Assess the Effect of Zolpidem, Silenor & Placebo on Arousability, Ataxia/Balance & Cognition in Healthy Volunteers
Condition: Healthy
MeSH terms: Ataxia
Study type: Interventional
Phase: Phase 4

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
    

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.
    

Intervention name(s): Silenor 6 mg; zolpidem 10 mg; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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
Other intervention name(s): doxepin; zolpidem
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Cognition; Balance