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Mianserin, a molecule indicated in patients with severe depressive symptoms, should not be taken lightly, otherwise there is a risk of experiencing “potentially serious adverse effects”.
It was the National Medicines Safety Agency (ANSM) which sounded the alert in a press release. According to the agency, “reports of off-label use of mianserin, in the management of sleep disorders, in patients without associated depression, have been reported to laboratories, particularly in patients aged over 65 years.“However, its effectiveness in treating sleep disorders has not yet been confirmed.
A drug mainly used to treat depression
If mianserin has proven itself with patients suffering from depression – thanks to its tranquilizing and sedative effect, it reduces the symptoms – its use in the context of sleep disorders “has not yet been evaluated“, warns the press release.
This does not prevent some patients from misusing it. A habit which is not without consequences for their health.
The ANSM is therefore sounding the alarm and reminding that taking it, only on medical prescription, requires certain precautions.
Side effects that can be serious
The medication can in fact cause various very serious side effects, such as:
- exceptional cases of agranulocytosis, which refers to a blood abnormality. “This is why a blood count check is recommended, especially when the patient presents with fever, sore throat or other signs of infection.“, details the press release.
- Drowsiness, likely to have significant consequences in elderly patients;
- hepatitis;
- seizures;
- risks of suicidal-type behavior occurring in depressed patients or in patients with a history of suicide-type behavior.
“It is therefore important to respect the indication in the Marketing Authorization, the dosage, the warnings and the contraindications (including severe liver damage), particularly in elderly patients.“, concludes the press release.
If in doubt about the use of the molecule, a doctor should be consulted.