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

Study Overview
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Brief Summary
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The purpose of the study is to investigate the efficacy and safety of zolpidem modified release (MR) tablet using estazolam (Eurodin) as a comparative drug in patients with primary insomnia.

Official Title
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A Randomized, Open-Label, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Zolpidem Modified Release (MR) 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: Estazolam


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 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: Zolpidem group<br> | Drug: Zolpidem MR<br>* oral<br>* Other names: Ambient CR;|
| Active Comparator: Estazolam group<br> | Drug: Estazolam<br>* oral<br>* Other names: Eurodin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total score of Pittsburgh Sleep Quality Index (PSQ) |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's clinical global impression (CGI) |  | 3 weeks | 
| Patient's global impression (PG) |  | 3 weeks | 
| Sleep latency, total sleep time, number of awakenings, wake time after sleep onset as derived from sleep diary |  | 3 weeks | 
| Incidence and severity of adverse events, including abnormal sleep behavior |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Zolpidem, Estazolam