A Study of the Effect of Daridorexant on Nighttime Body Posture, the Noise Level Required to Wake up, and the Ability to Remember Words Previously Presented

A Study of the Effect of Daridorexant on Nighttime Body Posture, the Noise Level Required to Wake up, and the Ability to Remember Words Previously Presented

Inclusion Criteria:Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.Male and female subjects aged 18 years or older at Screening (18 subjects must be 65 years or older).Woman of childbearing potential (WoCBP) who has a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 pre-dose. She must agree to use consistently and correctly (from Screening, during the entire study, and for at least 5-7 days after last study treatment administration) an acceptable method of contraception with a failure rate of less than 1% per year, be sexually inactive, or have a vasectomized partner. If a hormonal contraceptive is used, it must be initiated 1 month before first treatment administration.Woman of non-childbearing potential, i.e., postmenopausal (defined as 12 consecutive months with no menses without an alternative medical cause, confirmed by a follicle-stimulating hormone [FSH] test), with previous bilateral salpingectomy, bilateral-oophorectomy or hysterectomy, or with premature ovarian failure (confirmed by a specialist), XY genotype, Turner syndrome, or uterine agenesis.Body mass index (BMI) of 18.0 to 35.0 kg/m2 (inclusive) at Screening.Ability to communicate well with the investigator, in a language understandable to the subject, and to understand and comply with the study requirements.Exclusion Criteria:Known hypersensitivity to daridorexant, or treatments of the same class, or any of its excipients.Any known factor or disease (e.g., unstable medical condition, significant medical disorder, or acute illness) that might interfere with subject's safety, study conduct, or interpretation of the results, such asHistory of narcolepsy.Shift work within 2 weeks prior to Screening, or planned shift work during the study.Travel across 3 or more time zones within 1 week prior to Screening, or planned travel across 3 or more time zones during the study.Previous (i.e., within 2 weeks prior to first study treatment administration) and ongoing treatment with any prescribed central nervous system (CNS)-active medications, and/or diuretics that would affect nighttime rest, and/or moderate to strong cytochromes P450(CYP)3A4 inhibitors or inducers.