A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia

Inclusion Criteria:

• Signed and dated informed consent form (ICF) prior to any study-mandated procedure.

• Male or female subjects ≥ 55 years old at the time of signing the ICF.

• Insomnia complaints for at least 3 months prior to Visit 1.

• Insomnia Severity Index© (ISI©) score ≥ 13 at Visit 1.

• Nocturia severity: on average ≥ 3 nocturnal voids per night reported by the subjectsfor at least 1 month prior to Visit 1.

• Ability to communicate well with the investigator, to understand the studyrequirements and judged by the investigator to be alert and oriented to person,place, time, and situation.

Exclusion Criteria:

• Woman of childbearing potential, pregnant or plans to become pregnant.

• Planned travel across ≥ 3 time zones during study.

• Life time history of suicidality assessed via Columbia Suicide Severity RatingScale© (C-SSRS©).

• Regular caffeine consumption after 4 pm.

• Unable to refrain from smoking during the night.

• Known and documented diagnosis of narcolepsy, periodic limb movement disorder,moderate to severe obstructive sleep apnea, restless legs syndrome, circadian rhythmsleep-wake disorder, or rapid eye movement (REM) sleep behavior disorder.

• Known and documented diagnosis of Type 1 diabetes mellitus, uncontrolled Type 2diabetes mellitus, central or nephrogenic diabetes insipidus, and primary/secondarypolydipsia.

• Known and documented nocturia linked to urinary tract infection, neoplasms ofbladder, prostate or urethral cancer, bladder or urethral calculi, or neurogenicvoiding dysfunction within the last 6 months prior to Visit 1.

• Any known factor or disease that might interfere with treatment compliance, studyconduct, or interpretation of the results, such as drug or alcohol dependence orpsychiatric disease.