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Melatonin Receptor Agonist / 5-HT2C Antagonist

Agomelatine

Brand names: Valdoxan

Agomelatine is an antidepressant licensed for major depressive disorder in adults, with a mechanism distinct from conventional serotonergic antidepressants.

Dosing — being independently re-sourced

ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.

Clinical monograph

How it works

It is an agonist at melatonergic MT1 and MT2 receptors and an antagonist at serotonin 5-HT2C receptors, an action associated with antidepressant effects and resynchronisation of circadian rhythms.

Prescribing in practice

  • Agomelatine can cause dose-related hepatotoxicity, so liver function must be checked before starting and monitored during treatment, and it is contraindicated in hepatic impairment.
  • It is taken at bedtime and should be stopped if transaminases rise significantly or symptoms of liver injury develop.
  • Avoid co-administration with potent inhibitors of its hepatic metabolism and use cautiously with other interacting drugs, following current prescribing references.

Monitoring

Check liver function before treatment and periodically thereafter, and review mood, response and any symptoms of liver injury during therapy.

Counselling the patient

  • Explain that this antidepressant is taken at night and that blood tests are needed to check the liver.
  • Advise reporting jaundice, dark urine, abdominal pain, fatigue or unusual itching promptly.
  • Advise not to stop suddenly without discussion and to attend liver-monitoring blood tests.

Evidence & guidelines

Agomelatine is licensed for major depression with mandatory liver-function monitoring reflected in MHRA advice and current prescribing references because of the risk of hepatotoxicity.

Reference: EMA Agomelatine Assessment Report; NICE CG90 (Depression); Confirm identity and dosing against the manufacturer SPC (eMC) and NICE. Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.