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Trial record 4 of 16 for:    ZOLPIDEM AND Chronic Insomnia

Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic 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: NCT00383643
Recruitment Status : Completed
First Posted : October 3, 2006
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
Jed E Black, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Sleep Initiation and Maintenance Disorders
Interventions Drug: zolpidem tartrate
Drug: sodium oxybate
Drug: Matching Placebos
Enrollment 48
Recruitment Details Subjects were recruited through local newspaper ads and from the Stanford Sleep Disorders Clinic. A general description of the study was provided. Preliminary screening was conducted by telephone. Interested and qualified persons were scheduled for an in-person screening visit.
Pre-assignment Details  
Arm/Group Title Zolpidem Tartrate Placebo Sodium Oxybate
Hide Arm/Group Description Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind. Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind. Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
Period Title: Overall Study
Started 18 16 14
Completed 17 15 13
Not Completed 1 1 1
Arm/Group Title Zolpidem Tartrate Placebo Sodium Oxybate Total
Hide Arm/Group Description Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind. Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind. Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind. Total of all reporting groups
Overall Number of Baseline Participants 18 16 14 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 16 participants 14 participants 48 participants
52.3  (9.6) 56.4  (10.4) 49.6  (16.3) 53.2  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 14 participants 48 participants
Female
12
  66.7%
11
  68.8%
9
  64.3%
32
  66.7%
Male
6
  33.3%
5
  31.3%
5
  35.7%
16
  33.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Ethnic Minorities Number Analyzed 18 participants 16 participants 14 participants 48 participants
3 5 3 11
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 16 participants 14 participants 48 participants
18 16 14 48
1.Primary Outcome
Title Assessment of Clinical Global Impression-change.
Hide Description Clinician assessment of Clinical Global Impression-Change score at week 12 of treatment intervention. The Clinical Global Impression – Change scale is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the current time point. It is rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. One one clinician provided the ratings in this trial.
Time Frame Baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 & 8) were used to replace the missing value.
Arm/Group Title Zolpidem Tartrate Placebo Sodium Oxybate
Hide Arm/Group Description:
Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
Overall Number of Participants Analyzed 18 16 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.0  (1.2) 4.2  (1.4) 2.7  (0.6)
2.Primary Outcome
Title Assessment of Insomnia Severity Index
Hide Description

Current self-report on Insomnia Severity Index at week 12 of treatment intervention. This is a seven-item questionnaire where the sum of the answers indicate the severity of insomnia. Total score categories:

0–7 = No clinically significant insomnia 8–14 = Subthreshold insomnia 15–21 = Clinical insomnia (moderate severity) 22–28 = Clinical insomnia (severe)

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 & 8) were used to replace the missing value.
Arm/Group Title Zolpidem Tartrate Placebo Sodium Oxybate
Hide Arm/Group Description:
Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
Overall Number of Participants Analyzed 18 16 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.5  (3.9) 10.8  (6.5) 8.4  (4.3)
3.Primary Outcome
Title Assessment of Pittsburgh Sleep Quality Index (PSQI)
Hide Description

Current self-report on Pittsburgh Sleep Quality Index (PSQI) at week 12 of intervention. Consisting of 19 items, the PSQI measures several different aspects of sleep which can be combined into one global score.

Each item measure is scored on a scale of 0 to 3 where 3 is the extreme negative. The composite PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Based on this questionnaire, a composite score of 5 or greater is indicative of poor sleep quality.

