Trazodone is a Serotonin-2A Antagonist/Reuptake Inhibitor (SARI) that combines its ability as a 5/HT2A receptor antagonist with some serotonin reuptake blockade actions. Studies support its use in the treatment of behavioral disturbances in patients with Alzheimer's disease and frontotemporal dementia.

To evaluate the effectiveness of trazodone in behavioral symptoms and caregiver burden in elderly patients with dementia.

In 49 patients (males and females) older than 65 years with dementia (DSM-IV), trazodone was associated to the standard treatment in a single night variable dose (50–200 mg). On days 0, 14 and 42 neuropsychiatric disorders and caregiver burden (Neuropsychiatric Inventory-Nursing Home Version, NPI-NH) were assessed. On days 0 and 42 cognitive impairment was measured by the test Mini-Mental State Examination (MMSE). The Clinical Global Impression (CGI) was administered on the last visit. Statistical evaluation was done by SPSS 17®.

38 patients completed the study. Global score NPI-NH was significantly reduced (p < 0.001). Sleep quality subscale improved significantly (p < 0.001). The MMSE was not modified. The caregiver burden showed a significant decrease (p < 0.001) on each visit.

Trazodone was well tolerated (main adverse effects were: hypotension (4.1%) and somnolence (2%). Patients evolution was positive (CGI).

Results of this study suggest that trazodone is an effective treatment for behavioral symptoms of dementia. Trazodone reduces caregiver burden without modifying the patient’s cognitive function.