Title
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
Phase
Phase 3Lead Sponsor
Transcept PharmaceuticalsStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
InsomniaIntervention/Treatment
zolpidem ...Study Participants
82The purpose of this study is to evaluate sleep onset following administration of Transcept zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.
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 1.75 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 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.
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
| Event Type | Organ System | Event Term |
|---|
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Number of times a participant awoke following sleep onset after the middle-of-the-night awakening, as documented by the participant for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire.
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 in a subpopulation of patients with greater than 60 minutes to fall asleep after a MOTN awakening at baseline.
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 in the subpopulation of patients with greater than 60 minutes to fall asleep after a MOTN awakening at baseline.