Time Frame One month
Hide Outcome Measure Data
Hide Analysis Population Description
All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 & 8) were used to replace the missing value.
Arm/Group Title Zolpidem Tartrate Placebo Sodium Oxybate
Hide Arm/Group Description:
Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
Overall Number of Participants Analyzed 18 16 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.3  (2.6) 10.2  (3.5) 7.9  (2.9)
4.Primary Outcome
Title Assessment of Fatigue
Hide Description Current self-report on Profile of Mood State -- Fatigue (POMS-F) at week 12 of intervention. This subscale of the POMS consists of 7 items each scored on a scale of 0 (not at all) to 4 (extremely) which are summed to provide a composite score of fatigue. The range is 0 to 28 for this subscale. Higher scores indicate more fatigue.
Time Frame One month
Hide Outcome Measure Data
Hide Analysis Population Description
All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 & 8) were used to replace the missing value.
Arm/Group Title Zolpidem Tartrate Placebo Sodium Oxybate
Hide Arm/Group Description:
Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
Overall Number of Participants Analyzed 18 16 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.7  (5.4) 8.0  (7.1) 5.1  (4.4)
5.Primary Outcome
Title Assessment of Sleepiness
Hide Description Current self-report on Epworth Sleepiness Scale (ESS) at week 12 of intervention. This measure consists of 8 scenarios in which the participant is asked to assess how likely s/he is to fall asleep. Scale: 0 = would never doze; 1 = slight chance of dozing; 2 = moderate chance of dozing; 3 = high chance of dozing. Responses are summed for a total score ranging from 0 to 24. The higher the score, the greater the self-reported sleepiness. Scores of 9 and below are considered in the normal range.
Time Frame One month
Hide Outcome Measure Data
Hide Analysis Population Description
All analysis are intent to treat. In the case of missing data, an average value of the available data points (weeks 4 & 8) were used to replace the missing value.
Arm/Group Title Zolpidem Tartrate Placebo Sodium Oxybate
Hide Arm/Group Description:
Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind.
Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind.
Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
Overall Number of Participants Analyzed 18 16 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.7  (3.7) 2.9  (2.7) 4.4  (3.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zolpidem Tartrate Placebo Sodium Oxybate
Hide Arm/Group Description Eligible subjects randomized to this arm received zolpidem as a gelatin capsule and a placebo liquid capsule to fully maintain the blind. Eligible subjects randomized to this arm received placebo (also known as a sugar pill) as gelatin capsule and a liquid capsule to fully maintain the blind. Eligible subjects randomized to this arm received placebo as a gelatin capsule and a sodium oxybate capsule to fully maintain the blind.
All-Cause Mortality
Zolpidem Tartrate Placebo Sodium Oxybate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Zolpidem Tartrate Placebo Sodium Oxybate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/16 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zolpidem Tartrate Placebo Sodium Oxybate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/18 (88.89%)      12/16 (75.00%)      14/15 (93.33%)    
Cardiac disorders       
Hypertension   2/18 (11.11%)  2 0/16 (0.00%)  0 0/15 (0.00%)  0
Gastrointestinal disorders       
Cramp   0/18 (0.00%)  0 0/16 (0.00%)  0 2/15 (13.33%)  2
Pain   1/18 (5.56%)  1 2/16 (12.50%)  2 0/15 (0.00%)  0
Constipation   2/18 (11.11%)  2 0/16 (0.00%)  0 0/15 (0.00%)  0
Diarrhea   2/18 (11.11%)  2 0/16 (0.00%)  0 1/15 (6.67%)  1
Loose stools   0/18 (0.00%)  0 2/16 (12.50%)  2 0/15 (0.00%)  0
Gagging   1/18 (5.56%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Nausea   2/18 (11.11%)  2 2/16 (12.50%)  2 9/15 (60.00%)  9
Vomiting   2/18 (11.11%)  2 0/16 (0.00%)  0 4/15 (26.67%)  4
General disorders       
seasonal allergy   0/18 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Chills   0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Toothache   0/18 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Dehydration   1/18 (5.56%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Dry Mouth   0/18 (0.00%)  0 2/16 (12.50%)  2 0/15 (0.00%)  0
Dry eyes   1/18 (5.56%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Thirst   0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Sleep apnea   0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Nightmares   1/18 (5.56%)  1 0/16 (0.00%)  0 1/15 (6.67%)  1
