Study to Compare the Awakening Threshold Effects of Belsomra 10 mg and 20 mg to Placebo in Non-elderly Insomniacs
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Suvorexant 10 mg; Suvorexant 20 mg; Placebo oral capsule
Intervention description: Subject will receive suvorexant 10mg; Subject will receive suvorexant 20mg; Subject will receive placebo.
Intervention MeSH terms: Suvorexant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: double-blind, randomized 3-way crossover design
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Study is double blinded. Investigator, participant, or care provider will be blinded to watch drug the subject receives during each treatment week.
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: insomnia; belsomra; suvorexant

Summary:

      Phase IV 3-Way Double-blind, Randomized, Crossover Study to Compare the Awakening Threshold
      Effects (responsivity) of Belsomra 10 mg and 20 mg to Placebo in non-elderly Insomniacs
    

Eligibility criteria:

        Inclusion Criteria

          -  Meets DSM-5 ( Diagnostic and statistical manual) diagnostic criteria for insomnia
             disorder

          -  ISI ( Insomnia Severity Index) > 10

          -  Age >18 and < 65

          -  Negative audiological screening exam

        Exclusion Criteria:

          -  BMI >35 kg/m2

          -  Have symptoms consistent with the diagnosis of any sleep disorder other than insomnia
             (e.g., sleep apnea, narcolepsy, periodic leg movements, or restless leg syndrome).

          -  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 or exaggerated pharmacological sensitivity, hypersensitivity, or
             intolerance to Belsomra.

          -  Currently taking CYP3A inhibitors.

          -  Positive breathalyzer test for alcohol at Screening, PSG Screening or any Treatment
             night, or a positive urine drug screen (for amphetamines, barbiturates,
             benzodiazepines, cocaine, opiates, or cannabinoids) at Screening;

          -  History of hearing difficulty (e.g., use of a hearing aid).

          -  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 > 14
             alcoholic beverages weekly over the past week;

          -  Have a history of epilepsy or serious head injury

          -  Average Time in Bed < 6.5 hrs.

          -  Have used prescribed or OTC medications within 7 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. This restriction includes taking medications that affect
             the Central nervous system. Any chronic maintenance therapy should have been
             maintained at a stable dosing regimen for at least 30 days before screening and
             subjects must continue this regimen throughout the study.

          -  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 belsomra or zolpidem