Evaluating Trazodone for Treating Insomnia in Adults 65 and Older A Randomized Crossover Study

What this Trial Is About

Researchers are evaluating the effectiveness of trazodone in treating insomnia in adults aged 65 years and older. The main goal is to determine if trazodone reduces the severity of insomnia symptoms better than a placebo in this older population. This study is a randomized controlled trial sponsored by the Centre hospitalier de lUniversite de Montreal CHUM. Participants are adults who meet criteria for insomnia according to ICSD-3R guidelines. Participants will receive either 25 to 50 mg of trazodone or a matching placebo once daily at bedtime for 28 days. After a 14-day break without treatment, they will switch to the other medication for an additional 28 days. This crossover design allows each participant to try both trazodone and placebo in sequence. The trazodone dose may be increased from 25 mg to 50 mg after 14 days. The study includes two treatment periods separated by a washout period. During the study, participants will visit the clinic three times for checkups and testing. They will complete a sleep diary and wear an actimeter a device to measure movement at night to track sleep patterns. Researchers will assess insomnia severity using the Insomnia Severity Index at the start, day 36, and day 77. Other sleep measures and potential side effects will also be monitored throughout the study. Total participation lasts approximately 12 weeks, including treatment and washout periods.

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