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

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

Official Title
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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)

Conditions
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Insomnia

Intervention / Treatment
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* Drug: zolpidem tartrate sublingual tablet
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with history of sleeplessness Exclusion Criteria: Allergic to investigational drug Any conditions and medications that may interfere with study drug evaluation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zolpidem 3.5mg<br> | Drug: zolpidem tartrate sublingual tablet<br>* 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.<br>* Other names: Intermezzo®;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia