National Trends in Off-Label Use of Atypical Antipsychotics in Children and Adolescents in the United States
Open accessAbstract
The objectives of the study were as follows: to examine the national trend of pediatric atypical antipsychotic (AAP) use in the United States; to identify primary mental disorders associated with AAPs; to estimate the strength of independent associations between patient/provider characteristics and AAP use. Data are from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey. First, average AAP prescription rates among 4 and 18-year-old patients between 1993 and 2010 were estimated. Second, data from 2007 to 2010 were combined and analyzed to identify primary mental disorders related to AAP prescription. Third, a multivariate logistic regression model was developed having the presence of AAP prescription as the dependent variable and patient/provider characteristics as explanatory variables. Adjusted odds ratios (AORs) with associated 95% confidence intervals (CIs) were estimated. Outpatient visits including an AAP prescription among 4 to 18-year-old patients significantly increased between 1993 and 2010 in the United States, and over 65% of those visits did not have diagnoses for US Food and Drug Administration-approved AAP indications. During 2007 to 2010, the most common mental disorder was attention-deficit hyperactivity disorder, accounting for 24% of total pediatric AAP visits. Among visits with attention-deficit hyperactivity disorder diagnosis, those with Medicaid as payer (AOR 1.66, 95% CI 1.01-2.75), comorbid mental disorders (e.g., psychoses AOR 3.34, 95% CI 1.35-8.26), and multiple prescriptions (4 or more prescriptions AOR 4.48, 95% CI 2.08-9.64) were more likely to have an AAP prescription. The off-label use of AAPs in children and adolescents is prevalent in the United States. Our study raises questions about the potential misuse of AAPs in the population.
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Off-label use of low-dose second-generation antipsychotics for indications like sleep and anxiety is increasingly being prescribed.
“off-label use of low dose second generation antipsychotic for indications like sleep and anxiety, as this might create equally serious weight problems and is increasingly being prescribed (98).”
From Reversibility of Antipsychotic-Induced Weight Gain: A Systematic Review and Meta-Analysis (2021) · cites this paper as [98]
The Discussion (page not provided) reports increasing off-label prescribing of atypical antipsychotics in pediatric outpatient visits. The paper does not establish that the increase involved low-dose prescriptions specifically for sleep or anxiety; its Results instead identify ADHD as the most common primary diagnosis among visits without an FDA-approved indication. (LLM, conf=0.88)
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Verhaegen, A. A., & Van Gaal, L. F. (2021) · Current Obesity Reports · doi:10.1007/s13679-020-00419-5 · Cited by 53 · see citing works
Reversibility of Antipsychotic-Induced Weight Gain: A Systematic Review and Meta-Analysis
Speyer, H., Westergaard, C., Albert, N., Karlsen, M., Stürup, A. E., Nordentoft, M., & Krogh, J. (2021) · Frontiers in Endocrinology · doi:10.3389/fendo.2021.577919 · Cited by 44 · see citing works
- Authors
- Sohn, M., Moga, D. C., Blumenschein, K., & Talbert, J.
- Affiliations
- United States Food and Drug Administration (US)
- Corresponding author
- Sohn, Minji
- Venue
- Medicine
- Published
- 2016-06
- Volume
- 95
- Issue
- 23
- Pages
- e3784
- ISSN
- 0025-7974 (ISSN-L)
- PMC
- PMC4907659
- OpenAlex
- W2466519839
- Cited by
- 102
- References
- 0
- Citations by year
- 2026: 10 · 2025: 5 · 2024: 6 · 2023: 9 · 2022: 9 · 2021: 14 · 2020: 16 · 2019: 11 · 2018: 11 · 2017: 10 · 2016: 1
- FWCI
- 11.11
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc-nd
- Locations
- Medicine (publishedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- UKnowledge (University of Kentucky) (submittedVersion, cc-by-nc-nd)
- Topics
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Social Sciences › Psychology › Social Psychology › Mental Health Treatment and Access
- Keywords
- atypical antipsychotics, off-label drug use, pediatric prescribing, children and adolescents, attention deficit hyperactivity disorder, Medicaid, comorbid mental disorders, psychosis, prescribing trends, outpatient visits
- MeSH terms
- Adolescent, Attention Deficit Disorder with Hyperactivity, Child, Child, Preschool, Cross-Sectional Studies, Drug Utilization, Follow-Up Studies, Humans, Population Surveillance, Psychotic Disorders, Retrospective Studies, Antipsychotic Agents, United States, Incidence, Off-Label Use
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