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

ClinicalTrials.gov ID: NCT00466193

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Official title

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of the Zolpidem Tartrate Sublingual Tablet in Adult Subjects With Insomnia Characterized by Difficulty Returning to Sleep After Awakening in the Middle-of-the-Night (MOTN)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID: NCT00466193
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Transcept Pharmaceuticals; Industry
Enrollment: 295 participants

Conditions and interventions

Conditions

Insomnia

Interventions

zolpidem tartrate sublingual tablet Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 64 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 2007 (Type not available)
Primary completion: Nov 2007 (Actual)
Completion: Nov 2007 (Actual)
Last update posted: Feb 14, 2012

2007

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Transcept Investigational Site	Durham	North Carolina	27710	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00466193, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 14, 2012 · Synced Nov 12, 2026