Slenyto

RSS

melatonin

Authorised
This medicine is authorised for use in the European Union.

Overview

Slenyto is a medicine for treating insomnia (difficulty sleeping) in children and adolescents (2 to 18 years old) who have:

  • autism spectrum disorder (ASD), a range of conditions that affects the patient’s social interactions;
  • Smith-Magenis syndrome, a condition that can lead to learning difficulties.

Slenyto is used after other measures such as keeping to a regular sleeping routine have not worked.

The medicine contains the active substance melatonin.

This EPAR was last updated on 29/03/2021

Authorisation details

Product details
Name
Slenyto
Agency product number
EMEA/H/C/004425
Active substance
melatonin
International non-proprietary name (INN) or common name
melatonin
Therapeutic area (MeSH)
  • Sleep Initiation and Maintenance Disorders
  • Autistic Disorder
Anatomical therapeutic chemical (ATC) code
N05CH01
Publication details
Marketing-authorisation holder
RAD Neurim Pharmaceuticals EEC SARL
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
20/09/2018
Contact address

4 rue de Marivaux
75002 Paris
France

Product information

18/02/2021 Slenyto - EMEA/H/C/004425 - II/0017

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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

Psycholeptics

Therapeutic indication

Slenyto is indicated for the treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.

Assessment history

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