At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 48 enrolled
Drug / intervention
zolpidem tartrate +2 moredrug
Likely dose
Not stated in 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.
Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Study.
In Brief
A Phase 2 clinical trial evaluating zolpidem tartrate, sodium oxybate, and 1 other intervention for Sleep Initiation and Maintenance Disorders. Completed, enrolled 48 participants across 1 site.
Detailed Summary
The primary purpose of the study is to evaluate the long term efficacy of sodium oxybate (Xyrem®) and zolpidem tartrate (Ambien®) in treating chronic insomnia. We will compare the efficacy of sodium oxybate with zolpidem tartrate (Ambien®), and compare the efficacy of each of these two medications with placebos.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2006
First PostedOct 2006
Primary CompletionDec 2009
TodayJul 2026
First PostedOct 3, 2006
Enrollment StartMay 1, 2006
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 19.7 years ago
Interventions
zolpidem tartratedrug
sodium oxybatedrug
Matching Placebosdrug