Agomelatine Classification in Australia and Medication Type
Agomelatine is classified as a melatonergic antidepressant that is a Schedule 4 (Prescription Only) medication in the Australian medication schedule. 1, 2
Medication Type and Mechanism of Action
Agomelatine is a synthetic analogue of the hormone melatonin that acts through a dual mechanism of action 1:
- Agonist at melatonergic MT₁ and MT₂ receptors
- Antagonist at serotonin 5-HT₂C receptor subtypes
Unlike traditional antidepressants that primarily target monoamine neurotransmitters, agomelatine's unique mechanism involves both the melatonergic and serotonergic systems 2, 3
Regulatory Status in Australia
- In Australia, agomelatine is classified as a Schedule 4 (S4) medication, requiring a prescription from a registered medical practitioner 1
- It has been approved for use in Australia for the treatment of major depressive disorder (MDD) 2
- Unlike some psychotropic medications, agomelatine is not classified as a controlled substance in Australia (not Schedule 8) 4
Clinical Applications
- Primary indication: Treatment of major depressive disorder in adults 1, 2
- Emerging evidence suggests potential efficacy for generalized anxiety disorder (GAD) 5
- May be particularly beneficial for patients with depression accompanied by sleep disturbances due to its melatonergic properties 3
Important Clinical Considerations
- Agomelatine is contraindicated in patients with impaired liver function 1
- Regular monitoring of liver function is recommended throughout treatment due to potential for elevated liver enzymes 1
- Not recommended for use with potent CYP1A2 inhibitors that can significantly affect its metabolism 1
- Generally well-tolerated with an adverse effect profile different from other antidepressants 1, 3
- Recent research suggests potential for use in pediatric patients with moderate to severe MDD, though this remains an area of ongoing investigation 6
Comparison to Other Antidepressants
- Unlike many other antidepressants, agomelatine has demonstrated improvements in sleep quality and ease of falling asleep in depressed patients 3
- Polysomnographic studies show agomelatine decreases sleep latency and improves sleep stability 3
- Side effect profile differs from SSRIs and SNRIs, with generally mild to moderate adverse events at a frequency similar to placebo in clinical trials 3