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

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.

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