drugset / Trial / NCT00380081

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

NCT00380081 ↗

Phase 3 Completed 82 enrolled Transcept Pharmaceuticals
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2006-04
Primary completion
2006-07
Completion
2006-07

Outcome

Met primary endpoint

registry analysis (superiority or other test); Zolpidem 3.5 mg vs Zolpidem 1.75 mg vs Placebo; p <0.001; ANCOVA; note: Treatment effect NCT00380081 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Zolpidem Small molecule 1.75 mg Other
Subject Zolpidem Small molecule 3.5 mg Other

Indications