Trial Outcomes & Findings for A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia (NCT NCT00466193)
NCT ID: NCT00466193
Last Updated: 2012-02-14
Results Overview
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?
COMPLETED
PHASE3
295 participants
Weeks -1 to 0
2012-02-14
Participant Flow
Seven hundred and three (703) subjects were screened. Three hundred (300) subjects were randomized, but 5 subjects never took drug.
Participant milestones
| Measure |
Zolpidem 3.5 mg
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
|
Placebo
Placebo sublingual tablet taken following a middle-of-the-night awakening.
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
145
|
|
Overall Study
COMPLETED
|
138
|
137
|
|
Overall Study
NOT COMPLETED
|
12
|
8
|
Reasons for withdrawal
| Measure |
Zolpidem 3.5 mg
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
|
Placebo
Placebo sublingual tablet taken following a middle-of-the-night awakening.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
2
|
|
Overall Study
Patient refused Visit 4 procedures
|
1
|
0
|
Baseline Characteristics
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
Baseline characteristics by cohort
| Measure |
Zolpidem 3.5 mg
n=150 Participants
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
|
Placebo
n=145 Participants
Placebo sublingual tablet taken following a middle-of-the-night awakening.
|
Total
n=295 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Weight
|
74.27 kilograms
STANDARD_DEVIATION 15.050 • n=5 Participants
|
75.73 kilograms
STANDARD_DEVIATION 13.434 • n=7 Participants
|
74.99 kilograms
STANDARD_DEVIATION 14.273 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
150 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
42.3 years
STANDARD_DEVIATION 11.38 • n=5 Participants
|
43.4 years
STANDARD_DEVIATION 11.30 • n=7 Participants
|
42.8 years
STANDARD_DEVIATION 11.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
47 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
96 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
150 participants
n=5 Participants
|
145 participants
n=7 Participants
|
295 participants
n=5 Participants
|
|
Body Mass Index
|
26.17 kilogram per square meter
STANDARD_DEVIATION 3.860 • n=5 Participants
|
26.55 kilogram per square meter
STANDARD_DEVIATION 3.754 • n=7 Participants
|
26.35 kilogram per square meter
STANDARD_DEVIATION 3.807 • n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks -1 to 0Population: 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.
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?
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=150 Participants
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
|
Placebo
n=144 Participants
Placebo sublingual tablet taken following a middle-of-the-night awakening.
|
|---|---|---|
|
Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline
|
68.13 minutes
Interval 63.9 to 72.64
|
69.42 minutes
Interval 65.03 to 74.1
|
PRIMARY outcome
Timeframe: Weeks 1 to 4Population: 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.
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?
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=150 Participants
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
|
Placebo
n=144 Participants
Placebo sublingual tablet taken following a middle-of-the-night awakening.
|
|---|---|---|
|
Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment
|
38.22 minutes
Interval 35.06 to 41.66
|
56.37 minutes
Interval 51.63 to 61.56
|
SECONDARY outcome
Timeframe: Weeks -1 to 0Population: 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.
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?
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=150 Participants
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
|
Placebo
n=144 Participants
Placebo sublingual tablet taken following a middle-of-the-night awakening.
|
|---|---|---|
|
Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline
|
241.2 minutes
Interval 229.1 to 253.4
|
222.9 minutes
Interval 210.5 to 235.3
|
SECONDARY outcome
Timeframe: Weeks 1 to 4Population: 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.
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?
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=150 Participants
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
|
Placebo
n=144 Participants
Placebo sublingual tablet taken following a middle-of-the-night awakening.
|
|---|---|---|
|
Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment
|
264.1 minutes
Interval 255.7 to 272.4
|
255.0 minutes
Interval 246.5 to 263.5
|
SECONDARY outcome
Timeframe: Weeks -1 to 0Population: 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.
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?
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=150 Participants
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
|
Placebo
n=144 Participants
Placebo sublingual tablet taken following a middle-of-the-night awakening.
|
|---|---|---|
|
Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.
0 awakenings
|
16.7 percentage of participants
|
11.8 percentage of participants
|
|
Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.
>0 and <=1 awakenings
|
46.0 percentage of participants
|
45.1 percentage of participants
|
|
Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.
>1 and <=2 awakenings
|
26.0 percentage of participants
|
27.1 percentage of participants
|
|
Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.
>2 awakenings
|
11.3 percentage of participants
|
16.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1 to 4Population: 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.
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?
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=150 Participants
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
|
Placebo
n=144 Participants
Placebo sublingual tablet taken following a middle-of-the-night awakening.
|
|---|---|---|
|
Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment
0 awakenings
|
30.0 percentage of participants
|
16.7 percentage of participants
|
|
Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment
>0 and <=1 awakenings
|
46.0 percentage of participants
|
43.1 percentage of participants
|
|
Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment
>1 and <=2 awakenings
|
17.3 percentage of participants
|
25.0 percentage of participants
|
|
Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment
>2 awakenings
|
6.7 percentage of participants
|
15.3 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks -1 to 0Population: 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.
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?
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=150 Participants
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
|
Placebo
n=144 Participants
Placebo sublingual tablet taken following a middle-of-the-night awakening.
|
|---|---|---|
|
Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline
No wake time
|
16.7 percentage of participants
|
11.8 percentage of participants
|
|
Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline
>0 to 20 minutes
|
18.7 percentage of participants
|
14.6 percentage of participants
|
|
Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline
21 to 60 minutes
|
25.3 percentage of participants
|
32.6 percentage of participants
|
|
Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline
>60 minutes
|
39.3 percentage of participants
|
41.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1 to 4Population: 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.
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?
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=150 Participants
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
|
Placebo
n=144 Participants
Placebo sublingual tablet taken following a middle-of-the-night awakening.
|
|---|---|---|
|
Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment
No wake time
|
30.0 percentage of participants
|
16.7 percentage of participants
|
|
Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment
>0 to 20 minutes
|
27.3 percentage of participants
|
26.4 percentage of participants
|
|
Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment
21 to 60 minutes
|
26.0 percentage of participants
|
31.9 percentage of participants
|
|
Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment
> 60 minutes
|
16.7 percentage of participants
|
25.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks -1 to 0Population: Safety population: participants who took at least one dose of study medication post-randomization.
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.
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=150 Participants
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
|
Placebo
n=145 Participants
Placebo sublingual tablet taken following a middle-of-the-night awakening.
|
|---|---|---|
|
Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline
|
4.87 units on a scale
Interval 4.61 to 5.13
|
4.71 units on a scale
Interval 4.45 to 4.97
|
SECONDARY outcome
Timeframe: Weeks 1 to 4Population: Safety population: participants who took at least one dose of study medication post-randomization.
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.
Outcome measures
| Measure |
Zolpidem 3.5 mg
n=150 Participants
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
|
Placebo
n=145 Participants
Placebo sublingual tablet taken following a middle-of-the-night awakening.
|
|---|---|---|
|
Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment
|
5.59 units on a scale
Interval 5.42 to 5.76
|
5.24 units on a scale
Interval 5.06 to 5.41
|
Adverse Events
Zolpidem 3.5 mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Leader
Purdue Pharma LP
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER