Antipsychotic off-label use in the 21st century: An enduring public health concern.

Dialogues Clin Neurosci

University Bordeaux, Inserm, Bordeaux Population Health Research Center, Team Pharmacoepidemiology, UMR 1219, Bordeaux, France.

Published: December 2025

Soon after the introduction of second-generation antipsychotics, antipsychotic off-label use (OLU) progressively became a common prescribing practice. This evolving practice should be regularly monitored considering the growing number of persons exposed to the adverse effects of antipsychotics. The aim of the present review was to synthesise the literature published over the last 15 years on antipsychotic OLU for mental health symptoms. Observational studies confirm the persisting high rate of antipsychotic OLU prescription in two out of three youths and 30-60% of adults using antipsychotics. Increasing rates of low-dose quetiapine prescriptions for anxiety or sleep symptoms are paradigmatic of the current public health concern regarding antipsychotic OLU. Such prescriptions receive impetus from industry-funded marketing strategies and prescribers' feeling of innocuousness, with a resulting underestimation of the risk of adverse drug reactions (ADR). However, antipsychotic OLU should be neither trivialised nor demonised since it may be the only therapeutic option in persons with resistant psychiatric disorders or serious ADR with labelled drugs. To reduce the populational impact of antipsychotic OLU, it is necessary to better control the influence of the pharmaceutical industry regarding newly marketed drugs and to better inform prescribers and users about the risks associated with OLU prescribing.

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http://dx.doi.org/10.1080/19585969.2025.2449833DOI Listing

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Antipsychotic off-label use in the 21st century: An enduring public health concern.

Dialogues Clin Neurosci

December 2025

University Bordeaux, Inserm, Bordeaux Population Health Research Center, Team Pharmacoepidemiology, UMR 1219, Bordeaux, France.

Soon after the introduction of second-generation antipsychotics, antipsychotic off-label use (OLU) progressively became a common prescribing practice. This evolving practice should be regularly monitored considering the growing number of persons exposed to the adverse effects of antipsychotics. The aim of the present review was to synthesise the literature published over the last 15 years on antipsychotic OLU for mental health symptoms.

View Article and Find Full Text PDF

Objective: Only little is known about antipsychotic (AP) off-label use (OLU) in pediatric populations. It was the aim of this study to examine the frequency as well as the risks of off-label AP use in underaged patients.

Methods: To calculate the frequency of off-label AP prescriptions for the years 2004-2011, we used claims data of more than two million minors aged 0-17 years.

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