NCT01181232

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Initiation and Maintenance Disorders
• Primary Insomnia

Interventions

Type	Name	Description
DRUG	Zolpidem MR	oral
DRUG	Zolpidem IR	oral

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-08-13
• Last updated: 2014-09-10

Locations

2 sites across 1 country: Taiwan