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

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of the Zolpidem Tartrate Sublingual Tablet in Adult Subjects With Insomnia Characterized by Difficulty Returning to Sleep After Awakening in the Middle-of-the-Night (MOTN)

The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Drug: zolpidem tartrate sublingual tablet; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 295
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Transcept Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults with history of sleeplessness

Exclusion Criteria:

• Allergic to investigational drug
• Any conditions and medications that may interfere with study drug evaluation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study 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 3.5mg	Drug: zolpidem tartrate sublingual tablet; 3.5 milligram zolpidem tartrate sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.; Other Names: Intermezzo®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline	Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?	Weeks -1 to 0
Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment	Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?	Weeks 1 to 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline	Total sleep time in minutes after waking in the middle of the night. The values were recorded by participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how long did you sleep until you woke up this morning?	Weeks -1 to 0
Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment	Total sleep time in minutes after waking in the middle of the night. The values were recorded by participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how long did you sleep until you woke up this morning?	Weeks 1 to 4
Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.	Number of awakenings following middle-of-the-night awakening were recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how many times did you wake up again before waking up in the morning?	Weeks -1 to 0
Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment	Number of awakenings following middle-of-the-night awakening were recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how many times did you wake up again before waking up in the morning?	Weeks 1 to 4
Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline	The number of minutes subjects reported being awake after onset of sleep following middle-of-the-night awakening during the baseline period. Values were recorded using a telephone interactive voice response system (IVRS) to answer the question: Considering all of these awakenings (after taking study medication and returning to sleep), how long were you awake from the time you went back to sleep after dosing until you got out of bed this morning?	Weeks -1 to 0
Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment	The number of minutes subjects reported being awake after onset of sleep following middle-of-the-night awakening during double-blind treatment. Values were recorded using a telephone interactive voice response system (IVRS) to answer the question: Considering all of these awakenings (after taking study medication and returning to sleep), how long were you awake from the time you went back to sleep after dosing until you got out of bed this morning?	Weeks 1 to 4
Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline	Morning sleepiness was assessed using a 9-point sleepiness scale (1=very sleepy to 9=wide awake and alert). During the baseline period, all participants received placebo.	Weeks -1 to 0
Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment	Morning sleepiness was assessed using a 9-point sleepiness scale (1=very sleepy to 9=wide awake and alert). Values are from dosing nights during double-blind treatment.	Weeks 1 to 4

Collaborators and Investigators

• Sponsor: Transcept Pharmaceuticals
• Investigators: Principal Investigator: Andrew Krystal, MD, Clinical Neurophysiology Training Program, Duke University; Principal Investigator: Thomas Roth, PhD, Sleep Disorders and Research Center, Henry Ford Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: April 24, 2007
• First Submitted That Met QC Criteria: April 24, 2007
• First Posted (Estimate): April 27, 2007

Study Record Updates

• Last Update Posted (Estimate): February 14, 2012
• Last Update Submitted That Met QC Criteria: February 10, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Insomnia
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; GABA Agents; Sleep Aids, Pharmaceutical; GABA-A Receptor Agonists; GABA Agonists; Zolpidem
• Other Study ID Numbers: ZI-12