Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00383643
First received: September 29, 2006
Last updated: July 6, 2011
Last verified: July 2011
  Purpose

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
Sleep Initiation and Maintenance Disorders
Drug: zolpidem tartrate
Drug: sodium oxybate
Drug: Matching Placebos

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • To assess the long term efficacy of sodium oxybate and zolpidem tartrate in reducing insomnia and improving sleep quality. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare the magnitude of sleep improvement sodium oxybate produces with that of zolpidem tartrate. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: May 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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.

Exclusion Criteria:

  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 dehydrogenase deficiency)
  8. Has a known clinically significant drug sensitivity to sodium oxybate or sedative hypnotics.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383643

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Jed E Black Stanford University
  More Information

No publications provided

Responsible Party: Jed E Black, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00383643     History of Changes
Other Study ID Numbers: 95900
Study First Received: September 29, 2006
Last Updated: July 6, 2011
Health Authority: null:null

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Sodium Oxybate
Zolpidem
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014