Slenyto (generic name: melatonin) is a hormonal sleep regulator used to help children aged 2 to 18 years with autism spectrum disorder or Smith-Magenis syndrome who have trouble falling asleep. It provides a form of artificial melatonin, a natural substance the body makes to control the sleep-wake cycle. This helps restore a more regular sleep rhythm, which many children in these groups struggle to maintain.
Slenyto belongs to the pharmacological class of prolonged-release melatonin formulations. It supports the body’s natural sleep cycle by providing a consistent low-level signal through the night. The formulation ensures a smooth and sustained release, aiming to minimize early-morning awakenings and daytime tiredness.
The cream-like tablets are made to release melatonin slowly overnight, helping the user fall asleep and stay asleep for several hours. This gradual release mimics the body’s own overnight signal, promoting better sleep quality and longer sleep duration. Slenyto is designed to reduce night-time awakenings and improve overall sleep regularity in children with neurodevelopmental conditions.
Dosage
It is important to follow the dosage instructions printed on the label of the box. Check with a doctor or pharmacist if there are any doubts regarding the proper dosage and treatment regimen.
The usual starting dose of Slenyto is
2 mg each evening, taken
30 minutes before bedtime. For children who continue to have difficulty sleeping, the dose may be increased by the prescribing doctor by
1 mg at intervals of at least one week, up to a maximum of
5 mg per day. Tablets should be
swallowed whole, not chewed or crushed, with a drink of water. If a dose is missed, it should
not be taken the next day; instead, the next dose should be taken at the usual bedtime the following day.
Storage
Slenyto tablets should be stored in the original container between
15-25°C (59-77°F). The packaging should remain
tightly closed, kept
away from moisture and light, and
out of reach and sight of children, especially since melatonin can affect natural sleep-wake cycles if used incorrectly. Refrigeration or freezing is
not required. Any unused or expired tablets should be disposed of according to local guidelines.
This text is for informational purposes only. Please consult a doctor or pharmacist before using any medication.
Read the information leaflet that comes with the medication.
If a sudden allergic reaction (anaphylaxis) occurs shortly after taking Slenyto, with symptoms like swelling of the face, tongue, or throat making it difficult to breathe or swallow, or there is wheezing, hives, rash, blistering, or peeling of the skin, call a doctor or 911 right away, or go to an emergency room immediately.
Most people who use Slenyto do not experience any adverse side effects. Doctors prescribe this medication because they assess the benefits of such treatment outweigh any likely unwanted effects.
Some of the side effects that have been reported include:
- headache
- abdominal pain
- dizziness
- irritability
- nightmares.
These are typically mild and most often seen in the first few weeks of use.
Serious side effects are rare but may include:
-
Daytime drowsiness or sleepiness, which could indicate excessive dosing; dose adjustment or administration earlier in the evening may help.
-
Mood swings, agitation, or depression, which require prompt medical follow-up.
Not all side effects are listed here. If these or other unlisted symptoms persist or worsen, consult a healthcare provider or pharmacist.
Slenyto treats sleep-onset insomnia in children and adolescents aged 2 to 18 who have autism spectrum disorder (ASD) or Smith-Magenis syndrome (SMS). Sleep-onset insomnia involves difficulty falling asleep, delayed bedtime, and insufficient night-time rest, which can worsen daytime behavior, concentration, and mood. The prolonged-release formulation helps align sleep patterns to more natural rhythms. Slenyto is not indicated for adults or children without these conditions. It is specifically used when sleep problems are linked to ASD or SMS and when behavioral and environmental approaches have not been sufficient.