Status:
COMPLETED
Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.
Lead Sponsor:
Stanford University
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 o...
Detailed Description
Primary aim: 1\. To assess the long term efficacy of sodium oxybate and zolpidem tartrate in reducing insomnia and improving sleep quality as assessed by a range of self-reported measures. Questionn...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 (Any woman becoming pregnant during the study will be withdrawn from the study.)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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00383643
Start Date
May 1 2006
End Date
December 1 2009
Last Update
June 1 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305