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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
295
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.
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.
Transcept Investigational Site
Durham, North Carolina, United States
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?
Time frame: 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?
Time frame: Weeks 1 to 4
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?
Time frame: 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?
Time frame: 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?
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Time frame: 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?
Time frame: 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?
Time frame: 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?
Time frame: 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.
Time frame: 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.
Time frame: Weeks 1 to 4