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

Centre hospitalier de l'Université de Montréal (CHUM)

Status and phase: Begins enrollment this month; Phase 2

Conditions: Drug Therapy; Older People; Insomnia Chronic

Treatments: Drug: Trazodone 25 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06983080

2025-12893

Details and patient eligibility

About

This study aims to evaluate how effective trazodone is in treating insomnia in adults aged 65 years and older. The main question it aims to answer is :

• Is trazodone more effective than a placebo in reducing the severity of insomnia symptoms in older adults?

Participants will :

• Take 25 to 50 mg of trazodone or a matching placebo before bed for 28 days. After a 2-week break, they will then take the other medication for another 28 days.
• Visit the clinic three times for checkup and test
• Complete a sleep diary and wear an actimeter during the night.

Enrollment: 40 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

40 participants in 2 patient groups

Crossover Trazodone then Placebo arm

Experimental group

Description:

Participants will receive 25 to 50 mg of trazodone once daily at bedtime for 28 days. After a 14-day washout period, participants will receive a placebo for another 28 days.

Treatment:

Drug: Trazodone 25 mg

Crossover Placebo then Trazodone arm

Experimental group

Description:

Participants will receive a placebo once daily at bedtime for 28 days. After a 14-day washout period, participants will receive 25 to 50 mg of trazodone for another 28 days.

Treatment:

Drug: Trazodone 25 mg