At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 135 enrolled
Drug / intervention
Ramelteon and zolpidem +1 moredrug
Likely dose
Ramelteon and zolpidem 8 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double Blind, Placebo-Controlled Study to Assess Whether the Administration of Ramelteon Could Facilitate the Discontinuation of Zolpidem (Ambien®) ≥10 mg Therapy in Subjects With Chronic Insomnia
In Brief
A Phase 4 clinical trial evaluating Ramelteon and zolpidem and Placebo and zolpidem for Chronic Insomnia. Completed, enrolled 135 participants across 41 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Insomnia
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2007
First PostedJun 2007
Primary CompletionMar 2008
Study CompletionMay 2008
TodayJul 2026
First PostedJun 27, 2007
Enrollment StartApr 1, 2007
Primary CompletionMar 1, 2008
Study CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 19.0 years ago
Interventions
Ramelteon and zolpidemdrug
Ramelteon 8 mg, tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks.
Placebo and zolpidemdrug
Ramelteon placebo-matching tablets, orally, once daily and current zolpidem therapy incrementally reduced by dose, frequency, or both for up to 10 weeks.