NCT00630175

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

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. A Double-Blind, Randomized, Placebo-Controlled,Three Way Cross-Over Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Initiation and Maintenance Disorders

Interventions

Type	Name	Description
DRUG	zolpidem-MR (modified release)
DRUG	zolpidem (SL800750)
DRUG	placebo

Timeline

• Start date: 2003-09-01
• Primary completion: 2004-02-01
• Completion: 2004-02-01
• First posted: 2008-03-06
• Last updated: 2009-05-18

Locations

3 sites across 3 countries: United States, Australia, Canada