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Trial record 42 of 119 for:    zolpidem AND Hypnotics

Assess the Effect of Zolpidem, Silenor & Placebo on Arousability, Ataxia/Balance & Cognition in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02353299
Recruitment Status : Completed
First Posted : February 2, 2015
Results First Posted : December 7, 2017
Last Update Posted : January 2, 2018
Sponsor:
Collaborator:
Henry Ford Hospital
Information provided by (Responsible Party):
Pernix Theraputics LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Diagnostic
Condition Healthy
Interventions Drug: Silenor 6 mg
Drug: zolpidem 10 mg
Drug: Placebo
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PBO-4H Then PBO-1.5H Then DXP-4H Then ZOL-1.5H PBO-1.5H Then ZOL-1.5H Then PBO-4H Then DXP-4H ZOL-1.5H Then DXP-4H Then PBO-1.5H Then PBO-4H DXP-4H Then PBO-4H Then ZOL-1.5H Then PBO-1.5H
Hide Arm/Group Description Period 1: Doxepin-matching placebo-single nighttime dose Period 2: Zolpidem-matching placebo-single nighttime dose Period 3: Doxepin 6mg-single nighttime dose Period 4: Zolpidem 10 mg-single nighttime dose Period 1: Zolpidem-matching placebo-single nighttime dose Period 2: Zolpidem 10 mg-single nighttime dose Period 3: Doxepin-matching placebo-single nighttime dose Period 4: Doxepin 6mg-single nighttime dose Period 1: Zolpidem 10mg-single nighttime dose Period 2: Doxepin 6mg-single nighttime dose Period 3: Zolpidem-matching placebo-single nighttime dose Period 4: Doxepin-matching placebo-single nighttime dose Period 1: Doxepin 6mg-single nighttime dose Period 2: Doxepin-matching placebo-single nighttime dose Period 3: Zolpidem 10mg-single nighttime dose Period 4: Zolpidem-matching placebo-single nighttime dose
Period Title: First Intervention (1 Night)
Started 13 13 13 13
Completed 13 13 13 13
Not Completed 0 0 0 0
Period Title: Second Intervention (1 Night)
Started 13 13 13 13
Completed 13 13 13 13
Not Completed 0 0 0 0
Period Title: Third Intervention (1 Night)
Started 13 13 13 13
Completed 13 13 13 13
Not Completed 0 0 0 0
Period Title: Fourth Intervention (1 Night)
Started 13 12 [1] 13 13
Completed 13 12 13 13
Not Completed 0 0 0 0
[1]
One patient withdrawn from study prior to start of fourth intervention.
Arm/Group Title All Study Participants
Hide Arm/Group Description A single group of subjects were recruited and assigned all study treatments in random order
Overall Number of Baseline Participants 52
Hide Baseline Analysis Population Description
Subjects were healthy males
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
<=18 years
0
   0.0%
Between 18 and 65 years
52
 100.0%
>=65 years
0
   0.0%
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
male Number Analyzed 52 participants
52
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
American Indian or Alaska Native
0
   0.0%
Asian
5
   9.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   5.8%
White
30
  57.7%
More than one race
0
   0.0%
Unknown or Not Reported
14
  26.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 52 participants
52
1.Primary Outcome
Title Auditory Arousal Threshold (AAT) at T-max
Hide Description

AAT will performed at T-max for Silenor and matching placebo at 4 hours post dose. Assessments performed at t max for zolpidem and placebo at 1.5 hours post dose.

An acoustic stimulus (1000 Hz tone) was presented through audiometric earphones (E-A-RTone 3A Insert Earphones). Tones began at 30 dB and increased by 5 dB until the participant woke up or the maximum dB-level (110 dB) was reached.

Time Frame at either 1.5 or 4 hours post dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Silenor 6 mg (DXP-4H) Placebo (PBO-4H) Zolpidem 10 mg (ZOL-1.5H) Placebo (PBO-1.5H)
Hide Arm/Group Description:

Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments

Silenor 6 mg: Silenor 6 mg single nighttime dose.

placebo single nightime dose -4 hour post dose arousability and cognitive assessments

Silenor 6 mg: Silenor 6 mg single nighttime dose.

zolpidem 10 mg single nightime dose - 1.5 hour arousability and cognitive assessments

zolpidem 10 mg: Zolpidem 10 mg single nighttime dose

placebo single nightime dose -1.5 hour arousability and cognitive assessments

zolpidem 10 mg: Zolpidem 10 mg single nighttime dose

Overall Number of Participants Analyzed 51 52 52 52
Mean (Standard Deviation)
Unit of Measure: Decibels (dB)
85.2  (11.8) 78.0  (18.6) 103.2  (11.8) 84.7  (17.1)
2.Secondary Outcome
Title Tandem Walk Step-Offs
Hide Description

Tandem walk will be performed at T-max for Silenor and matching placebo at 4 hours post dose and at 1.5 hours post dose for zolpidem 10 mg and matching placebo.

