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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zolpidem 3.5mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zolpidem tartrate sublingual tablet | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Krystal, MD | Clinical Neurophysiology Training Program, Duke University | Principal Investigator |
| Thomas Roth, PhD | Sleep Disorders and Research Center, Henry Ford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Transcept Investigational Site | Durham | North Carolina | 27710 | United States |
Seven hundred and three (703) subjects were screened. Three hundred (300) subjects were randomized, but 5 subjects never took drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zolpidem 3.5 mg | Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening. |
| FG001 | Placebo | Placebo sublingual tablet taken following a middle-of-the-night awakening. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zolpidem 3.5 mg | Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening. |
| BG001 | Placebo | Placebo sublingual tablet taken following a middle-of-the-night awakening. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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? | Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Weeks -1 to 0 |
|
Weeks 1-4
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zolpidem 3.5 mg | Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader | Purdue Pharma LP | 800-733-1333 |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| Placebo | Drug | 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. |
|
| 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 |
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Patient refused Visit 4 procedures |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Body mass index is an estimate of body fat based on body weight divided by height squared. | Mean | Standard Deviation | kilogram per square meter |
|
| Weight | Mean | Standard Deviation | kilograms |
|
Placebo sublingual tablet taken following a middle-of-the-night awakening.
|
|
| Secondary | 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? | Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Weeks -1 to 0 |
|
|
|
| Secondary | 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? | Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Weeks 1 to 4 |
|
|
|
| Secondary | 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? | Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value. | Posted | Number | percentage of participants | Weeks -1 to 0 |
|
|
|
| Secondary | 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? | Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value. | Posted | Number | percentage of participants | Weeks 1 to 4 |
|
|
|
|
| Secondary | 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? | Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value. | Posted | Number | percentage of participants | Weeks -1 to 0 |
|
|
|
| Secondary | 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? | Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value. | Posted | Number | percentage of participants | Weeks 1 to 4 |
|
|
|
|
| Secondary | 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. | Safety population: participants who took at least one dose of study medication post-randomization. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Weeks -1 to 0 |
|
|
|
| Primary | 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? | Efficacy population: randomized participants who took at least one dose of study medication and had at least one latency to sleep onset following a middle-of-the-night awakening value. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Weeks 1 to 4 |
|
|
|
| Secondary | 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. | Safety population: participants who took at least one dose of study medication post-randomization. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Weeks 1 to 4 |
|
|
|
|
| 0 |
| 150 |
| 0 |
| 150 |
| EG001 | Placebo | Placebo sublingual tablet taken following a middle-of-the-night awakening. | 0 | 145 | 0 | 145 |
Sponsor agrees to review manuscripts within sixty (60) days prior to submission for publication. If sponsor determines the publication includes patentable subject matter, sponsor may take an additional sixty (60) days to permit the filing of any patent applications.
| D001523 |
| Mental Disorders |
| >1 and <=2 awakenings |
|
| >2 awakenings |
|
| >1 and <=2 awakenings |
|
| >2 awakenings |
|
| 21 to 60 minutes |
|
| >60 minutes |
|
| 21 to 60 minutes |
|
| > 60 minutes |
|