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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
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.
Details
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 1025 |
| Start date | 2004-08 |
| Completion | 2006-01 |
Conditions
- Sleep Initiation and Maintenance Disorders
Interventions
- zolpidem-MR (SL800750)
Primary outcomes
- The primary efficacy variable is item 1 (which assessed sleep aid) of the Patient Global Impression (PGI) scale at week 12.
Countries
United States