Trial Outcomes & Findings for A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia (NCT NCT00380081)
NCT ID: NCT00380081
Last Updated: 2012-02-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
82 participants
Primary outcome timeframe
Days 1 and 2 for each treatment
Results posted on
2012-02-14
Participant Flow
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.
Participant milestones
| Measure |
Placebo/Zolpidem 3.5/Zolpidem 1.75
Cross-over interventions administered in the order listed.
|
Placebo/Zolpidem 1.75/Zolpidem 3.5
Cross-over interventions administered in the order listed.
|
Zolpidem 3.5/Placebo/Zolpidem 1.75
Cross-over interventions administered in the order listed.
|
Zolpidem 3.5/Zolpidem 1.75/Placebo
Cross-over interventions administered in the order listed.
|
Zolpidem 1.75/Placebo/Zolpidem 3.5
Cross-over interventions administered in the order listed.
|
Zolpidem 1.75/Zolpidem 3.5/Placebo
Cross-over interventions administered in the order listed.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
13
|
15
|
13
|
14
|
|
Overall Study
COMPLETED
|
14
|
13
|
13
|
15
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo/Zolpidem 3.5/Zolpidem 1.75
Cross-over interventions administered in the order listed.
|
Placebo/Zolpidem 1.75/Zolpidem 3.5
Cross-over interventions administered in the order listed.
|
Zolpidem 3.5/Placebo/Zolpidem 1.75
Cross-over interventions administered in the order listed.
|
Zolpidem 3.5/Zolpidem 1.75/Placebo
Cross-over interventions administered in the order listed.
|
Zolpidem 1.75/Placebo/Zolpidem 3.5
Cross-over interventions administered in the order listed.
|
Zolpidem 1.75/Zolpidem 3.5/Placebo
Cross-over interventions administered in the order listed.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Family Emergency
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
Baseline characteristics by cohort
| Measure |
Placebo/Zolpidem 3.5/Zolpidem 1.75
n=14 Participants
Cross-over interventions administered in the order listed.
|
Placebo/Zolpidem 1.75/Zolpidem 3.5
n=13 Participants
Cross-over interventions administered in the order listed.
|
Zolpidem 3.5/Placebo/Zolpidem 1.75
n=13 Participants
Cross-over interventions administered in the order listed.
|
Zolpidem 3.5/Zolpidem 1.75/Placebo
n=15 Participants
Cross-over interventions administered in the order listed.
|
Zolpidem 1.75/Placebo/Zolpidem 3.5
n=13 Participants
Cross-over interventions administered in the order listed.
|
Zolpidem 1.75/Zolpidem 3.5/Placebo
n=14 Participants
Cross-over interventions administered in the order listed.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
82 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age Continuous
|
48.2 years
STANDARD_DEVIATION 10.21 • n=5 Participants
|
47.2 years
STANDARD_DEVIATION 14.90 • n=7 Participants
|
49.6 years
STANDARD_DEVIATION 10.74 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 9.64 • n=4 Participants
|
41.8 years
STANDARD_DEVIATION 13.33 • n=21 Participants
|
43.5 years
STANDARD_DEVIATION 12.99 • n=10 Participants
|
45.9 years
STANDARD_DEVIATION 11.97 • n=115 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
58 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
6 participants
n=4 Participants
|
7 participants
n=21 Participants
|
6 participants
n=10 Participants
|
42 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
2 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
9 participants
n=4 Participants
|
6 participants
n=21 Participants
|
7 participants
n=10 Participants
|
36 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
2 participants
n=115 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
13 participants
n=5 Participants
|
15 participants
n=4 Participants
|
13 participants
n=21 Participants
|
14 participants
n=10 Participants
|
82 participants
n=115 Participants
|
|
Body Mass Index
|
27.72 kilograms/square meters
STANDARD_DEVIATION 3.494 • n=5 Participants
|
27.10 kilograms/square meters
STANDARD_DEVIATION 4.164 • n=7 Participants
|
27.27 kilograms/square meters
STANDARD_DEVIATION 4.164 • n=5 Participants
|
27.43 kilograms/square meters
STANDARD_DEVIATION 3.717 • n=4 Participants
|
25.92 kilograms/square meters
STANDARD_DEVIATION 4.393 • n=21 Participants
|
26.84 kilograms/square meters
STANDARD_DEVIATION 2.681 • n=10 Participants
|
27.06 kilograms/square meters
STANDARD_DEVIATION 3.718 • n=115 Participants
|
|
Height
|
174.6 centimeters
STANDARD_DEVIATION 9.353 • n=5 Participants
|
166.4 centimeters
STANDARD_DEVIATION 7.574 • n=7 Participants
|
172.4 centimeters
STANDARD_DEVIATION 10.740 • n=5 Participants
|
167.2 centimeters
STANDARD_DEVIATION 10.246 • n=4 Participants
|
167.4 centimeters
STANDARD_DEVIATION 8.775 • n=21 Participants
|
169.8 centimeters
STANDARD_DEVIATION 9.955 • n=10 Participants
|
169.6 centimeters
STANDARD_DEVIATION 9.700 • n=115 Participants
|
|
Number of Nights with Middle of the Night Awakening
|
9.3 number of nights
STANDARD_DEVIATION 0.99 • n=5 Participants
|
9.4 number of nights
STANDARD_DEVIATION 1.19 • n=7 Participants
|
8.9 number of nights
STANDARD_DEVIATION 1.38 • n=5 Participants
|
9.3 number of nights
STANDARD_DEVIATION 0.98 • n=4 Participants
|
9.3 number of nights
STANDARD_DEVIATION 1.11 • n=21 Participants
|
8.6 number of nights
STANDARD_DEVIATION 1.50 • n=10 Participants
|
9.1 number of nights
