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Background: Dementia is associated with progressive cognitive impairment and behavioral and psychological symptoms. Sleep-wake cycle disturbances are common in patients with dementia. This study evaluated the efficacy and safety of risperidone in the treatment of the behavioral and psychological symptoms of dementia (BPSD) and associated sleep-wake cycle disturbances.Methods: In this open-label, 12-week, observational, prospective study, the effects of risperidone were assessed using the Neuropsychiatric Inventory (NPI) total and subscale scores. Sleep-wake cycle disturbances were rated by patients/caregivers using a newly developed sleep behavior questionnaire that included assessment of sleep duration, quality, awakenings, and effects on daily activities. Tolerability assessments included the Udvalg for Kliniske Undersogelser (UKU) subscale for extrapyramidal symptoms (EPS) and the recording of adverse events.Results: A total of 338 patients entered the study, with 321 patients completing. Following 12 weeks of risperidone treatment (mean dose 1.49 mg/day at end-point), the mean NPI score was reduced to 10.6 from a baseline score of 28.7. Compared with baseline, patients/caregivers reported significant improvements following 12 weeks of risperidone in total sleep hours at night (5.5 vs. 7.1 hours), hours awake in bed at night (2.3 vs. 1.2 hours), insomnia (40.1% vs. 8.4%), and other sleep-related variables. Six patients reported a total of 10 adverse events, including somnolence (n = 3) and sialorrhea (n = 2). Scores on the UKU subscale of EPS improved significantly (mean 4.0 at baseline vs. 1.7 at week 12).Conclusions: Risperidone is effective and well tolerated in the treatment of BPSD and associated sleep disturbances. [ABSTRACT FROM AUTHOR]