A large registry-based investigation conducted in Finland by researchers from the University of Oulu and the University of Eastern Finland has found that a substantial number of older adults are prescribed antipsychotic medications for conditions that fall outside their officially approved medical indications. This practice, commonly known as off-label prescribing, occurs when physicians use a medication to treat symptoms or disorders not specified in the drug’s regulatory approval. While off-label prescribing is legal and sometimes clinically justified, the study highlights how frequently it occurs among older adults and raises questions about the circumstances that lead to such prescribing patterns.
The research team examined comprehensive national registry data covering 209,346 community-dwelling older adults in Finland who did not have Alzheimer’s disease. By analysing this large population dataset, the investigators were able to explore patterns of antipsychotic medication use among older people living at home rather than in institutional care settings. Participants were divided into three comparison groups: individuals who received antipsychotics for conditions that were not officially approved indications, patients who were prescribed these medications for approved indications, and individuals who were not using antipsychotic drugs at all.
The analysis revealed a striking pattern. Approximately 70 per cent of all antipsychotic use in the study population occurred in situations classified as off-label. In addition to being common, off-label prescribing also increased during the study period, suggesting a growing reliance on these medications outside their formally approved uses. Among the drugs involved, risperidone and quetiapine were the most frequently prescribed antipsychotics for off-label purposes.
Doctors sometimes prescribe antipsychotic medications to older patients in an attempt to manage persistent behavioural symptoms, agitation, or sleep disturbances. However, these conditions are generally not included among the medications’ approved indications. Earlier research has raised concerns about this pattern of prescribing, particularly when non-pharmacological approaches are not attempted first. Some experts have argued that relying on these medications without exploring alternative strategies may even constitute a form of elder mistreatment. Structural challenges in elderly care—including limited staffing, insufficient resources, and restricted access to non-drug interventions—may contribute to the increasing use of antipsychotics in these circumstances.
The Finnish registry study also identified important differences in the health profiles of patients receiving antipsychotics off-label. Compared with individuals in the other study groups, off-label users were more likely to have cardiovascular diseases and cerebrovascular disorders. They were also more frequently prescribed opioid medications, which may indicate more complex health conditions or symptom management challenges.
According to Tuomas Majuri, a postdoctoral researcher at the University of Oulu involved in the study, this finding was particularly unexpected. Off-label users, he explained, actually showed higher rates of cardiovascular and cerebrovascular conditions than patients who were prescribed antipsychotics for approved indications such as psychotic disorders. Majuri suggested that this pattern may reflect inadequate monitoring of the metabolic and cardiovascular side effects associated with antipsychotic medications when they are used outside their intended indications.
The researchers emphasise that their findings highlight an urgent need to develop better treatment options for symptoms that are currently managed through off-label antipsychotic prescribing. They argue that clearer clinical guidelines are necessary to ensure appropriate monitoring of potential metabolic side effects and to encourage safer prescribing practices. Expanding access to non-pharmacological treatments and strengthening support within elderly care systems may also help reduce reliance on these medications in situations where safer alternatives could be used.
More information: Tuomas Majuri et al, Characteristics and predictors of antipsychotic medication off-label use among community-dwelling older people, Nordic Journal of Psychiatry. DOI: 10.1080/08039488.2026.2631597
Journal information: Nordic Journal of Psychiatry Provided by University of Oulu, Finland
