Formulary
Agomelatine: Indications, Dosing, Side Effects and Interactions
A melatonin receptor agonist and a selective serotonin-receptor antagonist; it does not affect the uptake of serotonin, noradrenaline, or dopamine.
MedNext Academy | 3 min read
Agomelatine: Indications, Dosing, Side Effects and Interactions
A melatonin receptor agonist and a selective serotonin-receptor antagonist; it does not affect the uptake of serotonin, noradrenaline, or dopamine.
Drug action
A melatonin receptor agonist and a selective serotonin-receptor antagonist; it does not affect the uptake of serotonin, noradrenaline, or dopamine.
Indications and dose
**Major depression**
- **Adult** (By Mouth): 25 mg once daily, to be taken at bedtime, increased if necessary to 50 mg once daily, to be taken at bedtime, increased dose may be used after 2 weeks of initial treatment.
Cautions
Alcoholism; bipolar disorder; diabetes; elderly with dementia (safety and efficacy not established); excessive alcohol consumption; hypomania; mania; non-alcoholic fatty liver disease; obesity; patients 75 years of age or older (safety and efficacy not established)
Side effects
Common or very common Abdominal pain; anxiety; back pain; constipation; diarrhoea; dizziness; drowsiness; fatigue; headaches; nausea; sleep disorders; vomiting; weight changes Uncommon Aggression; confusion; hyperhidrosis; mood altered; movement disorders; paraesthesia; skin reactions; suicidal behaviours; tinnitus; vision blurred Rare or very rare Angioedema; face oedema; hallucination; hepatic disorders; urinary retention Side-effects, further information The use of antidepressants has been linked with suicidal thoughts and behaviour; children, young adults, and patients with a history of suicidal behaviour are particularly at risk. Where necessary patients should be monitored for suicidal behaviour, self-harm, or hostility, particularly at the beginning of treatment or if the dose is changed.
Interactions
**Other interactions (14):**
- Potential interactions affecting agomelatine Agomelatine is metabolised mainly by cytochrome P450 1A2 (CYP1A2) (90%) and by CYP2C9/19 (10%).
- Medicinal products that interact with these isoenzymes may decrease or increase the bioavailability of agomelatine.
- Fluvoxamine, a potent CYP1A2 and moderate CYP2C9 inhibitor markedly inhibits the metabolism of agomelatine resulting in a 60-fold (range 12-412) increase of agomelatine exposure.
- Combination of agomelatine with oestrogens (moderate CYP1A2 inhibitors) results in a several fold increased exposure of agomelatine.
- While there was no specific safety signal in the 800 patients treated in combination with oestrogens, caution should be exercised when prescribing agomelatine with other moderate CYP1A2 inhibitors...
- Rifampicin an inducer of all three cytochromes involved in the metabolism of agomelatine may decrease the bioavailability of agomelatine.
Pregnancy
Manufacturer advises avoid.
Breast feeding
Avoid-present in milk in animal studies.
Hepatic impairment
Manufacturer advises caution if transaminases are elevated; avoid in hepatic impairment or if transaminases exceed 3 times the upper limit of normal.
Renal impairment
Caution in moderate to severe impairment. M
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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