. 2) Concern with internal vs external stimuli (MMPI Hysteria scale): 20

MMPI Hypochondriasis scale: 19.0 ± 5.3 vs 12.5 ± 3.1, p<0.001; Zuckerman Sensation-Seekinp<0.001. Memory and cognitive function: Wechsler Adult Intelligence Scale 1) Low scores: Block Comp<0.05, Object Assembly: 8.4 ± 3.4 vs 11.4 ± 3.4, p<0.05 and Performance IQ: 107.1 ± 13.5 vs Non-significant Psychiatric illness and psychological problems: 1) MMPI K: 14.24 ± 4.43 vs 16.33 ± 5.39; 2

29.24 ± 9.88 vs 24.39 ± 9.47; 3) Depression Adjective Checklist: 8.94 ± 6.78 vs 7.0 ± 6.32; 4) M

4.71 vs 20.83 ± 4.51; 5) Eysenck’s Extraversion: 11.82 ± 3.13 vs 11.56 ± 4.18; all p=NS. All Teneurotic scales NS differences. Memory and cognitive function: Wechsler Adult Intelligence 

for: Information, Comprehension, Arithmetic, Similarities, Digit span, Vocabulary, Digit symbol, 

Full scale IQ. 
C-5

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Crenshaw, MC / 1999 Moderate (3/9) 

Study Design: 

Age Group

mean ± SD: GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 67.7 ± 4.8 yrs (CS) 67.5 ± 5.7 yrs (CT) 16 (CS), 16 (CT) 16 (CS), 16 (CT) NR 64 total 32 (CS), 32 (CT) NR 

Co-Morbidity:

Stable medical conditions: 3.2 ± 2.4 vs 2.3 ± 1.7, p>0.10. CS vs CT: hypertension 43.8% (14/39.4% (3/32) vs 3.1% (1/32), asthma 6.3% (2/32) vs 6.3% (2/32). Associated Factors: 

Significant None detected Non-significant Cognitive function: Performance measures: 1) SRT- latency (ms): 256.9 ± 77.1 vs 265.4 ± 92

± 29.7 vs 67.9 ± 37.5; 3) CPT-mean latency (ms): 381.6 ± 60.0 vs 373.9 ± 60.0; 4) CPT-mean 

20.7; 5) SWAT - Part I: mean latency (ms): 306.9 ± 63.8 vs 293.0 ± 57.3; 6) SWAT - Part I: me± 26.0; 7) SWAT - Part II: mean latency (ms): 472.8 ± 93.3 vs 478.2 ± 77.4; 8) SWAT - Part II: 

111.8 ± 43.2. For all, p >0.10. SRT = simple reaction time; CPT = continuous performance test; SWAT = Switching attention t

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Dorsey, CM / 1997 Low (2/9) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 18-25 yrs 14 17 NR 31 total 18 (CS), 13 (CT) NR 

Associated Factors: 

Non-significant Psychiatric illness and psychological problems: Objective Insomnia vs Subjective Insomnia Inventory Extraversion scale: 10.2 ± 3.9 vs 12.7 ± 3.9 vs 14.4 ± 3.7, p<0.058; 2) Neuroticism: 9

4.3, p=0.062, 3) Sociability 5.0 ± 3.0 vs 6.8 ± 2.3 vs 7.7 ± 3.1 p >0.05. 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Edinger, JD / 2000A Moderate (4/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 40-59 yrs (CS) 40-59 yrs (CT) 55.6%, 15/27 (CS) 51.6%, 16/31 (CT) 44.4%, 12/27 (CS) 48.4%, 15/31 (CT) NR 32 (CS), 32 (CT) 84.4%, 27/32 (CS) 96.9%, 31/32 (CT) 

Associated Factors: 

Significant Cognitive function: Performance measures - mean latencies (ms): 1) SWAT Part II: 406.7 ± 7SWAT-Part III-B-direction: 611.9 ± 110.0 vs 689.8 ± 177.9, p=0.05. Non-significant Cognitive function: Performance measures - mean latencies (ms): 1) Simple reaction time: 22p=NS; 2) Continuous performance test: 353.8 ± 37.3 vs 362.7 ± 45.2, p=NS; 3) SWAT - Part I: p=NS; 4) SWAT - Part III-A-side: 459.7 ± 138.7 vs 543.2 ± 192.0, p=NS. SWAT = Switching attention test 
C-6

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Edinger, JD / 2000B High (8/9) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 40-79 yrs 32 (CS), 31 (CT) 32 (CS), 31 (CT) NR 128 total 64 (CS), 64 (CT) 100%, 64/64 (CS) 95.3%, 61/64 (CT) 

Associated Factors: 

Significant Psychiatric illness and psychological problems: Objective Insomnia CS vs Objective normadysfunctional beliefs and attitudes about sleep control: 37.7 ± 11.6 vs 18.5 ± 10.9; p<0.05. SubSubjective normal sleepers: 2) High scores on Trait portion of the State-Trait Anxiety Inventory 

6.5; p<0.05. 3) High scores on the Beck Depression Inventory: 8.6 ± 5.2 vs 3.5 ± 3.3; p<0.05. 4beliefs and attitudes about sleep effects: 44.6 ± 18.6 vs 26.9 ± 20.4; p<0.05. 5) High scores on attitudes about sleep control: 33.6 ± 11.4 vs 18.3 ± 10.8; p<0.05. 6) High scores on Dysfunctiosleep needs: 46.3 ± 24.4 vs 30.6 ± 15.9; p<0.05. Non-significant Psychiatric illness and psychological problems: Objective Insomnia CS vs Objective normadysfunctional beliefs and attitudes about sleep [a] Effects: 41.5 ± 19.9 vs 33.2 ± 15.6, [b] Cause

Needs: 38.3 ± 15.9 vs 37.2 ± 11.9, [d] Habits: 25.7 ± 13.9 vs 27.0 ± 11.1, all p>0.05. 2) High sc

State-Trait Anxiety Inventory (STAI-2): 34.9 ± 6.7 vs 30.7 ± 6.1, p>0.05. 3) High scores on the ± 4.0 vs 4.6 ± 3.7, p>0.05. Subjective Insomnia CS vs Subjective normal sleepers: 1) High scoattitudes about sleep [a] Cause: 30.6 ± 17.0 vs 23.0 ± 15.4, p>0.05; [b] Habits: 27.2 ± 13.3 vs 2

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Fichtenberg, NL / 2002 Moderate (4/8) 

Study Design: 

Age Group

mean ± SD: GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional 36.5 ± 14.5 yrs (TBI) 38.2 ± 13.5 yrs (SCI) 47.3 ± 12.2 yrs (MSK) 44%, 22/50 (TBI) 24%, 6/25 (SCI) 80%, 20/25 (MSK) 56%, 28/50 (TBI) 76%, 19/25 (SCI) 20%, 5/25 (MSK) NR 100 total 50 (TBI), 25 (SCI), 25 (MSK) 100% 

Co-Morbidity:

Traumatic back injury, spinal cord injury, or muskuloskeletal injury. Prevalence: 

DSM-IV Criteria: 30% (15/50) 95%CI: 27.3-42.7% of TBI patients. PSQI Criteria: 28% (14/50) patients. 56% (14/25) 95%CI: 36.5-75.5 for SCI patients. 56% (14/25) 95%CI: 36.5-75.5 for MS
C-7

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Hajak, G / 2001 High (6/8)  - cross sectional High (7/9)  - case control 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol Over 18 yrs Cross-sectional: 53.1% (1016/1913) 46.8% (897/1913) NR 1913 Cross-sectional 368 Case-control: 206 (CS), 162 (CT) NR 

Prevalence: 

One-month prevalence: (Sleep disturbances) 45% (784/1913), 95%CI: 42.7-47.2%. (Severe i

3.2-4.8%. Male: 3% (26/897), 95%CI: 1.89-4.11%. Female: 5% (51/1016), 95%CI: 3.66-6.34%

Associated Factors: 

Significant Cross-sectional data: Gender: 1) Female: OR: 1.77; 95%CI: 1.09-2.86; p=0.04. Social relationdivorced: OR: 3.45; 95%CI: 1.84-6.47, p<0.01; 2) Living in cities > 20,000: OR: 12.88; 95%CI: 

Case-control: Healthcare utilization: 1) Regular medication use: OR: 1.63; 95%CI: 1.06-2.52; 

≤ 6 mo.: OR: 1.54; 95%CI: 1.02-2.34. Cross-sectional: Quality of life: 1) Bad/Very Bad QoL (S

21.97. Non-significant Age: <65 vs > 65: OR 1.06; 95%CI: 0.60-1.89. Social Relationships: # in household, # childre

status: working status, type of employment; all p=NS. Healthcare utilization: 1) Consult phys

95%CI: 0.78-2.18; 2) Hospitalizations in <12 m: OR 1.38; 95% C!: 0.71-2.65. Quality of life: Qvs no sleep complaints; SF-36 scores); Vitality scale: 41.17 vs 62.7; Social functioning scale: 6

scale: 55.17 vs 87.57; Mental health scale: 50.35 vs 73.61; all p=NS. 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Han, SY / 2002 Low (2/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional 27-78 yrs 39% (32/82) 61% (50/82) NR 82 NR 

Co-Morbidity: 

Diabetes requiring hemodyalisis.Prevalence: 

Point prevalence: (Sleep difficulties ≥2 months): 68.2% (56/82), 95%CI: 58.2-78.2; Male: 72% 

Female: 62.5% (20/32), 95%CI: 45.7-79.2. Associated Factors: 

Significant Psychiatric illness and psychological problems: 1) Depression (Center for Epidemiologic S

CES-D) score ± SD; insomnia vs non-insomnia: 25.2 ± 12.1 vs 18.9 ± 10.3; p=0.02. Medical coadj OR: 0.80; 95%CI: 0.67-0.98; p=0.028. Non-significant Age: Older vs younger: CS vs CT: 60.5 ± 9.0 vs 56.1 ± 9.6; p=0.053. Gender: M/F: OR 1.54; 9Socioeconomic status: 1) Education (>12yr vs ≤12yrs): OR 0.81; 95%CI: 0.25-2.63; 2) Job (y

1.13, p=NS. Medical conditions: Duration of diabetes, frequency of somatic symptoms, p=NS

Alcohol, p=NS.
C-8

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Harvey, AG / 2003 Moderate (3/9) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 20.4 ± 4.7 yrs (CS) 22.3 ± 8.9 yrs (CT) 60%, 18/30 (CS) 63.3%, 19/30 (CT) 40%, 12/30 (CS) 36.7%, 11/30 (CT) NR 60 total 30 (CS), 30 (CT) NR 

Associated Factors: 

SignificantPsychiatric illness and psychological problems: Measures of Psychopathology 1) Sleep co

"Very much") 3.7 ± 1.8 vs 0.1 ± 0.3, p<0.001. Quality of life: Cost (scale: 0 "There is no cost, s

me at all" to 10 "Sleeping badly is extremely costly and significantly disrupts my life") 5.5 ± 1.8 

Psychiatric conditions: 1) Beck Anxiety Inventory 13.6 ± 9.6 vs 7.3 ± 7.2, p<0.01. 2) Penn St

15.1 vs 41.2 ± 14.9, p<0.001. Non-significant Age: Insomnia vs good sleeper: (mean ± SD): 20.4 ± 4.7 vs 22.3 ± 8.9, p=NS.

Psychiatric illness and psychological problems: 1) Beck Depression Inventory 10.3 ± 7.3 v

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Hauri, PJ / 1997 High (7/9) 

Study Design: 

Age Group

mean ± SD: GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 47.7 ± 11.8 yrs 19 (CS), 19 (CT) 7 (CS), 7 (CT) NR 52 total 26 (CS), 26 (CT) NR 

Associated Factors: 

Significant Memory and cognitive function: (CS vs CT) Performance: 1) Simple reaction tasks: Sway Fo41.2, p<0.02; Initiation time (msec): 486 ± 614 vs 330 ± 115, p<0.01; Total time (msec): 662 ± 

Complex reaction tasks: Initiation time (msec): 489 ± 218 vs 401 ± 98, p<0.02; Total time (mse

p<0.03; 3) Performance on Digit Span test (Number remembered): 21.4 vs 24.5; p<0.01), 4) Sl(Stanford Sleepiness scale mean scores: 3.67 vs 2.33; p<0.0001).Non-significant Memory and cognitive function: Performance: 1) Sway sideward (sec) 43.4 vs 49.7; 2) Simp

time (msec) 188 ± 150 vs 156 ± 79; 3) Complex reaction tasks: Initiation time (msec) 259 ± 157 

on Digit Span test: Divided Attention: Sum of squares 2711 vs 1826; Reaction time (msec) 274

substitution: # attempted 58.9 vs 62.1, all p=NS. 
C-9

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Healey, ES / 1981 High (8/9) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 19-63 yrs (CS) 18-63 yrs (CT) 22 (CS), 22 (CT) 9 (CS), 9 (CT) NS 62 total 31 (CS), 31 (CT) NS 

Associated Factors:

Significant Psychiatric illness and psychological problems: Childhood variables 1) Nightmares (1-5 scp<0.05, 2) Sleeping problems (1-5 scale); 1 = never: 1.90 vs 1.48; p<0.05, 3) Sleep quality in cexcellent: 1.90 vs 1.45; p<0.01, 4) Reporting of eating problems: 1.77 vs 1.35; p<0.05. Self con

Affiliation: 42.3 vs 48.2; p<0.05, 2) Abasement: 54.4 vs 47.8; p<0.05, 3) Aggression: 55.9 vs 49

readiness: 55.9 vs 47.4; p<0.01, 5) Low defensiveness: 43.1 vs 52.4; p<0.01, 6) Low self-contrpersonal adjustment: 41.4 vs 50.9; p<0.01, 8) Low achievement: 46.1 vs 52.7; p<0.05, 9) Low p<0.05, 10) Low affiliation: 39.9 vs 49.7; p<0.001, 11) Poor self-perception: 59.3% vs 4.5%; p<

perception: 65.2% vs 21.7%; p<0.01, 13) Passive traits: 60% vs 20%; p<0.05, 14) Nervousnes

vs 31.8%; p<0.05, 15) Suicidal thoughts: Health Questionnaire: 35.5% vs 9.7%; p<0.05, 16) Incdisturbance (Health Questionnaire): 38.7% vs 6.5%; p<0.01. Medical conditions: 1) Total # ill

3.19% vs 1.84%; p<0.001, 2) Incidence of allergies (Health Questionnaire): 45.2% vs 12.9%; p

1) Change in financial status (Social Readjustment Rating Scale): 53.23 vs 40.48 ± 69.37; p<0work: 56.13 vs 41.61; p<0.05. Healthcare utilization 1) More hospitalizations two years prior tevaluation time (Health Questionnaire): 1.55% vs 0.34%; p<0.01, 2) Major hospitalizations ≥ 3 Questionnaire): 1.07% vs 0.26%; p<0.05. Quality of life: 1) Satisfaction with parent relationshisubscores; 1 = satisfied): 4.07 vs 2.85; p<0.01, 2) Satisfaction with social life (Life Satisfaction 

satisfied): 3.74 vs 2.94; p<0.05, 3) Satisfaction with leisure time (Life Satisfaction scale mean s

3.16; p<0.05, 4) Satisfaction with living arrangements (Life Satisfaction scale mean subscores; p<0.01, 5) Satisfaction with oneself (Life Satisfaction scale mean subscores; 1 = satisfied): 3.9

with health prior to sleep problem (Life Satisfaction scale mean subscores; 1 = satisfied): 2.90 

with health in the present (Life Satisfaction scale mean subscores; 1 = satisfied): 3.84 vs 1.97; health complaints (Health Questionnaire): 9.55 vs 5.87; p<0.001, 9) Lack of energy (Health Qup<0.05. Social relationships: 1) Mean # losses from social field: 1.19 ± 1.01 vs 0.52 ± 1.03; pfunction: 1) Trouble concentrating (Health Questionnaire): 51.6% vs 12.9%; p<0.05. Other fac

year of insomnia onset (Life Change Unit scale): 157.52 ± 65.96 vs 91.90 ± 69.37; p<0.0), 2) Rof insomnia onset (Schedule of Recent Experience interview): 345.56 ± 148.08 vs 197.78 ± 15personal events experienced: 2.71 ± 1.97 vs 1.58 ± 1.95; p<0.05, 4) Mean # undesirable eventp<0.001. Non-significant Social relationships: Area of activity: 1) mean # life events: work, financial, legal, family, desir

p=NS. 2) Mean # entrances into social field 0.32 ± 0.60 vs 0.19 ± 0.48; p=NS. 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Hetta, J / 1999 Low (0/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional Over 18 yrs NS NS NS 1,996 total 25%, 499/1996 

Prevalence: 

One-month prevalence: 31% (155/499) (95%CI: 27-35). No prevalence data by gender. 
C-10

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Hidalgo, MP / 2002 Moderate (5/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional 18-35 yrs 41.8%, 143/342 58.2%, 199/342 NS 342 total NS 

Prevalence: 

One-year prevalence: (Sleep difficulties ≥ 1 mo): 26% (89/342) 95%CI: 21.3-30.6. No prevalenAssociated Factors: 

Significant Psychiatric illness and psychological problems: 1) Minor psychiatric disorders and insomni4.56; p<0.05. Non-significant Gender: (F vs M) OR 0.87; 95%CI: 0.56-0.65; p=NS. Psychiatric illness and psychological 

psychopathologies: OR 0.99, 95%CI: 0.5 -1.96; p=NS. 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Hohagen, F / 1993 Moderate (4/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional 18-65 yrs 55.3%, 1389/2512 44.7%, 1123/2512 NS 2,512 total 97.9%, 2459/2512 

Prevalence: 

Six-month prevalence: (Severe, moderate, mild insomnia): 45.9% (1152/2512) 95%CI: 44-4895%CI: 17.1-20.2. No prevalence data by gender. Associated Factors: 

Significant Psychiatric illness and psychological problems: 1) Depression (mild chronic insomnia): n = 

ChI: n = 18, 7%; p<0.001; severe ChI: n = 85, 21.7%; p<0.001, 2) Neurosis/personality disorde= 28, 7.2%; p<0.001, 3) Acute psychological distress (moderate chronic insomnia): n = 20, 7.8%10.2%; p<0.001, 4) Alcohol drug abuse (severe ChI): n = 18, 4.6%; p<0.001, 5) Psychosomatic 5.6%; p<0.001. Non-significant Psychiatric illness and psychological problems: 1) Neurosis/personality disorders - modera

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Hohagen, F / 1994 Moderate (4/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional Over 65 yrs 72%, 237/330 8%, 93/330 NS 338 97.5%, 330/338 

Prevalence: 

Point prevalence: (All DSM-III-R insomnia): 56.3% (186/330) 95%CI: 50.9-61.6. Severe DSM-95%: 18.4-27.5. No prevalence data by gender. Associated Factors: 

Significant Gender: severe insomnia F/M 29.1 vs 7.9, p <0.001. Healthcare utilization: 1) Prescribed hyp

95%CI: 3.19-12.0; p<0.001; physician report: OR: 2.09; 95%CI: 2.09-12.6; p<0.001. Psychiatrproblems: Depression OR 2.93; 95%CI: 1.51-5.71; p <0.01. Mental disorders (Total) OR 1.71; Non-significant Medical conditions (acute/chronic): reported NS. 
C-11

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Ishigooka, J / 1999 Moderate (5/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional 15-65 yrs 58.1%, 3645/6277 41.9%, 2632/6277 All Asian (Japanese) 7112 total 88.3%, 6277/7112 

Prevalence: 

Point prevalence: (Insomnia lasting ≥ 1 mo): 11.7% (735/6277), 95%CI: 10.9-12.4. Male: 11.2

Female: 12% (440/3645), 95%CI: 10.9-13. Associated Factors:

SignificantAge: 1) Older age group (45-54 yrs): OR 1.42; p<0.001; 55-64 yrs OR: 1.81; p<0.0001; 65+ OR

Female/male: OR 1.12; p<0.05. Healthcare utilization: 1) Neurology service: OR: 1.73; p<0.01), 2) Psychiatry service: OR: 3.8

Living alone: OR: 1.18; p<0.05), 2) Dissatisfaction with sleep environment: OR: 1.58; p<0.0001Non-significant Other factors: Occupation, Residential area, Season, Alcohol consumption, Smoking, Caffein

p=NS. (no data) 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Kageyama, T / 2001 Moderate (5/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional study 24-59 yrs NS NS Japanese 555 total NS 

Prevalence: 

Point prevalence: 29.2% (162/555) 95%CI: 28.7, 29.7. 

