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

The purpose of this study is to evaluate sleep onset following administration of TransOral zolpidem versus placebo in adult insomnia patients.

Study Type: Interventional

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

Study Primary Completion Date: July 2006

Intervention(s) in this Clinical Trial

• Drug: Zolpidem 3.5
  • Zolpidem 3.5 milligram sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved.
• Drug: Zolpidem 1.75
  • Zolpidem 1.75 milligram sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved.
• Drug: Placebo
  • Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: placebo/zolpidem 3.5/zolpidem 1.75
• Experimental: placebo/zolpidem 1.75/zolpidem 3.5
• Experimental: zolpidem 3.5/placebo/zolpidem 1.75
• Experimental: zolpidem 3.5/zolpidem 1.75/placebo
• Experimental: zolpidem 1.75/placebo/zolpidem 3.5
• Experimental: zolpidem 1.75/zolpidem 3.5/placebo

Primary Measures

• Average latency to persistent sleep after middle-of-the-night awakening
  • Time Frame: 6 nights total (2 nights for each of the 3 treatments)
    Safety Issue?: No

Secondary Measures

• Average total sleep time
  • Time Frame: 6 nights total (2 nights for each of the 3 treatments)
    Safety Issue?: No
• Average sleep efficiency
  • Time Frame: 6 nights total (2 nights for each of the 3 treatments)
    Safety Issue?: No
• Sleep quality rating
  • Time Frame: 6 nights total (2 nights for each of the 3 treatments)
    Safety Issue?: No
• Average sleep onset latency
  • Time Frame: 6 nights total (2 nights for each of the 3 treatments)
    Safety Issue?: No
• Average subjective total sleep time
  • Time Frame: 6 nights total (2 nights for each of the 3 treatments)
    Safety Issue?: No

Inclusion Criteria:

• Insomnia as defined by DSM-IV criteria and supported by subject diary
• Male or female between the ages of 18-64 years
• Body mass index (BMI) between 18-34
• Females of childbearing potential must use a medically acceptable method of contraception
• Capable of understanding and willing to comply with study procedures and has provided informed consent

Exclusion Criteria:

• Females who are pregnant, breast-feeding or have a positive pregnancy test
• Any circadian rhythm disorder including planned travel across several time zones during the study period
• Known hypersensitivity to Zolpidem
• Has performed regular shift work with the past several months prior to screening
• An acute clinically significant illness or surgery as determined by the PI within 30 days of screening
• Patients that have used any central nervous system (CNS) medication or other medication known to impact the sleep/wake cycle
• A history of psychiatric disorder as defined by DSM-IV
• A history of drug addiction or alcohol abuse
• Any current significant disease, unless adequately controlled with a protocol allowed medication
• Known history of HIV or Hepatitis B or C
• Patients who have received an investigational drug within several months of screening

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

Thomas Roth, PhD Principal Investigator Henry Ford Hospital , Sleep Disorders and Research Center  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00380081

Study ID Number: ZI-06-010

ClinicalTrials.gov Identifier: NCT00380081

Health Authority: United States: Food and Drug Administration