Trazodone for insomnia in adults 65 and older
The Efficacy of Trazodone for the Treatment of Insomnia in Older Adults: A Randomized Controlled Trial (The TRADITION Study)
This trial will test whether taking low-dose trazodone at bedtime helps reduce insomnia symptoms in adults aged 65 and older compared with a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06983080 on ClinicalTrials.gov |
What this trial studies
This phase 2, randomized, placebo-controlled crossover trial gives participants 25–50 mg of trazodone or a matching placebo each night for 28 days, followed by a 2-week washout and 28 days on the alternate treatment. Participants keep a sleep diary, wear a night-time actimeter, and attend three clinic visits for checks and outcome measures. The trial enrolls outpatient adults aged 65 and older who meet ICSD-3R criteria for chronic insomnia and excludes those with contraindications to trazodone or major medical/psychiatric conditions that affect sleep. Outcomes focus on change in insomnia severity and objective sleep measures over the treatment periods.
Who should consider this trial
Good fit: Ideal candidates are outpatient adults aged 65 or older with chronic insomnia per ICSD-3R who are not using other sleep-inducing medications and have no contraindications to trazodone.
Not a fit: People with contraindications to trazodone (for example certain heart rhythm problems, recent myocardial infarction), active unstable psychiatric illness, major neurocognitive disorder, Parkinson's disease, or those already taking hypnotics or other sleep drugs are unlikely to be eligible or benefit from participation.
Why it matters
Potential benefit: If successful, the treatment could improve sleep quality and reduce insomnia symptoms in older adults, offering a possible low-dose medication option.
How similar studies have performed: Some small studies and clinical experience suggest trazodone can improve sleep, but high-quality randomized evidence specifically in older adults is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Montreal, Quebec
- Centre Hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Patrick Nguyen, B. Pharm, M.Sc.
- Email: patrick.nguyen.chum@ssss.gouv.qc.ca
- Phone: 514-890-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.