OBJECTIVE: To determine the efficacy and safety of risperidone compared to placebo and haloperidol in the treatment of behavioral and psychological symptoms of dementia. METHODOLOGY: In a systematic review of literature, all articles published from January 1990 - September 2005 that conducted double-blind, randomized controlled clinical trials evaluating the efficacy and safety of risperidone and haloperidol for the treatment of BPSD were selected. The search was performed by means of MEDLINE, PUBMED, Cochrane Library database limited to studies written in English from 1990 to 2005. Key journals and textbooks were also searched in addition to the electronic database search. References mentioned in these studies were likewise reviewed. Two reviewers independently did validity assessment. Analysis of data was done by statistical packs Revman 4.2.7 from Cochrane Collaboration and SPSS (statistical package for the social sciences) v 9.0. RESULTS: Five trials were included in this study. A total of 964 patients were evaluated. Risperidone was superior to placebo as evidenced by significant reduction in the scores of total BEHAVE-AD score (WMD = 2.97, 95% CI = 1.65 - 4.29), BEHAVE-AD aggression subscale (WMD = 1.40, 95% CI = 1.34 - 1.46), and CMAI total aggression subscale (WMD = 3.82, 95% CI = 3.04 - 4.60). Comparison of risperidone and haloperidol showed significant reduction in the total BEHAVE- AD score in patients receiving risperidone (WMD = 1.80, 95% CI = 0.43 - 3.18). Comparing the odds ratio of having an adverse effect, analysis revealed greater chance of developing somnolence (OR = 1.88, 95% CI = 1.27 - 2.77), peripheral edema (OR = 2.43, 95% CI = 1.29 - 4.59) and extrapyramidal symptoms (OR = 1.93, 95% CI = 1.04 - 3.61) with risperidone. CONCLUSION: Risperidone is effective and relatively safe in the treatment of behavioral and psychological symptoms of dementia. Higher incidence of somnolence, peripheral edema and extrapyramidal symptoms was noted with risperidone compared to placebo. Compared with haloperidol, risperidone was superior in the total BEHAVE- AD scale and showed more favorable results in the total CMAI scale, BEHAVE-AD aggression and CMAI total aggression subscales.