STANDARD_DEVIATION 1.20 • n=115 Participants
|
|
Weight
|
84.41 kilograms
STANDARD_DEVIATION 11.409 • n=5 Participants
|
75.10 kilograms
STANDARD_DEVIATION 12.665 • n=7 Participants
|
81.83 kilograms
STANDARD_DEVIATION 17.816 • n=5 Participants
|
77.46 kilograms
STANDARD_DEVIATION 16.739 • n=4 Participants
|
72.91 kilograms
STANDARD_DEVIATION 14.421 • n=21 Participants
|
77.50 kilograms
STANDARD_DEVIATION 10.331 • n=10 Participants
|
78.25 kilograms
STANDARD_DEVIATION 14.249 • n=115 Participants
|
PRIMARY outcome
Timeframe: Days 1 and 2 for each treatmentPopulation: Intent-to-treat population
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.
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=80 Participants
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.
|
Zolpidem 1.75 mg
n=82 Participants
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.
|
Placebo
n=81 Participants
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.
|
|---|---|---|---|
|
Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography
|
9.69 minutes
Interval 8.06 to 11.65
|
16.89 minutes
Interval 14.07 to 20.26
|
28.12 minutes
Interval 23.41 to 33.77
|
SECONDARY outcome
Timeframe: Days 1 and 2 for each treatmentPopulation: Intent to treat population
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.
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=80 Participants
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.
|
Zolpidem 1.75 mg
n=82 Participants
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.
|
Placebo
n=81 Participants
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.
|
|---|---|---|---|
|
Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening
|
60 participants
|
46 participants
|
23 participants
|
SECONDARY outcome
Timeframe: Days 1 and 2 for each treatmentPopulation: Intent-to-treat population.
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.
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=80 Participants
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.
|
Zolpidem 1.75 mg
n=82 Participants
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.
|
Placebo
n=81 Participants
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.
|
|---|---|---|---|
|
Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography
|
208.99 minutes
Interval 200.92 to 217.38
|
197.80 minutes
Interval 190.23 to 205.68
|
183.12 minutes
Interval 176.08 to 190.45
|
SECONDARY outcome
Timeframe: Days 1 and 2 for each treatmentPopulation: Intent to treat population
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.
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=80 Participants
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.
|
Zolpidem 1.75 mg
n=82 Participants
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.
|
Placebo
n=81 Participants
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.
|
|---|---|---|---|
|
Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening
|
172.51 minutes
Interval 161.92 to 183.1
|
162.36 minutes
Interval 151.87 to 172.85
|
148.61 minutes
Interval 138.07 to 159.15
|
SECONDARY outcome
Timeframe: Days 1 and 2 for each treatmentPopulation: Intent to treat population
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.
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=80 Participants
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.
|
Zolpidem 1.75 mg
n=82 Participants
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.
|
Placebo
n=81 Participants
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.
|
|---|---|---|---|
|
Subjective Sleep Quality Rating
Poor
|
18.8 percentage of participants
|
29.3 percentage of participants
|
34.6 percentage of participants
|
|
Subjective Sleep Quality Rating
Fair
|
38.8 percentage of participants
|
37.8 percentage of participants
|
42.0 percentage of participants
|
|
Subjective Sleep Quality Rating
Good
|
36.3 percentage of participants
|
30.5 percentage of participants
|
19.8 percentage of participants
|
|
Subjective Sleep Quality Rating
Excellent
|
6.3 percentage of participants
|
2.4 percentage of participants
|
3.7 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1 and 2 for each treatmentPopulation: Intent to treat population
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.
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=80 Participants
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.
|
Zolpidem 1.75 mg
n=82 Participants
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.
|
Placebo
n=81 Participants
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.
|
|---|---|---|---|
|
Subjective Level of Refreshed Sleep
Poor
|
17.5 percentage of participants
|
22.0 percentage of participants
|
32.1 percentage of participants
|
|
Subjective Level of Refreshed Sleep
Fair
|
42.5 percentage of participants
|
41.5 percentage of participants
|
44.4 percentage of participants
|
|
Subjective Level of Refreshed Sleep
Good
|
35.0 percentage of participants
|
34.1 percentage of participants
|
19.8 percentage of participants
|
|
Subjective Level of Refreshed Sleep
Excellent
|
5.0 percentage of participants
|
2.4 percentage of participants
|
3.7 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1 and 2 for each treatmentPopulation: Intent to treat population
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.
