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NERVOUS SYSTEM › PSYCHOANALEPTICS › ANTIDEPRESSANTS › Other antidepressants
agomelatine
N06AX22
Forms & Strengths
- Tablets 25 mg
- Tablets 50 mg
Adult Dosing
- Start 25 mg PO nightly at bedtime
- If no response after 2 weeks, may increase to 25 mg additional (max 50 mg/day)
- Maximum recommended dose 50 mg once daily
- Do not exceed 50 mg; avoid twice‑daily dosing
- Assess liver function before initiation and periodically during therapy
Pediatric Dosing
- Not approved for patients <18 years
Indications
- Major depressive disorder (MDD) in adults
- Adjunct for seasonal affective disorder (off‑label)
Mechanism of Action
- Agonist at melatonin MT1 and MT2 receptors → resynchronizes circadian rhythms
- Antagonist at serotonin 5‑HT2C receptors → disinhibits dopamine and norepinephrine release in frontal cortex
- Promotes sleep onset and improves mood
Contraindications
- Severe hepatic impairment or hepatic disease
- Concomitant use of strong CYP1A2 inhibitors (e.g., fluvoxamine)
- Elevated baseline transaminases (>3× ULN) or bilirubin (>2× ULN)
- Known hypersensitivity to agomelatine
- Pregnancy and lactation (risk/benefit unfavourable)
Adverse Reactions
- Elevated ALT/AST; rare hepatic failure
- Headache
- Dizziness
- Nausea or abdominal discomfort
- Somnolence or insomnia
- Increased suicidal thoughts (especially early treatment)
Drug Interactions
- Strong CYP1A2 inhibitors (fluvoxamine, ciprofloxacin, enoxacin) markedly increase agomelatine levels
- CYP1A2 inducers (carbamazepine, rifampin, smoking) reduce exposure
- Concurrent hepatotoxic drugs may augment liver injury risk
- Warfarin: monitor INR as agomelatine may alter metabolism
- Avoid coadministration with other antidepressants that increase serotonin syndrome risk (though mechanism differs)
Curated Content: Needs Vetting Before Put to Clinical Use