Associated Factors: 

Significant Age: (40-49 yrs reference group): <24 yrs: 34% (62/184), adj OR = 2.34; 95%CI: 1.19-4.62. W

mean score ± SE): 1) Workload: 2.47 ± 0.06 vs 2.30 ± 0.004, p<0.05; 2) Mental workload: 2.41 3) Problem in personal relationships: 2.18 ± 0.06 vs 2.00 ± 0.03, p<0.05; 4) Job satisfaction: 2.p<0.05; 5) Support from colleagues and superiors: 2.66 ± 0.05 vs 2.82 ± 0.03, p<0.01; 7) Seve0.06 vs 2.57 ± 0.04, p<0.01. 8) # non-working days in ≤ 3mo: (≤ 6 days/mo): OR 2.62; 95%CI: 

3mo. (≥ 9 nights/mo is reference gr): (1-3 nights/mo) OR 3.32; 95%CI: 1.0-11.16. Socioecono

last 3 mo (<10 vs ≥10) p<0.05 

Non-significantAge: (40-49 yrs reference group): 25-29 yrs: 26% (37/143), adj OR = 1.45; 95%CI: 0.69-30.2), = 1.48; 95%CI: 0.71-3.11; 50-59 yrs: 33% (14/43), adj OR = 2.41; 95%CI: 0.96-6.05, all p=NS. 

Undergoing medical treatment (no vs yes): 27% (119/441) vs 36% (37/104), p=NS. Work perfoscore ± SE): 1) Job control: 2.36 ± 0.05 vs 2.45 ± 0.03, p=NS). 2) # non-working days in ≤ 3mo

95%CI: 0.74-1.76; 3) # night shifts in ≤ 3mo. (≥ 9 nights/mo is reference gr): (4-5 nights/mo) OR 

nights/mo): OR 1.80; 95%CI: 0.54-6.02. Relationships: 1) Marital status OR 1.31; 95%CI: 0.89

nurse relationship: 1.94 ± 0.04 vs 2.10 ± 0.06. 3) # Children < 6: OR 0.95; 95%CI: 0.51-1.76, 4

2): OR 0.74, 95%CI: 0.49-1.12. Medical conditions: Current OR 0.67, 95%CI: 0.43-1.05. 
C-12

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Kageyama, T / 1997 High (6/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional 20 - 80 yrs 3600 0 Japanese 3600 total Varied between district 51-59% 

Prevalence: 

Point prevalence: 11.2% (403/3600) 95%CI: 10.2, 12.2. 

Associated Factors: 

SignificantAge: (% ± SE, reference group 30-39 yr): 70+ years: 14.2% (46/322) ± 1.9, adj OR = 2.1; 95%

1) Sleep apnea-like symptoms (absent vs present, absent is reference category): adj OR = 2.7

Disease: OR = 2.4, p<0.01. Relationships: 1) Children ≤ 6 in home: OR 1.5; 95%CI: 1.0-2.1; 2

1.4; 95%CI 1.1-1.9. Healthcare utilization: 1) Consulting a physician or other specialist (insomSE): Current: 11.4% ± 1.6 (46/403) vs 1.3% ± 0.2 (42/3197), OR = 9.68; 95%CI: 6.28-14.92; Pa

4.9% ± 0.4 (157/3197), OR = 4.07; 95%CI: 3.00-5.51; Never: 71.2% ± 2.3 (287/403) vs 93.8% 

95%CI: 0.13-0.21; 2) Undergoing medical treatment (yes vs no, no is reference category) adj Operformance: (insomniacs vs non-insomniacs % ± SE): 1) Inefficiency in work: 17.2% ± 1.9 (6p<0.001, OR = 2.20; 95%CI: 1.65-2.93; 2) Tardiness: 10.2% ± 1.5 (41/403) vs 4.4% ± 0.4 (14195%CI: 1.71-3.53; 3) Prone to errors in work (8.9% ± 1.4 (36/403) vs 3.5% ± 0.3 (112/3197), p<3.99. Non-significant Age: (% ± SE, reference group 30-39 yr): 20-29 yrs: 13.3% (45/337) ± 1.8, adj OR = 1.5; 95%C

(90/982) ± 0.9, adj OR = 1.1; 95%CI: 0.7-1.7, 50 - 59 yrs: 12.6% (107/852) ± 1.1, adj OR = 1.1; 

13.1% (66/501) ± 1.5, adj OR = 1.6; 95%CI: 0.9-2.6; all p=NS. Socio-economic status: (% wit10.5% (183/1739) ± 0.7, unemployed: 11.9% (195/1639) ± 0.8; p=NS. Social relationships: M(291/2722) ± 0.2, Single 13.0% (94/721) ± 1.3, p=NS. Other factors: Exercise, Smoking, Alcohdata). 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Kales, AK / 1983 Moderate (4/9) 

Study Design: 

Age Group

mean ± SD: GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 43.1 ± 0.9 (CS) 40.9 ± 1.5 (CT) 59%, 177/300 (CS) 59%, 59/100 (CT) 41%, 123/300 (CS) 41%, 41/100 (CT) NS 400 total 300 (CS), 100 (CT) 93%, 279/300 (CS) 97%, 97/100 (CT) 

Associated Factors: 

SignificantPsychiatric illness and psychological problems: (MMPI) (mean ± SE): 1) F Scale: 7.4 ± 0.2 

13.9 ± 0.3 vs 15.8 ± 0.5, p<0.01; 3) Hypochondriasis Scale: 63.2 ± 0.8 vs 50.2 ± 0.8, p<0.01); 4

vs 52.8 ± 1.1, p<0.01; 5) Conversion Hysteria Scale: 66.8 ± 0.7 vs 54.8 ± 0.8, p<0.01; 6) Psych

0.7 vs 56.2 ± 1.1, p<0.01; 9) Paranoia Scale: 60.7 ± 0.6 vs 55.4 ± 0.9, p<0.01; 10) Psychasthe

0.9, p<0.01; 11) Schizophrenia Scale: 66.4 ± 0.9 vs 54.5 ± 1.0, p<0.01. 

Non-significant Psychiatric illness and psychological problems: (MMPI) (mean ± SE): 1) L Scale: 50.1 ± 0.

Masculine-Feminine Scale: Male 65.5 ± 0.9 vs 62.3 ± 1.7, p=NS. Female 45.2 ± 0.7 vs 45.5 ± 157.2 ± 0.7 vs 55.0 ± 1.0, p=NS. MMPI = Minnesota Multiphasic Personality Inventory Scale 
C-13

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Kales, AK / 1982 Low (2/9) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 18-78 yrs (CS) 18-74 yrs (CT) 118 (CS), 59 (CT) 82 (CS), 41(CT) NS 300 total 200 (CS), 100 (CT) NS 

Associated Factors: 

SignificantPsychiatric illness and psychological problems: (CSs with sleep apnea vs CTs with sleep ain MMPI Psychopathic deviate scale: 64.5 ± 2.2 vs 52.4 ± 2.7; p<0.01. 2) Elevation in MMPI Ps

vs 55.7 ± 2.1; p<0.01. 3) Elevation in MMPI Schizophrenia scale: 64.4. ± 2.9 vs 53.8 ± 1.8; p<0

MMPI scale: 68.4% vs 36.4%; p<0.01. 5) Mean # elevated MMPI scales: 1.9 ± 0.5 vs 0.4 ± 0.2myoclonic activity vs CTs with nocturnal myoclonic activity; mean ± SD): 1) Elevation in MMPI 50.5 ± 3.2; p<0.01. 2) Elevation in MMPI Conversion hysteria scale: 64.3. ± 2.8 vs 55.6 ± 2.2; pPsychopathic deviate scale: 65.8. ± 2.6 vs 54.8 ± 2.8; p<0.01. 4) Elevation in MMPI Psychasth

2.4; p<0.01. 5) Elevation in MMPI Schizophrenia scale: 64.2. ± 2.6 vs 50.6 ± 2.7; p<0.01. 6) Elescale: 62.2. ± 3.1 vs 51.4 ± 2.1; p<0.01. 7) Elevations in at least one MMPI scale: 83.3% vs 36elevated MMPI clinical scales: 2.1 ± 0.5 vs 0.4 ± 0.2; p<0.01. Non-significant Psychiatric illness and psychological problems: 1) CSs with sleep apnea vs CTs with sleep difference in frequency: 9.1± 1.3 vs 9.5 ± 2.2 or duration of episodes (sec): 16.2 ± 1.0 vs 13.8 ± 

myoclonic activity vs CTs with nocturnal myoclonic activity; mean ± SE: Prevalence: 5% (n=10) 

106.5 ± 16.9 vs 171.3 ± 41.2, p=NS. 3) Elevation in MMPI Hypochndriasis scale: 60.9 ± 3.8 vs 

MMPI Paranoia scale: 56.4 ± 2.3 vs 53.2 ± 2.5; p=NS. MMPI = Minnesota Multiphasic Personality Inventory Scale 
C-14

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Kales, JD / 1984 Low (1/9) 

Study Design: 

Age Group

mean ± SD: GenderFemale: Male:Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 43.1± NS (CS) 48.2 ± 1.5 (CT) 58.9%, 126/214 (CS) 59%, 59/100 (CT) 41.1%, 88/214 (CS) 41%, 41/100 (CT) NS 314 total 214 (CS), 100 (CT) NS (CS) 94%, 94/100 (CT) 

Associated Factors:

Significant Psychiatric illness and psychological problems: 1). Mental Health: a) More nervous than ot(11/94), p<0.01 (OR = 7.55, 95%CI: 3.81-14.95), b) Ready to go to pieces 51% (109/214) vs 12

95%CI: 3.95-15.52), c) Feeling life is a strain 46% (99/214) vs 7% (7/94), p<0.01 (OR = 10.70, 

happy than others 52% (111/214) vs 20% (19/94), p<0.01 (OR = 4.25, 95%CI: 2.40-7.53), e) L

(94/214) vs 20% (19/94), p<0.01 (OR = 3.09, 95%CI: 1.75-5.47), f) Lonely much of the time 43(OR = 9.37, 95%CI: 4.14-21.20), g) Brood a great deal 41% (88/214) vs 8% (8/94), p<0.01 (OR 

Feeling blue 35% (75/214) vs 2% (2/94), p<0.01 (OR = 24.82, 95%CI: 5.95-103.59), i) Feeling vs 0, p<0.01), j) "take things hard" 65% (139/214) vs 34% (32/94), p<0.01 (OR = 3.59, 95%CI: "the right kind of life" 31.8% (68/214) vs 11.7% (11/94), p<0.01 (OR = 3.51, 95%CI: 1.76-7.02)

"wrong with their mind" 21.5% (46/214) vs 2.1% (2/94), p<0.01 (OR = 12.60, 95%CI: 2.99-53.0

(174/214) vs 38.3% (36/94), p<0.01 (OR = 7.01, 95%CI: 4.09-12.02), n) Feeling anxious 50.5% 

p<0.01 (OR = 12.66, 95%CI: 5.60-28.62), o) Feeling "high strung" 59.8% (128/214) vs 17.0% (

95%CI: 3.97-13.27), p) Not usually feeling calm 43.5% (93/214) vs 11.7% (11/94), p<0.01 (OR 

Medical conditions: a) Poor currently 43% (43/100) vs 3% (3/100), p<0.01 (OR = 24.39, 95%

doctor's care 55% (55/100) vs 11% (11/100), p<0.01 (OR = 9.89, 95%CI: 4.72-20.73), c) "Psyc(126/214) vs 31% (29/94), p<0.01 (OR = 3.21, 95%CI: 1.92-5.37), d) Work limited by illness 49p<0.01 (OR = 4.69, 95%CI: 2.44-9.01), e) Hospitalizations (means only) 2.7 vs 1.4, p<0.01, f) H

1.1% (1/94), p<0.01 (OR = 22.04, 95%CI: 2.98-162.81), g) Diarrhea 28.0% (60/214) vs 9.6% (9

95%CI: 1.40-6.15), h) Stomach discomfort 28.5% (61/214) vs 3.2% (3/94), p<0.01 (OR = 12.09

Palpitations 40.7% (87/214), 16.0% (15/94), p<0.01 (OR = 3.61, 95%CI: 1.95-6.68), j) Non-spe

13.8% (13/94), p<0.01 (OR = 3.29, 95%CI: 1.72-6.31), k) Tiredness 64.0% (137/214) vs 12.8% 

95%CI: 6.24-23.69), l) Weakness 26.2% (56/214) vs 3.2% (3/94), p<0.01 (OR = 10.75, 95%CI: 

Utilization: Hospitalizations (mean #) 2.7 vs 1.4 times, p<0.01). Quality of life: a) "I believe th

that of most people I know” 64.5% (138/214) vs 94.7% (89/94), p<0.01 (OR = 0.08, 95%CI: 0.0

friends about as quickly as others do" 69.2% (148/214) vs 91.5% (86/94), p<0.01 (OR = 0.21, 9

children" 79.9% (171/214) vs 95.7% (90/94), p<0.01 (OR = 0.18, 95%CI: 0.06-0.51), d) "My sex 

(113/214) vs 81.9% (77/94), p<0.01 (OR = 0.16, 95%CI: 0.09-0.29). Mood: Behavioural correla

before going to sleep: a) "Mind racing" 48% (48/100) vs 15% (15/100), p<0.01 (OR = 5.23, 95%

Tense/anxious 44% (44/100) vs 2% (2/100), p<0.01 (OR = 38.50, 95%CI: 8.99, 164.89), c) Wo

(6/100), p<0.01 (OR = 8.44, 95%CI: 3.36-21.21), d) Depressed 24% (24/100) vs 2% (2/100), p

67.52), e) Desperate 10% (10/100) vs 0%, p<0.01, f) Mentally tired 56% (56/100) vs 39% (39/1

1.13-3.50), g) Sleepy 31% (31/100) vs 71% (71/100), p<0.01 (OR = 0.18, 95%CI: 0.10-0.34). 2

sleep: a) About getting enough sleep 77% (77/100) vs 12% (12/100), p<0.01 (OR = 24.55, 95%

personal problems 49% (49/100) vs 30% (30/100), p<0.05 (OR = 2.24, 95%CI: 1.25-4.00), c) A

(29/100), p<0.05 (OR = 2.17, 95%CI: 1.21-3.89), d) About health 36% (36/100) vs 16% (16/100

1.51-5.79), e) About death 14% (14/100) vs 3% (3/100), p<0.05 (OR = 5.26, 95%CI: 1.16-18.94

without thoughts or ideas bothering me" 23.8% (51/214) vs 80.9% (76/94), p<0.01 (OR = 0.07, frightened in the middle of the night 25.2% (54/214) vs 5.3% (5/94), p<0.01 (OR = 6.01, 95%C

Non-significant Medical conditions: a) Poor in childhood 19% (19/100) vs 11% (11/100), OR = 1.90; 95%CI: 0

11% vs 3%, p=NS. Smoking and Caffeine consumption reported NS. 
C-15

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Kappler, C / 2003 Low (2/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size: Response Rate: 

Cross-sectional 18-65 yrs 50.1%, 1257/2512 49.9%, 1253/2512 NS 2512 total 37.6%, 945/2512 

Prevalence: Six-month prevalence: (DSM-III severe/moderate insomnia): 27.3% (258/945) (95%CI: 24.5-3

gender. Associated Factors: 

SignificantAge: 1) Older (OR: 18.17; p<0.001). Psychiatric illness and psychological problems: (95%disorder (OR: 7.38; p=0.007). Socio-economic status: 1) Social status (OR: 1.64; p=0.0009). 

housekeeping (OR: 11.02; p=0.01). Social relationships: 1) Conflicts with relatives (OR: 16.44

relatives (OR: 1.7; p=0.04), 3) Overload profession (OR: 11.02; p=0.0003). Non-significant None reported 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Kawada, T / 2003 High (6/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional 20-80 yrs 1286 0 All Asian (Japanese) 1286 50.4%, 648/1286 

Prevalence: 

Point prevalence: (DSM-IV criteria for at least 1 month): 8.8% (57/648) (95%CI: 6.6-10.9). No 

Associated Factors: 

SignificantPsychiatric illness and psychological problems: 1) Depressive state (adj OR: 1.2; 95%CI: 1

condition: 1) Poor self-rated health (adj OR: 3.2; 95%CI: 1.0-10.1; p<0.05). 2) Medical treatmeOther factors: 1) Experiencing a major life event (adj OR: 4.4; 95%CI: 1.7-11.4; p<0.01). 2) Ch

1.13-3.84. Non-significant Age: (<50 vs >50) adj OR: 2.7; 95%CI: 0.9-7.9. Social Relationships: (Married vs not married

Socioeconomic status: (Employed vs other) OR: 0.97; 95%CI: 0.26-1.7. Other factors: 1) Sm

2.5; 2) Alcohol (yes vs no) OR: 1.42; 95%CI: 0.76-2.66; 3) Regular exercise: OR: 0.67; 95%CI: 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Leger, D / 2000 High (6/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional Over 18 yrs 53%, 6772/12,778 47%, 6006/12,778 NS 14,998 85.2%, 12778/14,997 

Prevalence: 

One-month prevalence: (Insomnia) 19% (2376/12,778) (95%CI: 18.3-19.6). Associated Factors: 

Significant Gender: Male: 14% (841/6006), 95%CI: 13.1-14.80). Female: 23% (1542/6772), 95%CI: 22-24

(1192/12,778), 95%CI: 8.51-9.49. Male: 6.3% (377/6006), 95%CI: 5.4-6.6. Female: 12% (815/6

Age: Severe insomnia increased significantly both sexes p<10-4. 

