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

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)”

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

Intervention(s) in this Clinical Trial

• Drug: zolpidem tartrate sublingual tablet
  • 3.5 milligram zolpidem tartrate sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study 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 taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Zolpidem 3.5mg
• Placebo Comparator: Placebo

Primary Measures

• Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline
  • Time Frame: Weeks -1 to 0
    Safety Issue?: No
• Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment
  • Time Frame: Weeks 1 to 4
    Safety Issue?: No

Secondary Measures

• Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline
  • Time Frame: Weeks -1 to 0
    Safety Issue?: No
• Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment
  • Time Frame: Weeks 1 to 4
    Safety Issue?: No
• Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.
  • Time Frame: Weeks -1 to 0
    Safety Issue?: No
• Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment
  • Time Frame: Weeks 1 to 4
    Safety Issue?: No
• Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline
  • Time Frame: Weeks -1 to 0
    Safety Issue?: No
• Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment
  • Time Frame: Weeks 1 to 4
    Safety Issue?: No
• Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline
  • Time Frame: Weeks -1 to 0
    Safety Issue?: No
• Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment
  • Time Frame: Weeks 1 to 4
    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 Investigator: Transcept Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 08, 2012

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