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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2006-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo/zolpidem 3.5/zolpidem 1.75

Group Type EXPERIMENTAL

zolpidem tartrate sublingual tablet 3.5mg

Intervention Type DRUG

Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

zolpidem tartrate sublingual tablet 1.75mg

Intervention Type DRUG

Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

Placebo

Intervention Type DRUG

Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

placebo/zolpidem 1.75/zolpidem 3.5

Group Type EXPERIMENTAL

zolpidem tartrate sublingual tablet 3.5mg

Intervention Type DRUG

Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

zolpidem tartrate sublingual tablet 1.75mg

Intervention Type DRUG

Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

Placebo

Intervention Type DRUG

Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

zolpidem 3.5/placebo/zolpidem 1.75

Group Type EXPERIMENTAL

zolpidem tartrate sublingual tablet 3.5mg

Intervention Type DRUG

Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

zolpidem tartrate sublingual tablet 1.75mg

Intervention Type DRUG

Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

Placebo

Intervention Type DRUG

Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

zolpidem 3.5/zolpidem 1.75/placebo

Group Type EXPERIMENTAL

zolpidem tartrate sublingual tablet 3.5mg

Intervention Type DRUG

Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

zolpidem tartrate sublingual tablet 1.75mg

Intervention Type DRUG

Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

Placebo

Intervention Type DRUG

Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

zolpidem 1.75/placebo/zolpidem 3.5

Group Type EXPERIMENTAL

zolpidem tartrate sublingual tablet 3.5mg

Intervention Type DRUG

Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

zolpidem tartrate sublingual tablet 1.75mg

Intervention Type DRUG

Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

Placebo

Intervention Type DRUG

Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

zolpidem 1.75/zolpidem 3.5/placebo

Group Type EXPERIMENTAL

zolpidem tartrate sublingual tablet 3.5mg

Intervention Type DRUG

Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

zolpidem tartrate sublingual tablet 1.75mg

Intervention Type DRUG

Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

Placebo

Intervention Type DRUG

Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

Interventions

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zolpidem tartrate sublingual tablet 3.5mg

Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

Intervention Type DRUG

zolpidem tartrate sublingual tablet 1.75mg

Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

Intervention Type DRUG

Placebo

Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

Intervention Type DRUG

Other Intervention Names

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Intermezzo® Intermezzo®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No