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Asenapine tablets (Saphris, Schering-Plough) have been approved to treat both schizophrenia and bipolar I disorder in adults.
A boxed warning is included to alert prescribers about an increased risk of death associated with the off-label use of this atypical antipsychotic medication for treating behavioral problems in older people with dementia-related psychosis. Asenapine is not approved for these patients.
In various trials, asenapine showed superior efficacy, compared with placebo, in reducing symptoms of schizophrenia and bipolar drug disorder.
Source: FDA, August 14, 2009
