NCT00425243

Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia (ZOLONG)

Evaluation of the Long-Term Efficacy and Safety of Zolpidem-MR 12.5 mg Compared to Placebo, When Both Are Administered Over a Long-Term Period "as Needed", in Patients With Chronic Primary Insomnia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,025 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the hypnotic efficacy of zolpidem-MR 12.5 mg in comparison with placebo, when administered over a long-term period, on an "as needed" basis, in patients with chronic primary insomnia. Secondary objectives of the study are to evaluate the drug taking behavior over a long-term period and the clinical safety and tolerability of zolpidem-MR 12.5 mg in comparison to placebo administered over a long-term period, on an as needed basis.

Conditions

• Sleep Initiation and Maintenance Disorders

Interventions

Type	Name	Description
DRUG	zolpidem-MR (SL800750)

Timeline

• Start date: 2004-08-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2007-01-22
• Last updated: 2009-04-06

Locations

1 site across 1 country: United States