Clinical trial NCT01181232: A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients
Official title: A Randomized, Active Control, Parallel Study to Evaluate the Efficacy and Safety of Zolpidem MR (Stilnox CR) Versus Zolpidem (Stilnox) in Patients With Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Initiation and Maintenance Disorders
Primary Insomnia
Keywords: insomnia
zolpidem
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Taiwan, Inc.
First posted: 2010-08-13
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified release) compared to zolpidem IR (immediate release) in patients with primary insomnia.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary insomnia based on DSM-IV criteria (307.42)
* Written informed consent has been obtained

Exclusion Criteria:

* Patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome
* Patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem
* Patients who are known to be current drug or alcohol abuser or likely to concomitantly consume alcoholic beverages (more than 3 times/week)
* Patients who have received antihistamines or antipsychotics will not allow to discontinue the previous medication throughout the study
* Patients who are pregnant, lactating or intend to become pregnant during the study period
* Patients who have received antidepressants or anxiolytics will not allow to change the dose or discontinue the previous medication throughout the study
* Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
* Participation in any clinical trial within 1 month prior to randomization

Primary outcomes:
measure: Rest/activity cycles measured by Actigraphy
timeFrame: For 2 weeks (Day 0, Day 7, Day 14)
measure: Total score of Pittsburgh Sleep Quality Index (PSQI)
timeFrame: For 2 weeks (Day 0, Day 7, Day 14)
Secondary outcomes:
measure: Physician's clinical global impression (CGI)
timeFrame: For 2 weeks (Day 0, Day 7, Day 14)
measure: Patient's global impression (PGI)
timeFrame: For 2 weeks (Day 0, Day 7, Day 14)
measure: Sleep latency as derived from sleep diary
timeFrame: For 2 weeks (Day 0, Day 7, Day 14)
measure: Number of awakenings as derived from sleep diary
timeFrame: For 2 weeks (Day 0, Day 7, Day 14)
measure: Total sleep time as derived from sleep diary
timeFrame: For 2 weeks (Day 0, Day 7, Day 14)
measure: Wake time after sleep onset as derived from sleep diary
timeFrame: For 2 weeks (Day 0, Day 7, Day 14)
measure: Day time function as assessed by Epworth Sleepiness Scale (ESS)
timeFrame: For 2 weeks (Day 0, Day 7, Day 14)
Other outcomes:
Locations:
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References: