Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate sleep onset following administration of Transcept zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo/zolpidem 3.5/zolpidem 1.75 | Experimental |
| |
| placebo/zolpidem 1.75/zolpidem 3.5 | Experimental |
| |
| zolpidem 3.5/placebo/zolpidem 1.75 | Experimental |
| |
| zolpidem 3.5/zolpidem 1.75/placebo | Experimental |
| |
| zolpidem 1.75/placebo/zolpidem 3.5 | Experimental |
| |
| zolpidem 1.75/zolpidem 3.5/placebo | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zolpidem tartrate sublingual tablet 3.5mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography | 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. | Days 1 and 2 for each treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography for Participants With More Severe Insomnia | 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 in the subpopulation of patients with greater than 60 minutes to fall asleep after a MOTN awakening at baseline. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas Roth, PhD | Henry Ford Hospital, Sleep Disorders and Research Center | Principal Investigator |
| Martin Scharf, PhD | Tri-State Sleep Disorders Center | Principal Investigator |
Not provided
A total of 83 patient volunteers were enrolled and of these, 82 patients were randomized, received at least 1 dose of study drug during the double-blind treatment period and were included in safety and efficacy analyses.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Zolpidem 3.5/Zolpidem 1.75 | Cross-over interventions administered in the order listed. |
| FG001 | Placebo/Zolpidem 1.75/Zolpidem 3.5 | Cross-over interventions administered in the order listed. |
| FG002 | Zolpidem 3.5/Placebo/Zolpidem 1.75 | Cross-over interventions administered in the order listed. |
| FG003 | Zolpidem 3.5/Zolpidem 1.75/Placebo | Cross-over interventions administered in the order listed. |
| FG004 | Zolpidem 1.75/Placebo/Zolpidem 3.5 | Cross-over interventions administered in the order listed. |
| FG005 | Zolpidem 1.75/Zolpidem 3.5/Placebo | Cross-over interventions administered in the order listed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/Zolpidem 3.5/Zolpidem 1.75 | Cross-over interventions administered in the order listed. |
| BG001 | Placebo/Zolpidem 1.75/Zolpidem 3.5 | Cross-over interventions administered in the order listed. |
| 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 Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography | 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. | Intent-to-treat population | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Days 1 and 2 for each treatment |
|
Approximately one month
Not provided
Not provided
| 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 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 until it dissolved. |
Not provided
Not provided
Scheduled nocturnal awakening is an established method used to evaluate treatments for naturally occurring middle-of-the-night awakenings. Additional studies are needed to determine the generalizability of the findings to 'real world' conditions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader | Purdue Pharma LP | 800-733-1333 |
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
|
| zolpidem tartrate sublingual tablet 1.75mg | Drug | 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. |
|
|
| Placebo | Drug | 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. |
|
| Days 1 and 2 for each treatment |
| Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography | 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. | Days 1 and 2 for each treatment |
| Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening | 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. | Days 1 and 2 for each treatment |
| Subjective Sleep Quality Rating | 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. | Days 1 and 2 for each treatment |
| Subjective Level of Refreshed Sleep | 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. | Days 1 and 2 for each treatment |
| Subjective Ability to Function | 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. | Days 1 and 2 for each treatment |
| Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening | 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. | Days 1 and 2 for each treatment |
| Subjective Sleep Onset Latency After Middle-of-the-Night Awakening | 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. | Days 1 and 2 for each treatment |
| Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening | 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. | Days 1 and 2 for each treatment |
| Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening | 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. | Days 1 and 2 for each treatment |
| Polysomnography Number of Awakenings After Middle-of-the-Night Awakening | 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. | Days 1 and 2 for each treatment |
| Days 1 and 2 for each treatment |
| Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography for a Subpopulation of Participants With More Severe Insomnia | 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 in a subpopulation of patients with greater than 60 minutes to fall asleep after a MOTN awakening at baseline. | Days 1 and 2 for each treatment |
| Family Emergency |
|
| BG002 | Zolpidem 3.5/Placebo/Zolpidem 1.75 | Cross-over interventions administered in the order listed. |
| BG003 | Zolpidem 3.5/Zolpidem 1.75/Placebo | Cross-over interventions administered in the order listed. |
| BG004 | Zolpidem 1.75/Placebo/Zolpidem 3.5 | Cross-over interventions administered in the order listed. |
| BG005 | Zolpidem 1.75/Zolpidem 3.5/Placebo | Cross-over interventions administered in the order listed. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | 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 | kilograms/square meters |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Number of Nights with Middle of the Night Awakening | Number of nights with Middle of the Night (MOTN) Awakenings is based upon self-reports on more than or equal to 3 nights and completion of at least 7 days of the 10-day Screening Morning Sleep Diary. | Mean | Standard Deviation | number of nights |
|
| Weight | Mean | Standard Deviation | kilograms |
|
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 until it dissolved.
| OG002 | 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 until it dissolved. |
|
|
|
| Secondary | Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening | 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. | Intent to treat population | Posted | Number | participants | Days 1 and 2 for each treatment |
|
|
|
|
| Secondary | Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography | 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. | Intent-to-treat population. | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Days 1 and 2 for each treatment |
|
|
|
|
| Other Pre-specified | Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography for Participants With More Severe Insomnia | 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 in the subpopulation of patients with greater than 60 minutes to fall asleep after a MOTN awakening at baseline. | Intent to treat population | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Days 1 and 2 for each treatment |
|
|
|
|
| Secondary | Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening | 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. | Intent to treat population | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Days 1 and 2 for each treatment |
|
|
|
|
| Other Pre-specified | Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography for a Subpopulation of Participants With More Severe Insomnia | 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 in a subpopulation of patients with greater than 60 minutes to fall asleep after a MOTN awakening at baseline. | Intent to treat population | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Days 1 and 2 for each treatment |
|
|
|
|
| Secondary | Subjective Sleep Quality Rating | 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. | Intent to treat population | Posted | Number | percentage of participants | Days 1 and 2 for each treatment |
|
|
|
|
| Secondary | Subjective Level of Refreshed Sleep | 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. | Intent to treat population | Posted | Number | percentage of participants | Days 1 and 2 for each treatment |
|
|
|
|
| Secondary | Subjective Ability to Function | 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. | Intent to treat population | Posted | Number | percentage of participants | Days 1 and 2 for each treatment |
|
|
|
|
| Secondary | Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening | 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. | Intent to treat population | Posted | Least Squares Mean | 95% Confidence Interval | percentage of time asleep | Days 1 and 2 for each treatment |
|
|
|
|
| Secondary | Subjective Sleep Onset Latency After Middle-of-the-Night Awakening | 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. | Intent to treat population | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Days 1 and 2 for each treatment |
|
|
|
|
| Secondary | Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening | 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. | Intent to treat population | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Days 1 and 2 for each treatment |
|
|
|
|
| Secondary | Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening | 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. | Intent to treat population | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Days 1 and 2 for each treatment |
|
|
|
|
| Secondary | Polysomnography Number of Awakenings After Middle-of-the-Night Awakening | 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. | Intent to treat population | Posted | Least Squares Mean | 95% Confidence Interval | number of awakenings | Days 1 and 2 for each treatment |
|
|
|
|
| Post-Hoc | Subjective Number of Awakenings After Middle-of-the-Night Awakening | Number of times a participant awoke following sleep onset after the middle-of-the-night awakening, as documented by the participant for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. | Intent to treat population | Posted | Least Squares Mean | 95% Confidence Interval | number of awakenings | Days 1 and 2 for each treatment |
|
|
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| EG001 | Zolpidem 1.75 mg | 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 until it dissolved. | 0 | 82 | 0 | 82 |
| EG002 | 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 until it dissolved. | 0 | 81 | 0 | 81 |
Sponsor agrees to review manuscripts within a reasonable period of time. If sponsor determines the publication included patentable subject matter, sponsor will be granted no less than 120 days to prepare patent applications.
| D001523 |
| Mental Disorders |
| Title | Measurements |
|---|---|
|
| Good |
|
| Excellent |
|
| Title | Measurements |
|---|---|
|
| Good |
|
| Excellent |
|
| Title | Measurements |
|---|---|
|
| Good |
|
| Excellent |
|
Period effect |
| 95 |
| No |
| Superiority or Other |