Assess the Effect of Zolpidem, Silenor & Placebo on Arousability, Ataxia/Balance & Cognition in Healthy Volunteers
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.
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ClinicalTrials.gov Identifier: NCT02353299
First Posted : February 2, 2015
Results First Posted : December 7, 2017
Last Update Posted : January 2, 2018
Information provided by (Responsible Party):
Pernix Theraputics LLC
Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Diagnostic
Drug: Silenor 6 mg
Drug: zolpidem 10 mg
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.
Layout table for Results Point of Contact information
Christopher L Drake
Sleep Disorders and Research Center Henry Ford Hospital
Hori T, Sugita Y, Koga E, Shirakawa S, Inoue K, Uchida S, Kuwahara H, Kousaka M, Kobayashi T, Tsuji Y, Terashima M, Fukuda K, Fukuda N; Sleep Computing Committee of the Japanese Society of Sleep Research Society. Proposed supplements and amendments to 'A Manual of Standardized Terminology, Techniques and Scoring System for Sleep Stages of Human Subjects', the Rechtschaffen & Kales (1968) standard. Psychiatry Clin Neurosci. 2001 Jun;55(3):305-10.
Berg Balance Scale (BBS)
Gottlieb DJ, Yenokyan G, Newman AB, O'Connor GT, Punjabi NM, Quan SF, Redline S, Resnick HE, Tong EK, Diener-West M, Shahar E. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation. 2010 Jul 27;122(4):352-60. doi: 10.1161/CIRCULATIONAHA.109.901801. Epub 2010 Jul 12.
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.
Layout table for additonal information
Pernix Theraputics LLC
History of Changes
Other Study ID Numbers:
January 23, 2015
February 2, 2015
Results First Submitted:
January 30, 2017
Results First Posted:
December 7, 2017
Last Update Posted:
January 2, 2018