Frequently Asked Questions
Here is a list of commonly asked questions you or your patients may have about their child’s insomnia-related symptoms and treatment.
Click on any of the questions below to expand the answer
What is Slenyto?
Slenyto is a prescription medicine used to treat ASD and/or SMS children aged 2-18 with insomnia. Slenyto is a 3mm diameter minitablet of prolonged-release melatonin, taken every night, 30-60 minutes before bed time at the appropriate dosage.
Slenyto has demonstrated significant clinical benefits in a Phase III study that have led to its approval by EMA.
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What dosages are available and how to choose the right dose?
Slenyto is available in two dosage forms - 1mg (Pink minitablet) and 5mg (Orange minitablet). The recommended starting dose is 2 mg (2 x 1mg). You may raise Slenyto dose to 5mg (1 x 5mg orange minitablet) or 10mg (2 x 5mg orange minitablet) according to patient individual response.
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How is Slenyto stored?
Slenyto should be stored below 30°C and out of the sight and reach of children.
How is Slenyto administered?
Slenyto should be taken daily, at night, 30-60 minutes before bedtime. Slenyto may be taken with a glass of water or be put into food such as yogurt, orange juice or ice-cream to help with swallowing. It should not be crushed or chewed.
If the child misses a dose of Slenyto, it could be taken before they go to sleep that night but after this time, no other Slenyto tablet should be taken before the next evening.
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What are some possible adverse reactions of Slenyto?
The safety profile of Slenyto was established in the longest clinical trial program in Pediatric ASD. Slenyto offers favorable safety, both short and long term.
Fatigue, moodswings, headache, irritability, aggression and hangover occurred in 1:10-1:100 children. Overall, similar treatment-related side effects in Slenyto and placebo groups, except mild to moderate somnolence, which was more common with Slenyto. The occurrence of side effects was lower with long term use of Slenyto and there were no reports of dependence, abuse, tolerance, withdrawal or rebound.
Compliance with the Slenyto mini-tablets was close to 100% throughout the 24 months study.
For detailed information, please see the Patient Information Leaflet.
What are the treatment options for Pediatric Insomnia?
Sleep hygiene is a non-pharmacological approach that is recommended for insomnia in children before trying any pharmacological therapy. It includes behavioral and environmental practices that are intended to promote better sleep. If sleep hygiene does not work, pharmacological therapy could be initiated. Slenyto (prolonged release melatonin) is the only pharmacotherapy approved for the treatment of insomnia in ASD and SMS.
Why choose Slenyto for your pediatric ASD insomnia patients?
Slenyto is the only European Medicinal Agency (EMA)-approved medication for the treatment of insomnia
in ASD and / or SMS children and adolescents. Slenyto has a prolonged release profile that mimics endogenous melatonin secretion. It has a well-defined pharmaceutical characterization and is manufactured in accordance with the highest regulatory standards.
Only Slenyto improves sleep latency, maintenance and total sleep time and has shown positive effect on child behavior and social functioning resulting in improving parents well-being.
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