Agomelatine

Generic Details

Generic Name

Agomelatine

Other Names

  • Valdoxan

Drug Class

  • Melatonin Receptor Agonist
  • Serotonin Modulator

Chemical Formula

C15H17NO2

Molecular Weight

243.30 g/mol

Mechanism of Action

  • Agonist activity at melatonergic receptors (MT1 and MT2) and antagonist activity at 5-HT2C serotonin receptors

Indications

  • Major Depressive Disorder

Common Dosage Forms

  • Tablet

Typical Dosage

  • 25 mg once daily at bedtime

Pediatric Dosage

  • Not recommended for use in children and adolescents under 18 years

Geriatric Dosage

  • Dosage adjustment may be needed in the elderly

Side Effects

  • Nausea
  • Dizziness
  • Headache
  • Fatigue
  • Insomnia
  • Anxiety

Contraindications

  • Hepatic impairment
  • Severe renal impairment
  • Patients under 18 years

Pregnancy Category

  • Category B: No evidence of risk in humans

Lactation Safety

  • Limited data available, caution advised

Drug Interactions

  • Avoid concomitant use with strong CYP1A2 inhibitors

Overdose Symptoms

  • Lethargy
  • Somnolence
  • Nausea
  • Vomiting
  • Tachycardia

Antidote for Overdose

  • No specific antidote, manage symptoms supportively

Storage Conditions

  • Store at room temperature away from moisture and heat

Pharmacokinetics

  • Absorption: Well-absorbed orally
  • Distribution: Highly protein-bound (about 80%)
  • Metabolism: Extensively metabolized by hepatic enzymes
  • Excretion: Mainly excreted in feces

Precautions

  • Monitor liver function tests periodically

Warnings

  • May increase the risk of suicidal thinking and behavior in children, adolescents, and young adults

Others

  • Agomelatine is an atypical antidepressant with a unique mechanism of action that differs from traditional SSRIs and tricyclic antidepressants.