Socio-economic status: 1) Retired: 18.3%; p <0.0001, 2) White-collar worker: 20.8%; p<0.03

less insomnia than other states 13% p<10-4. 

Non-significant Other factors: Urban vs rural p=NS
C-16

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Leppavuori, A / 2002 Moderate (4/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional 55-85 yrs 49.1%, 136/277 50.9%, 141/277 NS 277 NS 

Co-Morbidity: 

Medically ill (stroke).Prevalence: 

Point prevalence: (DSM-IV criteria of insomnia): 37.6% (104/277) (95%CI: 31.9-43.3). (Insom

(157/277) (95%CI: 50.9-62.5). (Before-stroke insomnia complaints): 38.6% (107/277) (95%CI: insomnia complaints): 18.1% (50/277) (95%CI: 13.6-22.6). (Before-stroke DSM-IV insomnia): 677.9). (Post-stroke DSM-IV insomnia): 60% (30/50) (95%CI: 46.5-73.5). No prevalence data by Associated Factors:

SignificantAge: 1) Age (mean ± SD years) (71.1 ± 7.1 vs 72.6 ± 7.2 (p<0.01) vs 71.6 ± 7.8 (p<0.05) vs 69

(Prestroke insomniacs vs New insomniacs vs All insomniacs vs Non-insomniacs: 52.3% vs 60% Psychiatric illness and psychological problems: 1) History of depression (29.9% vs 16% vs anxiety disorders (32.7% (p<0.001) vs 8.0% vs 24.8% (p<0.01) vs 11.7%), 2) Any depression ((p<0.001) vs 51.6% (p<0.00001) vs 25%), 3) Major depression (34.6% (p<0.001) vs 34% (p<015.0%), 4) Organic depression (3.7% vs 18% (p<0.01) vs 8.3% vs 4.2%), 5) Any anxiety disord30.0% (p<0.001) vs 31.2% (p<0.00001) vs 9.2%), 6) Generalized anxiety (21.5% (p<0.00001) 4.2%), 7) Organic anxiety (9.3% vs 22.0% (p<0.001) vs 13.4% (p<0.01) vs 4.2%), 8) Dementia 24.2% (p<0.05) vs 13.3%), 9) High scores on Beck Depression Inventory (mean score ± SD: 1

5.2 (p<0.01) vs 11.2 ± 7.6 (p<0.00001) vs 7.1 ± 5.9) 10) High scores on Montgomery-Åsberg D(MADRS): 9.9 ± 8.0 (p<0.00001) vs 10.3 ± 8.6 (p<0.00001) vs 10.1 ± 8.2 (p<0.00001) vs 4.9 ± depression scale (40.7 ± 10.0 (p<0.00001) vs 41.7 ± 9.3 (p<0.00001) vs 41.0 ± 9.7 vs 35.0 ± 9anxiety scale (30.9 ± 7.8 (p<0.00001) vs 30.5 ± 7.1 (p<0.00001) vs 30.8 ± 7.6 (p<0.00001) vs 2Global Assessment of Functioning scale (GAF) after stroke (58.6 ± 13.1 (p<0.00001) vs 56.6 ± (p<0.00001) vs 65.3 ± 11.1), 14) Low score on Global Assessment of Functioning scale (GAF) 

(p<0.00001) vs 72.6 ± 8.8 vs 70.7 ± 9.3 (p<0.00001) vs 74.8 ± 7.3). Medical conditions: 1) Ma

(14.2% vs 26.0% (p<0.05) vs 17.9% vs 12.5%, 2) Stroke severity (Scandinavian Stroke Scale m49.9 ± 12.3 (p<0.01) vs 53.3 ± 9.0 vs 54.8 ± 8.1). 3) Migraine (17.8% vs 10.0% vs 15.3% (p<0.Being dependent (34.6% vs 56.0% (p<0.001) vs 41.4% (p<0.01) vs 25.8%), 2) Activities of dailscore ± SD: 72.4 ± 15.4 vs 61.6 ± 23.1 (p<0.00001) vs 68.9 ± 18.9 (p<0.01) vs 74.4 ± 13.7). Me

1) Cognition (Mini Mental Status Examination mean score ± SD: 25.7 ± 4.0 vs 23.8 ± 5.4 (p<0.026.6 ± 3.0). Prestroke insomniacs vs New insomniacs vs All insomniacs vs Non-insomni

insomnia): 1) Sleep-promoting drug use (86.9% (p<0.0001) vs 78% (p<0.0001) vs 84.1% (p<0(32.7% (p<0.0001) vs 22% (p<0.0001) vs 29.3% (p<0.0001) vs 1.7%), 3) Antidepressants use 32.5% (p<0.0001) vs 10.8%), 4) Antipsychotics use (8.4% (p<0.05) vs 14.0% (0.01) vs 10.2% Non-significant Non reported 
C-17

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Levitt, H / 2004 Low (2/9) 

- case control 

Low (0/9)  - cohort 

Study Design: 

Age Group: 

mean ± SD: GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 20-30 yrs 24.1±3.4 (CS) 23.3±1.9 (CT) 85.7%, 6/7 (CS) 87.5%, 7/8 (CT) 14.3%, 1/7 (CS) 12.5%, 1/8 (CT) NS 15 total 7 (CS), 8 (CT) 100% 

Associated Factors: 

SignificantPsychiatric illness and psychological problems (CS vs CT): 1) Hamilton Rating Scale for A

-8.74, p<0.001. 2) Inventory of depressive symptomatology: 11.6 ± 3.0 vs 1.9 ± 2.2, t = -7.01, pQuality Index: 8.9 ± 1.0 vs 1.4 ± 1.1, t = -6.33, p<0.001. 4) SF-36 Vitality Index: 52.9 ± 21.4 vs Cognitive function: 1) Subjective alertness morning: 46.59 ± 5.28 vs 80.86 ± 4.27, p=0.003. 2vs 84.08 ± 5.11, p=0.003; noon: 73.28 ± 5.45 vs 87.68 ± 4.10, p=0.052. 3) Concentration morn

5.23, p=0.003; night: 53.01 ± 4.78 vs 68.21 ± 4.93, p=0.045. Mood (CS vs CT, mean ± SE) mo

4.49, p=0.004. Non-significant Psychiatric illness and psychological problems (CS vs CT): 1) Perceived Stress Scale: 12.NS. 2) SF-36 General Health Perceptions Index: 84.4 ± 9.3 vs 91.0 ± 8.5, t = 1.42, p=NS. Cog

alertness noon: 75.88 ± 4.62 vs 88.34 ± 4.69, p=0.08; evening: 74.32 ± 3.96 vs 83.04 ± 4.29, p45.65 ± 3.87, p=0.74. 2) Energy evening: 72.17 ± 4.26 vs 84.08 ± 5.21; p=0.098; night: 51.40 ± Concentration noon: 69.96 ± 6.67 vs 83.17 ± 5.42, p=0.15; evening: 70.20 ± 5.53 vs 81.67 ± 5.

mean ± SE) noon: 77.43 ± 3.83 vs 86.99 ± 3.75, p=0.10; evening: 77.02 ± 4.30 vs 86.16 ± 3.43

83.25 ± 3.95, p=0.17. 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Lichstein, KL / 2001 Moderate (5/9) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol Over 58 yrs 58 (CS) primary 23 (CS) secondary 35 (CT) 24 (CS) primary 23 (CS) secondary 23 (CT) NS 189 total 82 (CS) primary 46 (CS) secondary 61 (CT) NS 

Co-Morbidity:

Among secondary insomnia: Depression (n = 13), Anxiety (n = 8), Chronic pain (n = 10), Prostadisorders (n = 5), Respiratory disease (n = 3). Associated Factors: 

SignificantPsychiatric illness and psychological problems: (primary insomnia vs secondary insomnia 

reported anxiety (State-Trait Anxiety Inventory -Form Y Trait Scale (STAI): 33.6 ± 7.7 (p<0.00129.8 ± 7.1; 2) Depression (Geriatric Depression Scale (GDS): 5.4 ± 4.3 (p<0.001) vs 11.6 ± 7.9 

of life: 1) Mental health (SF-36 Mental health subscale: 80.7 ± 14.0 vs 56.0 ± 21.0 (p<0.001) v

functioning (SF-36 Physical functioning subscale: 78.1 ± 18.5 vs 52.4 ± 24.3 (p<0.001) vs 77.7 Non-significant Age: 68.1 ± 7.0 vs 68.4 ± 6.4 vs 71.4 ± 6. Socioeconomic status: Education years (primary in

± 2.2). Gender: 70%; 95%CI: 60-80 vs 57%; 95%CI: 36-64 vs 57%; 95%CI: 45-69; all reported 
C-18

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Linzmayer, L / 2002 Low (1/9) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 22-63 yrs 51.1%, 93/182 (CS) 52.2%, 131/251 (CT) 48.9%, 89/182 (CS) 47.8%, 120/251 (CT) NS 433 total 182 (CS), 251 (CT) NS 

Co-Morbidity:

Group A: nonorganic insomnia (psychophysiological insomnia in ICSD’ primary insomnia in DSGroup B: bipolar affective disorder (N = 16 CS, 32 CT). Group C: depressive episode (N = 13 depressive disorder (N = 31 CS, 31 CT). Group E: dysthymia (N = 30 CS, 30 CT). Group F: ge

41 CS, 41 CT). Group G: mixed anxiety and depressive disorder (N = 16 CS, 27 CT). Group H

CS, 32 CT). Associated Factors:

Significant Cognitive function: Intelligence (IQ): Group A: 100-112, Group B: 100-118, Group C: 100-118

100-112, Group F: 100-118, Group G: 100-107, Group H: 100-112). IQ not ascertained in contvalues found in Groups B, C and F. Memory: 1) Visual Memory: differed significantly (>2 points

dependent expected values only for Group F. 2) Numerical Memory (GVG): Group B (5.6 ± 1.7 

(4.9 ± 1.4 vs 6.4 ± 1.7, p ≤ 0.01), Group D (5.3 ± 1.5 vs 6.2 ± 1.8, p ≤ 0.05). 3) Total Verbal Me

vs 27.8 ± 6.4, p ≤ 0.05), Group D (25.3 ± 7.6 vs 28.7 ± 6.7, p ≤ 0.05). Mood: 1) Thymopsychic 

SD): Drive: Group C (70.8 ± 22.3 vs 34.7 ± 27.0, p ≤ 0.01), Group D (51.4 ± 24.9 vs 24.4 ± 19.921.5 vs 23.9 ± 20.9, p ≤ 0.01) 2) Mood (VAS): Group C (35.9 ± 18.1 vs 69.4 ± 25.1, p ≤ 0.01) G

19.1, p ≤ 0.01), Group E (47.8 ± 18.0 vs 66.7 ± 22.7, p ≤ 0.01). 3) Affectivity (VAS): Group C (4

0.01), Group D (57.9 ± 19.6 vs 83.5 ± 14.0, p ≤ 0.001), Group E (60.1 ± 14.9 vs 81.9 ± 18.8, p 

77.8 ± 22.9, p ≤ 0.01). 4) Wakefulness (VAS): Group A (48.7 ± 21.0 vs 31.0 ± 21.9, p ≤ 0.05), G

26.7, p ≤ 0.01), Group D (54.3 ± 30.0 vs 22.2 ± 19.9, p ≤ 0.01), Group E (55.9 ± 28.4 vs 28.4 ± 

30.2 vs 29.0 ± 25.8, p ≤ 0.05), Group H (43.1 ± 26.9 vs 25.2 ± 25.0, p ≤ 0.05). 5) Well-being (B

8.3, p ≤ 0.01), Group C (32.5 ± 13.6 vs 12.6 ± 10.4, p ≤ 0.01), Group D (29.1 ± 11.6 vs 9.9 ± 8.

10.5 vs 13.6 ± 10.5, p ≤ 0.01), Group G (20.5 ± 12.0 vs 13.0 ± 12.1, p ≤ 0.01), Group H (19.1 ± 

State Anxiety: Group B (49.3 ± 13.9 vs 35.7 ± 7.1, p ≤ 0.01), Group C (54.3 ± 13.8 vs 37.0 ± 9.12.1 vs 33.6 ± 5.8, p ≤ 0.01), Group E (45.5 ± 9.9 vs 38.9 ± 8.7, p ≤ 0.05), Group G (45.1 ± 8.4 

Anxiety: Group B (58.5 ± 6.7 vs 34.6 ± 9.2, p ≤ 0.01), Group C (53.5 ± 11.2 vs 38.6 ± 12.3, p ≤ 

34.7 ± 8.2, p ≤ 0.01), Group E (50.4 ± 9.0 vs 39.9 ± 12.0, p ≤ 0.01), Group G (49.6 ± 8.0 vs 37.

Non-significant Cognitive function: 1) Intelligence (IQ): Daytime Nonpsychic performance (cases vs controls, 

Memory: Group A: (8.7 ± 1.9 vs 9.9 ± 2.1, p ≤ 0.10), Group B: (8.8 ± 1.5 vs 8.8 ± 2.5, p=NS), G

p=NS), Group D: (7.9 ± 2.4 vs 8.5 ± 2.6, p=NS), Group E: 8.3 ± 2.2 vs 8.4 ± 2.6, p=NS), Group p=NS), Group G: 7.6 ± 2.7 vs 8.5 2.5, p ≤0.10), Group H: (8.1 ± 1.3 vs 8.0 ± 2.6, p=NS). 3) Ass

(Gruenberger Verbal Memory): Memory Test: Group A (14.9 ± 2.7 vs 16.2 ± 3.2, p ≤ 0.10), Gro

p=NS), Group C (11.9 ± 3.8 vs 13.2 ± 4.3, p=NS), Group D (12.1 ± 5.1 vs 14.1 ± 4.3, p=NS), Gp=NS), Group F (15.1 ± 3.6 vs 13.5 ± 4.3, p ≤ 0.10), Group G (11.9 ± 5.2 vs 14.1 ± 4.3, p ≤ 0.1

4.3, p=NS). 4) Numerical Memory (GVG): Group A (6.1 ± 2.2 vs 6.1 ± 1.9, p=NS), Group E (6.2 

Group F (6.0 ± 2.0 vs 6.1 ± 1.9, p=NS), Group G (6.2 ± 1.7 vs 6.4 ± 1.7, p=NS), Group H (5.8 ± Total Verbal Memory (GVG): Group A (29.8 ± 5.6 vs 32.8 ± 5.1, p ≤ 0.10), Group B (27.9 ± 4.3 

(27.4 ± 6.0 vs 28.5 ± 6.5, p=NS), Group F (30.1 ± 6.2 vs 28.3 ± 7.0, p=NS), Group G (25.7 ± 8.

H (26.5 ± 6.0 vs 28.4 ± 6.9, p ≤ 0.10). Mood: 1)Thymopsychic Variables (cases vs controls, meA (43.9 ± 11.9 vs 35.0 ± 24.8, p ≤ 0.10), Group B (41.1 ± 31.5 vs 26.7 ± 21.2, p=NS), Group F 

p=NS), Group G (36.0 ± 25.7 vs 31.6 ± 26.3, p=NS), Group H (30.4 ± 19.5 vs 25.6 ± 24.4, p=N

(66.3 ± 17.0 vs 71.3 ± 18.5. p=NS), Group B (59.3 ± 29.3 vs 73.1 ± 21.0, p=NS), Group F (69.1 Group G (73.5 ± 10.8 vs 71.6 ± 24.5, p=NS), Group H (71.3 ± 20.5 vs 67.3 ± 26.2, p=NS). 3) A

23.0 vs 76.1 ± 19.1, p ≤ 0.10), Group B (64.3 ± 27.2 vs 78.8 ± 18.4, p ≤ 0.10), Group F (77.8 ± 

Group H (77.7 ± 15.4 vs 77.1 ± 22.7, p=NS). 4) Wakefulness (VAS): Group B (46.4 ± 34.8 vs 2

(41.5 ± 28.5 vs 29.6 ± 25.7, p ≤ 0.10). 5) Well-being (Bf): Group A (13.7 ± 5.8 vs 11.1 ± 9.2, p ≤ 

13.4 ± 11.2, p=NS). 6) State Anxiety: Group A (33.4 ± 7.2 vs 37.2 ± 7.1, p ≤ 0.10), Group F (40

Group H (42.0 ± 13.1 vs 36.0 ± 7.9, p ≤ 0.10). 6) Trait Anxiety: Group A (32.5 ± 5.8 vs 36.9 ± 1

vs 37.9 ± 10.2, p ≤ 0.10), Group H (42.9 ± 9.4 vs 39.3 ± 12.5, p ≤ 0.10). 
C-19

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Lundh, LG / 1997 Moderate (5/9) 

Study Design: 

Age Group

mean ± SD:GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 20-65 yrs 46.5 ± 11.3 (CS) 45.5 ± 11.1 (CT) 16 (CS) 16 (CT) 4 (CS) 4 (CT) NS 40 total 20 (CS), 20 (CT) NS 

Associated Factors: 

Significant Psychiatric illness and psychological problems: (CS vs CT; mean scores): 1) Depression (

scores; 8.5 vs 3.7; p<0.01). Memory and cognitive function: 1) Verbal ability (WAIS-R vocab

p<0.05). 2) Cued recall (Emotional Stroop test scores: 0.37 vs 0.47; p<0.005). 

