Efficacy and Safety of ACT-541468 in Elderly With Insomnia Disorder

The study consists of 3 phases: a screening phase, a double-blind treatment phase consisting
of 5 periods, and a safety follow-up phase. Safety is monitored throughout the study.

Inclusion Criteria:

- Signed informed consent prior to any study-mandated procedure.

- Male or female aged ≥ 65 years.

- Body mass index (BMI): 18.5 ≤ BMI (kg/m2 ) < 32.0

- Insomnia disorder according to DSM-5 criteria.

- Self-reported history of insufficient sleep quantity.

- Insufficient sleep quantity as collected subjectively in the sleep diary and validated
objectively by polysomnography.

- Insomnia Severity Index score ≥ 15.

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 ≥
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 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.