Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 30 of 116 for:    ZOLPIDEM AND AIDS

A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00466193
Recruitment Status : Completed
First Posted : April 27, 2007
Results First Posted : January 20, 2012
Last Update Posted : February 14, 2012
Sponsor:
Information provided by (Responsible Party):
Transcept Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Insomnia
Interventions Drug: zolpidem tartrate sublingual tablet
Drug: Placebo
Enrollment 295
Recruitment Details  
Pre-assignment Details Seven hundred and three (703) subjects were screened. Three hundred (300) subjects were randomized, but 5 subjects never took drug.
Arm/Group Title Zolpidem 3.5 mg Placebo
Hide Arm/Group Description Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening. Placebo sublingual tablet taken following a middle-of-the-night awakening.
Period Title: Overall Study
Started 150 145
Completed 138 137 [1]
Not Completed 12 8
Reason Not Completed
Adverse Event             0             1
Lost to Follow-up             2             4
Physician Decision             1             0
Protocol Violation             1             1
Withdrawal by Subject             7             2
Patient refused Visit 4 procedures             1             0
[1]
One patient did not report at least one Latency Sleep Onset following middle-of-the-night awakening.
Arm/Group Title Zolpidem 3.5 mg Placebo Total
Hide Arm/Group Description Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening. Placebo sublingual tablet taken following a middle-of-the-night awakening. Total of all reporting groups
Overall Number of Baseline Participants 150 145 295
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 145 participants 295 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
150
 100.0%
145
 100.0%
295
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 150 participants 145 participants 295 participants
42.3  (11.38) 43.4  (11.30) 42.8  (11.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 145 participants 295 participants
Female
107
  71.3%
94
  64.8%
201
  68.1%
Male
43
  28.7%
51
  35.2%
94
  31.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 145 participants 295 participants
American Indian or Alaska Native
1
   0.7%
2
   1.4%
3
   1.0%
Asian
3
   2.0%
2
   1.4%
5
   1.7%
Native Hawaiian or Other Pacific Islander
1
   0.7%
0
   0.0%
1
   0.3%
Black or African American
47
  31.3%
45
  31.0%
92
  31.2%
White
96
  64.0%
94
  64.8%
190
  64.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   1.3%
2
   1.4%
4
   1.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 150 participants 145 participants 295 participants
150 145 295
Body Mass Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter
Number Analyzed 150 participants 145 participants 295 participants
26.17  (3.860) 26.55  (3.754) 26.35  (3.807)
[1]
Measure Description: Body mass index is an estimate of body fat based on body weight divided by height squared.
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 150 participants 145 participants 295 participants
74.27  (15.050) 75.73  (13.434) 74.99  (14.273)
1.Primary Outcome
Title Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Zolpidem 3.5 mg Placebo
Hide Arm/Group Description:
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
Placebo sublingual tablet taken following a middle-of-the-night awakening.
Overall Number of Participants Analyzed 150 144
Least Squares Mean (95% Confidence Interval)
Unit of Measure: minutes
68.13
(63.90 to 72.64)
69.42
(65.03 to 74.10)
2.Primary Outcome
Title Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Zolpidem 3.5 mg Placebo
Hide Arm/Group Description:
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
Placebo sublingual tablet taken following a middle-of-the-night awakening.
Overall Number of Participants Analyzed 150 144
Least Squares Mean (95% Confidence Interval)
Unit of Measure: minutes
38.22
(35.06 to 41.66)
56.37
(51.63 to 61.56)
3.Secondary Outcome
Title Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Zolpidem 3.5 mg Placebo
Hide Arm/Group Description:
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
Placebo sublingual tablet taken following a middle-of-the-night awakening.
Overall Number of Participants Analyzed 150 144
Least Squares Mean (95% Confidence Interval)
Unit of Measure: minutes
241.2
(229.1 to 253.4)
222.9
(210.5 to 235.3)
4.Secondary Outcome
Title Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Zolpidem 3.5 mg Placebo
Hide Arm/Group Description:
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
Placebo sublingual tablet taken following a middle-of-the-night awakening.
