Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia

Phase 3

Completed

• Conditions: Sleep Initiation and Maintenance Disorders

• Registration Number: NCT00630175
• Lead Sponsor: Sanofi

Brief Summary

The primary objective is to evaluate the hypnotic efficacy of zolpidem-MR (modified release) 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo in patients with primary insomnia and sleep maintenance difficulties, using polysomnography (PSG) recordings and patient sleep questionnaires.

The secondary objective is to evaluate the clinical safety and tolerability of zolpidem-MR 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Study First Submitted: 2008-02-26
• Study First Submitted QC: 2008-03-05
• Study First Posted: 2008-03-06
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-15
• Last Update Posted: 2009-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

• Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Polysommography (PSG) wake time after sleep onset (WASO)

Secondary Outcome Measures

Name	Time	Method
PSG parameters, Patient's sleep questionnaire, Patient's global impression, Relative degree of satisfaction with the different study drugs

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇨🇦 Laval, Canada