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Sponsored by: |
Stanford University |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00383643 |
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.
Condition | Intervention |
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Sleep Initiation and Maintenance Disorders |
Drug: sodium oxybate Drug: zolpidem tartrate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 60 |
Primary aim:
1. To assess the long term efficacy of sodium oxybate and zolpidem tartrate in reducing insomnia and improving sleep quality.
Secondary aims:
To compare the magnitude of sleep improvement sodium oxybate produces with that of zolpidem tartrate.
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Jed E Black | Stanford University |
Study ID Numbers: | 95900 |
Study First Received: | September 29, 2006 |
Last Updated: | April 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00383643 History of Changes |
Health Authority: | null:null |
Sleep Initiation and Maintenance Disorders Zolpidem Anesthetics, Intravenous Neurotransmitter Agents Adjuvants, Immunologic Sleep Disorders Dyssomnias Anesthetics |
Central Nervous System Depressants Sleep Disorders, Intrinsic Mental Disorders Anesthetics, General GABA Agonists Hypnotics and Sedatives Sodium Oxybate |
Sleep Initiation and Maintenance Disorders Zolpidem Anesthetics, Intravenous Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Central Nervous System Depressants Anesthetics Dyssomnias Sleep Disorders |
Pharmacologic Actions Sleep Disorders, Intrinsic Adjuvants, Anesthesia Anesthetics, General Mental Disorders GABA Agonists Therapeutic Uses Hypnotics and Sedatives GABA Agents Central Nervous System Agents Sodium Oxybate |