A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia - Full Text View

Purpose

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

Condition	Intervention	Phase
Insomnia	Drug: zolpidem tartrate sublingual tablet 3.5mg Drug: zolpidem tartrate sublingual tablet 1.75mg Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Zolpidem Zolpidem tartrate

U.S. FDA Resources

Further study details as provided by Transcept Pharmaceuticals:

Primary Outcome Measures:

Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
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:

Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
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.

Enrollment:	82
Study Start Date:	April 2006
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: placebo/zolpidem 3.5/zolpidem 1.75	Drug: 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. Other Name: Intermezzo® 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. Other Name: Intermezzo® 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.
Experimental: placebo/zolpidem 1.75/zolpidem 3.5	Drug: 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. Other Name: Intermezzo® 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. Other Name: Intermezzo® 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.
Experimental: zolpidem 3.5/placebo/zolpidem 1.75	Drug: 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. Other Name: Intermezzo® 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. Other Name: Intermezzo® 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.
Experimental: zolpidem 3.5/zolpidem 1.75/placebo	Drug: 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. Other Name: Intermezzo® 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. Other Name: Intermezzo® 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.
Experimental: zolpidem 1.75/placebo/zolpidem 3.5	Drug: 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. Other Name: Intermezzo® 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. Other Name: Intermezzo® 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.
Experimental: zolpidem 1.75/zolpidem 3.5/placebo	Drug: 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. Other Name: Intermezzo® 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. Other Name: Intermezzo® 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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380081

Sponsors and Collaborators

Transcept Pharmaceuticals

Investigators

Principal Investigator:	Thomas Roth, PhD	Henry Ford Hospital, Sleep Disorders and Research Center
Principal Investigator:	Martin Scharf, PhD	Tri-State Sleep Disorders Center

More Information

No publications provided

Responsible Party:	Transcept Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00380081 History of Changes
Other Study ID Numbers:	ZI-06-010
Study First Received:	September 21, 2006
Results First Received:	December 15, 2011
Last Updated:	February 10, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Transcept Pharmaceuticals:

Insomnia

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013