Melatonin

ATC code

N05CH01

Therapeutic class

Melatonin receptor agonist · Melatonin receptor agonists

Forms

prolonged-release tablet

Brand names

Circadin (ES) · Slenyto (EU)

Overall confidence

high

Regulatory sources consulted

Treatment of insomnia in children and adolescents aged 2-18 years with Autism Spectrum Disorder (ASD), and/or neurogenetic disorders, where sleep hygiene measures have been insufficient.
Short-term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over.

May cause drowsiness. Use with caution if the effects of drowsiness can be associated with a safety risk. — EMA SPC
Use in patients with autoimmune diseases is not recommended. — EMA SPC

HighFluvoxamineN06AB08
Mechanism: Potent inhibition of CYP1A2 and CYP2C19, increasing melatonin AUC up to 17-fold.
Recommendation: The combination of melatonin and fluvoxamine should be avoided.
AEMPS CIMA FT 07392003
ModerateCarbamazepine, RifampicinN03AF01
Mechanism: Inducers of CYP1A2/2C19 that can reduce plasma concentrations of melatonin.
Recommendation: Monitor clinical efficacy; a melatonin dose adjustment may be necessary.
AEMPS CIMA FT 07392003

somnolence · headache · fatigue · mood swings

As a precautionary measure, it is preferable to avoid the use of melatonin during pregnancy. Not recommended during breastfeeding.

Melatonin in sleep disorders.
Poza JJ, et al. · Neurologia (Engl Ed) · 2022 · Relevance 4/5
Revisión sobre la fisiología de la melatonina y su uso en trastornos del sueño. Destaca que, a pesar de su base teórica para tratar el insomnio (especialmente en mayores), la evidencia científica que respalda su beneficio es limitada y las dosis y preparaciones óptimas no están claramente definidas.
[Nutrition in improving sleep quality and fighting insomnia].
Ortega RM, et al. · Nutr Hosp · 2025 · Relevance 2/5
Revisión sobre el papel de la nutrición en la calidad del sueño. Menciona que el triptófano es precursor de la serotonina y melatonina, y que una dieta adecuada puede mejorar el sueño.