Slenyto
Authorised
This medicine is authorised for use in the European Union
melatonin
MedicineHumanAuthorised
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.
Slenyto is available as tablets (1 and 5 mg). The normal dose is 2 mg taken 30 minutes to one hour before bedtime. The dose can be increased up to a maximum of 10 mg if the medicine is not working well enough. The doctor should review treatment regularly, at least every 6 months, and only continue treatment if the patient is benefits from it.
The medicine can only be obtained with a prescription. For more information about using Slenyto, see the package leaflet or contact your doctor or pharmacist.
The active substance in Slenyto, melatonin, is a naturally occurring hormone, which is normally produced by a gland in the brain called the pineal gland. Melatonin is involved in coordinating the body’s sleep cycle by acting on cells in specific areas of the brain and helping to bring about sleep. Its levels in the blood normally increase after the onset of darkness and peak in the middle of the night. Patients with developmental conditions may produce less melatonin, leading to the development of insomnia. Slenyto increases levels of melatonin in the blood, helping them to sleep. Because Slenyto releases melatonin slowly over a few hours, it mimics the natural production of melatonin in the body.
Slenyto has been shown to be effective at improving sleeping time in children and adolescents with neurological conditions, including autism spectrum disorder and Smith-Magenis syndrome. In a main study of 125 patients, those given Slenyto over 13 weeks slept on average for 51 extra minutes of sleep a night compared with and 19 extra minutes for those given placebo (a dummy treatment). In addition, children who took Slenyto fell asleep around 38 minutes earlier than normal while those taking placebo fell asleep 13 minutes earlier.
All patients had previously tried other measures, such as keeping to a regular sleeping routine, which did not work.
The most common side effects with Slenyto (which may affect up to 1 in 10 people) are sleepiness, tiredness, mood swings, headache, irritability, aggression and feeling hungover. For the full list of side effects and restrictions, see the package leaflet.
The proportion of children with neurological conditions, such as autism spectrum disorder (ASD) and Smith-Magenis syndrome, who also have insomnia is high and not many treatments are available.
Slenyto has been shown to improve sleeping times in these patients, with patients taking Slenyto sleeping for an extra 51 minutes a night compared with an extra 19 minutes with placebo. The side effects seen with the medicine over 2 years appear mild or moderate but more data are needed on longer term safety.
The European Medicines Agency decided that Slenyto’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Slenyto have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Slenyto are continuously monitored. Side effects reported with Slenyto are carefully evaluated and any necessary action taken to protect patients.
Slenyto received a marketing authorisation valid throughout the EU on 20 September 2018.
Product information
Latest procedure affecting product information: N/0027
16/02/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Slenyto
- 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
Pharmacotherapeutic group
PsycholepticsTherapeutic 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.
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