Grant: Prize: IHSPR Rising Star Award

Background: Trazodone is increasingly prescribed for behavioral and psychological symptoms of dementia, but little is known about its risk of harm. Our objective was to describe the comparative risk of falls and fractures among older adults with dementia dispensed trazodone or atypical antipsychotics. Methods: We obtained data on long-term care dwelling adults with dementia (excluding patients with chronic psychotic illnesses) aged 66 years and older from routinely-collected, linked health administrative databases in Ontario, Canada. We compared new users of trazodone with new users of atypical antipsychotics (risperidone, olanzapine, quetiapine) between December 1, 2009 and December 31, 2015. The primary outcome was a composite of fall or major osteoporotic fracture within 90 days of first prescription. Secondary outcomes were falls, major osteoporotic fractures, hip fractures, and all-cause mortality. Results: We included 6,588 older adults dispensed trazodone and 2,875 dispensed an atypical antipsychotic, of whom 95.2% received a low dose of these medications. Compared to atypical antipsychotics, trazodone was associated with similar rates of falls or major osteoporotic fractures (weighted hazard ratio (HR) 0.89, 95% CI 0.73 to 1.07), major osteoporotic fracture (weighted HR 1.03, 95% CI 0.73 to 1.47), falls (weighted HR 0.91, 95% CI 0.75 to 1.11), or hip fractures (weighted HR 0.92, 95% CI 0.59 to 1.43). Trazodone was associated with a lower rate of mortality (weighted HR 0.75, 95% CI 0.66 to 0.85). Conclusion: Trazodone is not a uniformly safer alternative to atypical antipsychotics given their similar risk of falls and fractures among older adults with dementia.