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: Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Zolpidem

Primary Measures

• Sleep onset

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

Lead Sponsor: TransOral 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 November 19, 2008

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