Regulatory PathRegulatory requirements compared

Active substance

Melatonin

Open in the medicines table

EMA European Union — centrally authorised medicines

Circadin RAD Neurim Pharmaceuticals EEC SARL · Authorised · authorised 29 Jun 2007 · ATC N05CH01

Therapeutic indication (EMA)

Circadin is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.

Slenyto RAD Neurim Pharmaceuticals EEC SARL · Authorised · authorised 20 Sep 2018 · ATC N05CH01

Therapeutic indication (EMA)

Slenyto is indicated for: treatment of insomnia in children and adolescents aged 2-18 years with Autism Spectrum Disorder (ASD), and / or neurogenetic disorders with aberrant diurnal melatonin secretion and /or nocturnal awakenings, where sleep hygiene measures have been insufficient. treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient.

Melatonin Neurim RAD Neurim Pharmaceuticals EEC SARL · Authorised · authorised 7 Nov 2022 · ATC N05CH01

Therapeutic indication (EMA)

Melatonin Neurim is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
SLENYTO025607981 MGTABLET (EXTENDED-RELEASE) · ORALNEURIM PHARMACEUTICALS LTD.
SLENYTO025608015 MGTABLET (EXTENDED-RELEASE) · ORALNEURIM PHARMACEUTICALS LTD.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffMelatonin 1mg modified-release tablets£32.9660 tablet1 Oct 2026
NHS Drug TariffMelatonin 1mg tablets£10.8930 tablet1 Oct 2026
NHS Drug TariffMelatonin 1mg/ml oral solution sugar free£9.81150 ml1 Oct 2026
NHS Drug TariffMelatonin 2mg capsules£57.5030 capsule1 Oct 2026
NHS Drug TariffMelatonin 2mg modified-release tablets£2.5530 tablet1 Oct 2026
NHS Drug TariffMelatonin 2mg tablets£10.8930 tablet1 Oct 2026
NHS Drug TariffMelatonin 2mg/ml oral solution sugar free£55.0025 ml1 Oct 2026
NHS Drug TariffMelatonin 3mg capsules£62.5030 capsule1 Oct 2026
NHS Drug TariffMelatonin 3mg tablets£7.3830 tablet1 Oct 2026
NHS Drug TariffMelatonin 4mg tablets£10.8930 tablet1 Oct 2026
NHS Drug TariffMelatonin 5mg capsules£105.0030 capsule1 Oct 2026
NHS Drug TariffMelatonin 5mg modified-release tablets£82.4030 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.