Clinical trial NCT00380081: A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia
Keywords: Insomnia
Lead sponsor: Transcept Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-09-25
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography
timeFrame: Days 1 and 2 for each treatment
Secondary outcomes:
measure: Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening
timeFrame: Days 1 and 2 for each treatment
measure: Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography
timeFrame: Days 1 and 2 for each treatment
measure: Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening
timeFrame: Days 1 and 2 for each treatment
measure: Subjective Sleep Quality Rating
timeFrame: Days 1 and 2 for each treatment
measure: Subjective Level of Refreshed Sleep
timeFrame: Days 1 and 2 for each treatment
measure: Subjective Ability to Function
timeFrame: Days 1 and 2 for each treatment
measure: Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening
timeFrame: Days 1 and 2 for each treatment
measure: Subjective Sleep Onset Latency After Middle-of-the-Night Awakening
timeFrame: Days 1 and 2 for each treatment
measure: Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening
timeFrame: Days 1 and 2 for each treatment
measure: Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening
timeFrame: Days 1 and 2 for each treatment
measure: Polysomnography Number of Awakenings After Middle-of-the-Night Awakening
timeFrame: Days 1 and 2 for each treatment
Other outcomes:
measure: Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography for Participants With More Severe Insomnia
timeFrame: Days 1 and 2 for each treatment
measure: Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography for a Subpopulation of Participants With More Severe Insomnia
timeFrame: Days 1 and 2 for each treatment
Locations:
Study officials:
affiliation: Henry Ford Hospital, Sleep Disorders and Research Center
name: Thomas Roth, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tri-State Sleep Disorders Center
name: Martin Scharf, PhD
role: PRINCIPAL_INVESTIGATOR
References: