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

September 29, 2006
July 6, 2011
May 2006
December 2009   (final data collection date for primary outcome measure)
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 ]
  • 1. To assess the long term efficacy of sodium oxybate and zolpidem tartrate in reducing insomnia and
  • improving sleep quality.
Complete list of historical versions of study NCT00383643 on ClinicalTrials.gov Archive Site
To compare the magnitude of sleep improvement sodium oxybate produces with that of zolpidem tartrate. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.
Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Study.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Sleep Initiation and Maintenance Disorders
  • Drug: zolpidem tartrate
  • Drug: sodium oxybate
  • Drug: Matching Placebos
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00383643
95900
Not Provided
Jed E Black, Stanford University School of Medicine
Stanford University
Not Provided
Principal Investigator: Jed E Black Stanford University
Stanford University
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP