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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Transcept Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00380081
First received: September 21, 2006
Last updated: February 10, 2012
Last verified: February 2012
History of Changes
Results First Received: December 15, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Insomnia
Interventions: Drug: zolpidem tartrate sublingual tablet 3.5mg
Drug: zolpidem tartrate sublingual tablet 1.75mg
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    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  
STARTED     14     13     13     15     13     14  
COMPLETED     14     13     13     15     12     13  
NOT COMPLETED     0     0     0     0     1     1  
Withdrawal by Subject                 0                 0                 0                 0                 1                 0  
Family Emergency                 0                 0                 0                 0                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    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  
Number of Participants  
[units: participants]
 		  14     13     13     15     13     14     82  
Age  
[units: participants]
 		             
<=18 years     0     0     0     0     0     0     0  
Between 18 and 65 years     14     13     13     15     13     14     82  
>=65 years     0     0     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  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  
Gender  
[units: participants]
 		             
Female     8     10     10     11     10     9     58  
Male     6     3     3     4     3     5     24  
Race/Ethnicity, Customized  
[units: 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  
[units: participants]
 		             
United States     14     13     13     15     13     14     82  
Body Mass Index [1]
[units: kilograms/square meters]
Mean ± Standard Deviation 		  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  
Height  
[units: centimeters]
Mean ± Standard Deviation 		  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 [2]
[units: number of nights]
Mean ± Standard Deviation 		  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  
Weight  
[units: kilograms]
Mean ± Standard Deviation 		  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] Body mass index is an estimate of body fat based on body weight divided by height squared.
[2] 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.



  Outcome Measures
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1.  Primary:   Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography   [ Time Frame: Days 1 and 2 for each treatment ]
  Show Outcome Measure 1

2.  Secondary:   Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening   [ Time Frame: Days 1 and 2 for each treatment ]
  Show Outcome Measure 2

3.  Secondary:   Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography   [ Time Frame: Days 1 and 2 for each treatment ]
  Show Outcome Measure 3

4.  Secondary:   Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening   [ Time Frame: Days 1 and 2 for each treatment ]
  Show Outcome Measure 4

5.  Secondary:   Subjective Sleep Quality Rating   [ Time Frame: Days 1 and 2 for each treatment ]
  Show Outcome Measure 5

6.  Secondary:   Subjective Level of Refreshed Sleep   [ Time Frame: Days 1 and 2 for each treatment ]
  Show Outcome Measure 6

7.  Secondary:   Subjective Ability to Function   [ Time Frame: Days 1 and 2 for each treatment ]
  Hide Outcome Measure 7

Measure Type Secondary
Measure Title Subjective Ability to Function
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat population

Reporting Groups
  Description
Zolpidem 3.5 mg Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
Zolpidem 1.75 mg Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
Placebo Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.

Measured Values
    Zolpidem 3.5 mg     Zolpidem 1.75 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  80     82     81  
Subjective Ability to Function  
[units: 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  


Statistical Analysis 1 for Subjective Ability to Function
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.012
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Treatment effect



8.  Secondary:   Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening   [ Time Frame: Days 1 and 2 for each treatment ]
  Show Outcome Measure 8

9.  Secondary:   Subjective Sleep Onset Latency After Middle-of-the-Night Awakening   [ Time Frame: Days 1 and 2 for each treatment ]
  Show Outcome Measure 9

10.  Secondary:   Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening   [ Time Frame: Days 1 and 2 for each treatment ]
  Show Outcome Measure 10

11.  Secondary:   Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening   [ Time Frame: Days 1 and 2 for each treatment ]
  Show Outcome Measure 11

12.  Secondary:   Polysomnography Number of Awakenings After Middle-of-the-Night Awakening   [ Time Frame: Days 1 and 2 for each treatment ]
  Show Outcome Measure 12

13.  Other Pre-specified:   Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography for Participants With More Severe Insomnia   [ Time Frame: Days 1 and 2 for each treatment ]
  Show Outcome Measure 13

14.  Other Pre-specified:   Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography for a Subpopulation of Participants With More Severe Insomnia   [ Time Frame: Days 1 and 2 for each treatment ]
  Show Outcome Measure 14

15.  Post-Hoc:   Subjective Number of Awakenings After Middle-of-the-Night Awakening   [ Time Frame: Days 1 and 2 for each treatment ]
  Show Outcome Measure 15


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.  


Results Point of Contact:  
Name/Title: Clinical Leader
Organization: Purdue Pharma LP
phone: 800-733-1333


No publications provided


Responsible Party: Transcept Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00380081     History of Changes
Other Study ID Numbers: ZI-06-010
Study First Received: September 21, 2006
Results First Received: December 15, 2011
Last Updated: February 10, 2012
Health Authority: United States: Food and Drug Administration