drugset / Trial / NCT00492232

Facilitation of Zolpidem (≥10 mg) Discontinuation Through Use of Ramelteon in Subjects With Chronic Insomnia

NCT00492232 ↗

Phase 4 Completed 135 enrolled Takeda
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to assess whether ramelteon, once daily (QD), can facilitate the discontinuation of zolpidem in subjects with chronic insomnia.

Timeline

Start
2007-04
Primary completion
2008-03
Completion
2008-05

Outcome

Missed primary endpoint

registry Ramelteon 8 mg QD vs Placebo QD; p = 0.484; Adjusted Odds Ratio 0.71 (95% CI 0.27 to 1.85) NCT00492232 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ramelteon Unknown 8 mg Oral
Subject Zolpidem Small molecule — —

Indications