To assess the incidence, likely indication, and extent of off-label antipsychotic use among children and adolescents in Sweden.
Approach:
Study Design: Nationwide register-based study identifying individuals younger than 18 years with at least one antipsychotic dispensing from 1 January 2008 to 31 December 2021.
Data Analysis: Estimated yearly age-standardised and sex-standardised incidence per 1000 persons and assessed temporal trends using Poisson log-linear regression.
Indication Assessment: Evaluated likely indications and the proportion of on-label and off-label use.
Key Findings:
24,742 children and adolescents initiated antipsychotic treatment, contributing to 25,576 incident dispensings.
Incidence increased from 0.48 to 1.28 per 1000 persons (risk ratio, RR per year 1.08, 95% CI 1.05 to 1.11; cumulative increase 180%).
The rise was more pronounced in females (0.43 to 1.51 per 1000; RR 1.11, 95% CI 1.10 to 1.12; 284%) than males (0.53 to 1.06 per 1000; RR 1.06, 95% CI 1.05 to 1.07; 113%), particularly among adolescents aged 12–17 years.
Quetiapine and aripiprazole showed the largest drug-specific increases, with quetiapine increasing from 0.04 to 0.33 per 1000 (RR per year 1.18, 95% CI 1.17 to 1.19; cumulative increase 804%) and aripiprazole from 0.03 to 0.36 per 1000 (RR per year 1.16, 95% CI 1.14 to 1.18; cumulative increase 608%).
64.3% of incident dispensings had a likely indication, with autism spectrum disorder (15.4%) and ADHD (10.9%) being the most common.
81% of dispensings with identifiable indications were off-label.
Interpretation:
Limitations:
Limited data on long-term outcomes of antipsychotic use in children and adolescents.
Potential underreporting of indications or misclassification in the register data.
