The ANSM warns against the non-compliant use of mianserin in non-depressed seniors. Despite its indication for major depressive episodes, its use in the treatment of sleep disorders in people over 65 is regularly reported. It is an unvalidated use which exposes patients to unnecessary iatrogenic risks.
Mianserin is a medication commonly prescribed for cases of major depression. It happens to be at the heart of concerns linked to its non-compliant use. Indeed, reports indicating inappropriate use of this medication have recently been brought to the attention of the National Agency for the Safety of Medicines and Health Products (ANSM). Faced with this situation, the ANSM issued a warning in a press release published on September 14. It warns against the non-compliant use of mianserin, particularly in people aged over 65 without depression. Prescriptions seeking to treat sleep disorders were noted. This specific use has not yet been the subject of any evaluation or validation within the framework of the Marketing Authorization (AMM).
Misuse in hospitals too
In France, a detailed investigation, published in 2021, looked into the correct use of mianserin-based drugs within hospital establishments. Of the 102 hospitals questioned during the survey, nearly 11% admitted to using mianserin-based specialties in the treatment of sleep disorders. However, according to the ANSM, the currently available data do not allow the use of mianserin outside of its main indication. Such off-label use unnecessarily exposes patients to avoidable adverse effects. This situation highlights the crucial importance of strictly using medicines in accordance with their Marketing Authorization to ensure the safety and effectiveness of treatment for patients.
