Assess the Effect of Zolpidem, Silenor & Placebo on Arousability, Ataxia/Balance & Cognition in Healthy Volunteers
Condition: Healthy
MeSH terms: Ataxia
Intervention: Silenor 6 mg; zolpidem 10 mg; Placebo; Placebo
Intervention description: Silenor 6 mg single nighttime dose.; Zolpidem 10 mg single nighttime dose; placebo single nighttime dose-1.5 hours; placebo single nighttime dose-4 hours
Intervention MeSH terms: Zolpidem
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 52.0
Sex: Male
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cognition; Balance

Summary:

      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
    

Eligibility criteria:

        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