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=80 Participants
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.
|
Zolpidem 1.75 mg
n=82 Participants
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.
|
Placebo
n=81 Participants
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.
|
|---|---|---|---|
|
Subjective Ability to Function
Fair
|
41.3 percentage of participants
|
42.7 percentage of participants
|
42.0 percentage of participants
|
|
Subjective Ability to Function
Good
|
45.0 percentage of participants
|
41.5 percentage of participants
|
33.3 percentage of participants
|
|
Subjective Ability to Function
Excellent
|
6.3 percentage of participants
|
6.1 percentage of participants
|
6.2 percentage of participants
|
|
Subjective Ability to Function
Poor
|
7.5 percentage of participants
|
9.8 percentage of participants
|
18.5 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1 and 2 for each treatmentPopulation: Intent to treat population
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.
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=80 Participants
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.
|
Zolpidem 1.75 mg
n=82 Participants
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.
|
Placebo
n=81 Participants
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.
|
|---|---|---|---|
|
Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening
|
87.08 percentage of time asleep
Interval 83.73 to 90.57
|
82.63 percentage of time asleep
Interval 79.47 to 85.9
|
76.31 percentage of time asleep
Interval 73.38 to 79.35
|
SECONDARY outcome
Timeframe: Days 1 and 2 for each treatmentPopulation: Intent to treat population
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.
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=80 Participants
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.
|
Zolpidem 1.75 mg
n=82 Participants
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.
|
Placebo
n=81 Participants
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.
|
|---|---|---|---|
|
Subjective Sleep Onset Latency After Middle-of-the-Night Awakening
|
25.23 minutes
Interval 21.58 to 29.49
|
28.58 minutes
Interval 24.49 to 33.36
|
40.43 minutes
Interval 34.62 to 47.23
|
SECONDARY outcome
Timeframe: Days 1 and 2 for each treatmentPopulation: Intent to treat population
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.
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=80 Participants
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.
|
Zolpidem 1.75 mg
n=82 Participants
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.
|
Placebo
n=81 Participants
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.
|
|---|---|---|---|
|
Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening
|
15.06 minutes
Interval 12.54 to 18.08
|
15.81 minutes
Interval 13.18 to 18.97
|
15.71 minutes
Interval 13.09 to 18.86
|
SECONDARY outcome
Timeframe: Days 1 and 2 for each treatmentPopulation: Intent to treat population
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.
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=67 Participants
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.
|
Zolpidem 1.75 mg
n=74 Participants
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.
|
Placebo
n=70 Participants
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.
|
|---|---|---|---|
|
Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening
|
28.69 minutes
Interval 24.25 to 33.94
|
29.43 minutes
Interval 25.03 to 34.62
|
34.22 minutes
Interval 29.0 to 40.37
|
SECONDARY outcome
Timeframe: Days 1 and 2 for each treatmentPopulation: Intent to treat population
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.
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=80 Participants
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.
|
Zolpidem 1.75 mg
n=82 Participants
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.
|
Placebo
n=81 Participants
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.
|
|---|---|---|---|
|
Polysomnography Number of Awakenings After Middle-of-the-Night Awakening
|
3.71 number of awakenings
Interval 3.22 to 4.19
|
3.70 number of awakenings
Interval 3.22 to 4.18
|
4.13 number of awakenings
Interval 3.65 to 4.62
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1 and 2 for each treatmentPopulation: Intent to treat population
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.
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=37 Participants
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.
|
Zolpidem 1.75 mg
n=38 Participants
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.
|
Placebo
n=37 Participants
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.
|
|---|---|---|---|
|
Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography for Participants With More Severe Insomnia
|
194.58 minutes
Interval 179.72 to 210.65
|
179.98 minutes
Interval 166.34 to 194.73
|
166.62 minutes
Interval 153.9 to 180.39
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1 and 2 for each treatmentPopulation: Intent to treat population
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.
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=37 Participants
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.
|
Zolpidem 1.75 mg
n=38 Participants
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.
|
Placebo
n=37 Participants
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.
|
|---|---|---|---|
|
Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography for a Subpopulation of Participants With More Severe Insomnia
|
12.62 minutes
Interval 9.12 to 17.47
|
23.28 minutes
Interval 16.88 to 32.12
|
37.89 minutes
Interval 27.38 to 52.43
|
POST_HOC outcome
Timeframe: Days 1 and 2 for each treatmentPopulation: Intent to treat population
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.
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=80 Participants
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.
|
Zolpidem 1.75 mg
n=82 Participants
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.
|
Placebo
n=81 Participants
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.
|
|---|---|---|---|
|
Subjective Number of Awakenings After Middle-of-the-Night Awakening
|
0.86 number of awakenings
Interval 0.7 to 1.04
|
1.03 number of awakenings
Interval 0.85 to 1.25
|
1.14 number of awakenings
Interval 0.94 to 1.39
|
Adverse Events
Zolpidem 3.5 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Zolpidem 1.75 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Leader
Purdue Pharma LP
Phone: 800-733-1333
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER