Trazodone for Insomnia in Seniors
(TRADITION Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether trazodone, a medication, reduces insomnia symptoms more effectively than a placebo in people aged 65 and older. Participants will take trazodone or a placebo before bed for 28 days, then switch after a two-week break. The study involves clinic visits, maintaining a sleep diary, and wearing a sleep-tracking device. It suits seniors who struggle with insomnia but do not have certain heart issues, active psychiatric disorders, or regularly use sleep-altering substances. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires that you stop taking any medications intended to induce sleep, like mirtazapine or quetiapine, and certain other medications like monoamine oxidase inhibitors or strong CYP 3A4 inducers or inhibitors. If you're on these, you may need to stop them to participate.
Is there any evidence suggesting that trazodone is likely to be safe for humans?
Research has shown that trazodone is generally well-tolerated for treating insomnia. A review found it effective with minimal risk for most people. However, concerns exist, particularly for seniors. One study noted that trazodone might cause drowsiness, increasing the risk of falls in older adults. Additionally, there is mention of possible sudden muscle movements in elderly patients, although these appear rare. Overall, trazodone is considered safe, but participants should be aware of these potential side effects, especially in older age groups.12345
Why do researchers think this study treatment might be promising for insomnia?
Trazodone is unique because it offers a potential alternative to the standard treatments for insomnia, such as benzodiazepines and non-benzodiazepine sleep aids like zolpidem (Ambien). Unlike these medications, trazodone is primarily an antidepressant that also has sedative properties, which means it may help improve sleep without the same risk of dependency or cognitive side effects. Researchers are excited about trazodone because it could provide seniors with a safer, effective way to manage insomnia, especially since it acts on different neurotransmitter systems, potentially offering a better safety profile.
What evidence suggests that trazodone might be an effective treatment for insomnia in seniors?
Research has shown that trazodone can help treat insomnia by improving sleep quality and reducing early wake-ups. One study found that trazodone helps individuals stay asleep longer without waking up too soon. However, not all studies agree; some found no significant difference compared to a placebo. Another review showed that trazodone works similarly to zolpidem, a well-known sleep aid, in helping people fall asleep faster and sleep better. This trial will evaluate trazodone's effectiveness specifically in older adults, as its effectiveness in this age group still has mixed results. Participants in this trial will experience both treatment arms: one where they receive trazodone first, followed by a placebo, and another where they receive a placebo first, followed by trazodone.14678
Are You a Good Fit for This Trial?
The TRADITION study is for older adults aged 65 and over who are experiencing chronic insomnia. Participants will take trazodone or a placebo before bed for a period, with clinic visits and sleep monitoring involved. Specific inclusion and exclusion criteria details were not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 25 to 50 mg of trazodone or placebo before bed for 28 days, followed by a 14-day washout, then switch to the other medication for another 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Trazodone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor