Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Study.
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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Matching Placebos
- drug : zolpidem tartrate
- drug : sodium oxybate
Ages Eligible For Study:
1. Written informed consent is obtained. 2. The patient is an outpatient, man or woman of any ethnic origin, 18-75 years of age (inclusive). 3. Patient reports insomnia for at least six months, and insomnia causes the patient distress. 4. The Investigator determines that the patient meets diagnostic criteria for Chronic Insomnia according to International Classification of Sleep Disorders (ICSD) criteria. 5. Sleep diary based screening shows sleep onset latency >30 minutes, and /or wake after sleep onset >30 minutes per night at least 3 nights per week, with combined wake-time-in-bed _> 45 minutes. 6. The patient is in good health as determined by a medical and psychiatric history, and physical examination. 7. Women must be surgically sterile, 2 years post-menopausal, or if of child-bearing potential, using a medically accepted method of birth control, and agree to continued use of this method for the duration of the study. 8. The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol.