ID-078-302: Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects Suffering From Difficulties to Sleep

The main purpose of this Phase 3 study is to evaluate the efficacy of 10 mg and 25 mg ACT-541468 on objective sleep parameters in subjects with insomnia disorder.

Inclusion Criteria:

• Signed informed consent prior to any study-mandated procedure;
• Male or female aged ≥ 18 years;
• Insomnia disorder according to DSM-5 criteria;
• Insomnia Severity Index score ≥ 15;
• Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography;
• Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake.