Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.
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|ClinicalTrials.gov Identifier: NCT00383643|
Recruitment Status : Completed
First Posted : October 3, 2006
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Information provided by (Responsible Party):
Jed E Black, Stanford University
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment|
Sleep Initiation and Maintenance Disorders
Drug: zolpidem tartrate
Drug: sodium oxybate
Drug: Matching Placebos
|Recruitment Details||Subjects were recruited through local newspaper ads and from the Stanford Sleep Disorders Clinic. A general description of the study was provided. Preliminary screening was conducted by telephone. Interested and qualified persons were scheduled for an in-person screening visit.|
Insufficient power for most parameters was a planned limitation of the study. Replication with a larger sample is needed.