Clinical Overview
Agomelatine is a novel melatonergic antidepressant. It acts as a potent agonist at melatonin MT1 and MT2 receptors and a selective antagonist at serotonin 5-HT2C receptors in the frontal cortex, resynchronizing circadian sleep-wake cycles and elevating local dopamine and norepinephrine levels without increasing serotonin. Indicated for the treatment of major depressive episodes in adults.
Active Pharmaceutical Ingredients
Verified Clinical References
Usage Guidelines
Take orally once daily strictly at bedtime with water, with or without food. Liver function tests (ALT/AST) must be performed at baseline and at 3, 6, 12, and 24 weeks of therapy.
General Administration Advice: Adhere strictly to the prescribed dosage, frequency, and treatment course. For oral medications, swallow with sufficient water. Never stop antibiotics, psychiatric medications, or antihypertensives abruptly without clinical direction.
Possible Side Effects
Common: Headache, nausea, dizziness, somnolence, insomnia, fatigue, back pain. Rare/Severe: Severe hepatotoxicity (transaminitis, acute hepatitis, hepatic failure), suicidal thoughts, and angioedema.
*Note: Individual physiological responses vary. While many patients experience few or no side effects, notify your treating physician if adverse reactions persist or if hypersensitivity (angioedema, skin rash, dyspnea) occurs.
Precautions & Warnings
Black box warning: Hepatotoxicity. Mandatory liver function test monitoring prior to initiation and regularly thereafter; discontinue immediately if transaminases exceed 3 times the upper limit of normal. Contraindicated in hepatic impairment or concurrent potent CYP1A2 inhibitors (fluvoxamine, ciprofloxacin).
Schedule H (Prescription Required)
This medication is scheduled under statutory drug regulatory frameworks (CDSCO / Drugs & Cosmetics Rules). Dispensing requires a valid medical prescription from a registered medical practitioner. Self-medication or unsupervised dosage adjustment carries significant clinical risks.
Medical Disclaimer: Statutory Clinical Disclaimer: The information provided is for educational and price-transparency purposes only and does not constitute medical advice, clinical diagnosis, or treatment recommendations. Always consult a registered medical practitioner or qualified pharmacist before initiating, modifying, or substituting any medication regimen.