A Post Approval Study to Investigate the Efficacy of Daridorexant in Subjects With Insomnia and Comorbid Nocturia

A post approval study to investigate the efficacy of daridorexant in subjects with insomnia and comorbid nocturia

Inclusion Criteria:Signed and dated 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.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 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 REM sleep behavior disorder.Known and documented diagnosis of Type 1 diabetes mellitus, uncontrolled Type 2 diabetes mellitus, and central or nephrogenic diabetes insipidus.Nocturia linked to urinary tract infection, neoplasms of bladder, prostate or urethral cancer, bladder or urethral calculi, or neurogenic voiding dysfunction.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.