Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.
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.
Sleep Initiation and Maintenance Disorders
Drug: zolpidem tartrate
Drug: sodium oxybate
Drug: Matching Placebos
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Study.|
- To assess the long term efficacy of sodium oxybate and zolpidem tartrate in reducing insomnia and improving sleep quality. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- To compare the magnitude of sleep improvement sodium oxybate produces with that of zolpidem tartrate. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
1. To assess the long term efficacy of sodium oxybate and zolpidem tartrate in reducing insomnia and improving sleep quality.
To compare the magnitude of sleep improvement sodium oxybate produces with that of zolpidem tartrate.
To compare and contrast the profile of effects of oxybate and zolpidem on sleep architecture, sleep latency, wake after sleep onset, and sleep efficiency.
To explore the extent to which sodium oxybate and zolpidem tartrate improve daytime functions that are adversely affected by poor/inadequate sleep.
To assess the extent of rebound insomnia that is associated with abrupt discontinuation of sodium oxybate and zolpidem tartrate.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383643
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Jed E Black||Stanford University|