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

Transcept Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Insomnia

Treatments: Drug: zolpidem tartrate sublingual tablet 1.75mg; Drug: zolpidem tartrate sublingual tablet 3.5mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00380081

ZI-06-010

Details and patient eligibility

About

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

Enrollment: 82 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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82 participants in 6 patient groups

placebo/zolpidem 3.5/zolpidem 1.75

Experimental group

Treatment:

Drug: Placebo

Drug: zolpidem tartrate sublingual tablet 1.75mg

Drug: zolpidem tartrate sublingual tablet 3.5mg

placebo/zolpidem 1.75/zolpidem 3.5

Experimental group

Treatment:

Drug: Placebo

Drug: zolpidem tartrate sublingual tablet 1.75mg

Drug: zolpidem tartrate sublingual tablet 3.5mg

zolpidem 3.5/placebo/zolpidem 1.75

Experimental group

Treatment:

Drug: Placebo

Drug: zolpidem tartrate sublingual tablet 1.75mg

Drug: zolpidem tartrate sublingual tablet 3.5mg

zolpidem 3.5/zolpidem 1.75/placebo

Experimental group

Treatment:

Drug: Placebo

Drug: zolpidem tartrate sublingual tablet 1.75mg

Drug: zolpidem tartrate sublingual tablet 3.5mg

zolpidem 1.75/placebo/zolpidem 3.5

Experimental group

Treatment:

Drug: Placebo

Drug: zolpidem tartrate sublingual tablet 1.75mg

Drug: zolpidem tartrate sublingual tablet 3.5mg

zolpidem 1.75/zolpidem 3.5/placebo

Experimental group

Treatment:

Drug: Placebo

Drug: zolpidem tartrate sublingual tablet 1.75mg

Drug: zolpidem tartrate sublingual tablet 3.5mg