Periodic limb movements   1/18 (5.56%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Insomnia   0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Sleep paralysis   0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Confusional arousal   0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Snoring   0/18 (0.00%)  0 0/16 (0.00%)  0 2/15 (13.33%)  2
Eating during sleep   0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Enuresis   0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Bitter aftertaste   0/18 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Infections and infestations       
Cold   4/18 (22.22%)  4 4/16 (25.00%)  4 1/15 (6.67%)  1
Influenza-like symptom   2/18 (11.11%)  2 2/16 (12.50%)  2 0/15 (0.00%)  0
Gastroenteritis viral   0/18 (0.00%)  0 3/16 (18.75%)  3 0/15 (0.00%)  0
Urinary Tract Infection   1/18 (5.56%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Laryngitis   1/18 (5.56%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Gum inflammation   0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Injury, poisoning and procedural complications       
Sprained ankle   0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Fall   0/18 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Metabolism and nutrition disorders       
Appetite loss   0/18 (0.00%)  0 1/16 (6.25%)  1 2/15 (13.33%)  2
Musculoskeletal and connective tissue disorders       
Aches & pains   6/18 (33.33%)  6 1/16 (6.25%)  1 1/15 (6.67%)  1
Cramps   0/18 (0.00%)  0 0/16 (0.00%)  0 2/15 (13.33%)  2
Twitch   1/18 (5.56%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Stiffness   0/18 (0.00%)  0 1/16 (6.25%)  1 1/15 (6.67%)  1
Nervous system disorders       
Memory   2/18 (11.11%)  2 0/16 (0.00%)  0 1/15 (6.67%)  1
Pressured speech   1/18 (5.56%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Slow/disorganized speech   0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Racing thoughts   0/18 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Difficulty with spelling   1/18 (5.56%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Coordination/balance   4/18 (22.22%)  4 0/16 (0.00%)  0 2/15 (13.33%)  2
Disorientation/confusion upon waking   1/18 (5.56%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Dizziness   1/18 (5.56%)  1 3/16 (18.75%)  3 10/15 (66.67%)  10
Lightheadedness   0/18 (0.00%)  0 0/16 (0.00%)  0 2/15 (13.33%)  2
Drugged/intoxication feeling   2/18 (11.11%)  2 0/16 (0.00%)  0 4/15 (26.67%)  4
Groggy/hangover   3/18 (16.67%)  3 0/16 (0.00%)  0 1/15 (6.67%)  1
Residual/daytime drowsiness   9/18 (50.00%)  9 2/16 (12.50%)  2 1/15 (6.67%)  1
Headache   7/18 (38.89%)  7 2/16 (12.50%)  2 4/15 (26.67%)  4
Neuralgia   1/18 (5.56%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Tinglingness   0/18 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Tremor   0/18 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Peripheral neuropathy   1/18 (5.56%)  1 1/16 (6.25%)  1 0/15 (0.00%)  0
Psychiatric disorders       
Anxiety   1/18 (5.56%)  1 0/16 (0.00%)  0 1/15 (6.67%)  1
Depressed mood   1/18 (5.56%)  1 0/16 (0.00%)  0 1/15 (6.67%)  1
Irritability   1/18 (5.56%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Renal and urinary disorders       
Nocturnia   0/18 (0.00%)  0 0/16 (0.00%)  0 3/15 (20.00%)  3
Kidney stone   0/18 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Urinary incontinence   0/18 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Reproductive system and breast disorders       
Hot flashes   1/18 (5.56%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Nasal congestion   1/18 (5.56%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Skin and subcutaneous tissue disorders       
Rash   1/18 (5.56%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Indicates events were collected by systematic assessment
Insufficient power for most parameters was a planned limitation of the study. Replication with a larger sample is needed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jed Black
Organization: Stanford University School of Medicine, Dept of Psychiatry
Phone: 650 736 4559
EMail: jedblack@stanford.edu
Layout table for additonal information
Responsible Party: Jed E Black, Stanford University
ClinicalTrials.gov Identifier: NCT00383643     History of Changes
Other Study ID Numbers: 95900
First Submitted: September 29, 2006
First Posted: October 3, 2006
Results First Submitted: February 15, 2017
Results First Posted: June 1, 2017
Last Update Posted: June 1, 2017