Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study)

Exclusion Criteria

• •Contraindication to trazodone (hypersensitivity)
• •Presence of a ventricular cardiac arrhythmia (e.g., torsades de pointes)
• •Recent myocardial infarction (\< 6 months)
• •Substances that may alter sleep (hypnotics or any other medication intended to induce sleep, such as mirtazapine or quetiapine, corticosteroids, melatonin, psychostimulant drugs)
• •Active, unstable psychiatric disorder
• •Initiation or titration of an antidepressant within the past 6 months
• •Cognitive-behavioral therapy ongoing or planned during the study period
• •Major neurocognitive disorder (NCD) moderate or severe, or other cognitive disorders that may prevent the participant from being able to participate in the study, according to the judgment of the evaluating physician
• •Parkinson's disease
• •Priapism
• •Known angle-closure glaucoma
• •Symptomatic restless leg syndrome \> 3 times per week
• •QTc interval \> 500 ms
• •Parasomnias, dyssomnias other than insomnia
• •Severe sleep apnea with AHI \> 30 without CPAP treatment
• •Use of a monoamine oxidase inhibitor
• •Use of a strong CYP 3A4 inducer or inhibitor
• •Hospitalized individuals
• •Seizure within the past 6 months
• •History of orthostatic hypotension
• •History of delirium within the last 6 months
• •Consumption of \> 14 alcoholic drinks per day or use of alcohol to induce sleep.