Overview

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