Non-significant Psychiatric illness and psychological problems: (CS vs CT; mean scores): Spielberger Travs 35.4; p=NS. 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Martikainen, K / 2003 Moderate (5/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional 41-55 yrs 57.8%, 362/626 42.2%, 264/626 NS 1190 52.6%, 626/1190 

Prevalence: 

Three-month prevalence: 14% (88/626) 95%CI: 11.3-16%. Male: 9.8% (26/264) 95%CI: 6.2-1

95%CI: 13.1-20.8%. Associated Factors: 

Significant (CS vs CT) Age: (> 55 yrs): p<0.01. Psychiatric illness and psychological problems: 1) Depression: ad

p=0.023. 2) Nervousness and tension: adj OR: 3.05; 95%CI: 1.66-5.63; p<0.001. Medical con

2.24; 95%CI: 1.22-4.12; p<0.001, 2) Hypertension: adj OR: 2.05; 95%CI: 1.10-3.82; p=0.026. 3heart failure): 14 vs 4%, p=<0.001. 4) Allergic rhinitis: 18.6%; p=0.006. Socio-economic statu

95%CI: 1.82-20.5; p<0.001; Unemployed: 83.9 vs 91.7%; p=0.019. Healthcare utilization: Hop=0.003 Other factors: 1) Moving house: adj OR: 0.19; 95%CI: 0.04-0.83; p=0.003. 2) Insomn

8 vs 17.1%; p=0.032; 3) Insomniacs less caffeine/day (mean cups coffee): 4.16 vs 4.76; p=0.0

Non-significant Other factors: Marital status, BMI, Exercise, Snoring, Alcohol consumption all reported p=NS. 

conditions (Angina, myocardial or brain infarction) p=NS 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Mendelson, WB / 1984 Moderate (4/9) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 22-44 yrs 9 (CS), 9 (CT) 1 (CS), 1 (CT) NS 20 total 10 (CS), 10 (CT) NS 

Associated Factors:

SignificantPsychiatric illness and psychological problems: (CS vs CT; mean scores ± SD): 1) Depres

62.0 ± 9.3 vs 49.0 ± 6.5; p<0.009). 2) Social introversion (MMPI Social introversion scale: 56.3 Memory and cognitive function: (CS vs CT; number of responses ± SD): 1) Long-term sema

time of day) (11 am: 10.4 ± 3.3 vs 12.9 ± 3.6. 2 pm: 11.3 ± 3.9 vs 13.8 ± 2.7. 5 pm: 10.6 ± 3.6 v

13.9 ± 3.3). Non-significant Psychiatric illness and psychological problems: (CS vs CT; mean scores ± SD): MMPI subPT, SC, MA all p=NS. Psychomotor functioning: On 12 tasks no significant differences. CogVigilance, Learning and Memory no significant difference. 
C-20

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Millar, A / 2004 High (6/9) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 26-68 yrs (CS) 27-67 yrs (CT) 11 (CS), 11 (CT) 8 (CS), 8 (CT) NS 51 total 32 (CS), 19 (CT) Follow-up rate: 59.3%, 19/32 (CS) NS (CT) 

Prevalence: 

Percentage of reported longstanding sleep disturbances (Sleep History Questionnaire): Cases

(4/19) (95%CI: 2.7-39.3). No data by gender.

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Niemcewicz, S / 2001 Low (2/9) 

Study Design: 

Age Group

mean ± SD: GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Case-control 21-55 yrs 40.8 ± 11.3 56%, 9/16 (CS) 56%, 9/16 (CT) 44%, 7/16 (CS) 44%, 7/16 (CT) NS 32 total 16 (CS), 16 (CT) 100% 

Associated Factors:

SignificantPsychiatric illness and psychological problems: (MMPI scale, CS vs CT, mean ± SD): 1) H49.00 ± 6.65, t = -2.489, df = 30, p = 0.019). 2) Depression (57.31 ± 10.44 vs 45.53 ± 7.79, t = 

Hysteria (58.62 ± 8.77 vs 50.50 ± 6.34, t = -3.001, df = 30, p = 0.005). 4) Psychasthenia (51.18 2.999, df = 30, p = 0.005). 5) Hamilton score (6.4 ± 2.4 vs 0.5 ± 1.0, U = 2.5, p<0.001). 6) Beck = 42.5, p = 0.001). 6) Hyperarousal score (65.0 ± 7.54 vs 55.12 ± 8.74, U = 49.0, p = 0.003). Memory: (CS vs CT, mean ± SD: 1) (Selective Reminding Test) # of presentations needed to m

vs 6.56 ± 2.25, U = 68.5, p=0.02). 2) Reaction time (514.60 ± 69.24 msec vs 577.44 ± 78.25 mNon-significant Memory: 1) False target detections (Continuous Attention Test) (2.81 ± 3.10 vs 2.16 ± 4.19, U

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Ohayon, MM / 2003 High (7/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional Over 15 yrs 52.1% 7771/14,915 47.9% 7144/14,915 NS 18,972 78.6%, 14,915/18,972 

Prevalence: 

Point prevalence: (ChI > 6 mo): 17.6% (2625/14,915), 95%CI: 16.9-18.21. Male: 13.5% (965/

Female: 22.3% (1733/7771), 95%CI: 21.38-23.22. (Insomnia ≥ month): 18.4% (2744/14,915), 9Associated Factors: Significant Psychiatric illness and psychological problems: 1) Previous psychiatry hx: adj OR: 5.8; 95%Non-significant None reported 
C-21

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Ohayon, MM / 2002A High (8/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional Over 15 yrs 51.8%, 2055/3470 48.2%, 1916/3470 NS 4442 89.4%, 3970/4442 

Prevalence: 

One-year prevalence (Insomnia symptoms): 27.6% (1096/3970) (95%CI: 26.2-28.9). Male: 24

26.4). Female: 30.5% (627/2055) (95%CI: 28.5-32.4). (Insomnia disorder diagnoses): 7% (278

4.2% (80/1916) (95%CI: 3.3-5.1). Female: 9.2% (189/2055) (95%CI: 8.0-10.4). 

Associated Factors: 

SignificantGender (DSM-IV insomnia diagnoses): 1) Gender: OR: 9.2; 95%CI: 8.0-10.4; p<0.001. 

Non-significant Healthcare utilization: (95%CI not reported) 1) Use of sleep-enhancing medication (Having onHaving two insomnia symptoms: OR: 3.4; Having three or four insomnia symptoms: OR: 2.9. O

sleep dissatisfaction) Marital status, BMI, MSK disease, heart disease, hypertension, snoring, d

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Ohayon, MM / 2002B High (8/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional Over 18 yrs 51.8%, 509/982 48.2%, 473/982 NS 1256 78.2%, 982/1256 

Prevalence: 

Point prevalence: Insomnia disorder diagnoses: 11.7% (115/982). No prevalence data by gen

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Ohayon, MM / 2002C High (8/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional 15-90 yrs 50.5%, 1877/3719 49.5%, 1842/3719 NS 4067 91.4%, 3719/4067 

Prevalence: 

Point prevalence: 5% (186/3719) (95%CI: 4.3, 5.7). 

Associated Factors: 

Significant Age: Elderly (>65yr) 8.2% (26/314) vs other age groups (4.2 to 5%), p<0.05. Non-significant Gender: Male 4.7% (87/1842) vs Female 5.1% (96/1877), OR = 0.92 (0.68, 1.24). 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FACT

Ohayon, MM / 2001A High (7/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional 19-24 yrs 50.5%, 731/1447 49.5%, 716/1447 NS 1447 NS 

Co-Morbidity:

Psychiatric illness and psychological problems: 12.6% (182/1447) had ICDS dyssomnia or with a mental disorder. Prevalence: 

Point prevalence: 8.1% (117/1447) (95%CI: 7.4, 8.8). 
C-22

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Ohayon, MM / 2001B High (8/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional Over 15 yrs 51%, 12665/24600 49%, 11936/24600 NS 24,600 total (France=5622, UK=4972, Germany=4115, Italy=3970, Portugal=1856) 81.0% overall (Germany=68.1, all others over 80%) 

Prevalence: 

Point prevalence: 6.1% (1,501/24,600) (95%CI: 5.8, 6.4). 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Ohayon, MM / 2001C High (8/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size: Response Rate: 

Cross-sectional Over 15 yrs 52.1%, 6791/13,057 47.9%, 6266/13,057 NS 16,738 78%, 13,057/16,738 

Prevalence: 

No prevalence estimates for DSM-IV insomnia disorder overall. Data for each insomnia symsleep: 13.11% (1712/13,057) 95%CI: 12.6-13.6%, 2) Disrupted sleep: 21.3% (2792/13,057) morning awakenings: 13.1% (1712/13,057) 95%CI: 12.6-13.6%, 4) Nonrestorative sleep: 1415% (data extracted from graphs). No prevalence data by gender. Associated Factors:

SignificantFor difficulties initiating sleep: Gender: 1) Female (adj OR: 1.4; 95%CI: 1.2-1.6; p<0.001Physical illness (adj OR: 1.9; 95%CI: 1.7-2.2; p<0.001). Psychiatric illness and psycholog

disorder (adj OR: 3.5; 95%CI: 3.1-4.1; p<0.001). Quality of life: Satisfaction with life (adj OR

For disrupted sleep: Gender: 1) Female (adj OR: 1.3; 95%CI: 1.2-1.5; p<0.001). Psychiat

factors: 1) Mental disorder (adj OR: 3.0; 95%CI: 2.6-3.4; p<0.001). Quality of life: Satisfac95%CI: 0.2-0.7; p<0.01). For early morning awakening: Gender: 1) Female (adj OR: 1.3; 95%CI: 1.1-1.4; p<0.001)

Physical illness (adj OR: 1.6; 95%CI: 1.4-1.8; p<0.001). For nonrestorative sleep: Gender: 1) Female (adj OR: 1.3; 95%CI: 1.1-1.4; p<0.001). Med

illness (adj OR: 1.9; 95%CI: 1.6-2.2; p<0.001). Psychiatric illness and psychological fact

3.6; 95%CI: 3.2-4.2; p<0.001). Quality of life: Satisfaction with life (adj OR: 0.4; 95%CI: 0.2

Non-significant None reported 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Ohayon, MM / 2000 High (7/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional 19 - 24 yrs 50.8%, 1102/2169 49.2%, 1067/2169 NS 2169 NS 

Co-Morbidity:

Psychiatric disorders: 1) adjustment disorders (20, 0.9%, 95%CI: 0.5-1.3), 2) anxiety disorde2a) panic disorder (37, 1.7%, 95%CI: 1.2-2.2), 2b) generalized anxiety (24, 1.1%, 95%CI: 0.compulsive disorder (11, 0.5%, 95%CI: 0.2-0.8), 2d) posttraumatic stress disorder (30, 1.4%

phobia (20, 0.9%, 95%CI: 0.5-1.3), 2f) specific phobia (46, 2.1%, 95%CI: 1.5-2.7), 2g) agora0.7), 3) depressive disorders (52, 2.4%, 95%CI: 1.8-3.0). Prevalence: 

Point prevalence: 5.4% (117/2169), 95%CI: 4.5, 6.4. 
C-23

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Ohayon, MM / 1999 Moderate (5/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size: Response Rate: 

Cross-sectional Over 15 yrs 55.5%, 6555/11,810 44.5%, 5255/11,810 NS 11,810 NS 

Prevalence: 

Point prevalence: (Complaint of insomnia symptoms accompanied with sleep dissatisfactio

15.3--16.7. No prevalence data by gender. 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Ohayon, MM / 1997 High (8/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional Over 15 yrs 52.1%, 2929/5622 47.9%, 2693/5622 NS 6966 80.7%, 5622/6966 

Prevalence: 

Point prevalence: (Insomnia complaints lasting for at least 1 month): 15.3% (860/5622) (95

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Pallesen, S / 2002 High (7/9) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size: Response Rate: 

Cross-sectional casecontrol 60-84 yrs (CS) 63-83 yrs (CT) - Gs 60-86 yrs (CT) - Com 49 (CS), 32 (CT) - Gs 41 (CT) - Com 11 (CS), 9 (CT) - Gs 19 (CT) - Com NS 187 total 60 (CS), 41 (CT) - Gs, 60 (CT) - Com NS (CS), NS (CT) - Gs, 82.6% (CT) - Com 

Associated Factors: 

SignificantPsychiatric illness and psychological problems: (CS vs GS vs CT; mean ± SD): 1) Sleep Index scale: 23.1 ± 4.8 vs 10.1 ± 2.7 vs 14.6 ± 6.0; F(1,96) = 237.6), 2) Somatization (Sympvs GS: 0.78 ± 0.59 vs 0.32 ± 0.28 F(1, 97) = 20.3), 3) Obsessive-compulsive traits (Symptom GS: 0.95 ± 0.80 vs 0.44 ± 0.31; F(1, 95) = 14.0), 4) Interpersonal sensitivity (Symptom Chec

0.56 ± 0.58 vs 0.25 ± 0.28; F(1, 97) = 9.4), 5) Depression (Symptom Checklist 90-Revised: C0.26; F(1, 95) = 14.7), 6) Anxiety (Symptom Checklist 90-Revised: CS vs GS): 0.46 ± 0.47 v7) Hostility (Symptom Checklist 90-Revised: CS vs GS): 0.32 ± 0.33 vs 0.11 ± 0.16; F(1, 96) (Symptom Checklist 90-Revised: CS vs GS): 0.17 ± 0.27 vs 0.03 ± 0.07; F(1, 97) = 10.4). 9) (GSI CS vs GS: 0.61 ± 0.39 vs 0.23 ± 0.15; F(1, 92) = 31.0; Positive Symptom Distress IndeF(1, 92) = 39.6; Positive Symptom Total: 31.4 ± 16.8 vs 16.6 ± 9.6; F(1, 99) = 25.8; PSWQ: 92) = 18.8, TAS-20: 49.8 ± 9.4 vs 42.6 ± 8.8; F(1, 91) = 14.2) 10) Difficulties identifying feeliGS: 15.2 ± 5.8 vs 11.4 ± 4.3; F (1, 93) = 11.7). Socioeconomic status: Education: CS vs G

controls (p=0.26). Non-significant Age: CS vs GS (p=0.48) vs CT (p=0.23). Gender: CS vs GS (p=0.65) vs community contro

and psychological problems: (CS vs GS vs CT; mean ± SD): 1) Paranoid ideation: 0.35 ± 0.41; F=NS; 2) Psychoticism: 0.21 ± 0.27 vs 0.09 ± 0.14 vs 0.19 ± 0.26; p=NS; 3) Difficulty d11.8 ± 3.7 vs 12.6 ± 3.9; p=NS; 4) Externally oriented thinking: 21.2 ± 4.1 vs 19.3 ± 4.7 vs 2

3.5 ± 3.36 vs 3.1 ± 1.7 vs 4.55 ± 4.21; p=NS; 6) Subjective impact Life events: 8.52 ± 9.44 v

p=NS. 
C-24

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Pavlova, M / 2001 Moderate (4/9) 

Study Design: 

Age Group

mean ± SD: GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 45.9 ± 14 yrs (CS) 44.6 ± 15 yrs (CT) NS NS NS 532 total 256 (CS), 139 (CT) NS 

Associated Factors: 

SignificantPsychiatric illness and psychological problems: (CS vs CT; mean scores for scales/subIntrospectiveness (Introspectiveness score from the Hyperarousal scale): 40.5 ± 0.3 vs 37.1 

cognitive function: (CS vs CT) 1) Hyperarousal (Hyperarousal scale mean total score ± SD

39.9-42.3) vs 32.6 ± 7.3 (95%CI: 31.4-33.8); p<0.0001). 2) Reaction type (Median React sco± range: 4.5 (6-23) vs 2 (0-12). Non-significant None reported 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Perlis, ML / 2001 Moderate (5/9) 

Study Design: 

Age Group

mean ± SD: GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 30.6 ± 8.9 yrs (CS) 32.3 ± 11.5 yrs (CT) 3 (CS), 2 (CT) 2 (CS), 2 (CT) NS 9 total 5 (CS), 4 (CT) NS 

Associated Factors: 

SignificantMemory: (CT vs CS, mean ± SD): 1) First trial: 46.2 ± 12.6 vs 75.8 ± 12.7, p=0.01. Non-significant Memory: (CT vs CS, mean ± SD): 1) number of words encoded (43 ± 20.0 vs 49 ± 18.3, p=

positive %) (8.9 ± 7.2 vs 20 ± 19.1, p=0.27), 3) free recall (all trials, %) (4.6 ± 3.2 vs 9.8 ± 10trials (%) (45.2 ± 11.8 vs 68.6 ± 19.9, p=0.08), Second trial (42.0 ± 17.6 vs 58.0 ± 38.1, p=0

59.7 ± 25.5, p=0.38), Fourth trial (51.6 ± 8.6 vs 59.3 ± 29.9, p=0.69), 5) Recognition speed (vs 2137 ± 761, p=0.29), 6) Recognition speed (false-positive, msec) (3358 ± 510 vs 2664 ± (false/true-positive) (1.259 ± 0.20 vs 1.261 ± 0.17, p = 0.99). 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Riedel, BW / 2004 High (6/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional 20-98 yrs 50.7%, 390/769 49.3%, 379/769 53.6%, 536/769 (White) 28.6%, 220/769 (Black) 0.7%, 6/769 (Asian) 10.8%, 7/769 (NS) 1769 43.4%, 769/1769 

Prevalence: 

Point prevalence: 32.1% (247/769) (95%CI: 28.8-35.3). No prevalence data by gender. Associated Factors:

Significant (3 groups: Nonsmokers, Light smokers (<15/day) Heavier smoker (≥15/day).

