The objective of this study was to evaluate the antipsychotic drug prescribing pattern in the Italian general population, elderly, and especially elderly with dementia, in relation to the safety warnings issued by international regulatory agencies about the risk of cerebrovascular adverse events and mortality in 2004 and 2005. A cohort study was conducted using the electronic medical records of the Italian general practice database 'Health Search/Thales'. On the basis of prescription data, 1-year and monthly prevalence estimates were calculated for atypical and typical antipsychotic use in general population, elderly, and elderly demented outpatients. One-year prevalence of individual medication use in elderly demented patients was calculated as well. The prevalence of use of atypical agents in demented patients progressively increased from 2000 [0.2 (0.05-0.7) per 10 000] until the beginning of 2004 [9.7 (8.1-11.6) per 10 000], after which a slight decrease started, whereas the prevalence of use of typical antipsychotics decreased from 2001 [15.7 (13.5-18.2) per 10 000] until 2004 [10.7 (9.0-12.7) per 10 000], then slightly increased in December 2005 [12.1 (10.4-14.2) per 10 000]. Monthly trends in general population and elderly were quite similar and differed significantly from the trend in elderly with dementia: stable use of atypicals from 2002 to 2005 and strong reduction of typicals from 2001 to the end of 2004. The recent safety warnings led to an increasing trend in the use of typical agents and decreasing trend in the use of atypical agents in elderly demented outpatients in Italy. Similar trends were not observed in general population and elderly as a whole.