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Trial record 57 of 120 for:    zolpidem AND Hypnotics

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

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ClinicalTrials.gov Identifier: NCT00380081
Recruitment Status : Completed
First Posted : September 25, 2006
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: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Insomnia
Interventions Drug: zolpidem tartrate sublingual tablet 3.5mg
Drug: zolpidem tartrate sublingual tablet 1.75mg
Drug: Placebo
Enrollment 82
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Placebo/Zolpidem 3.5/Zolpidem 1.75 Placebo/Zolpidem 1.75/Zolpidem 3.5 Zolpidem 3.5/Placebo/Zolpidem 1.75 Zolpidem 3.5/Zolpidem 1.75/Placebo Zolpidem 1.75/Placebo/Zolpidem 3.5 Zolpidem 1.75/Zolpidem 3.5/Placebo
Hide Arm/Group Description Cross-over interventions administered in the order listed. Cross-over interventions administered in the order listed. Cross-over interventions administered in the order listed. Cross-over interventions administered in the order listed. Cross-over interventions administered in the order listed. Cross-over interventions administered in the order listed.
Period Title: Overall Study
Started 14 13 13 15 13 14
Completed 14 13 13 15 12 13
Not Completed 0 0 0 0 1 1
Reason Not Completed
Withdrawal by Subject             0             0             0             0             1             0
Family Emergency             0             0             0             0             0             1
Arm/Group Title Placebo/Zolpidem 3.5/Zolpidem 1.75 Placebo/Zolpidem 1.75/Zolpidem 3.5 Zolpidem 3.5/Placebo/Zolpidem 1.75 Zolpidem 3.5/Zolpidem 1.75/Placebo Zolpidem 1.75/Placebo/Zolpidem 3.5 Zolpidem 1.75/Zolpidem 3.5/Placebo Total
Hide Arm/Group Description Cross-over interventions administered in the order listed. Cross-over interventions administered in the order listed. Cross-over interventions administered in the order listed. Cross-over interventions administered in the order listed. Cross-over interventions administered in the order listed. Cross-over interventions administered in the order listed. Total of all reporting groups
Overall Number of Baseline Participants 14 13 13 15 13 14 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 13 participants 15 participants 13 participants 14 participants 82 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
13
 100.0%
13
 100.0%
15
 100.0%
13
 100.0%
14
 100.0%
82
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 13 participants 13 participants 15 participants 13 participants 14 participants 82 participants
48.2  (10.21) 47.2  (14.90) 49.6  (10.74) 45.0  (9.64) 41.8  (13.33) 43.5  (12.99) 45.9  (11.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 13 participants 15 participants 13 participants 14 participants 82 participants
Female
8
  57.1%
10
  76.9%
10
  76.9%
11
  73.3%
10
  76.9%
9
  64.3%
58
  70.7%
Male
6
  42.9%
3
  23.1%
3
  23.1%
4
  26.7%
3
  23.1%
5
  35.7%
24
  29.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 13 participants 15 participants 13 participants 14 participants 82 participants
Caucasian 8 8 7 6 7 6 42
Hispanic 1 0 1 0 0 0 2
Black 5 5 4 9 6 7 36
Asian/Pacific 0 0 1 0 0 1 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 13 participants 13 participants 15 participants 13 participants 14 participants 82 participants
14 13 13 15 13 14 82
Body Mass Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms/square meters
Number Analyzed 14 participants 13 participants 13 participants 15 participants 13 participants 14 participants 82 participants
27.72  (3.494) 27.10  (4.164) 27.27  (4.164) 27.43  (3.717) 25.92  (4.393) 26.84  (2.681) 27.06  (3.718)
[1]
Measure Description: Body mass index is an estimate of body fat based on body weight divided by height squared.
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 14 participants 13 participants 13 participants 15 participants 13 participants 14 participants 82 participants
174.6  (9.353) 166.4  (7.574) 172.4  (10.740) 167.2  (10.246) 167.4  (8.775) 169.8  (9.955) 169.6  (9.700)
Number of Nights with Middle of the Night Awakening   [1] 
Mean (Standard Deviation)
Unit of measure:  Number of nights
Number Analyzed 14 participants 13 participants 13 participants 15 participants 13 participants 14 participants 82 participants
9.3  (0.99) 9.4  (1.19) 8.9  (1.38) 9.3  (0.98) 9.3  (1.11) 8.6  (1.50) 9.1  (1.20)
[1]
Measure Description: 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.
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 14 participants 13 participants 13 participants 15 participants 13 participants 14 participants 82 participants
84.41  (11.409) 75.10  (12.665) 81.83  (17.816) 77.46  (16.739) 72.91  (14.421) 77.50  (10.331) 78.25  (14.249)
1.Primary Outcome
Title Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography
Hide Description 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.
Time Frame Days 1 and 2 for each treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Zolpidem 3.5 mg Zolpidem 1.75 mg Placebo
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 80 82 81
Least Squares Mean (95% Confidence Interval)
Unit of Measure: minutes
9.69
(8.06 to 11.65)
16.89
(14.07 to 20.26)
28.12
(23.41 to 33.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 3.5 mg, Zolpidem 1.75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Treatment effect
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening
Hide Description 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.
Time Frame Days 1 and 2 for each treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Zolpidem 3.5 mg Zolpidem 1.75 mg Placebo
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 80 82 81
Measure Type: Number
Unit of Measure: participants
60 46 23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 3.5 mg, Zolpidem 1.75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Treatment effect
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography
Hide Description 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.
Time Frame Days 1 and 2 for each treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population.
Arm/Group Title Zolpidem 3.5 mg Zolpidem 1.75 mg Placebo
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 80 82 81
Least Squares Mean (95% Confidence Interval)
Unit of Measure: minutes
208.99
(200.92 to 217.38)
197.80
(190.23 to 205.68)
183.12
(176.08 to 190.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 3.5 mg, Zolpidem 1.75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Treatment effect
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening
Hide Description 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.
Time Frame Days 1 and 2 for each treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Zolpidem 3.5 mg Zolpidem 1.75 mg Placebo
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 80 82 81
Least Squares Mean (95% Confidence Interval)
Unit of Measure: minutes
172.51
(161.92 to 183.10)
162.36
(151.87 to 172.85)
148.61
(138.07 to 159.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 3.5 mg, Zolpidem 1.75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Treatment effect
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Subjective Sleep Quality Rating
Hide Description 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.
Time Frame Days 1 and 2 for each treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Zolpidem 3.5 mg Zolpidem 1.75 mg Placebo
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 80 82 81
Measure Type: Number
Unit of Measure: percentage of participants
Poor 18.8 29.3 34.6
Fair 38.8 37.8 42.0
Good 36.3 30.5 19.8
Excellent 6.3 2.4 3.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 3.5 mg, Zolpidem 1.75 mg, Placebo
Comments The outcome noted above reflects the all-night sleep quality rating of study subjects who had a scheduled awakening after approximately 4 hours of sleep, were kept awake for 30 minutes and then allowed to return to bed and to sleep. After 4 hours, they were awakened again and disconnected from the PSG apparatus. Morning testing was conducted that included the Sleep Quality questionnaire. Evaluation of the results should reflect the nature of the study and the scheduled sleep disturbance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Treatment effect
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
6.Secondary Outcome
Title Subjective Level of Refreshed Sleep
Hide Description 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.
Time Frame Days 1 and 2 for each treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Zolpidem 3.5 mg Zolpidem 1.75 mg Placebo
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 80 82 81
Measure Type: Number
Unit of Measure: percentage of participants
Poor 17.5 22.0 32.1
Fair 42.5 41.5 44.4
Good 35.0 34.1 19.8
Excellent 5.0 2.4 3.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 3.5 mg, Zolpidem 1.75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.004
Comments Treatment effect
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
7.Secondary Outcome
Title Subjective Ability to Function
Hide Description 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.
Time Frame Days 1 and 2 for each treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Zolpidem 3.5 mg Zolpidem 1.75 mg Placebo
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 80 82 81
Measure Type: Number
Unit of Measure: percentage of participants
Poor 7.5 9.8 18.5
Fair 41.3 42.7 42.0
Good 45.0 41.5 33.3
Excellent 6.3 6.1 6.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 3.5 mg, Zolpidem 1.75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments Treatment effect
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
8.Secondary Outcome
Title Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening
Hide Description 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.
Time Frame Days 1 and 2 for each treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Zolpidem 3.5 mg Zolpidem 1.75 mg Placebo
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 80 82 81
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage of time asleep
87.08
(83.73 to 90.57)
82.63
(79.47 to 85.90)
76.31
(73.38 to 79.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 3.5 mg, Zolpidem 1.75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Treatment effect
Method ANCOVA
Comments [Not Specified]
9.Secondary Outcome
Title Subjective Sleep Onset Latency After Middle-of-the-Night Awakening
Hide Description 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.
Time Frame Days 1 and 2 for each treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Zolpidem 3.5 mg Zolpidem 1.75 mg Placebo
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 80 82 81
Least Squares Mean (95% Confidence Interval)
Unit of Measure: minutes
25.23
(21.58 to 29.49)
28.58
(24.49 to 33.36)
40.43
(34.62 to 47.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 3.5 mg, Zolpidem 1.75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Treatment effect
Method ANCOVA
Comments [Not Specified]
10.Secondary Outcome
Title Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening
Hide Description 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.
Time Frame Days 1 and 2 for each treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Zolpidem 3.5 mg Zolpidem 1.75 mg Placebo
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 80 82 81
Least Squares Mean (95% Confidence Interval)
Unit of Measure: minutes
15.06
(12.54 to 18.08)
15.81
(13.18 to 18.97)
15.71
(13.09 to 18.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 3.5 mg, Zolpidem 1.75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.790
Comments Treatment effect
Method ANCOVA
Comments [Not Specified]
11.Secondary Outcome
Title Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening
Hide Description 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.
Time Frame Days 1 and 2 for each treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Zolpidem 3.5 mg Zolpidem 1.75 mg Placebo
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 67 74 70
Least Squares Mean (95% Confidence Interval)
Unit of Measure: minutes
28.69
(24.25 to 33.94)
29.43
(25.03 to 34.62)
34.22
(29.00 to 40.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 3.5 mg, Zolpidem 1.75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.083
Comments Treatment effect
Method ANCOVA
Comments [Not Specified]
12.Secondary Outcome
Title Polysomnography Number of Awakenings After Middle-of-the-Night Awakening
Hide Description 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.
Time Frame Days 1 and 2 for each treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Zolpidem 3.5 mg Zolpidem 1.75 mg Placebo
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 80 82 81
Least Squares Mean (95% Confidence Interval)
Unit of Measure: number of awakenings
3.71
(3.22 to 4.19)
3.70
(3.22 to 4.18)
4.13
(3.65 to 4.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 3.5 mg, Zolpidem 1.75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.072
Comments Treatment effect
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zolpidem 3.5 mg, Zolpidem 1.75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Period effect
Method ANCOVA
Comments [Not Specified]
13.Other Pre-specified Outcome
Title Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography for Participants With More Severe Insomnia
Hide Description 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.
Time Frame Days 1 and 2 for each treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Zolpidem 3.5 mg Zolpidem 1.75 mg Placebo
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 37 38 37
Least Squares Mean (95% Confidence Interval)
Unit of Measure: minutes
194.58
(179.72 to 210.65)
179.98
(166.34 to 194.73)
166.62
(153.90 to 180.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 3.5 mg, Zolpidem 1.75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Treatment effect
Method ANCOVA
Comments [Not Specified]
14.Other Pre-specified Outcome
Title Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography for a Subpopulation of Participants With More Severe Insomnia
Hide Description 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.
Time Frame Days 1 and 2 for each treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Zolpidem 3.5 mg Zolpidem 1.75 mg Placebo
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 37 38 37
Least Squares Mean (95% Confidence Interval)
Unit of Measure: minutes
12.62
(9.12 to 17.47)
23.28
(16.88 to 32.12)
37.89
(27.38 to 52.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 3.5 mg, Zolpidem 1.75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Treatment effect
Method ANCOVA
Comments [Not Specified]
15.Post-Hoc Outcome
Title Subjective Number of Awakenings After Middle-of-the-Night Awakening
Hide Description 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.
Time Frame Days 1 and 2 for each treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population
Arm/Group Title Zolpidem 3.5 mg Zolpidem 1.75 mg Placebo
Hide Arm/Group Description:
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 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 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.
Overall Number of Participants Analyzed 80 82 81
Least Squares Mean (95% Confidence Interval)
Unit of Measure: number of awakenings
0.86
(0.70 to 1.04)
1.03
(0.85 to 1.25)
1.14
(0.94 to 1.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem 3.5 mg, Zolpidem 1.75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments Treatment effect
Method ANCOVA
Comments [Not Specified]
Time Frame Approximately one month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zolpidem 3.5 mg Zolpidem 1.75 mg Placebo
Hide Arm/Group Description 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 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 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.
All-Cause Mortality
Zolpidem 3.5 mg Zolpidem 1.75 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Zolpidem 3.5 mg Zolpidem 1.75 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   0/82 (0.00%)   0/81 (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 Zolpidem 1.75 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   0/82 (0.00%)   0/81 (0.00%) 
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.
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 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.
Results Point of Contact
Name/Title: Clinical Leader
Organization: Purdue Pharma LP
Phone: 800-733-1333
Responsible Party: Transcept Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00380081     History of Changes
Other Study ID Numbers: ZI-06-010
First Submitted: September 21, 2006
First Posted: September 25, 2006
Results First Submitted: December 15, 2011
Results First Posted: January 20, 2012
Last Update Posted: February 14, 2012