Official Title: “A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of the Zolpidem Tartrate Sublingual Lozenge in Adult Subjects With Insomnia Characterized by Difficulty Returning to Sleep After Awakening in the Middle-of-the-Night (MOTN)”

The purpose of the study is to evaluate sleep onset following administration of Zolpidem Tartrate Lozenge (Intermezzo) versus placebo in adult insomnia patients.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2007

Intervention(s) in this Clinical Trial

• Drug: Zolpidem Tartrate
  • 3.5 milligram sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period.
• Drug: Placebo
  • Placebo sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Zolpidem
• Placebo Comparator: Placebo

Primary Measures

• Average latency to sleep onset following middle-of-the-night awakening.
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• The average subjective total sleep time following middle-of-the-night awakening.
  • Time Frame: 4 weeks
    Safety Issue?: No
• The average subjective number of awakenings following middle-of-the-night awakening.
  • Time Frame: 4 weeks
    Safety Issue?: No
• The average subjective wakening after sleep onset following middle-of-the-night awakening.
  • Time Frame: 4 weeks
    Safety Issue?: No

Inclusion Criteria:

• Adults with history of sleeplessness

Exclusion Criteria:

• Allergic to investigational drug
• Any conditions and medications that may interfere with study drug evaluation

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Transcept Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Andrew Krystal, MD Principal Investigator Clincal Neurophysiology Training Program, Duke University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00466193

Study ID Number: ZI-12

ClinicalTrials.gov Identifier: NCT00466193

Health Authority: United States: Food and Drug Administration