Melatonin Neurim



This medicine is authorised for use in the European Union.


Melatonin Neurim is a medicine used on its own for the short-term treatment of primary insomnia (poor quality of sleep) in patients aged 55 years or over. ‘Primary’ means that the insomnia does not have any identified cause, including any medical, mental or environmental cause.

Melatonin Neurim contains the active substance melatonin.

This medicine is the same as Circadin, which is already authorised in the EU. The company that makes Circadin has agreed that its scientific data can be used for Melatonin Neurim (‘informed consent’).

This EPAR was last updated on 25/11/2022

Authorisation details

Product details
Melatonin Neurim
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Sleep Initiation and Maintenance Disorders
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
RAD Neurim Pharmaceuticals EEC SARL
Date of issue of marketing authorisation valid throughout the European Union
Contact address

4 rue de Marivaux
75002 Paris

Product information

Melatonin Neurim - EMEA/H/C/005603 -

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


Therapeutic indication

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.

Assessment history

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