In recent years, the prescribing of psychotropic medications to children and adolescents has surged, driven in part by an increasing awareness of pediatric mental health conditions. However, a growing body of research indicates that a significant proportion of these prescriptions are classified as off-label, meaning the medications are used in a manner not approved by regulatory agencies. A groundbreaking study published in BMC Psychiatry sheds new light on the prevalence and patterns of off-label psychotropic drug use in youth, revealing critical insights that could reshape how clinicians approach pediatric psychopharmacology.
The study represents one of the most comprehensive analyses to date, leveraging data extracted from the Norwegian Prescription Database (NorPD), coupled with firsthand insights from child and adolescent psychiatrists across Norway. Through this dual approach, researchers were able to quantify the extent of off-label prescribing, characterizing the drugs most frequently prescribed, and contextualizing these findings within specific psychiatric diagnoses. Such rigorous methodology ensures that the findings are robust, nuanced, and clinically relevant.
A staggering 55,066 prescriptions were examined, revealing that over half—55%—were prescribed off-label to children and adolescents. This figure is even more pronounced when excluding medications prescribed for hyperkinetic disorders (commonly equated with attention-deficit/hyperactivity disorder, ADHD), where off-label use plummets to a mere 1%. Once these are removed from the equation, off-label prescribing skyrockets to 95%, signifying a widespread tendency to deviate from approved guidelines in most other psychiatric contexts.
This gap underscores the complexity and limitations inherent in pediatric psychopharmacology. Hyperkinetic disorders benefit from a richer evidence base and a more clearly defined pharmacological armamentarium, notably with drugs like methylphenidate enjoying clear regulatory endorsements. In contrast, many other psychiatric diagnoses—such as mood disorders, anxiety, bipolar disorder, and schizophrenia—lack pediatric-specific approvals for many medications, forcing prescribers to extrapolate from adult data or resort to clinical judgment to fill these gaps.
The most commonly prescribed medications reflect this dichotomy. Methylphenidate was unsurprisingly the frontline agent for hyperkinetic disorders, demonstrating low off-label usage. Conversely, quetiapine lead prescriptions for schizophrenia and bipolar disorder, though it is frequently used off-label in youth. Sertraline was the dominant therapeutic choice for depressive and anxiety-related disorders, including obsessive-compulsive disorder, but its application remains predominantly off-label in pediatric populations. These findings illuminate a pattern where certain psychotropic agents are adopted into pediatric practice without rigorous formal approval.
Mood stabilizers, hypnotics, and sedatives emerged as the medication classes with the highest propensity for off-label use—approaching 100%. This trend highlights a critical area of concern given the distinct neurodevelopmental considerations in youth, alongside the profound implications for drug safety and long-term cognitive and emotional development. The widespread off-label application signals an urgent need for expanded clinical trials and post-marketing surveillance tailored specifically to pediatric populations.
The authors of the study emphasize the urgent necessity for ongoing monitoring of psychotropic prescribing practices among children and adolescents. This recommendation aligns with a broader call within psychiatric epidemiology for the establishment of standard guidelines and regulatory frameworks designed to reduce uncertainty and variability in treatment. Enhanced surveillance mechanisms could help identify adverse outcomes earlier and promote safer, evidence-based interventions.
Moreover, this study serves as a catalyst for deeper investigations into the efficacy and adverse effect profiles of psychotropic agents in youth. Currently, the extrapolation of adult efficacy data to children is fraught with scientific and ethical challenges, given developmental neurobiology and the heterogeneity of psychiatric presentations. The substantial off-label use observed suggests that clinicians are compelled to make nuanced decisions that must balance therapeutic benefits against potential risks in the absence of robust pediatric data.
The implications of this research extend beyond Norway and resonate internationally, as similar off-label prescribing trends have been documented globally. Yet, the degree of adherence to approved indications varies significantly across regions and healthcare systems, influenced by regulatory environments, availability of medications, cultural attitudes, and healthcare provider training. Understanding Norway’s data provides a benchmark and a stimulus for comparative studies aimed at harmonizing pediatric psychotropic use worldwide.
In addition to regulatory and clinical ramifications, this research touches on ethical questions surrounding the prescription of psychotropic drugs to vulnerable populations. Children and adolescents with psychiatric conditions often have limited autonomy and depend on caregivers and clinicians to make informed decisions. Thus, the ethical imperative to optimize treatment paradigms calls for transparency, rigorous evidence generation, and safeguarding of pediatric patients from insufficiently studied therapeutic approaches.
Importantly, the study utilized an innovative methodology integrating nationwide prescription data with qualitative survey responses from practicing psychiatrists. This mixed-methods approach not only quantified off-label use but also contextualized prescribing rationales, revealing gaps in guideline dissemination, variations in clinical practice, and the real-world challenges faced by prescribers. Such insights are invaluable in informing policy interventions and continuing medical education focused on pediatric mental health pharmacotherapy.
Ultimately, this landmark investigation into the off-label use of psychotropic drugs among youth provides a clarion call for action across clinical, research, and regulatory domains. It underscores the urgent need to bridge the knowledge gap with high-quality pediatric studies, to develop evidence-based guidelines attuned to developmental nuances, and to implement vigilant pharmacovigilance systems that collectively ensure safe and effective psychiatric care for children and adolescents.
Subject of Research:
Article Title: Off-label use of psychotropic drugs in youth
Article References:
Rosland, H.G., Wergeland, G.J. & Holst, L. Off-label use of psychotropic drugs in youth. BMC Psychiatry 25, 739 (2025). https://doi.org/10.1186/s12888-025-07176-6
Image Credits: AI Generated
DOI: https://doi.org/10.1186/s12888-025-07176-6
Keywords: Psychotropic medications, off-label prescribing, pediatric psychiatry, adolescent mental health, methylphenidate, quetiapine, sertraline, mood stabilizers, hypnotics, sedatives, prescription practices, drug safety, pediatric pharmacology
