A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
- Conditions
- Insomnia
- Interventions
- Registration Number
- NCT00380081
- Lead Sponsor
- Transcept Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description placebo/zolpidem 1.75/zolpidem 3.5 zolpidem tartrate sublingual tablet 1.75mg - placebo/zolpidem 3.5/zolpidem 1.75 zolpidem tartrate sublingual tablet 1.75mg - zolpidem 3.5/placebo/zolpidem 1.75 zolpidem tartrate sublingual tablet 3.5mg - zolpidem 3.5/placebo/zolpidem 1.75 zolpidem tartrate sublingual tablet 1.75mg - placebo/zolpidem 3.5/zolpidem 1.75 zolpidem tartrate sublingual tablet 3.5mg - placebo/zolpidem 3.5/zolpidem 1.75 Placebo - placebo/zolpidem 1.75/zolpidem 3.5 zolpidem tartrate sublingual tablet 3.5mg - placebo/zolpidem 1.75/zolpidem 3.5 Placebo - zolpidem 3.5/placebo/zolpidem 1.75 Placebo - zolpidem 3.5/zolpidem 1.75/placebo zolpidem tartrate sublingual tablet 3.5mg - zolpidem 3.5/zolpidem 1.75/placebo zolpidem tartrate sublingual tablet 1.75mg - zolpidem 3.5/zolpidem 1.75/placebo Placebo - zolpidem 1.75/placebo/zolpidem 3.5 zolpidem tartrate sublingual tablet 3.5mg - zolpidem 1.75/placebo/zolpidem 3.5 zolpidem tartrate sublingual tablet 1.75mg - zolpidem 1.75/placebo/zolpidem 3.5 Placebo - zolpidem 1.75/zolpidem 3.5/placebo zolpidem tartrate sublingual tablet 3.5mg - zolpidem 1.75/zolpidem 3.5/placebo zolpidem tartrate sublingual tablet 1.75mg - zolpidem 1.75/zolpidem 3.5/placebo Placebo -
- Primary Outcome Measures
Name Time Method Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography Days 1 and 2 for each treatment Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period.
- Secondary Outcome Measures
Name Time Method Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening Days 1 and 2 for each treatment Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period. A participant was considered to be a responder if the time to return to persistent sleep was less than twenty minutes.
Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography Days 1 and 2 for each treatment Polysomnography was used to measure the time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period.
Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening Days 1 and 2 for each treatment The time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period was recorded by each participant using the Treatment Morning Sleep Questionnaire.
Subjective Sleep Quality Rating Days 1 and 2 for each treatment Sleep quality was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.
Subjective Level of Refreshed Sleep Days 1 and 2 for each treatment Level of refreshed sleep was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.
Subjective Ability to Function Days 1 and 2 for each treatment Ability to function was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.
Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening Days 1 and 2 for each treatment Sleep efficiency is a measurement of the percentage of time asleep to the total time in bed. It was measured by polysomnography for each day of every two-day treatment period.
Subjective Sleep Onset Latency After Middle-of-the-Night Awakening Days 1 and 2 for each treatment Participants documented the time to return to sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire.
Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening Days 1 and 2 for each treatment Amount of time awake after sleep onset following a middle-of-the-night awakening was measured by polysomnography for each day of every two-day treatment period.
Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening Days 1 and 2 for each treatment Amount of time awake after sleep onset following a middle-of-the-night awakening was recorded by participants using the Treatment Morning Sleep Questionnaire for each day of every two-day treatment period.
Polysomnography Number of Awakenings After Middle-of-the-Night Awakening Days 1 and 2 for each treatment Number of times a participant awoke following sleep onset after the middle-of-the-night awakening, as measured by polysomnography for each day of every two-day treatment period.