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

Official Title: “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”

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

Intervention(s) in this Clinical Trial

• Drug: zolpidem tartrate sublingual tablet 3.5mg
  • 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.
• Drug: zolpidem tartrate sublingual tablet 1.75mg
  • 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.
• Drug: Placebo
  • 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.

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

• Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography
  • Time Frame: Days 1 and 2 for each treatment
    Safety Issue?: No

Secondary Measures

• Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening
  • Time Frame: Days 1 and 2 for each treatment
    Safety Issue?: No
• Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography
  • Time Frame: Days 1 and 2 for each treatment
    Safety Issue?: No
• Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening
  • Time Frame: Days 1 and 2 for each treatment
    Safety Issue?: No
• Subjective Sleep Quality Rating
  • Time Frame: Days 1 and 2 for each treatment
    Safety Issue?: No
• Subjective Level of Refreshed Sleep
  • Time Frame: Days 1 and 2 for each treatment
    Safety Issue?: No
• Subjective Ability to Function
  • Time Frame: Days 1 and 2 for each treatment
    Safety Issue?: No
• Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening
  • Time Frame: Days 1 and 2 for each treatment
    Safety Issue?: No
• Subjective Sleep Onset Latency After Middle-of-the-Night Awakening
  • Time Frame: Days 1 and 2 for each treatment
    Safety Issue?: No
• Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening
  • Time Frame: Days 1 and 2 for each treatment
    Safety Issue?: No
• Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening
  • Time Frame: Days 1 and 2 for each treatment
    Safety Issue?: No
• Polysomnography Number of Awakenings After Middle-of-the-Night Awakening
  • Time Frame: Days 1 and 2 for each treatment
    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 kg/m^2
• 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 Investigator: Transcept Pharmaceuticals Industry

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 February 08, 2012

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