Fall risk as impacted by balance was measured using the Tandem Walk Test (TWT), which assesses balance via a method of walking in which the toes of the back foot must touch the heel of the front foot at each step; this elicits postural control by reducing the base of support compared to normal walking. Endpoints were the number of step-offs from the beam.

Time Frame at either 1.5 or 4 hours post dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo (PBO-4H) Silenor 6 mg (DXP-4H) Zolpidem 10 mg (ZOL-1.5H) Placebo (PBO-1.5H)
Hide Arm/Group Description:

placebo single nightime dose -4 hour post dose arousability and cognitive assessments

Silenor 6 mg: Silenor 6 mg single nighttime dose.

Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments

Silenor 6 mg: Silenor 6 mg single nighttime dose.

zolpidem 10 mg single nightime dose - 1.5 hour arousability and cognitive assessments

zolpidem 10 mg: Zolpidem 10 mg single nighttime dose

placebo single nightime dose -1.5 hour arousability and cognitive assessments

zolpidem 10 mg: Zolpidem 10 mg single nighttime dose

Overall Number of Participants Analyzed 52 51 52 52
Mean (Standard Deviation)
Unit of Measure: number of step offs
0.9  (1.4) 1.5  (2.4) 8.1  (8.0) 1.0  (1.3)
3.Secondary Outcome
Title Tandem Walk Duration Over Five Trials
Hide Description

Tandem walk will be performed at T-max for Silenor and matching placebo at 4 hours post dose and at 1.5 hours post dose for zolpidem 10 mg and matching placebo.

Fall risk as impacted by balance was measured using the Tandem Walk Test (TWT), which assesses balance via a method of walking in which the toes of the back foot must touch the heel of the front foot at each step; this elicits postural control by reducing the base of support compared to normal walking. Endpoint: mean completion duration over five trials.

Time Frame at either 1.5 or 4 hours post dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo (PBO-4H) Silenor 6 mg (DXP-4H) Zolpidem 10 mg (ZOL-1.5H) Placebo (PBO-1.5H)
Hide Arm/Group Description:

placebo single nightime dose -4 hour post dose arousability and cognitive assessments

Silenor 6 mg: Silenor 6 mg single nighttime dose.

zolpidem 10 mg: Zolpidem 10 mg single nighttime dose

Placebo: placebo single nighttime dose-1.5 hours

Placebo: placebo single nighttime dose-4 hours

Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments

Silenor 6 mg: Silenor 6 mg single nighttime dose.

zolpidem 10 mg: Zolpidem 10 mg single nighttime dose

Placebo: placebo single nighttime dose-1.5 hours

Placebo: placebo single nighttime dose-4 hours

zolpidem 10 mg single nightime dose - 1.5 hour arousability and cognitive assessments

Silenor 6 mg: Silenor 6 mg single nighttime dose.

zolpidem 10 mg: Zolpidem 10 mg single nighttime dose

Placebo: placebo single nighttime dose-1.5 hours

Placebo: placebo single nighttime dose-4 hours

placebo single nightime dose -1.5 hour arousability and cognitive assessments

Silenor 6 mg: Silenor 6 mg single nighttime dose.

zolpidem 10 mg: Zolpidem 10 mg single nighttime dose

Placebo: placebo single nighttime dose-1.5 hours

Placebo: placebo single nighttime dose-4 hours

Overall Number of Participants Analyzed 52 51 52 52
Mean (Standard Deviation)
Unit of Measure: Seconds
4.82  (1.68) 4.97  (1.57) 6.69  (2.60) 4.83  (1.60)
4.Secondary Outcome
Title Berg Balance Test
Hide Description

Berg Balance will be performed at T-max for silenor and matching placebo at 4 hours post dose and at 1.5 hours post dose for zolpidem 10 mg and matching placebo.

Fall risk as impacted by gait was measured using the Berg Balance Scale (BBS). The BBS is a widely used clinical test of static and dynamic balance abilities. Comprising of 14 simple balance-related tasks, ranging from standing up from a sitting position to standing on one foot, the BBS takes 15–20 minutes to complete. Each component task is scored on a Likert scale: 0 (unable to perform) to 4 (performed independently). The sum of component scores yields the final BBS score (0-20: high fall risk; 21–40: medium fall risk; 41–56: low fall risk).

