A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder

Exclusion Criteria

• •Body mass index (BMI) ≥ 40.0 kg/m2
• •Documented medical history and/or comorbidity of sleep-related breathing disorder
• •History of and/or concurrent sleep apnea or suspected sleep apnea
• •Korean-Mini Mental State Examination-2 (K-MMSE-2) score \< 25 in subjects ≥ 50 years;
• •For female subjects: pregnant, lactating or childbearing potential who do not consent to true abstinence or use an effective method of contraception for required period
• •Initiation of the cognitive behavior therapy (CBT) for treatment of insomnia disorder within 4 weeks prior to the Screening visit (Visit 1) or planned CBT during the study
• •A history of moderate to severe hepatic impairment (eg, Child-Pugh Class B or C)
• •Positive urine drug test or presence of alcohol in exhaled breath as detected by breathalyzer test.