Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Toxicological Effects
  • Genes that may be involved
  • Substrate of
  • Drug Interactions
  • Nutrition/Nutraceutical Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names


Austria: Thymanax, Valdoxan. Belgium: Valdoxan. Bulgaria: Thymanax, Valdoxan. Czech Republic: Thymanax, Valdoxan. Denmark: Valdoxan. Estonia: Thymanax, Valdoxan. Finland: Valdoxan. France: Valdoxan. Germany: Thymanax, Valdoxan. Greece: Thymanax, Valdoxan. Hungary: Valdoxan. Ireland: Thymanax, Valdoxan. Italy: Thymanax. Latvia: Thymanax, Valdoxan. Lithuania: Thymanax, Valdoxan. Luxembourg: Thymanax, Valdoxan. Malta: Thymanax, Valdoxan. Netherlands: Thymanax, Valdoxan. Poland: Thymanax, Valdoxan. Portugal: Thymanax, Valdoxan. Romania: Thymanax, Valdoxan. Slovakia: Thymanax, Valdoxan. Slovenia: Thymanax, Valdoxan. Spain: Thymanax, Valdoxan. Sweden: Thymanax, Valdoxan. UK: Valdoxan.

Latin America

Argentina: Valdoxan. Brazil: Valdoxan.


Japan: Valdoxan.

Drug combinations


Agomelatine: C~15~H~17~NO~2~. Mw: 243.30. (1) N-[2-(7-Methoxy-naphthalen-1-yl)-ethyl]-acetamide; (2) N-[2-(7-Methoxy-naphthalen-1-yl)-ethyl]-acetamide. CAS-138112-76-2.

Pharmacologic Category

Antidepressants, Miscellaneous; Melatonergic agonist (MT~1~ and MT~2~ receptors) and 5-HT~2C~ antagonists. (ATC-Code: N06AX22).

Mechanism of action

Agomelatine is classified as a norepinephrine-dopamine disinhibitor (NDDI) due to its antagonism of the 5-HT~2C~ receptor. Activation of 5-HT~2C~ receptors by serotonin inhibits dopamine and norepinephrine release. Antagonism of 5-HT~2C~ results in an enhancement of dopamine and norepinephrine release and activity of frontocortical dopaminergic and adrenergic pathways.

Therapeutic use

Treatment of major depressive episodes in adults.

Pregnancy and lactiation implications

No direct/indirect harmful effects observed in animal studies. No clinical data in pregnant women. Use with caution in pregnant women. It is unknown whether agomelatine is excreted into human milk. Not recommended during lactation.

Unlabeled use


Hypersensitivity to agomelatine or any component of the formulation. Hepatic impairment (i.e. cirrhosis or active liver disease). Concomitant use of potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin). Lactose intolerance.

Warnings and precautions

Caution when prescribing with moderate CYP1A2 inhibitors (e.g. propranolol, grepafloxacine, enoxacine). Use with caution in history of mania/hypomania. Use with caution in history of suicide-related events. Do not use in elderly patients with dementia. May increase serum transaminases (>3 times ULN); usually return to normal levels when therapy is discontinued. Contraindicated in hepatic impairment. If jaundice is observed therapy should be discontinued. Concurrent use of alcohol should be avoided (may cause hepatic injury). Product contains lactose; patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.



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