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

A Multi-center, Double-blind, Randomized, Placebo-controlled, 2-way Cross-over Post Approval Study to Investigate the Efficacy of Daridorexant in Subjects With Insomnia and Comorbid Nocturia

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 subjects for at least 1 month prior to Visit 1.
• Ability to communicate well with the investigator, to understand the study requirements 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 Rating Scale© (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 rhythm sleep-wake disorder, or rapid eye movement (REM) sleep behavior disorder.
• Known and documented diagnosis of Type 1 diabetes mellitus, uncontrolled Type 2 diabetes mellitus, central or nephrogenic diabetes insipidus, and primary/secondary polydipsia.
• Known and documented nocturia linked to urinary tract infection, neoplasms of bladder, prostate or urethral cancer, bladder or urethral calculi, or neurogenic voiding dysfunction within the last 6 months prior to Visit 1.
• Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.