Overall Number of Participants Analyzed 150 144
Least Squares Mean (95% Confidence Interval)
Unit of Measure: minutes
264.1
(255.7 to 272.4)
255.0
(246.5 to 263.5)
5.Secondary Outcome
Title Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.
Hide Description 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 0
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Zolpidem 3.5 mg Placebo
Hide Arm/Group Description:
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
Placebo sublingual tablet taken following a middle-of-the-night awakening.
Overall Number of Participants Analyzed 150 144
Measure Type: Number
Unit of Measure: percentage of participants
0 awakenings 16.7 11.8
>0 and <=1 awakenings 46.0 45.1
>1 and <=2 awakenings 26.0 27.1
>2 awakenings 11.3 16.0
6.Secondary Outcome
Title Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Zolpidem 3.5 mg Placebo
Hide Arm/Group Description:
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
Placebo sublingual tablet taken following a middle-of-the-night awakening.
Overall Number of Participants Analyzed 150 144
Measure Type: Number
Unit of Measure: percentage of participants
0 awakenings 30.0 16.7
>0 and <=1 awakenings 46.0 43.1
>1 and <=2 awakenings 17.3 25.0
>2 awakenings 6.7 15.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 3.5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-value is for treatment
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Zolpidem 3.5 mg Placebo
Hide Arm/Group Description:
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
Placebo sublingual tablet taken following a middle-of-the-night awakening.
Overall Number of Participants Analyzed 150 144
Measure Type: Number
Unit of Measure: percentage of participants
No wake time 16.7 11.8
>0 to 20 minutes 18.7 14.6
21 to 60 minutes 25.3 32.6
>60 minutes 39.3 41.0
8.Secondary Outcome
Title Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Zolpidem 3.5 mg Placebo
Hide Arm/Group Description:
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
Placebo sublingual tablet taken following a middle-of-the-night awakening.
Overall Number of Participants Analyzed 150 144
Measure Type: Number
Unit of Measure: percentage of participants
No wake time 30.0 16.7
>0 to 20 minutes 27.3 26.4
21 to 60 minutes 26.0 31.9
> 60 minutes 16.7 25.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 3.5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments p-value is for treatment
Method ANCOVA
Comments [Not Specified]
9.Secondary Outcome
Title Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: participants who took at least one dose of study medication post-randomization.
Arm/Group Title Zolpidem 3.5 mg Placebo
Hide Arm/Group Description:
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
Placebo sublingual tablet taken following a middle-of-the-night awakening.
Overall Number of Participants Analyzed 150 145
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
4.87
(4.61 to 5.13)
4.71
(4.45 to 4.97)
10.Secondary Outcome
Title Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: participants who took at least one dose of study medication post-randomization.
Arm/Group Title Zolpidem 3.5 mg Placebo
Hide Arm/Group Description:
Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
Placebo sublingual tablet taken following a middle-of-the-night awakening.
Overall Number of Participants Analyzed 150 145
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
5.59
(5.42 to 5.76)
5.24
(5.06 to 5.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 3.5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0041
Comments P-value is for treatment
Method ANCOVA
Comments [Not Specified]
Time Frame Weeks 1-4
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zolpidem 3.5 mg Placebo
Hide Arm/Group Description Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening. Placebo sublingual tablet taken following a middle-of-the-night awakening.
All-Cause Mortality
Zolpidem 3.5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Zolpidem 3.5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/150 (0.00%)   0/145 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Zolpidem 3.5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/150 (0.00%)   0/145 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Clinical Leader
Organization: Purdue Pharma LP
Phone: 800-733-1333
Responsible Party: Transcept Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00466193     History of Changes
Other Study ID Numbers: ZI-12
First Submitted: April 24, 2007
First Posted: April 27, 2007
Results First Submitted: December 15, 2011
Results First Posted: January 20, 2012
Last Update Posted: February 14, 2012