Warning: Increased Mortality in Elderly Patients with Dementia-related Psychosis

---------------------------INDICATIONS AND USAGE----------------------------­ SAPHRIS is an atypical antipsychotic indicated for: • Treatment of schizophrenia. (1.1) Efficacy was established in two 6-week clinical trials and one maintenance trial in patients with schizophrenia in adults. (14.1) • Acute treatment, as monotherapy or adjunctive therapy, of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 3-week monotherapy trials and in one 3-week adjunctive trial in patients with manic or mixed episodes associated with bipolar I disorder in adults. (14.2)