Race/ethnicity: (non-smoker vs <15/day vs ≥15/day) p<0.01. Psychiatric illness and psyc

Depression (Beck depression inventory OR: 2.03, 95%CI: 1.45-2.83), 2) Anxiety (Trait Anxie

3.21-22.28; p<0.05). Other factors: 1) Heavy smoking among females (OR: 2.31; p<0.05), 

95%CI: 1.17-6.49; p<0.05). Medical conditions: 1) Physical health problems (Cancer OR: 2

2) High blood pressure (OR: 1.53, 95%CI: 1.11-2.69; p<0.05), 3) Breathing problems (OR: 3

4) Gastrointestinal problems (OR: 2.00, 95%CI: 1.22-3.28; p<0.05). Non-significant None reported 
C-25

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Robbins, L / 1995 Moderate (4/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Retrospective crosssectional 18-60 yrs 79.6%, 393/494 20.4%, 101/494 NS 494 100% 

Co-Morbidity:

Migraines. Prevalence: 

Sleep onset insomnia: 27% (133/494), 95%CI: 23.1-30.9. Difficulty maintaining sleep insom22.1-29.9. 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Rocha, FL / 2002A High (7/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size: Response Rate: 

Cross-sectional Over 60 yrs 61.1%, 926/1516 38.9%, 590/1516 NS 1742 87%, 1516/1742 

Prevalence: 

One-month prevalence: (Insomnia): 38.9% (590/1516), 95%CI: 34.6-41.3. Male: 28.8% (17Female: 45.3% (419/916), 95%CI: 42.0-48.5. Associated Factors: 

SignificantGender: 1) Female (adj OR: 1.78; 95%CI: 1.41-2.24). Medical condition: 1) Self-rated reas

1.50-2.72) and very bad health (adj OR: 3.12; 95%CI: 2.21-4.39), 2) History of previous medcondition (adj OR: 1.38; 95%CI: 1.10-1.73), 3) Inability to perform routine activities due to a weeks (adj OR: 1.54; 95%CI: 1.10-2.15). Other factors: 1) Staying in bed in the last 2 week2.48), 2) Dissatisfaction with free time arrangements (adj OR: 1.88; 95%CI: 1.28-2.77). Hea

sleeping pills: OR: 1.74 (95%CI: 1.38-2.21). Social Relationships: Social support UnsatisfiNon-significant Age: 60-69yr: 60.9 vs 59.2%, OR 1; 70-79yr: 29.1 vs 30.6% OR 0.92; 95%CI: 0.73-1.16); ≥8

95%CI: 0.68-1.37. Social Relationships: 1) Married/live together vs single: OR 1.05; 95%C

Indifferent OR 0.95; 95%CI: 0.62-1.43. 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Rocha, FL / 2002B High (7/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional Over 18 yrs 55.7%, 594/1066 44.3%, 472/1066 53.6%, 572/1066 (White) 2.4%, 26/1066 (Black) 43.8%, 467/1066 (Other) 0.2%, 1/1066 (Unknown) 1221 87.3%, 1066/1221 

Prevalence: 

One-month prevalence: 35.4% (377/1066), 95%CI: 32.5-38.3. Male: 20.7% (98/472), 95%

(279/594), 95%CI: 42.9-50.9. Associated Factors:

SignificantSocioeconomic status: 1) Low education: (1-3 years): males adj OR: 2.2; 95%CI: 1.1-4.1; 

1.1-3.0; no years of education: females adj OR: 2.6; 95%CI: 1.3-5.1. Age: 1) Age group ove

95%CI: 1.1-3.3. Healthcare utilization: 1) Use of sleeping pills in the previous 30 days: OR

Non-significant Race/Ethnicity: white vs other: p=0.751. Relationships: Religion: p=0.35 
C-26

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Roth, T / 1999 Moderate (3/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional 18-65 yrs NS NS 86%, 860/1000 (White) 8%, 80/1000 (Black) 3%, 30/1000 (Hispanic) 3%, 30/1000 (Other) 1950 51.2%, 1000/1950 

Associated Factors:

Significant Memory and cognitive function: 1) Impaired concentration (ChI vs non-insomnia); "little troDifficulties remembering things; "very often or sometimes": 53% vs 29%; p=0.0). Social relationships: 1) Ability to enjoy relationships; "good or excellent": 64% vs 89%; p=0

spouse; "good or excellent": 70% vs 81%; p=0.01. Medical condition 1) Self-perceived healt

86%; p=0.01. Psychiatric illness and psychological problems: Ability to handle minor irri

vs 81%; p = 0.0). Non-significant Accidents: (Had an automobile accident due to being tired; ChI vs non-insomnia): 5% vs 2% vs non-insomnia; "good or excellent": 70% vs 96%; p = NS). Psychiatric illness and psychperceived mental health; "good or excellent": 67% vs 90%; p=NS). 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Sabbatini, M / 2002 Moderate (3/8) 

Study Design: 

Age Group mean ± SD: GenderFemale: Male: Ethnicity: 

Sample Size:

Response Rate: 

Cross-sectional 61.0 ± 14.4 yrs 44.5%, 309/694 55.5%, 385/694 NS 694 NS 

Co-Morbidity: 

Medically Ill (Renal disorders). Prevalence: 

Point prevalence: 45% (311/694), 95%CI: 41.3-48.7. Male: 40.5% (156/385), 95%CI: 35.6-

95%CI: 44.5-55.6. Associated Factors:

SignificantPsychiatric illness and psychological problems: (insomnia vs non-insomnia): 1) Anxiety Medical conditions: 1) Longer time on dialysis (13-48 months adj OR: 1.7; 95%CI: 1.1-2.8; 1.8; 95%CI: 1.2-2.8; p=0.006; ≥ 85 months adj OR: 1.7; 95%CI: 1.2-2.7; p=0.01), 2) Having 

1.6; 95%CI: 1.2-2.2; p=0.003), 3) High levels of parathyroid hormone (> 149 pg/ml) (adj OR

Pruritus (% insomnia vs non-insomnia; 19.9% vs 13.1%; p<0.04). Non-significant Other factors: BMI, Blood pressure, Smoking, Alcohol, Caffeine intake all p=NS 
C-27

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Saletu-Zyhlarz, G / 1997 Low (1/9) 

Study Design: 

Age Group: 

mean ± SD: GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 24-65 yrs 43.2 ± 11.7 yrs (CS) 43.0 ± 11.7 yrs (CT) 56.8%, 25/44 (CS) 54.5%, 24/44 (CT) 43.2%, 19/44 (CS) 45.5%, 20/44 (CT) NS 88 total 44 (CS), 44 (CT) 100%, 44/44 (CS) 77.3%, 34/44 (CT) 

Co-Morbidity: 

Cases: all CS have generalized anxiety disorder (GAD). Controls: normal. 

Associated Factors: 

Significant Psychiatric illness and psychological problems: Mood: (CS vs CT, median, mean ± SD)

(18, 19 ± 12 vs 7, 11 ± 10, p<0.01), 2) Morning well-being score (16, 18 ± 12 vs 7, 11 ± 10, 26 vs 37, 38 ± 25, p<0.05), 4) Mood (mm) (63, 62 ± 18 vs 74, 75 ± 17, p<0.01), 5) Drowsine26, p<0.01). Cognitive function: (psychometry) (cases vs controls, median, mean ± SD): 1

37 ± 11 vs 52, 49 ± 9, p , 0.01), 2) Fine-motor activity, left (27, 28 ± 9 vs 41, 40 ± 11, p<0.01left (65, 66 ± 18 vs 91, 86 ± 17, p , 0.01), 4) Reaction time (mean score ) (534, 545 ± 108 vs Non-significant Psychiatric illness and psychological problems: Mood: Affectivity (mm) (68, 63 ± 23 vs 7

function: (psychometry) (CS vs CT, median, mean ± SD): 1) Attention score (522, 536 ± 14

Concentration (% errors) (3, 4 ± 3 vs 3, 5 ± 5, p=NS), 3) Attention variability score (15, 16 ± Numerical memory (6, 6 ± 2 vs 6, 6 ± 2, p=NS 5) Reaction time, variability (mean score) (10p=NS), 6) Reaction time, errors of omission (n) (1, 2 ± 2 vs 1, 3 ± 3, p=NS), 7) Reaction time

vs 0, 0 ± 1, p=NS). 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Savard, J / 2001 Moderate (4/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional 28-90 yrs 339 0 All White (Caucasian) 339 88%, 300/339 

Co-Morbidity: 

Medically ill (Metastatic breast cancer). Prevalence: 

Point prevalence: (Insomnia symptoms): 51.3% (154/300) (95%CI: 45.7-56.9); (Insomnia s(95%CI: 14.6-23.4); (Chronic Insomnia syndrome): 17.6% (53/300) (95%CI: 13.3-21.9). Associated Factors:

SignificantFor insomnia symptoms: Medical conditions: 1) Cancer stage at diagnosis (I-III) (OR: 0.4

2) Lumpectomy (OR: 5.2; 95%CI: 1.5-18.1; p<0.01), 3) Chemotherapy (OR: 4.3; 95%CI: 1.7

Relationships: 1) Widowhood (OR: 4.7; 95%CI: 1.5-15.2; p<0.01). Other factors: 1) Antec

(OR: 0.18; 95%CI: 0.06-0.52; p<0.01). For insomnia syndrome: Socioeconomic factors: Socioeconomic status: 1) University 15.0; p<0.05). Social Relationships: Separated/divorced (OR: 4.2; 95%CI: 1.4-13.1; p<0.0

95%CI: 0.01-0.64; p<0.05). Direct and indirect costs: 1) Sick leave: (OR: 14.1; 95%CI: 1.1-173.8; p<0.05), 2) Unemplo

13.6; p<0.05). Non-significant None reported 
C-28

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Schneider-Helmert, D / 1987 High (7/9) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size: Response Rate: 

Cross-sectional casecontrol 32-61 yrs (CS) 28-61 yrs (CT) 9 (CS), 9 (CT) 7 (CS), 7 (CT) NS 32 total 16 (CS), 16 (CT) NS 

Associated Factors: 

SignificantPsychiatric illness and psychological problems: (CS vs CT; mean scores ± SD): 1) Pers

Hypochondriasis: 62.3 ± 9.5 vs 48.1 ± 7.2,; p<0.00001; Depression: 64.0 ± 12.7 vs 45.9 ± 77.6 vs 52.7 ± 9.2, 0.0001; Psychopatic deviate: 62.9 ± 9.2 vs 49.2 ± 7.4, p<0.0001; Paranoiap<0.01; Psychasthenia: 47.3 ± 8.2 vs 62.0 ± 9.6, p<0.0001; Schizophrenia: 60.6 ± 11.0 vs 4strength: 44.4 ± 12.5 vs 56.5 ± 5.1, p<0.001; Impulsivity: 52.8 ± 8.8 vs 45.6 ± 5.6, p<0.01; CAnxiety: 57.3 ± 11.6 vs 45.2 ± 9.9, 0.005; Internalization: 55.2 ± 10.1 vs 48.8 ± 7.6, p<0.05. 

function: 7.9 vs 10.5, p<=0.001; 2) Line judgment all sessions p =0.01; 3) Line tracing (3 err

Non-significant Psychiatric illness and psychological problems: (CS vs CT; mean scores ± SD): 1) Scal

Scale K: 50.8 ± 8.3 vs 54.6 ±8.1; 3) Masculinity-femininity: 45.5 ± 10.3 vs 48.3 ± 11.0; 4) Hy12.3; 5) Social introversion: 56.9 ± 12.2 vs 52.3 ± 12.3. All p=NS. Cognitive function: (3 secorrect responses: Logical reasoning, Addition, Digit symbol substitution, Word detection, V

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Seidel, WF / 1984 High (6/9) 

Study Design: 

Age Group

mean ± SD: GenderFemale: Male: Ethnicity: Sample Size: Response Rate: 

Cross-sectional casecontrol 29 ± 5 yrs 23 (CS), 23 (CT) 15 (CS), 15 (CT) NS 76 total 38 (CS), 38 (CT) NS 

Associated Factors: 

SignificantLaboratory measures (CS vs CT; mean min. ± SD): 1) Objective total sleep time: 402.8 ± 50Subjective total sleep time: 352.2 ± 94.9 vs 441.2 ± 44.7, p<0.001. Non-significant Psychiatric illness and psychological problems: 1) Profile of mood state (POMS): Fatigu

Depression: 2.3 ± 3.6 vs 1.2 ± 1.9; Anger/hostility: 3.2 ± 5.9 vs 1.2 ± 2.2; Tension/anxiety:1.

6.5 vs 11.7 ± 7.8; Total mood disturbance: 5.2 ± 19.3 vs -5.9 ± 16.9; all p=NS. 2) MMPI scal

5.7; Scale F: 56.5 ± 8.7 vs 53.8 ± 10.2; Scale K: 54.3 ± 8.1 vs 56.5 ± 8.8; Hypochondriasis: 

Depression: 56.8 ± 9.8 vs 53.0 ± 8.1; Hysteria: 59.2 ± 7.2 vs 55.5 ± 8.5; Psychopathic devia

Paranoia: 61.1 ± 6.7 vs 57.7 ± 6.8; Psychasthenia: 59.9 ± 7.7 vs 55.1 ± 6.8; Schizophrenia: 

Hypomania: 65.2 ± 10.7 vs 61.6 ± 11.1. All p=NS. 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Sharpley, AL / 1997 Moderate (5/9) 

Study Design: 

Age Group

(mean, range) GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 54.7, 40-69 yrs (CS) 53.9, 40-68 yrs (CT) 50% (CS), 50% (CT) 50% (CS), 50% (CT) NS 40 total 20 (CS), 20 (CT) 100% in both groups 

Associated Factors: 

SignificantPsychiatric illness and psychological problems: (CS vs CT): 1) Past psychiatric disordeP<0.01; OR = 7.36, 95%CI: 1.34, 40.55, 2) Major depression 35% (7/20) vs 5% (1/20), p<0.

20% (4/20) vs 0, p<0.05,. Non-significant Psychiatric illness and psychological problems: (CS vs CT): 1) Panic disorder 5% (1/205% (1/20) vs 0, p=NS; 3) Past alcohol abuse 5% (1/20) vs 5% (1/20), p=NS; 4) Past drug de
C-29

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Shaver, JLF / 2002 High (6/9) 

Study Design: 

Age Group: 

mean ± SD: GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol PP-type: 46.7±3.3 yrs (CS) SO-type: 46.1±4.4 yrs (CS) 44.4±3.5 yrs (CT) 131 0 Cases: PP-type: White 76.2%, African American 9.5%, unknown 14.3%. Cases: SO-Type: White 72.2%, Asian/Pacific Islander 5.6%, African American 11.1%, Native American 5.6%, unknown 5.6%. Controls: White 92.9%, Asian/Pacific Islander 7.1% 101 (CS), 30 (CT) NS 

Associated Factors: 

Significant Psychiatric illness and psychological problems: Psychological Distress Scores (PP-type mean ± SD): 1) Somatization: 0.65 ± 0.61 vs 0.54 ± 0.47 vs 0.27 ± 0.31, p = 0.03; 2) Global 0.38 vs 0.28 ± 0.28, p = 0.04, 3) Positive symptom distress: 1.6 ± 0.40 vs 1.4 ± 0.20 vs 1.1 ± Non-significantPsychiatric illness and psychological problems: Stress Exposure (PP-type vs SO-type inDaily diary: the sum of items, how stressful: (a) felt today, (b) relationship with closest friend

= not at all to 6 = very much (2.4 ± 0.6 vs 2.4 ± 0.5 vs 2.2 ± 0.76, p=NS), 2) Daily hassles, DNumber (23.9 ± 15.1 vs 19.8 ± 13.9 vs 16.7 ± 15, p=NS), Severity (29.6 ± 26.2 vs 28 ± 22.4 Severity (1.1 ± 0.32 vs 0.89 ± 0.47 vs 0.95 ± 0.32, p=NS). 3) Stressful life events, Stressful Positive (4.8 ± 3.1 vs 4.6 ± 3.4 vs 6.2 ± 3.2, p=NS), Negative: (5.3 ± 3.9 vs 5.2 ± 4.8 vs 4.8 ± 

events, Inventory of Small Life Events: Positive (27.9 ± 10 vs 27.6 ± 8.9 vs 30.2 ± 7.9, p=NS± 7.3 vs 12.1 ± 6.0, p=NS). Psychological Distress Scores 1) Obsessive compulsive (0.78 ± 0.59, p = 0.24), 2) Interpersonal sensitivity (0.67 ± 0.64 vs 0.46 ± 0.43 vs 0.42 ± 0.54, p = 0.

vs 0.69 ± 0.63 vs 0.42 ± 0.37, p = 0.26), 4) Anxiety (0.47 ± 0.76 vs 0.39 ± 0.39 vs 0.16 ± 0.20.67 vs 0.32 ± 0.43 vs 0.27 ± 0.32, p = 0.98), 6) Psychoticism (0.31 ± 0.63 vs 0.25 ± 0.29 vs Phobic anxiety (0.21 ± 0.58 vs 0.12 ± 0.20 vs 0.06 ± 0.13, p = 0.52), 8) Paranoid ideation (0± 0.32, p = 0.85), 9) Positive symptom total (31.7 ± 20.8 vs 30.1 ± 17.7 vs 19.1 ± 16.7, p = 0PP-type = psychophysiologic type insomnia; SO-type = subjective only type insomnia; 
C-30

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Shochat, T / 1999 Low (1/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size: Response Rate: 

Cross-sectional 18-87 yrs 58%, 166/286 42%, 120/286 White 52%, Asian 28%, African-American 2.8%, Hispanic 4.5%, Other 12.2% 286 NS 

Prevalence: 

Point prevalence: 19% (54/286) (95%CI: 14.5, 23.5). 

