A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Sleep Initiation and Maintenance Disorders, Primary Insomnia

Intervention / Treatment
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* Drug: Zolpidem MR
* Drug: Zolpidem IR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MR low-dose group<br> | Drug: Zolpidem MR<br>* oral<br>* Other names: Ambient CR;|
| Experimental: MR high-dose group<br> | Drug: Zolpidem MR<br>* oral<br>* Other names: Ambient CR;|
| Active Comparator: IR group<br> | Drug: Zolpidem IR<br>* oral<br>* Other names: Stilnox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rest/activity cycles measured by Actigraphy |  | For 2 weeks (Day 0, Day 7, Day 14) | 
| Total score of Pittsburgh Sleep Quality Index (PSQI) |  | For 2 weeks (Day 0, Day 7, Day 14) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's clinical global impression (CGI) |  | For 2 weeks (Day 0, Day 7, Day 14) | 
| Patient's global impression (PGI) |  | For 2 weeks (Day 0, Day 7, Day 14) | 
| Sleep latency as derived from sleep diary |  | For 2 weeks (Day 0, Day 7, Day 14) | 
| Number of awakenings as derived from sleep diary |  | For 2 weeks (Day 0, Day 7, Day 14) | 
| Total sleep time as derived from sleep diary |  | For 2 weeks (Day 0, Day 7, Day 14) | 
| Wake time after sleep onset as derived from sleep diary |  | For 2 weeks (Day 0, Day 7, Day 14) | 
| Day time function as assessed by Epworth Sleepiness Scale (ESS) |  | For 2 weeks (Day 0, Day 7, Day 14) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insomnia, zolpidem