Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.
Completed · Phase 2 · Has a placebo group
Conditions studied: Sleep Initiation and Maintenance Disorders
In brief
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.
Key facts
- Study ID
- NCT00383643
- Run by
- Stanford University
- People needed
- 48
- Starts
- 2006-05-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2017-06-01
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Written informed consent is obtained.
- The patient is an outpatient, man or woman of any ethnic origin, 18-75 years of age (inclusive).
- Patient reports insomnia for at least six months, and insomnia causes the patient distress.
- The Investigator determines that the patient meets diagnostic criteria for Chronic Insomnia according to International Classification of Sleep Disorders (ICSD) criteria.
- 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.
- The patient is in good health as determined by a medical and psychiatric history, and physical examination.
- 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.
- The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol.
You may not qualify if…
- Has any clinically significant, uncontrolled medical or psychiatric conditions. (treated or untreated)
- Has a probable diagnosis of a current sleep disorder other than Chronic Insomnia.
- Used any prescription drugs disallowed by the protocol or clinically significant use of over-the counter(OTC) drugs within 14 days before the screening visit.
- Has a history of alcohol, narcotic, or any other abuse as defined by the DSM-V.
- Has a clinically significant deviation from normal in the physical examination.
- Is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
- Has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery and succinic semialdehyde dehydrogenase deficiency)
- Has a known clinically significant drug sensitivity to sodium oxybate or sedative hypnotics.
Where it is running
- Stanford University School of Medicine — Stanford, California, United States
Full record on ClinicalTrials.gov
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