Associated Factors: 

SignificantFor all factors (GS vs occasional insomniac vs ChI). Psychiatric illness and psychologica

mood Excellent p<0.0010 (25.3% (22/88) vs 11.3% (16/141) vs 11.3% (6/54)) Good (62.1% 49.1% (27/54) Fair (10.3% (9/88) vs 24.8% (35/141) vs 35.8% (19/54) Poor (1.1% (1/88) vs Ability to handle minor irritations p = 0.0060 Excellent (15.9% (14/88) vs 9.3% (13/141) vs 1(51/88) vs 43.6% (61/141) vs 45.3% (24/54)) Fair (21.6% (19/88) vs 36.4% (51/141) vs 30.210.7% (15/141) vs 13.2% (7/54). Cognitive function: 1) Ability to concentrate p = 0.0010 E

(13/141) vs 13.2% (7/54) Good (68.2% (60/88) vs 57.9% (82/141) vs 52.8% (29/54) Fair (11vs 30.2% (16/54) Poor (1.1% (1/88) vs 2.1% (3/141) vs 3.8% (2/54). Memory: 1) Having tro

Very often (4.5% (4/88) vs 9.3% (13/141) vs 11.1% (6/54) Sometimes (34.1% (30/88) vs 43Not very often (45.5% (40/88) vs 37.9% (53/141) vs 20.4% (11/54) Never (13.6% (12/88) vs Social relationships: 1) Personal relationship with spouse p = 0.0030 Excellent (44.9% (40

23.8% (13/54) Good (38.5% (34/88) vs 43.2% (61/141) vs 40.5% (22/54) Fair (14.1% (12/88(15/54) Poor (2.6% (2/88) vs 11.9% (17/141) vs 7.1% (4/54). 2) Ability to enjoy family/social (26/88) vs 16.3% (23/141) vs 17.0% (9/54)) Good 48.9% (43/88) vs 48.2% (68/141) vs 35.8vs 27.7% (39/141) vs 34.0% (18/54)) Poor (4.8% (4/88) vs 7.8% (11/141) vs 13.2% (7/54). Q

of life p = 0.0060 Excellent (18.2% (16/88) vs 10.7% (15/141) vs 9.6% (5/54)) Good (67.0% 51.9% (28/54)) fair (11.4% (10/88) vs 25.7% (36/141) vs 34.6% (19/54)) Poor (2.3% (2/88) vWork performance: 1) Ability to accomplish things during the day p<0.0010 Excellent (29.511.3% (6/54)) Good (59.1% (52/88) vs 53.6% (75/141) vs 56.6% (31/54)) Fair (6.8% (6/88) v(12/54)) Poor (3.4% (3/88) vs 3.6% (5/141) vs 7.5% (4/54)). Non-significant None reported 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Sugerman, JL / 1985 High (6/9) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 21-55 yrs 6 (CS)-objective 6 (CS)-subjective, 6 (CT) 2 (CS)-objective 2 (CS)-subjective, 2 (CT) NS 24 total 16 (CS), 8 (CT) NS 

Associated Factors:

Significant Memory and cognitive function: (Objective vs Subjective insomnia vs CT): 1) Waking funcnumber of misses: 7.73 vs 29.95 vs 6.68, p<0.05). Non-significant None reported 
C-31

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Taylor, DJ / 2003 High (6/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional 20-98 yrs 50.6%, 391/772 49.4%, 381/772 Caucasians 69.8% (539/772), African Americans 28.9% (223/772), Asian 0.9% (7/772), Hispanic 0.1% (1/772) 1769 49%, 859/1,769 

Prevalence: 

Prevalence parameters: 19.6% (151/772), 95%CI: 16.8, 22.4. Associated Factors: 

SignificantAge: (no insomnia vs insomnia, mean ± SD): 50.41 ± 19.1 vs 61.49 ± 19.68, F = 35.73, p<0

insomnia, % female): 45.3 (174/384) vs 60.0 (90/150), p<0.01, OR = 0.55 (0.38, 0.81. Medic

vs % insomnia): 1) Heart 9.1 (35/384) vs 23.3 (35/150), F = 19.15, p<0.001, OR = 0.32 (0.20vs 9.3 (14/150), F = 5.43, p<0.05, OR = 0.42 (0.20, 0.89), 3) HTN 18.2 (70/384) vs 44 (66/10.28 (0.19, 0.43), 4) Neurological 1.3 (5/384), vs 7.3 (11/150), F = 13.50, p<0.001, OR = 0.1

(22/384) vs 24.7 (37/150), F = 39.36, p<0.001, OR = 0.19 (0.11, 0.33), 6) Urinary 9.6 (37/38Race/Ethnicity: (no insomnia vs insomnia, % African American): 25 (96/384) vs 28 (42/150

F== 7.154, p<0.01, OR = 0.49 (0.28, 0.83), 7) Diabetes 3.6 (14/384) vs 12.7 (19/150), F = 10.54), 8) Pain 19 (73/384) vs 48 (72/150), F = 45.83, p<0.001, OR = 0.25 (0.17, 0.38), 9) Ga32.7 (49/150), F = 43.77, p<0.001, OR = 0.21 (0.13, 0.35). Healthcare Utilization: 1) Numb3.44 ± 2.79, F = 68.20, p<0.001.2) Psychiatric Conditions: Beck Depression Inventory 5.72 ± adjusted for ethnicity and gender: 6.63 ± 7.19 vs 12.42 ± 6.79, p<0.001, adjusted for neurolocigarette use, OR = 8.96 (3.97, 20.19, p<0.001, reference group people with insomnia). Psy9.33 vs 42.26 ± 11.70, p<0.001. Non-significant Race/Ethnicity: (no insomnia vs insomnia, % African American): 25 (96/384) vs 28 (42/150

Other factors: Alcohol (drinks/wk): 2.74 ±5.19 vs 2.0 ± 4.93, p=NS; Caffeine drinks/day: 2.3

Smoking and BMI p=NS. 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Terzano, MG / 2004 Moderate (4/8) 

Study Design:

Age Group: GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional > 18 yrs 60.9% 39.1% NS 3284 NS 

Co-morbidity: 

Medically ill: [1) Cardiovascular (1149; 35%), 2) MSK and connective (921; 28%), 3) Diges

nutritional, metabolic, immunity (556, 16.9%), 5) Brain, nervous system and sense organs (414%), 7) Genitourinary (362, 11%), 8) Infectious and parasitic (74, 2.3%), 9) Other (1008, 30Prevalence: 

Point prevalence (Sleep difficulties ≥ one month): 63.7% (2093/3284) (95%CI: 62-65). Mal

56.9-62.2). Female: 66.3% (1327/2000) (95%CI: 64.2-68.3). 

Associated Factors: 

Significant Age: Older (adj OR: 1.02; 95%CI: 1.02-1.03). Gender: 1) Female (adj OR: 1.19; 95%CI: 1.0

and psychological problems: 1) Depression (adj OR: 2.70; 95%CI: 2.31-3.15). Medical coorgan system (adj OR: 1.24; 95%CI: 1.06-1.48). Socioeconomic status: 1) < junior high (a

Healthcare utilization: 1) Use of prescribed drugs (OR: 2.26; 95%CI: 1.95-2.62), 2) > 1 hos

1.11-2.32), 3) > 1 GP home visit (OR: 2.31; 95%CI: 1.30-4.09), 4) > 1 GP office visit (OR: 1.

call to a GP (OR: 1.48; 95%CI: 1.27-1.73), 6) > 1 laboratory test (OR: 1.43; 95%CI: 1.23-1.61.81; 95%CI: 1.56-2.09). Quality of life: 1) SF-36 mean scores ± SD); No insomnia vs Leveextracted from graphs): Physical functioning (90.01 vs 81.11 vs 79.34), Role limitations physBodily pain (74.4 vs 69.8 vs 61.8), Health perception (69.8 vs 61.6 vs 55.9), Energy/fatigue functioning (81.4 vs 78.1 vs 64.0), Role limitations emotional (83.9 vs 78.5 vs 56.7), Mental Work Performance: Direct and indirect costs: 1) > 1 sick leave day (OR: 1.54; 95%CI: 1.17

patients). Non-significant Other factors: BMI, Smoking, and Caffeine intake p=NS.
C-32

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Vgontzas, AN / 1995 Low (2/9) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 18-86 yrs (CS) 16-80 yrs (CT) 50.1%, 188/375 (CS) 58.7%, 88/150 (CT) 49.9%, 187/375 (CS) 41.3%, 62/150 (CT) NS 525 total 375 (CS), 150 (CT) NS 

Co-Morbidity: 

Psychiatric illness in cases recruited from the sleep clinic: 98.3% (172/175) had at least one secondary disorder: 1) depression 58.3% (102/175): 1a) major depression 10.3% (18/175), 1c) other minor depression (atypical depression) 10.9% (19/175), 1d) bipolar disorder 5.7% Associated Factors:

Non-Significant Medical conditions: (CS vs CT) 1) sleep apnea 2.3% 8/375) vs 1.3% (2/150), OR = 1.61 (0activity 13.9% (52/375) vs 14.7% (22/150), OR = 0.94 (0.55, 1.61), 3) nocturnal myoclonus/n

11.5% (43/375) vs 8.5% (11/150), OR = 1.63 (0.82, 3.27). 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Vignola, A / 2000 Moderate (5/9) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol Over 55 yrs 10-ChI/BNZ (CS) 11-drug-free ChI (CS) 9 (CT) 10-ChI/BNZ (CS) 9-drug-free ChI (CS) 11 (CT) NS 60 total 20 – ChI/BNZ (CS), 20 drug-free ChI (CS), 20 (CT) NS 

Associated Factors:

SignificantPsychiatric illness and psychological problems: (drug-free ChI vs insomnia using benzo

1) Depression (Beck Depression Inventory): 9.00 ± 4.48 vs 9.40 ± 7.16 vs 1.75 ± 1.6, p<0.0Inventory): 9.10 ± 8.38 vs 8.60 ± 5.4 vs 1.20 ± 1.47, p<0.01. 3) Global security (Brief sympto

± 0.42 vs 0.13 ± 0.15, p<0.01. 4) Subjective measures related to neuropsychological performVAS for Energy): 49.80 ± 19.35 vs 46.10 ± 23.23 vs 24.25 ± 12.23, p<0.01. VAS for Mood: 3vs 15.75 ± 9.94, p<0.01. VAS for Tiredness: 51.50 ± 20.77 vs 47.70 ± 17.14 vs 21.55 ± 11.1Stress/Tension: 38.50 ± 18.70 vs 39.60 ± 17.90 vs 16.85 ± 8.77, p<0.01. VAS for Motivationvs 84.80 ± 15.7, p<0.05. Memory and cognitive function: 1) Attention and concentration (33.60 ± 27.23 vs 41.80 ± 28.89 vs 63.95 ± 25.64, p< 0.01; Digit Span Backward (percentiles21.43 vs 65.45 ± 23.32, p<0.05. 2) Subjective measures related to neuropsychological perfoVAS for alertness: 44.20 ± 22.52 (p<0.01) vs 37.55 ± 22.72 (p<0.05) vs 21.55 ± 13.01, VAS 

57.85 ± 17.22 (p<0.01) vs 73.55 ± 16.98 vs 83.90 ± 12.78, VAS for Performance: 61.40 ± 13(p<0.05) vs 71.07 ± 13.56).Non-significant Memory and cognitive function: 1) Mini-mental state: 29.1 ± 1.12 vs 28.75 ± 1.25 vs 28.8

3.84 vs 12.0 ± 3.09 vs 13.3 ± 2.36. 3) Information: 10.15 ± 3.51 vs 10.0 ± 3.01 vs 11.5 ± 3.4visual and verbal memory, p>0.19; psychomotor speed, p> 0.23; and executive functions, p
C-33

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Vincent, NK / 2000 Moderate (4/9) 

Study Design: 

Age Group

mean ± SD: GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 46.91±10.04 yrs (CS) 39.6 ±11.49 yrs (CT) 72%,23/32 (CS), NS(CT) 28%, 9/32 (CS), NS (CT) 30/32 Caucasian (CS) 58 total 32 (CS), 26 (CT) NS 

Co-Morbidity: 

Cases: 39% (12/32) had at least one secondary co-morbidity: generalized anxiety disorder (

hypochondriasis (3%), obsessive-compulsive disorder (3%), and major depression (3%). Co

Associated Factors: 

SignificantPsychiatric illness and psychological problems: Perfectionism variables (CS vs CT, mea

action: 10.38 ± 3.59 vs 7.46 ± 2.47, t = 3.52, p = 0.001; 2) Parental criticism: 9.44 ± 4.49 vs 3) Concern over mistake: 20.97 ± 7.29 vs 16.11 ± 5.38, t = 2.83, p = 0.007; 4) Socially presc13.92, t = 2.35, p = 0.02. Non-significant 1) Personal standards: 21.94 ± 4.87 vs 20.42 ± 5.08, t = 1.16, p = 0.25; 2) Parental expectat3.74, t = 0.76, p = 0.45. 3) Self-oriented; 64.24 ± 18.23 vs 58.38 ± 14.51;T = 1.34, P=0.36; 4vs 54.23 ± 13.08, t = 0.17, p = 0.86. 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Wang, W / 2001 Moderate (4/9) 

Study Design: 

Age Group

mean ± SD: GenderFemale: Male: Ethnicity: Sample Size:

Response Rate: 

Cross-sectional casecontrol 30.2 ± 7.0 yrs (CS) 27.2 ± 5.0 yrs (CT) 12 (CS), 19 (CT) 11 (CS), 9 (CT) NS 51 total 23 (CS), 28 (CT) 100%, 23/23 (CS) 89.2%, 25/28 (CT) 

Associated Factors: 

SignificantPsychiatric illness and psychological problems: (CS vs CT; mean ± SD): 1) Thrill and ad

(Zuckerman's sensation seeking scales): 4.0 ± 2.4 vs 6.4 ± 2.5; p<0.05; 2) Impulsivity (Zuck

questionnaire): 4.0 ± 1.9 vs 2.7 ± 1.6; p<0.05; 3) Neuroticism-anxiety (Zuckerman-Kuhlman'

± 4.6 vs 7.3 ± 2.8; p<0.05). Non-significant Psychiatric illness and psychological problems: Zuckerman's sensation seeking scales 

Experience seeking: 3.1 ± 1.7 vs 4.0 ± 1.9; 2) Disinhibition: 2.9 ± 2.1 vs 2.8 ± 1.8; 3) Boredo

± 1.5. 4) Impulsive sensation seeking (Zuckerman-Kuhlman's personality questionnaire): 8.8 sensation seeking: 4.8 ± 2.3 vs 5.5 ± 2.1; 6) Aggression-hostility: 7.8 ± 3.7 vs 6.3 ± 2.7; 7) A

Sociability: 7.3 ± 3.8 vs 7.3 ± 2.4. All p=NS. 

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Yeo, BKL / 1996 Moderate (3/8) 

Study Design: 

Age Group: 

GenderFemale: Male: Ethnicity: Sample Size: Response Rate: 

Cross-sectional 15-55 yrs 50%, 1209/2418 50%, 1209/2418 All Asian (Chinese and Malays) 2418 NR 

Prevalence: 

One-year prevalence: 15.3% (370/2418) (95%CI: 13.8-16.73). Male: 12.9% (159/1209) (95

17.5% (211/1209) (95%CI: 15.36-19.64). Associated Factors: 

SignificantGender: 1) Female (OR: 1.39; 95%CI: 1.11- 1.74; p<0.01). Race/ethnicity: 1) Malay vs Ch

1.75; p<0.05). Psychiatric illness and psychological problems: 1) Moderate to severe st2.58; p<0.001), 2) Phobic disorder (Insomnia vs Non insomnia; 20.5% vs 13.6%; p<0.001), 7.0%; p<0.001), 4) Anxiety disorder (6.5% vs 13.5%; p<0.001). Non-significant Age: % Insomniacs (15-29 vs 30-49 vs 50+ ) 40.8 vs 46.85 vs 12.4%, p=NS. Psychiatric ill

problems: Source of stress – work and others (financial, travel etc) p=NS 
C-34

Evidence Table C-1: Prevalence, natural history, incidence and associated factors of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

STUDY DESIGN & POPULATION CHARACTERISTICS CO-MORBIDITY / PREVALENCE / NATURAL HISTORY / INCIDENCE / ASSOCIATED FA

Zammit, GK / 1999 Moderate (4/9) 

Study Design: 

Age Group

mean ± SD: GenderFemale: Male: Ethnicity: Sample Size: Response Rate: 

Cross-sectional casecontrol 44.1±14.04 yrs (CS) 37.1±12.7 yrs (CT) 157 (CS), 63 (CT) 104 (CS), 38 (CT) NR 362 total 261 (CS), 101 (CT) NR 

Associated Factors:

SignificantPsychiatric illness and psychological problems: 1) Depression (Zung Depression Scale

p<0.0001), 2) Anxiety (Zung Anxiety Scale: 1.96 ± 0.02 vs 1.4 ± 0.04; p<0.0001). Quality of 

quality of life (SF-36 overall: No scores provided. F-21.73; p<0.001). 2) Quality of life domai84.46 vs 62.80 (p<0.0001), General health: 84.00 vs 61.05 (p<0.0001), Mental health: 80.27 emotional: 85.98 vs 48.82 (p<0.0001), Role physical: 94.48 vs 56.28 (p<0.0001), Social func(p<0.0001), Vitality: 71.65 vs 41.13 (p<0.0001), Physical functioning: 93.31vs 77.82 (p<0.00watching TV (Quality of Life Inventory: 3.26 ± 0.15 vs 2.46 ± 0.24; p<0.006), 4) Hours readin0.17; p<0.03), 5) Hours of recreation per day (1.54 ± 0.11 vs 2.3 ± 0.18; p<0.0001). Memory 

vs CT; mean ± SD): 1) Cognitive functions (Medical Outcomes Study Cognitive scale sum s0.58; p<0.0001). Work variables: (CS vs CT): 1) Levels of optimism regarding career and fDaily Activities Questionnaire: 3.17 ± 0.11 vs 3.90 ± 0.18; p<0.0001). 2) Average # days absvs 0.13 ± 0.22; p<0.001). Non-significant Memory and cognitive function: (Medical Outcomes Study Cognitive scale) Report no spe

significantly impaired. 
C-35

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C-37

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C-39
C-40

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults Abbreviations: CBT = cognitive behavioural therapy; CT = control; d = day; f = flunitrazepam; GOV = government; hr = hour; min. = minute; mg = milligrams; NA = not applic

placebo; q = quazepam; RCT = randomized controlled trial; RT = relaxation therapy; SD = standard deviation; Tr = treatment (drug): wk = week: wks = weeks; yr(s) = year(s). 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Aden, GC Moderate (2/5) 

Private (funds and materials) 

RCT Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

47 (NS) 23 – 59 29 / 21 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Allain, H / 2001 Moderate (3/5) 

Private RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

45.6 (9.6) - Tr 46.7 (11.5) - Pl 25 – 64 188 / 57 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 6.7 (8.0) – Tr 6.6 (7.3) – Pl NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Allain, H / 1998 High (4/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

54.3 (11.0) 32 – 84 67.9% / 32.1% 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 19.5% < 1 yr 80.5% > 1 yr NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Ascher, LM / 1979 Low (1/5) 

NS RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

39 (NS) 24 – 67 15 / 10 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 8 (NS) NS 

Type/Description: Frequency / Duration

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Asnis, GM / 1999 Moderate (3/5) 

Private RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

41.6 (1.2) Tr 41.6 (1.0) Pl 18 – 66 150 / 40 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

secondary various psychiatric conditions NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 
C-41

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued) 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Beary, MD / 1984 Moderate (3/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

NS 23 – 35 6 / 0 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS 0.3 – 2 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Botter PA / 1983 High (4/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

