CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 82 enrolled
Drug / intervention
zolpidem tartrate sublingual tablet 3.5mg +2 moredrug
Likely dose
zolpidem tartrate sublingual tablet 3.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00380081
NCT00380081Phase 3Completed
CompareCT.gov

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

Transcept Pharmaceuticals·interventional·Posted Sep 25, 2006·Updated Feb 14, 2012

In Brief

A Phase 3 clinical trial evaluating zolpidem tartrate sublingual tablet 3.5mg, zolpidem tartrate sublingual tablet 1.75mg, and 1 other intervention for Insomnia. Completed, enrolled 82 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 25, 2006
Enrollment StartApr 1, 2006
Primary CompletionJul 1, 2006
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 19.8 years ago

Interventions

zolpidem tartrate sublingual tablet 3.5mgdrug

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.

zolpidem tartrate sublingual tablet 1.75mgdrug

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.

Placebodrug

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.