Appendix D: Off-Label Use of Antipsychotics

Abilify, an atypical antipsychotic, has been the number one prescription drug in America for several years based on dollar-volume. Sales are $6.29 billion per year. But treatment of psychosis is not what made Abilify the top-selling drug in the United States. Abilify is now widely prescribed as an adjunctive drug for depression; and it is prescribed offlabel for many uses. The manufacturer says Abilify is indicated for: • Use as an add-on treatment to an antidepressant for adults with Major Depressive Disorder who have had an inadequate response to antidepressant therapy • Treatment of manic or mixed episodes associated with Bipolar I Disorder in adults and in pediatric patients 10 to 17 years of age • Treatment of schizophrenia in adults and in adolescents 13 to 17 years of age • Treatment of irritability associated with Autistic Disorder in pediatric patients 6 to 17 years of age The use of Abilify as a multi-purpose drug is part of a larger trend toward use of antipsychotics. Antipsychotic use in the U.S. increased from 6.2 million treatment visits in 1995 to 14.3 million visits by 2008. This was accompanied by a shift from typical agents (often called neuroleptics, although this term is now deprecated), which accounted for 84% of all antipsychotic visits in 1995, to atypical agents, which accounted for