It is not approved for use in the US, but its analogue, mirtazapine, is. Mianserin was the first antidepressant to reach the UK market that was less dangerous than the tricyclic antidepressants in overdose.
Similarly to its analogue, mirtazapine, mianserin has been tried as an augmentation strategy in treatment-resistant depression with some success. Mianserin has been tried, similarly to mirtazapine, as an adjunct in schizophrenia and has been found to reduce negative and cognitive symptoms.
Mianserin has demonstrated efficacy as a monotherapy for the treatment of Parkinson's disease psychosis in an open-label clinical trial.
Very common (incidence>10%) adverse effects include
Somnolence/drowsiness (transiently at the beginning of therapy)
Common (1%<incidence≤10%) adverse effects include
Somnolence/drowsiness (during maintenance therapy, that is, in some patients this side effect persists)
Uncommon (0.1%<incidence≤1%) adverse effects include
Weight gain — likely related to its potent antihistamine and 5-HT2C receptor-antagonist effects.
Rare (0.01%<incidence≤0.1%) adverse effects include
Oedema — the swelling of the body's tissues due to fluid draining into said tissues.
Arthralgia (joint pain)
Akathisia — a sense of inner restlessness that is often distressing for patients.
Orthostatic hypotension — the dropping of blood pressure upon standing up leading to light-headedness, dizziness and even fainting
Hypomania — an excessively elated/irritable mood that can be dangerous.
Bradycardia — low heart rate.
Disturbances of liver function (including jaundice) — the Australian Medicines Handbook recommends that patients with a history of liver disease undergo regular liver function tests and that treatment is ceased at the first sign of jaundice.
Very rare (Incidence≤0.01%) adverse effects include
Blood dyscrasias (particularly neutropaenia — a drop in the neutrophils which are part of the body's immune system that is particularly tailored to destroying bacteria — and agranulocytosis — a potentially life-threatening drop in the white blood cells of the immune system leaving the patient open to potentially fatal infections.) — for this reason in the Australian Medicines Handbook 2013 and the British National Formulary 65 it is recommended that the prescribing physician checks the patient's complete blood counts (CBCs) at the initiation of treatment and then every four weeks until 3 months have passed. Some cases of mianserin-induced blood dyscrasias have been fatal.
CYP2D6 inhibitors such as the selective serotonin reuptake inhibitors (SSRIs), quinidine, ritonavir, etc. would likely raise plasma levels of mianserin and hence could lead to mianserin toxicity. Conversely, CYP2D6 inducers would likely lead to reduced mianserin plasma concentrations and hence potentially diminish the therapeutic effects of mianserin.
In addition, mianserin also appears to be a potent antagonist of the neuronal octopamine receptor. What implications this may have on mood are currently unknown, however octopamine has been implicated in the regulation of sleep, appetite and insulin production and therefore may theoretically contribute to the overall side effect profile of mianserin.
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