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

Launched by CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL (CHUM) · May 13, 2025

Keywords

ClinConnect Summary

The TRADITION Study is a clinical trial that is looking at how effective a medication called trazodone is for treating insomnia in older adults aged 65 and above. The main goal of this study is to find out if trazodone can help reduce insomnia symptoms better than a placebo (a dummy pill that has no active ingredients). Participants will take either trazodone or the placebo before bedtime for 28 days, followed by a two-week break, and then switch to the other treatment for another 28 days. They will also visit the clinic three times for check-ups, keep a sleep diary, and wear a device that tracks their sleep patterns.

To join this study, participants need to be 65 or older and have insomnia as defined by specific medical guidelines. However, there are certain health conditions and medications that would exclude someone from participating, such as having a heart condition, currently taking other sleep medications, or having severe cognitive issues. This study is not yet recruiting participants, so those interested will need to wait until it begins. It’s important for potential participants to understand that their health will be closely monitored throughout the trial to ensure their safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Individuals aged 65 or older in an outpatient setting
• • Insomnia according to the criteria of the ICSD-3R
• 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.