Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.
Information source: Stanford University
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sleep Initiation and Maintenance Disorders
Intervention: zolpidem tartrate (Drug); sodium oxybate (Drug); Matching Placebos (Drug)
Sponsored by: Stanford University
Official(s) and/or principal investigator(s):
Jed E Black, Principal Investigator, Affiliation: Stanford University
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.
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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: To assess the long term efficacy of sodium oxybate and zolpidem tartrate in reducing insomnia and improving sleep quality.
Secondary outcome: To compare the magnitude of sleep improvement sodium oxybate produces with that of zolpidem tartrate.
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
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.
Minimum age: 18 Years.
Maximum age: 75 Years.
1. Written informed consent is obtained.
2. The patient is an outpatient, man or woman of any ethnic origin, 18-75 years of age
3. Patient reports insomnia for at least six months, and insomnia causes the patient
4. The Investigator determines that the patient meets diagnostic criteria for Chronic
Insomnia according to International Classification of Sleep Disorders (ICSD)
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
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.
1. Has any clinically significant, uncontrolled medical or psychiatric conditions.
(treated or untreated)
2. Has a probable diagnosis of a current sleep disorder other than Chronic Insomnia.
3. 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.
4. Has a history of alcohol, narcotic, or any other abuse as defined by the DSM-V.
5. Has a clinically significant deviation from normal in the physical examination.
6. Is a pregnant or lactating woman. (Any woman becoming pregnant during the study will
be withdrawn from the study.)
7. Has any disorder that may interfere with drug absorption, distribution, metabolism,
or excretion (including gastrointestinal surgery and succinic semialdehyde
8. Has a known clinically significant drug sensitivity to sodium oxybate or sedative
Locations and Contacts
Stanford University School of Medicine, Stanford, California 94305, United States
Starting date: May 2006
Last updated: July 6, 2011