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A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia

NCT00466193 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 295

Last updated 2012-02-14

Study results available
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Summary

The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.

Conditions

Interventions

DRUG

zolpidem tartrate sublingual tablet

3.5 milligram zolpidem tartrate sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

DRUG

Placebo

Placebo sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

Sponsors & Collaborators

  • Transcept Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Andrew Krystal, MD · Clinical Neurophysiology Training Program, Duke University

  • Thomas Roth, PhD · Sleep Disorders and Research Center, Henry Ford Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00466193 on ClinicalTrials.gov