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

NCT00380081 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2012-02-14

Study results available
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Summary

The purpose of this study is to evaluate sleep onset following administration of Transcept zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.

Conditions

Interventions

DRUG

zolpidem tartrate sublingual tablet 3.5mg

Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

DRUG

zolpidem tartrate sublingual tablet 1.75mg

Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment 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 administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment 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

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

  • Martin Scharf, PhD · Tri-State Sleep Disorders Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2006-07-31
Completion
2006-07-31

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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 NCT00380081 on ClinicalTrials.gov