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

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Transcept Pharmaceuticals
• Treatments: Zolpidem

Criteria

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