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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ur…