A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3)
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Suvorexant; Dose-matched Placebo to Suvorexant
Intervention description: Oral tablet (30 mg and 10 mg), administered daily before bedtime; Oral tablet, administered daily before bedtime
Intervention MeSH terms: Suvorexant
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 781.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will establish the safety and tolerability of suvorexant (MK-4305) when
      administered for up to 14 months. Participants will be randomized to receive suvorexant or
      placebo for a 12-month double-blind (DB) Treatment Phase. Participants who complete the
      12-month DB Treatment Phase will enter a 2-month DB Randomized Discontinuation Phase. At the
      time of initial randomization, participants assigned to receive suvorexant during the initial
      12-month Treatment Phase will be simultaneously randomized, in a 1:1 ratio, to receive either
      suvorexant or placebo during the 2-month Randomized Discontinuation Phase. Participants
      randomized to receive placebo in the initial 12-month Treatment Phase will continue to
      receive placebo during the 2-month Randomized Discontinuation Phase.

      The first 3 nights of the Randomized Discontinuation Phase are referred to as the Run-Out
      Phase, and will assess rebound and withdrawal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary insomnia

          -  Participant is able to read, understand, and complete questionnaires and diaries

          -  If female, participant and partner both agree to use acceptable contraception. If male
             partner does not use an effective form of contraception, female participant must use 2
             acceptable forms of contraception

          -  If ≥65 years of age, score of ≥25 on the Mini Mental State Examination (MMSE)

        Exclusion Criteria:

          -  If female, participant is pregnant

          -  Participant expects to donate eggs or sperm during the study

          -  Recent and/or active history of a confounding neurological disorder

          -  History of clinically unstable cardiovascular disorder within the last 6 months

          -  Lifetime history of bipolar disorder

          -  Psychiatric condition that requires treatment with a medication prohibited by the
             study, or any other psychiatric condition that would interfere with the participant's
             ability to participate in the study

          -  History of substance abuse/dependence

          -  History of cancer ≤5 years prior to study participation except for adequately treated
             basal cell or squamous cell skin cancer or in situ cervical cancer

          -  Evidence of suicidality (based on a score of 2 on the Quick Inventory of Depressive
             Symptomatology Self-Report 16-Item ([QIDS-SR16] suicide item #12)

          -  Participant has travelled across >3 time zones or >3 hour time difference in the last
             2 weeks

          -  History of permanent night shift work or rotating day/night shift work in the past 2
             weeks

          -  Body Mass Index (BMI) >40 kg/m^2