Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
Condition: Insomnia Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: ACT-541468 5 mg; ACT-541468 10 mg; ACT-541468 25 mg; Zolpidem; Placebo 1; Placebo 2
Intervention description: Capsule for oral administration containing ACT-541468 at a strength of 5 mg; Capsule for oral administration containing ACT-541468 at a strength of 10 mg; Capsule for oral administration containing ACT-541468 at a strength of 25 mg; Over-encapsulated zolpidem tablet at a strength of 10 mg; Placebo capsules matching ACT-541468 capsules; Placebo capsules matching over-encapsulated zolpidem
Intervention MeSH terms: Zolpidem
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 360.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Insomnia; Polysomnography

Summary:

      This study evaluates the dose response of ACT-541468 on the change of WASO from baseline to
      Days 1 and 2, assessed by PSG.
    

Eligibility criteria:

        Principal inclusion Criteria:

          -  Signed informed consent prior to any study-mandated procedure.

          -  Male or female aged 18-64 years (inclusive).

          -  Women of childbearing potential must have negative pregnancy tests and use reliable
             methods of contraception up to 30 days after EOT.

          -  Body mass index (BMI): 18.5 ≤ BMI (kg/m2) < 32.0.

          -  Insomnia disorder according to DSM-5 criteria.

          -  Insufficient sleep quantity as collected subjectively in the sleep diary and validated
             objectively by polysomnography.

          -  Insomnia Severity Index score ≥ 15.

        Principal exclusion Criteria:

          -  Any current history of sleep disorder other than insomnia, or any lifetime history of
             related breathing disorder, periodic limb movement disorder, restless legs syndrome,
             circadian rhythm disorder, rapid eye movement (REM) behavior disorder, or narcolepsy.

          -  Self-reported usual daytime napping ≥ 1 hour per day, and ≥ 3 days per week.

          -  Caffeine consumption ≥ 600 mg per day.

          -  Shift work within 2 weeks prior to the screening visit, or planned shift work during
             study.

          -  Travel ≥ 3 time zones within 1 week prior to the screening visit, or planned travel >
             or= 3 time zones during study.

          -  Hematology or biochemistry test results deviating from the normal range to a
             clinically relevant extent as per judgment of the Investigator.

          -  AST and/or ALT > 2 × ULN and/or direct bilirubin > 1.5 × ULN (except known history of
             Gilbert's syndrome).

          -  Severe renal impairment (known or defined as estimated creatinine clearance < 30
             mL/min).

          -  History or clinical evidence of any disease or medical condition or treatment, which
             may put the subject at risk of participation in the study or may interfere with the
             study assessments.

          -  Any circumstances or conditions, which, in the opinion of the investigator, may affect
             the subject's full participation in the study or compliance with the protocol.