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

NCT00383643 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-06-01

Study results available
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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 oxybate with zolpidem tartrate (Ambien®), and compare the efficacy of each of these two medications with placebos.

Conditions

  • Sleep Initiation and Maintenance Disorders

Interventions

DRUG

zolpidem tartrate

DRUG

sodium oxybate

DRUG

Matching Placebos

Sponsors & Collaborators

Principal Investigators

  • Jed E Black, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00383643 on ClinicalTrials.gov