Part 1: 44.3 (8) Tr 1mg 40.6 (7.7) Pl Part 2: 46.1 (7.2) Tr 2mg 44.8 (7.1) Pl NS 25 / 15 

Type: Co-morbidity: Duration (months)Mean (SD): Range: 

secondary anxiety neuroses Part 1: 1.3 (0.2) Tr 1mg 1.3 (0.2) Pl Part 2: 1.1 (0.2) Tr 2mg 1.1 (0.1) Pl NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Bowen, AJ / 1978 Moderate (3/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

NS 18 – 60 13 / 5 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Brown, CC / 1979 High (4/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

NS NS 18 / 0 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Campbell, RD / 1987 High (4/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

38 (2) NS 25 / 31 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 
C-42

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Carr-Kaffashan, L / 1979 Moderate (2/5) 

NS RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

40.1 (NS) 18 – 76 18 / 12 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 11.48 (NS) NS 

Type/Description: Frequency / Duration

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Chaudoir, PJ / 1983 Moderate (3/5) 

Private (prepacked drugs) 

RCT Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

50 (NS) 35 – 65 18 / 7 

Type: Co-morbidity: Duration:Mean (SD): Range: 

primary NA 6 months – Tr1 9 months – Tr2 NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Choliz, M / 1995 Moderate (2/5) 

NS RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

NS NS NS / NS 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Frequency / Duration

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Cohn, JB / 1991 Moderate (3/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

NS 18 – 65 NS / NS 

Type: Co-morbidity: Duration: Mean (SD): Range: 

primary NA 3 months or more NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Cohn, JB / 1984 Moderate (3/5) 

Private RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

41.4 (10.2) 18 – 61 18 / 12 

Type: Co-morbidity: Duration:Mean (SD): Range: 

primary various medical and psychiatric conditions 6 months or more (all but 1 patient) NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 
C-43

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Cohn, JB / 1983 High (4/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

41.5 (NS) 18 – 60 38 / 15 

Type: Co-morbidity: DurationMean (SD): Range: 

secondary depression 1 month or more (all but 1 subject) NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Coxeter, PD / 2003 High (5/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

54 (15) 22 – 75 12 / 10 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Davies, R / 1986 Moderate (2/5) 

GOV RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

58.59 (10.98) 35 – 78 16 / 18 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Frequency / Duration

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Dawson, D / 1998 Moderate (2/5) 

Private (supported research) 

RCT Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

65.67 (1.68) NS NS / NS 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Declerk, A / 1999 Moderate (3/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

54 (NS) NS 17 / 5 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Dominguez, RA / 1986 Moderate (3/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

46.6 (NS) 21 – 65 46% / 54% 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 
C-44

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Dominguez, RA / 1985 Moderate (3/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

NS 20 – 60 NS / NS 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Donath, F / 2000 Moderate (2/5) 

Private RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

49 (NS) 22 – 55 12 / 4 

Type: Co-morbidity: Duration:Mean (SD): Range: 

primary NA 3 months to several yrs NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Drake, CL / 2000 High (4/5) 

Private RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

41.6 (9.5) study 1 38.1 (11.1) study 2 21-60 38 / 45 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 5.7 (7.2) study 1 9.9 (9.8) study 2 NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Dujardin, K / 1998 Moderate (3/5) 

Private RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

NS 40 – 62 0 / 12 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Edinger, JD / 2003 Moderate (2/5) 

GOV RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

51.0 (13.7) NS 2 / 18 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary various medical conditions NS NS 

Type/Description: Frequency / Duration
C-45

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Edinger, JD / 2001 High (4/5) 

GOV RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

55.8 (12.1) CBT 54.5 (10.2) RT 55.7 (9.5) Pl 40-80 35 / 40 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 13.6 (NS) NS 

Type/Description: Frequency / Duration

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Elie, R / 1999 Moderate (3/5) 

Private RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

42.5 - 44.3 (12.0 - 12.9) Tr 42.1 (12.0) Pl 18–65 370 / 204 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Elie, R / 1990 Moderate (3/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

76 (1.3) 60 – 90 33 / 11 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 7 >= 1 yr 17 > 10 yrs NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Ellis, CM / 1996 High (4/5) 

GOV RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

46 (11) 32 – 67 6 / 9 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 21.7 (13) 1-45 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Espie, CA / 1989 Moderate (2/5) 

NS RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

44.9 (15.3) NS 47 / 23 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 12.4 (12.2) NS 

Type/Description: Frequency / Duration
C-46

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Farag NH / 2003 High (4/5) 

Private RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

37 (13) 21 – 63 20 / 5 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Ferguson, JM / 1991 High (4/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

43.4 (10.9) 18 – 65 56% / 44% 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

secondary major depression NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Fillingim, JM / 1982 High (5/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

81 (NS) NS 89% / 11% 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 1 yr or more NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Fleming, J / 1995 Moderate (3/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

33 – 37 (NS) 21 – 60 48% / 52% 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 7 – 10 (NS) NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Fry, J / 2000 Moderate (3/5) 

Private RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

40 - 43 (10 - 13) Tr 43 (12) Pl 18 – 65 342 / 244 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 
C-47

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Garfinkel, D / 1997 High (4/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

79 (5.2) 68 – 93 8 / 13 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary exhibiting various medical conditions NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Garfinkel, D / 1995 High (4/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

76 (8) 68 – 93 5 / 7 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Gelinas, B / 1985 High (4/5) 

Private RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

40.9 (2.19) 18 – 60 16 / 10 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Goethe, JW / 1982 Moderate (2/5) 

Private (provided materials & funding) 

RCT Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

NS 19 – 60 50 / 19 

Type: Co-morbidity: Duration:Mean (SD): Range: 

primary NA 6 months or more (all but 3 patients) NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Goldenberg, F / 1994 High (4/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

42.5 (8.6) Tr 43.3 (9.2) Pl 25 – 60 291 / 167 

Type: Co-morbidity: Duration (months)Mean (SD): Range: 

primary NA 1.6 (0.8) Tr 1.7 (1.1) Pl NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 
C-48

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Haffmans, PMJ High (4/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

44 (NS) NS 3 / 4 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

secondary previous severe major depression NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Haimov, I / 1995 High (4/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

73.1 (3.9) independent living 81.1 (8.9) institutionalized NS 16 / 10 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Hajak, G / 2000 Moderate (3/5) 

Private (grantsupported) 

RCT Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

47.6 (11.3) Tr 47.4 (16.8) Pl NS 36 / 11 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 11.2 (9.7) NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Hajak, G / 1996 Moderate (3/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

41.3 (9.5) NS 3 / 7 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 10.7 (7.9) NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Hajak, G / 1994 High (5/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

51 (11) NS 939 / 566 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description, Do

Frequency / DurationTiming: Route of Delivery: 
C-49

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Hartmann, E / 1983 Moderate (3/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

38 - 46 (NS) 39 (NS) Pl 18–71 48 / 48 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 13 (NS) NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Harvey, AG / 2003 Low (1/5) 

NS RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

21.1 (3.7) CBT 18.6 (5.1) CT NS 15 / 11 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary various psychiatric conditions (n=13) 6.4 (3.9) CBT 6.2 (5.8) CT NS 

Type/Description: Frequency / Duration

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Haynes, SN / 1977 Low (1/5) 

NS RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

29.3 (NS) NS 15 / 9 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 7.1 (NS) NS 

Type/Description: Frequency / Duration

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Haynes, SN / 1974 Low (1/5) 

Academic RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

NS 18–21 5 / 9 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 5.3 (NS) NS 

Type/Description: Frequency / Duration

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Hedner, J / 2000 Moderate (3/5) 

Private RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

72.5 (5.9 – 6.8) Tr 72.5 (6.8) Pl 59 – 91 Tr 63 – 95 Pl 285 / 137 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 
C-50

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Heidrich, H / 1981 High (4/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

44.6 (2) Tr 46 (2) Pl 64 – 21 Tr 63 – 28 Pl 67% / 33% 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 2.5 (NS) NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Hernandez, RL / 1983 Moderate (3/5) 

Private RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

NS 22 – 65 24 / 12 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Herrmann, WM / 1993 Moderate (3/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

NS 25 – 65 9 / 12 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Hughes, RC / 1978 Low (1/5) 

NS RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

34.2 (NS) NS 24 / 12 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Frequency / Duration

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Jacobson, AF / 1986 Moderate (3/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

72 (NS) Tr 69 (NS) Pl 60 – 82 slightly more than half female NS / NS 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 16 (16.4) Tr 14.5 (11.9) Pl 1 – 65 Tr 1 – 40 Pl 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 
C-51

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

James, SP / 1990 Moderate (2/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

33.4 (NS) 20 – 57 6 / 4 

Type: Co-morbidity: Duration:Mean (SD): Range: 

primary NA > 6 months NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Krystal, AD / 2003 Moderate (3/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

44 (11) 21 – 69 498 / 290 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Lacks, P / 1983 Moderate (2/5) 

Private (supported research) 

RCT Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

40.6 (NS) NS 48 / 16 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 13.8 (NS) NS 

Type/Description: Frequency / Duration

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Lacks, P / 1983 Moderate (2/5) 

GOV RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

43.0 (NS) 31 – 59 9 / 6 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 11.7 (NS) NS 

Type/Description: Frequency / Duration

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Lahmeyer, H / 1997 High (4/5) 

Private (grantsupported) 

RCT Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

44.9 (NS) 19 – 61 81 / 64 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Lamphere, JK / 1989 Moderate (2/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

36 (10) NS 3 / 9 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 
C-52

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Leppik, IE / 1997 Moderate (3/5) 

Private RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

69 (NS) 59 – 85 63% / 37% 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Lichstein, KL / 2001 Moderate (2/5) 

GOV RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

68.03 (7.04) 59 – 92 53 / 21 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 8.93 (11.54) 0.5-51 

Type/Description: Frequency / Duration

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Mamelak, M / 1989 Moderate (2/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

NS 60 – 72 NS / NS 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Mamelak, M / 1987 High (4/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

50 (NS) 32 – 60 21 / 9 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

McAlpine, CJ / 1984 High (4/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

NS 18 – 94 90 / 57 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 72 > 1 yr NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 
C-53

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Melo de Paula, A / 1984 Moderate (3/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

28 – 31 (NS) 19 – 55 42 / 16 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 1.3 – 2.1 (NS) 0.2-10 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Mendels, J / 1983 Moderate (3/5) 

Private RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

47 (NS) Tr 45 (NS) Pl 20 – 58 Tr 22 – 60 Pl 19 / 41 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 36 < 10 yrs 24 > 10 yrs NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Milby, JB / 1993 Low (1/5) 

Private RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: Gender Female / Male: 

30.4 (5.68) women 35 (6.13) men NS 8 / 7 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Minnekeer, RJ / 1988 High (4/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

53.2 (14.5) Tr (q) 55.4 (12.5) Tr (f) 54.9 (13.7) Pl NS 130 / 74 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 30% > 5 yrs Tr (q) 32% > 5 yrs Tr (f) 34% > 5 yrs Pl NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 
C-54

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Mitchell, KR / 1979 Low (1/5) 

NS RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

37.4 (NS) 28 – 51 9 / 15 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 6.3 (NS) 2.1 – 8.1 

Type/Description: Frequency / Duration

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Mitler, MM / 1984 Moderate (3/5) 

Private (grantsupported) 

RCT Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

37.7 – 45.4 (NS) 27 – 61 17 / 4 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary or secondary personality disorder or sleep-related myoclonus NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Monchesky, TC / 1986 High (4/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

47.1 (1.7) Tr 46.6 (1.8) Pl NS 65 / 26 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary various medical conditions 7.0 (1.2) Tr 6.4 (0.8) Pl NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Montes, LGA / 2003 Moderate (3/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

50 (12.7) 30 – 72 4 / 6 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 12.8 (12.1) 0.5 – 32 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Monti JM / 2000 Moderate (3/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

53.8 (1.8) Tr 50.0 (5.3) Pl 27 – 59 12 / 0 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 12.6 (4.9) Tr 17.7 (6.5) Pl NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 
C-55

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Monti, JM / 1996 Moderate (3/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

41.2 (3.9) Tr 47.3 (5.7) Pl NS 10 / 2 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 9.5 (3.5) Tr 9.3 (4.7) Pl NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Morin, CM / 1999 Moderate (2/5) 

GOV RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

65 (7) 55 or older 50 / 28 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 16.8 (16.9) NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Nair, NPV / 1990 Moderate (3/5) 

Private (grantsupported) 

RCT Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

46.9 (1.4) 18 – 65 28 / 32 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 9.8 (1.2) NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Negri, L / 1997 Moderate (2/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

42.95 (13.22) 15 – 68 70 / 30 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

secondary anxiety alone + mild depressive symptoms NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Nicassio, P / 1974 Low (1/5) 

GOV RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

45.1 (14.57) 22 – 71 21 / 9 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Frequency / Duration
C-56

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Pasche, E / 1996 Low (1/5) 

Private RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

39.0 (0.7) 21 – 55 59 / 47 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: 

Frequency / Duratio

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Perlis, ML / 2004 Moderate (3/5) 

Private (primary investigatorinitiated project) 

RCT Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

41.3 (13.4) 25 – 60 70.4% / 29.6% 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: 

Dose (mg):

Frequency / Duratio

Timing: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Poyares, DR / 2002 Moderate (3/5) 

Academic RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

43.3 (10.6) NS 15 / 4 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: 

Dose (mg): Frequency / DuratioTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Reeves, RL / 1977 High (4/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

68.6 (NS) Tr (t) 69.6 (NS) Tr (f) 70.4 (NS) Pl NS 27 / 14 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: 

Dose (mg):

Frequency / Duratio

Timing: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Rickles, K / 1986 High (4/5) 

Private (grantsupported) 

RCT Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

46 (12) NS 63% / 37% 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 8.6 (9.2) NS 

Type/Description: 

Dose (mg):

Frequency / Duratio

Timing: Route of Delivery: 
C-57

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Riemann, D / 2002 Moderate (3/5) 

Private RCT 

Double-blind Unclear 

Age (years)Mean (SD): Range: GenderFemale / Male: 

45.3 (10.3) Tr (l) 47.0 (10.8) Tr (t) 48.8 (11.6) Pl NS 23 / 32 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Rodenbeck, A Moderate (3/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

41.3 (9.5) NS 3 / 7 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 10.7 (7.9) NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Roehrs, T / 1999 Low (1/5) 

Unclear RCT 

Not reported as doubleblind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

34.1 (8.8) 21 – 55 5 / 6 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose: Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Roehrs, T / 1983 Moderate (3/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

33.3 (8.0) NS 8 / 4 

Type: Co-morbidity: Duration:Mean (SD): Range: 

primary NA > 6 months NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Roth, TG / 1997 Moderate (2/5 

Private RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

65.9 (4.6) NS 15 / 15 

Type: Co-morbidity: Duration:Mean (SD): Range: 

primary NA > 3 months NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 
C-58

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Roth, T / 1979 High (4/5) 

Private (provided drugs and funding) 

RCT Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

NS 18 – 65 0 / 16 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

unclear unclear NS NS 

Type/Description: 

Dose (mg):

Frequency / DuratioTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Saletu-Zyhlarz, G / 2003 Moderate (2/5) 

Private (funded pharmacological part of study) 

RCT Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

58 (5) 46 – 67 49 / 0 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary related to postmenopausal syndrome NS NS 

Type/Description: 

Dose (mg): Frequency / DuratioTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Sanavio, E / 1990 Low (1/5) 

NS RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

39.6 (NS) 25 – 50 24 / 16 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 11.8 (NS) 5 - 25 

Type/Description: 

Frequency / Duratio

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Sastre-yHernandez, M / 1988 High (4/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

NS 20 – 76 36 / 24 

Type: Co-morbidity: Duration:Mean (SD): Range: 

primary NA 53% > 1 yr 20% 3-12 months 27% < 3 months NS NS 

Type/Description: 

Dose (mg):

Frequency / DuratioTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Scharf, MB / 1994 Moderate (3/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

38 (NS) 22 – 60 48 / 27 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: 

Dose (mg): Frequency / DuratioTiming: Route of Delivery: 
C-59

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Scharf, MB / 1990 High (4/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

40.4 (13.5) Tr (e) 42.8 (13.9) Tr (f) 41.3 (13.0) Pl 21-65 NS / NS 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Shaw, SH / 1992 Moderate (3/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

74.9 (1.0) Tr 10mg 72.9 (1.0) Tr 20mg 75.7 (0.8) Pl 65-85 81 / 38 

Type: Co-morbidity: Duration (months)Mean (SD): Range: 

secondary various psychiatric conditions 23 (4) Tr 10mg 2.9 (4.6) Tr 20mg 2.6 (4.9) Pl NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Shealy, RC / 1979 Low (1/5) 

NS RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

19.8 (NS) 17 – 30 70 / 0 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Frequency / Duration

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Stanton, HE / 1989 Low (1/5) 

NS RCT 

Not reported as doubleblind Parallel (with option to crossover after Tr) 

Age (years)Mean (SD): Range: GenderFemale / Male: 

NS 23 – 67 26 / 19 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

unclear NS NS NS 

Type/Description: Frequency / Duration

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Steens, RD / 1993 Moderate (3/5) 

Private RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

58.2 (5.5) 35 – 69 9 / 15 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary mild to moderate chronic obstructive pulmonary disease 7.8 (6.9) 1 - 25 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 
C-60

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Stip, E / 1999 High (4/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

42.6 (1.6) 20 – 64 21 / 29 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary or secondary mild non-psychotic disorders 10.1 (NS) Tr (z) 9.7 (NS) Tr (t) 12.4 (NS) Pl NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Tietz, EI / 1981 Moderate (3/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

41.2 (16.8) 18 – 60 0 / 15 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Tuk, B / 1997 Moderate (3/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

NS 18 – 78 15 / 6 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Vallieres, A / 2004 Moderate (2/5) 

GOV RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

47.5 (7.92) 34 – 50 3 / 3 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 15.5 (9.2) NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Viukari, M / 1983 High (4/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

73.2 (2.9) group A 75.1 (1.5) group B NS 20 / 17 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary various medical and psychiatric conditions NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 
C-61

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

 Walsh, JK / 2002 Moderate (3/5) 

NS RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

43.2 (1.2) Tr 45.0 (1.3) Pl NS 115 / 48 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DuratioTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Walsh, JK / 2000 Moderate (3/5) 

Private (data analysis) 

RCT Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

67.5 (NS) 60 – 79 17 / 31 

Type: Co-morbidity: Duration (years)

Mean (SD): Range:

primary NA NS NS 

Type/Description: 

Dose (mg): Frequency / DuratioTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Walsh, JK / 2000 High (4/5) 

Private (research design, selection of investigators, data analysis) 

RCT Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

43.2 (1.2) Tr 45.0 (1.3) Pl 21 – 65 115 / 48 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DuratioTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Walsh, JK / 1998 High (4/5) 

Private RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

38.9 – 39.6 (10 – 11.7) Tr 43.1 (9.0) Pl 18 – 60 77 / 55 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA 7.4 – 11.8 (6.3 – 10.2) Tr 7.4 (7.3) Pl NS 

Type/Description: Dose (mg):

Frequency / DuratioTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Walsh, JK / 1998 Moderate (3/5) 

Private RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

42 (NS) 21 – 65 193 / 85 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DuratioTiming: Route of Delivery: 
C-62

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Walsh, JK / 1984 Moderate (3/5) 

Private RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

41.1 (NS) 19 – 65 52% / 48% 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Wang, RIH / 1977 Moderate (3/5) 

NS RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

NS NS NS / NS 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Waters, WF / 2003 Low (1/5) 

Foundation RCT 

Not reported as doubleblind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

44.1 (NS) 18 – 59 37 / 16 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Winsauer, HJ / 1984 Moderate (3/5) 

Private RCT 

Double-blind Parallel 

Age (years)Mean (SD): Range: GenderFemale / Male: 

NS 60 – 90 39 / 21 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg):

Frequency / DurationTiming: Route of Delivery: 
C-63

Evidence Table C-2: Efficacy and safety of treatments used in the management of chronic insomnia in adults (continued)

AUTHOR / YEAR QUALITY (score) 

FUNDING SOURCE 

STUDY DESIGN POPULATION CHARACTERISTICS INSOMNIA CHARACTERISTICS INTERVENTIONS 

Zhdanova, IV / 2001 Moderate (2/5) 

GOV RCT 

Double-blind Crossover 

Age (years)Mean (SD): Range: GenderFemale / Male: 

over 50 yrs NS NS NS / NS 

Type: Co-morbidity: Duration (years)Mean (SD): Range: 

primary NA NS NS 

Type/Description: Dose (mg): Frequency / DurationTiming: Route of Delivery: 
C-64

Evidence Table C-2: References 

 1. Aden GC, Thatcher C. Quazepam in the short-term 

treatment of insomnia in outpatients. J Clin 

Psychiatry 1983; 44(12):454-6. 