Time Frame at either 1.5 or 4 hours post dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Silenor 6 mg (DXP-4H) Placebo (PBO-4H) Zolpidem 10 mg (ZOL-1.5H) Placebo (PBO-1.5H)
Hide Arm/Group Description:

Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments

Silenor 6 mg: Silenor 6 mg single nighttime dose.

placebo single nightime dose -4 hour post dose arousability and cognitive assessments

Silenor 6 mg: Silenor 6 mg single nighttime dose.

zolpidem 10 mg single nightime dose - 1.5 hour arousability and cognitive assessments

zolpidem 10 mg: Zolpidem 10 mg single nighttime dose

placebo single nightime dose -1.5 hour arousability and cognitive assessments

zolpidem 10 mg: Zolpidem 10 mg single nighttime dose

Overall Number of Participants Analyzed 51 52 52 52
Mean (Standard Deviation)
Unit of Measure: sum of component scores
54.5  (1.9) 55.1  (1.4) 51.4  (4.3) 55.1  (1.4)
5.Secondary Outcome
Title Immediate Free Recall Task
Hide Description

Immediate Free Recall will be performed at T-max for silenor and matching placebo at 4 hours post dose and at 1.5 hours post dose for zolpidem 10 mg and matching placebo.

Free Recall is a basic paradigm in the psychological study of memory. In this paradigm, participants were presented with a total of 16 words serially. They were informed prior to the task that memory for the presented words would be tested later in the session.

Time Frame directly after the encoding task
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Silenor 6 mg (DXP-4H) Placebo (PBO-4H) Zolpidem 10 mg (ZOL-1.5H) Placebo (PBO-1.5H)
Hide Arm/Group Description:

Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments

Silenor 6 mg: Silenor 6 mg single nighttime dose.

placebo single nightime dose -4 hour post dose arousability and cognitive assessments

Silenor 6 mg: Silenor 6 mg single nighttime dose.

zolpidem 10 mg single nightime dose - 1.5 hour arousability and cognitive assessments

zolpidem 10 mg: Zolpidem 10 mg single nighttime dose

placebo single nightime dose -1.5 hour arousability and cognitive assessments

zolpidem 10 mg: Zolpidem 10 mg single nighttime dose

Overall Number of Participants Analyzed 51 52 52 52
Mean (Standard Deviation)
Unit of Measure: Number of words
7.86  (3.20) 8.14  (2.99) 4.78  (3.42) 7.71  (3.12)
6.Secondary Outcome
Title Delayed Free Recall Task
Hide Description

Delayed Free Recall Task was performed 15 minutes after final awakening the morning

Free Recall is a basic paradigm in the psychological study of memory. In this paradigm, participants were presented with a total of 16 words serially. They were informed prior to the task that memory for the presented words would be tested later in the session. Participants were asked to recall as many words as they can 15 minutes after final awakening in the morning

Time Frame 15 minutes after final awakening the morning
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Silenor 6 mg (DXP-4H) Placebo (PBO-4H) Zolpidem 10 mg (ZOL-1.5H) Placebo (PBO-1.5H)
Hide Arm/Group Description:

Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments

Silenor 6 mg: Silenor 6 mg single nighttime dose.

zolpidem 10 mg: Zolpidem 10 mg single nighttime dose

Placebo: placebo single nighttime dose-1.5 hours

Placebo: placebo single nighttime dose-4 hours

placebo single nightime dose -4 hour post dose arousability and cognitive assessments

Silenor 6 mg: Silenor 6 mg single nighttime dose.

zolpidem 10 mg: Zolpidem 10 mg single nighttime dose

Placebo: placebo single nighttime dose-1.5 hours

Placebo: placebo single nighttime dose-4 hours

zolpidem 10 mg single nightime dose - 1.5 hour arousability and cognitive assessments

Silenor 6 mg: Silenor 6 mg single nighttime dose.

zolpidem 10 mg: Zolpidem 10 mg single nighttime dose

Placebo: placebo single nighttime dose-1.5 hours

Placebo: placebo single nighttime dose-4 hours

placebo single nightime dose -1.5 hour arousability and cognitive assessments

Silenor 6 mg: Silenor 6 mg single nighttime dose.

zolpidem 10 mg: Zolpidem 10 mg single nighttime dose

Placebo: placebo single nighttime dose-1.5 hours

Placebo: placebo single nighttime dose-4 hours

Overall Number of Participants Analyzed 51 52 52 52
Mean (Standard Deviation)
Unit of Measure: Number of words
6.78  (3.68) 7.02  (3.59) 2.24  (2.77) 6.51  (3.48)
7.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Adverse events were defined by any negative event experienced by a participant during the study (assessed in the morning prior to participants leaving the lab) and included the washout period following each treatment.
Time Frame throughout the study until the final study visit, up to 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Silenor 6 mg (DXP-4H) Placebo (PBO-4H) Zolpidem 10 mg (ZOL-1.5H) Placebo (PBO-1.5H)
Hide Arm/Group Description:

Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments

Silenor 6 mg: Silenor 6 mg single nighttime dose.

placebo single nightime dose -4 hour post dose arousability and cognitive assessments

Silenor 6 mg: Silenor 6 mg single nighttime dose.

zolpidem 10 mg single nightime dose - 1.5 hour arousability and cognitive assessments

zolpidem 10 mg: Zolpidem 10 mg single nighttime dose

placebo single nightime dose -1.5 hour arousability and cognitive assessments

zolpidem 10 mg: Zolpidem 10 mg single nighttime dose

Overall Number of Participants Analyzed 51 52 52 52
Measure Type: Number
Unit of Measure: Participants
13 11 12 10
Time Frame Throughout the study period until the final study visit, up to 6 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Silenor 6 mg (DXP-4H) Placebo (PBO-4H) Zolpidem 10 mg (ZOL-1.5H) Placebo (PBO-1.5H)
Hide Arm/Group Description

Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments

Silenor 6 mg: Silenor 6 mg single nighttime dose.

placebo single nightime dose -4 hour post dose arousability and cognitive assessments

Silenor 6 mg: Silenor 6 mg single nighttime dose.

zolpidem 10 mg single nightime dose - 1.5 hour arousability and cognitive assessments

zolpidem 10 mg: Zolpidem 10 mg single nighttime dose

placebo single nightime dose -1.5 hour arousability and cognitive assessments

zolpidem 10 mg: Zolpidem 10 mg single nighttime dose

All-Cause Mortality
Silenor 6 mg (DXP-4H) Placebo (PBO-4H) Zolpidem 10 mg (ZOL-1.5H) Placebo (PBO-1.5H)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)      0/52 (0.00%)      0/52 (0.00%)      0/52 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Silenor 6 mg (DXP-4H) Placebo (PBO-4H) Zolpidem 10 mg (ZOL-1.5H) Placebo (PBO-1.5H)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/51 (0.00%)      0/52 (0.00%)      0/52 (0.00%)      0/52 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Silenor 6 mg (DXP-4H) Placebo (PBO-4H) Zolpidem 10 mg (ZOL-1.5H) Placebo (PBO-1.5H)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/51 (25.49%)      11/52 (21.15%)      12/52 (23.08%)      10/52 (19.23%)    
Gastrointestinal disorders         
Xerostomia  1  0/51 (0.00%)  0 0/52 (0.00%)  0 1/52 (1.92%)  1 0/52 (0.00%)  0
General disorders         
Fatigue/lethargy  1  2/51 (3.92%)  2 2/52 (3.85%)  2 0/52 (0.00%)  0 0/52 (0.00%)  0
Other  1  2/51 (3.92%)  2 1/52 (1.92%)  1 1/52 (1.92%)  1 7/52 (13.46%)  7
Nervous system disorders         
Memory Impairment  1  0/51 (0.00%)  0 1/52 (1.92%)  1 3/52 (5.77%)  3 0/52 (0.00%)  0
Somnolence  1  4/51 (7.84%)  4 4/52 (7.69%)  4 4/52 (7.69%)  4 0/52 (0.00%)  0
Insomnia  1  3/51 (5.88%)  3 3/52 (5.77%)  3 2/52 (3.85%)  2 2/52 (3.85%)  2
Syncope  1  1/51 (1.96%)  1 0/52 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0
Presyncope  1  1/51 (1.96%)  1 0/52 (0.00%)  0 1/52 (1.92%)  1 0/52 (0.00%)  0
Rigors  1  0/51 (0.00%)  0 0/52 (0.00%)  0 0/52 (0.00%)  0 1/52 (1.92%)  1
1
Term from vocabulary, MedDRA (7.0)
Indicates events were collected by systematic assessment
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
Name/Title: Christopher L Drake
Organization: Sleep Disorders and Research Center Henry Ford Hospital
Phone: 248-344-6672
Other Publications:
Davis KL, Charey D, Cuyle JT, Nemeroff C. Neuropsychopharmacology, The Fifth Generation of Progress. 2002; Section 13: 1938-1939
Silenor [prescribing information]. Pernix Pharmaceuticals, Inc., San Diego, CA; March 2010.
Sanofi-Synthelabo. Ambien (zolpidem tartrate) complete prescribing information. 2002.
Responsible Party: Pernix Theraputics LLC
ClinicalTrials.gov Identifier: NCT02353299     History of Changes
Other Study ID Numbers: PT-D1402
First Submitted: January 23, 2015
First Posted: February 2, 2015
Results First Submitted: January 30, 2017
Results First Posted: December 7, 2017
Last Update Posted: January 2, 2018