Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2025 Dec;27(1):1-12.
doi: 10.1080/19585969.2025.2449833. Epub 2025 Jan 10.

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

Hélène Verdoux  1
Affiliations
Review

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

Hélène Verdoux. Dialogues Clin Neurosci. 2025 Dec.

Abstract

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.

Keywords: Antipsychotic; marketing; metabolic; off-label use.

PubMed Disclaimer

Conflict of interest statement

The author reports that there are no competing interests to declare.

Similar articles

See all similar articles

References

    1. Aguglia A, Serafini G, Nebbia J, Salvi V, Martinotti G, Corbo M, Signorelli MS, Mineo L, Mencacci C, Di Sciascio G, et al. . 2021. Off-label use of second-generation antipsychotics in borderline personality disorder: a survey of Italian psychiatrists. J Pers Disord. 35(3):321–335. doi: 10.1521/pedi_2019_33_445. - DOI - PubMed
    1. Alexander GC, Gallagher SA, Mascola A, Moloney RM, Stafford RS.. 2011. Increasing off-label use of antipsychotic medications in the United States, 1995-2008. Pharmacoepidemiol Drug Saf. 20(2):177–184. doi: 10.1002/pds.2082. - DOI - PMC - PubMed
    1. Bastaki K, El Anbari M, Ghuloum S, Jithesh PV.. 2021. Prescription pattern and off-label use of antipsychotics in a middle eastern population. Front Pharmacol. 12:753845. doi: 10.3389/fphar.2021.753845. - DOI - PMC - PubMed
    1. Berge J, Abri P, Andell P, Movahed P, Ragazan DC.. 2022. Associations between off-label low-dose olanzapine or quetiapine and cardiometabolic mortality. J Psychiatr Res. 149:352–358. doi: 10.1016/j.jpsychires.2021.11.023. - DOI - PubMed
    1. Burcu M, Zito JM, Ibe A, Safer DJ.. 2014. Atypical antipsychotic use among Medicaid-insured children and adolescents: duration, safety, and monitoring implications. J Child Adolesc Psychopharmacol. 24(3):112–119. doi: 10.1089/cap.2013.0094. - DOI - PubMed

Substances

LinkOut - more resources