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Asian J Psychiatr. 2009 Mar;2(1):29-36. doi: 10.1016/j.ajp.2009.01.005. Epub 2009 Feb 27.

An analysis of the high psychotropic off-label use in psychiatric disorders The majority of psychiatric diagnoses have no approved drug.

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Case Western Reserve University, Cleveland, OH 44106, United States.



The authors' goals were to determine the extent of unapproved indications in the DSM-IV-TR, to highlight common off-label uses of psychotropic medications and offer insights into the rationale of the widespread off-label prescribing in psychiatry.


Indications for approved psychotropic agents, obtained from the Physicians Desk Reference and the Drug Information Handbook, Clinical Handbook of Psychotropic Drugs, 15th edition, and the Drugs@FDA online database were analyzed in the context of the DSM-IV-TR to determine the percent of DSM-IV-TR disorders that are indications for psychotropic agents. A literature search was performed to determine common off-label uses of major classes of psychotropic medications.


88.5% of all DSM-IV-TR categorized disorders lack an approved medication for their treatment. Atypical Antipsychotics had the most extensive off-label use for DSM-IV-TR categorized disorder, whereas Mood Stabilizers showed the greatest off-label use with regards to disorders and symptoms that are not DSM-IV classified. For each class of medications, more off-label uses exist than FDA-approved uses.


The vast majority of DSM-IV-TR categorized disorders lack approved medications for their treatment. The large unmet need for approved psychiatric indications may explain the widespread off-label use of psychotropic medications in clinical practice.


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