 2. Allain H, Arbus L, Schuck S. Efficacy and safety of 

zolpidem administered as needed in primary 

insomnia: results of a double-blind, placebocontrolled study. Clin Drug Invest 2001; 21(6):391-

400. 

 3. Allain H, Le Coz F, Borderies P et al. Use of 

zolpidem 10 mg as a benzodiazepine substitute in 

84 patients with insomnia. Hum Psychopharmacol 

1998; 13(8):551-9. 

 4. Ascher LM, Turner RM. Paradoxical intention and 

insomnia: an experimental investigation. Behav Res 

Ther 1979; 17(4):408-11. 

 5. Asnis GM, Chakraburtty A, DuBoff EA et al. 

Zolpidem for persistent insomnia in SSRI-treated 

depressed patients. J Clin Psychiatry 1999; 

60(10):668-76. 

 6. Beary MD, Lacey JH, Crutchfield MB et al. 

Psycho-social stress, insomnia and temazepam: a 

sleep laboratory evaluation in a "general practice" 

sample. Psychopharmacol 1984; 83(1):17-9. 

 7. Botter PA. Comparative double blind study of 

loprazolam, 1 mg and 2 mg, versus placebo in 

anxiety induced insomnia. Curr Med Res Opin 

1983; 8(9):626-30. 

 8. Bowen AJ. Comparative efficacy of triazolam, 

flurazepam and placebo in out-patient insomniacs. J 

Int Med Res 1978; 6(4):337-42. 

 9. Brown CC, Horrom NJ, Wagman AM. Effects of ltryptophan on sleep onset insomniacs. Waking 

Sleeping 1979; 3(2):101-8. 

 10. Campbell RD, Grace MGA, Bourgouin J et al. 

Efficacy and safety of zopiclone in the treatment of 

insomnia. Curr Ther Res 1987; 42(4):665-70. 

 11. Carr-Kaffashan L, Woolfolk RL. Active and 

placebo effects in treatment of moderate and severe 

insomnia. J Consult Clin Psychol 1979; 47(6):1072-

80. 

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D-1

Appendix D: Technical Expert Panel 

 The Technical Experts for this review are outlined below. Some of their professional 

affiliations are briefly described. The panel was consulted for their opinion regarding the 

definition of chronic insomnia used in the review, the inclusion criteria for the review and data 

analysis. They were also asked to provide feedback on the draft report. 

J. Todd Arnedt, Ph.D. 

Clinical Assistant Professor 

Sleep and Chronophysiology Laboratory 

Departments of Psychiatry and Neurology 

University of Michigan, Ann Arbor, MI 

Richard R. Bootzin, PhD 

Professor, University of Arizona, Department of Psychology; 

Professor, University of Arizona, Department of Psychiatry, 

College of Medicine; Director, Sleep Disorders Center, Insomnia Program, 

University of Arizona, College of Medicine 

Irvin Mayers, MD 

Professor, University of Alberta, Pulmonary Medicine; 

Director, University of Alberta, Pulmonary Medicine Division. 

Parameswaran Nair, MD, PhD 

Assistant Professor of Medicine, 

McMaster University, Division of Respirology. 

Larry Pawluk, MD 

Associate Professor, 

University of Alberta, Department of Psychiatry; 

Director, Sleep Medicine Program, 

University of Alberta, Department of Psychiatry. 
D-2

Arthur J. Spielman, PhD 

Professor, The City College of CUNY, Department of Psychology; 

Associate Director, Center for Sleep Disorders Medicine and Research, New York Methodist 

Hospital, Brooklyn, NY; 

Associate Director, Center for Sleep Medicine, Neurology, New York Presbyterian HospitalCornell, NY/Weill Medical College, Cornell University. 
E-1

Appendix E: Excluded Studies 

Four hundred and forty-nine studies were excluded for the questions on manifestations of 

chronic insomnia. The reasons for exclusion of studies potentially relevant to these questions are 

as follows: (1) the study was reported in a language other than English (n=9), (2) the report was a 

review (n=38), (3) the study was not relevant to the review topic (n=71), (4) the study was a case 

report (n=9), (5) the study did not have a control group (n=47), (6) the study did not examine an 

adult population (n=8), (7) the study population did not have chronic insomnia as defined in this 

report (208), (8) the study did not report on any of the outcomes of this review (n=58) and (9) 

data relevant to the study outcomes were not adequately reported (n=1). 

Excluded - Non-English 

The following studies were excluded because they were reported in a language other than 

English. 

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Prevalence and Treatment in the General Practice. Can 

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Excluded - Review 

The following studies were excluded because they were reviews. 

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E-2

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11. Bannerman C. Sleep disorders in the later years. 

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14. Chilcott LA, Shapiro CM. The socioeconomic impact 

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18. Daly MP. Insomnia in the elderly. Am Fam Phys 

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20. Ford DE, Cooper-Patrick L. Sleep disturbances and 

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21. Gaillard J-M, Merica H, Blois R. Clinical presentation 

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Excluded - Population (Not Chronic Insomnia) 

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E-18

18. Currie SR, Clark S, Rimac S et al. Comprehensive 

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25. Harvey AG. Sleep hygiene and sleep-onset insomnia. 

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28. Irwin M, Clark C, Kennedy B et al. Nocturnal 

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30. Kales A, Bixler EO, Vela-Bueno A et al. 

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33. Mariotti P, Della Marca G, Iuvone L et al. Sleep 

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35. Mendelson WB. Long-term follow-up of chronic 

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36. Mendelson WB. Are periodic leg movements 

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37. Mendelson WB, Garnett D, Linnoila M. Do 

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38. Morin CM, Stone J, Trinkle D et al. Dysfunctional 

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39. Morris M, Lack L, Dawson D. Sleep-onset insomniacs 

have delayed temperature rhythms. Sleep 1990; 

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40. Nowell PD, Buysse DJ, Reynolds CF 3rd et al. 

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41. Ohayon MM, Zulley J. Correlates of global sleep 

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42. Perlis ML, Kehr EL, Smith MT et al. Temporal and 

stagewise distribution of high frequency EEG activity 

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104. 

43. Perlis ML, Smith MT, Andrews PJ et al. Beta/Gamma 

EEG activity in patients with primary and secondary 

insomnia and good sleeper controls. Sleep 2001; 

24(1):110-7. 

44. Pollak CP, Perlick D, Linsner JP. Daily sleep reports 

and circadian rest-activity cycles of elderly 

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1992; 32(11):1019-27. 
E-19

45. Riedel BW, Lichstein KL. Objective sleep measures 

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46. Saletu-Zyhlarz GM, Anderer P, Berger P et al. 

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sleep laboratory studies with normal controls and 

placebo-controlled trials with alprazolam. Hum 

Psychopharmacol 2000; 15(4):241-54. 

47. Schneider-Helmert D, Whitehouse I, Kumar A et al. 

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48. Souza JC, Magna LA, Reimao R. Insomnia and 

hypnotic use in Campo Grande general population, 

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49. Staner L, Cornette F, Maurice D et al. Sleep 

microstructure around sleep onset differentiates major 

depressive insomnia from primary insomnia. J Sleep 

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50. Stepanski E, Zorick F, Roehrs T et al. Daytime 

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with asymptomatic control subjects. Sleep 1988; 

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51. Takekawa H, Kubo J, Miyamoto T et al. Amyotrophic 

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Clin Neurosci 2001; 55(3):263-4. 

52. Terashima K, Mikami A, Tachibana N et al. Sleep 

characteristics of menopausal insomnia: a 

polysomnographic study. Psychiatry Clin Neurosci 

2004; 58(2):179-85. 

53. Vallieres A, Morin CM. Actigraphy in the assessment 

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54. Vanable PA, Aikens JE, Tadimeti L et al. Sleep 

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55. Vgontzas AN, Tsigos C, Bixler EO et al. Chronic 

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56. Voderholzer U, Al-Shajlawi A, Weske G et al. Are 

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57. Walsh JK, Schweitzer PK. Ten-year trends in the 

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58. Zorick FJ, Roth T, Hartze KM et al. Evaluation and 

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Excluded - Outcomes (Inadequate Reporting) 

The following study was excluded because data relevant to the outcomes of interest were 

inadequately reported. 

 1. Winett CA. The mediating role of insomnia in the relation between life events and depression and mania. Miami (FL): 

University of Miami; 2001. 
E-20

Five hundred and fifty six studies were excluded for the question on management of chronic 

insomnia. The reasons for exclusion of studies were as follows: (1) the study was reported in a 

language other than English (n=27), (2) the report was a review/commentary/practice parameter 

(n=32), (3) the study report was a duplicate publication (n=3) (4) the study did not examine an 

adult population (n=17), (5) the study population did not suffer from chronic insomnia as defined 

in this report (n=221), (6) the study was not a randomized controlled trial (n=160), (7) the study 

did not have a placebo arm (n=48), (8) the study was not double-blind (n=15), (9) the study did 

not report on any of the outcomes of this review (n=18) and (10) the study outcomes were not 

adequately reported (n=15). 

Excluded - Non-English 

The following studies were excluded because they were reported in a language other than 

English. 

 1. Altamura AC, Colacurcio F, Mauri MC et al. 

Controlled clinical study on the effect of quazepam 

versus triazolam in patients with sleep disorders [Ital]. 

Minerva Psichiatr 1989; 30(3):159-64. 

 2. Bourin M, Andre-David F. Triazolam 0.25 mg versus 

loprazolam 1 mg in common insomnia treated by 

general practitioners (double blind cross-over 

randomized study). [Fr]. Therapie 1989; 44(2):107-14. 

 3. Buscaino GA, Steardo L. [Efficacy of the oral 

treatment with L-tryptophan in subjects with 

insomnia. Preliminary results]. [Italian]. Acta 

Neurologica 30(4), 411-5. 1975 Jul-Aug. 

 4. Carlini EA, Braz S, Troncone LR et al. [Hypnotic 

effect of homeopathic medication and placebo. 

Evaluation by double-blind and crossing technics]. 

[Portuguese]. Amb; Revista Da Associacao Medica 

Brasileira 33[5-6], 83-8. 1987 May-Jun. 

 5. Castellani A, Lescovelli M, Perbellini D. Clinical and 

EEG changes in sleep patterns after administration of 

N-demethyldiazepam to 25 psychiatric patients 

affected by insomnia. [Italian]. Lav Neuropsichiatr 

1975; 56(1, Suppl 3):155-83. 

 6. de Anna M, Zucconi M, Baruzzi A et al. Double blind 

trial of lormetazepam and flurazepam in the treatment 

of insomniacs. Farmaco Ed Prat 1982; 37:275-81. 

 7. Duriez R, Barthelemy C, Rives H et al. Clinical trial 

of zopiclone in insomnia. Therapie London Paris 

1979; 34(3):317-26. 

 8. Estivill-Sancho E, Jaraba G. The treatment of chronic 

insomnia: A program of creative relaxation and body 

consciousness as adjuvant of pharmacotherapy. 

[Spanish]. Psiquis: Revista de Psiquiatria, Psicologia y 

Psicosomatica. Vol 12(9) 1991, 52-57. Alpe Editores 

SA, Spain 12(9), 52-57. 1991. 

 9. Ferrero F, Zahnd J. [Tryptophan in the treatment of 

insomnia in hospitalized psychiatric patients]. 

[French]. Encephale 13(1), 35-7. 1987 Jan-Feb. 

10. Friede M, Liske E, Woelk H et al. Herbal agent for the 

treatment of insomnia. [German]. Tw Neurologie 

Psychiatrie 11(10), 697-700. 1997. 

11. Herberg KW, Laux G, Fischer W. Analysis of the 

effects of a 14 days treatment with zopiclone 7.5mg/d 

on performance capability, actual well-being, and 

quality of sleep of patients with primary insomnia. 

[Germ]. Psychopharmakother 2002; 9(1):25-34. 

12. Huang GG, Chen Q, Li L. Comparison between the 

effect of behavioral and drug therapy on the treatment 

of insomnia in patients with schizophrenia in 

rehabilitation period. [Chin]. Zhongguo Linchuang 

Kangfu 2004; 8(9):1628-9. 

13. Ito E, Matsui T, Okada T et al. A double-blind 

controlled trial of s-1530 in patients with insomnia . 

Rinsyoyakuri 1973; 4(2):61-75. 

14. Ito H, Yagi G, Tateyama M et al. Clinical evaluation 

of flunitrazepam on insomnia in neuropsychiatric 

field: a comparative double-blind cross-over study 

with nitrazepam. Rinsho Hyoka (Clin Eval) 1981; 

9(3):733-67. 

15. Kobayashi R, Ito K, Hirabayashi Y et al. Effectiveness 

of zopiclone (27 267 r so:p.) In insomnia: multi-center 

double-blind study in comparison with flurazepam 

(the second report). Rinsho Hyoka (Clin Eval) 1986; 

14(77-108). 

16. Kurihara M, Jinbo M, Hirose T et al. A study of the 

clinical efficacy of triazolam on insomnia -Doubleblind cross-over study among the smaller and larger 

doses of triazolam, and flurazepam. Rinsho Hyoka 

(Clin Eval) 1980; 8(1):79-110. 
E-21

17. Lan S, Deng M, Zhu X et al. Relaxation training and 

sleep related behavior modification in patients with 

insomnia. [Chin]. Chin Ment Health J 2002; 

16(9):625-7. 

18. Levin I. "Music of the Brain" in the treatment of 

insomnia patients. [Rus]. Zh Nevropatol Psikhiatr Im 

S S Korsakova 1997; 97(4):39-43. 

19. Li LH, Chen JD, Zhao JP et al. Zaleplon vs zolpidem 

in treatment of insomnia: a multicenter, randomized, 

double-blind controlled clinical trial. Zhongguo 

Xinyao Yu Linchuang Zazhi 2003; 22(11):667-70. 

20. Massot JE, Toblli JE. Double-blind study by 

comparing the effect of triazolam and nitrazepam on 

the sleep of usual insomniac patients. Prensa Med 

Argent 1983; 70(8):340-5. 

21. Montakab H. [Acupuncture and insomnia]. [German]. 

Forschende Komplementarmedizin. 6 Suppl 1:29-31, 

1999 Feb 1(6), 29-31. 

22. Rocha FL, Paprocki J, Bustamante LS et al. Doubleblind, randomized, comparative study between 

zopiclone (Imovane) and flunitrazepam (Rohypnol) in 

chronic insomniac patients. [Portuguese]. J Brasil 

Psiquiatr 1991; 40(4):199-215. 

23. Ruther E, Clarenbach P, Hajak G et al. Zopiclone in 

patients with disturbed sleep. Impact on sleep quality 

and day-time wellbeing in comparison of 

flunitrazepam, triazolam and placebo. [German]. 

Munch Med Wochenschr 1992; 134(46):59-65. 

24. Schadeck B, Chelly M, Amsellem D et al. 

Comparative efficacy of doxylamine (15 mg) and 

zolpidem (10 mg) for the treatment of common 

insomnia. A placebo-controlled study. [Fr]. Semaine 

Hopitaux 1996; 72(13-14):428-39. 

25. Yamamura Y, Kokubu T, Ueda E et al. Clinical effects 

of lorazepam on insomnia in the field of internal 

medicine -evaluated by double blind study using 

nitrazepam and placebo as control drugs. Rinsho 

Hyoka (Clin Eval) 1978; 6(2):201-21. 

26. Zhang H, Shen Y, Liu N et al. Effect and reliability of 

zaleplon on treatment of insomnia: A randomized, 

double-blind, control study. [Chin]. Zhongguo 

Linchuang Kangfu 2004; 8(18):3488-90. 

27. Zhou CL, Xie HJ, Wang LQ. Paroxetine in treatment 

of primary insomnia. Zhongguo Xinyao Yu Linchuang 

Zazhi 2002; 21(8):481-4. 

Excluded - Review/Commentary/Practice Parameter 

The following studies were excluded because they were reviews/commentaries/practice 

parameters. 

 1. Agargun MY, Kara H, Ozbek H et al. Restless legs 

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