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Assess the Effect of a Single Dose of Zolpidem, Silenor & Placebo on Arousability, Ataxia/Balance & Cognitive Performance in Healthy Volunteers

Information source: Pernix Theraputics LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Silenor 6 mg (Drug); zolpidem 10 mg (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Pernix Theraputics LLC


This is a Phase IV, randomized, double-blind, placebo-controlled, four-arm crossover study. The study will assess the effects of a single dose of Silenor 6 mg compared with matching placebo and a single dose of zolpidem 10 mg compared to its matching placebo at the respective T-max in normal healthy adult male volunteers. The study will be conducted in approximately 52 male subjects

Clinical Details

Official title: Phase IV 4 Way Crossover Study to Assess and Compare the Effect of a Single Nighttime Administration of Zolpidem, Silenor and Placebo on Arousability, Ataxia/Balance and Cognitive Performance in Healthy Volunteers.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Primary outcome: Auditory Arousal Threshold (AAT) at t-max

Secondary outcome:

Tandem Walk

Berg Balance Test

Free Recall

adverse events

Detailed description: Subjects will be screened and asked to complete sleep disorders questionnaires and a sleep diary to establish normal sleep patterns and to rule out any sleep disorder. Eligible subjects will be scheduled for a Screening PSG to rule out PLMS, sleep apnea and other sleep disorders. Subjects who meet the screening PSG criteria will be randomly assigned to a treatment sequence order that involves both the study drug and the time subjects are awakened in the middle-of-the-night using a crossover study design. These four sequences include Silenor 6 mg with a middle-of-the-night awakening at 4 hours (DXP-4H), zolpidem 10 mg with a middle-of-the-night awakening at 1. 5 hours (ZOL-1. 5H), placebo with a middle-of-the-night awakening at 4 hours (PBO-4H), and placebo with a middle-of-the-night awakening at 1. 5 hours (PBO-1. 5H). Study drug will be administered under fasted conditions (at least 4 hours) as a single dose at bedtime (approximately 2300 hours), and each subject will receive one dose of each active drug (Silenor 6 mg and zolpidem 10 mg), and two doses of placebo during the treatment period. Safety assessments will be performed throughout the study. During the night of assessment, subjects will be awoken at the estimated T-max of the active drugs, with a matching placebo group awakened at each of these time points with the same arousability protocol. Arousability will be assessed using the Auditory Awakening Threshold test (AAT) . Once the Auditory Awakening Threshold has been determined, subjects will perform a Tandem Walk assessment followed by the Berg Balance Scale (BBS) and finally by Free Recall Memory testing. Subjects will be discharged from the sleep center once all assessments have been completed. A final study visit will be performed for subjects either after they have completed all four Treatment Periods or they have prematurely discontinued the study.


Minimum age: 21 Years. Maximum age: 50 Years. Gender(s): Male.


Inclusion Criteria:

- Be in good general health as determined by the investigator;

- Have a 3-month history of a normal nightly sleep pattern based on the subject's

self report ;

- A usual time in bed

- A regular bedtime between 2200 and 2400 hours

- No habitual daytime napping;

- Epworth Sleepiness Scale score ≤ 10;

- Be able to read, understand, and provide written/dated informed consent before

enrolling in the study, and must be willing and able to comply with all study procedures;

- Be able to follow verbal and written instructions provided in English

Exclusion Criteria:

- Have a body mass index (BMI) >35 kg/m2

- Have symptoms consistent with the diagnosis of any sleep disorder (e. g., insomnia,

sleep apnea, narcolepsy, periodic leg movements, or restless leg syndrome);

- On screening PSG AHI > 10 or PLMAI >10;

- Have a known or suspected diagnosis of Acquired Immune Deficiency Syndrome (AIDS), or

have tested seropositive for human immunodeficiency virus (HIV) antibody or antigen previously;

- Have any clinically significant abnormal finding in physical examination,

neurological assessment, vital signs, elevated body temperature, or clinical laboratory tests, as determined by the Investigator;

- Have a known exaggerated pharmacological sensitivity, hypersensitivity, or history of

a clinically significant adverse reaction to zolpidem;

- Have a known or exaggerated pharmacological sensitivity, hypersensitivity, or

intolerance to doxepin HCl, any tricyclic antidepressant, or antihistamine;

- Currently taking cimetidine or a monoamine oxidase inhibitor (MAOI);

- Current diagnosis of severe urinary retention;

- Current diagnosis of untreated glaucoma;

- Intends to use any medication including over-the-counter (OTC) medications that would

interfere with normal sleep architecture (such as systemic steroids, beta-adrenergic blockers, amphetamines, modafinil, etc.);

- Self-reports use of products containing nicotine of greater than 15 cigarettes daily,

or cannot avoid products containing nicotine during the normal sleep periods;

- Self report consumption of more than five alcoholic beverages on any one day or

greater than 14 alcoholic beverages weekly over the past week;

- Have a history of epilepsy or serious head injury;

- Used CYP450 2D6 inducers or inhibitors within 7 days before screening;

- Have used prescribed or OTC medications within 30 days of screening (Day 0) or intend

to use any prescription or OTC medication during the study that may interfere with the evaluation of the study drug.

- Have used an investigational drug within 30 days or five half lives (whichever is

longer) before screening, or plans to use an investigational drug during the study or have used doxepin or zolpidem previously.

- Score of < 40 on the BBS at screening

Locations and Contacts

Henry Ford Hospital Sleep Disorders & Research Center, Novi, Michigan 48377, United States; Not yet recruiting
Christopher L Drake, PhD, Phone: 248-344-6672, Email: CDRAKE1@hfhs.org
Additional Information

Related 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.

Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5.

Starting date: January 2015
Last updated: January 28, 2015

Page last updated: August 23, 2015

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