Question 1

What is Slenyto?

Accepted Answer

Slenyto is a prescription medicine used for the treatment of insomnia:
 • in children and adolescents aged 2-18 years with Autism Spectrum Disorder (ASD), and / or neurogenetic disorders with aberrant diurnal melatonin secretion and /or nocturnal awakenings, where sleep hygiene measures have been insufficient. 
 • in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient.

Slenyto is a 3mm diameter minitablet of prolonged-release melatonin, taken every night, 30-60 minutes before bedtime 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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Question 2

How does Slenyto work?

Accepted Answer

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 blood levels normally increase after the onset of darkness and peak in the middle of the night. Patients with certain conditions may produce less melatonin, leading to the development of insomnia. When given before bedtime, Slenyto increases levels of melatonin in the blood, helping these patients to sleep. Because Slenyto releases melatonin slowly over a few hours, it mimics the natural production of melatonin in the body.

Question 3

Why choose Slenyto for your pediatric patients with ADHD and insomnia?

Accepted Answer

Slenyto has a prolonged release formulation that mimics endogenous melatonin secretion throughout the night, therefore is the only melatonin formulation that improves all main sleep parameters (Sleep initiation, sleep duration and sleep maintenance) as well as the daytime behavior and quality of life of the parents and child.

Slenyto has been designed especially for children, it is 3mm diameter coated mini tablet, odorless and tasteless. Slenyto has a well-defined pharmaceutical characterization and is manufactured in accordance with the highest requirements.

Children with ADHD often have delayed sleep onset and time of awakening, bedtime resistance, lighter sleep, poor sleep quality, and fragmented sleep with periods of nighttime awakenings. This, along with other sleep disturbances, is linked to behavioral and emotion regulation problems in ADHD. Slenyto improves main sleep parameters (Total Sleep Time and Sleep Onset Latency) without causing early awakenings like other melatonin preparations. Slenyto improves children’s daytime behavior and Quality of life of the child and parents.

Question 4

Why prescribe Slenyto (a medicinal product) instead of recommending patients to purchase melatonin food supplements?

Accepted Answer

Several studies have shown that many of the online purchased melatonin food supplements contain significantly higher doses than the amount on their label (up to 400%), while others contained less or even no melatonin. This has emerged a safety concern and the Health Authorities such as TGA (in Australia) advise consumers caution when purchasing medicines from overseas websites.

Needless to say that medicinal products are strictly regulated providing high standard of manufacturing practices (GMP certification), proven safety and efficacy (GVP guidelines), as well as controlled distribution conditions (GDP certification), whereas supplements are treated like foods and do not require the same level of testing; they can vary in potency or purity because they are not regulated as tightly.

Slenyto was approved by the EMA based on a full pediatric investigational plan including Phase III randomized, placebo-controlled trial that was conducted in the US and the EU for up to 24 months, in addition to new data that have accumulated.

Question 5

What are the clinical benefits of Slenyto on child’s sleep?

Accepted Answer

Slenyto prolonged release formulation achieves a therapeutically effective concentration of melatonin in the systemic circulation throughout the night and thus only Slenyto significantly improves sleep latency, sleep maintenance and total sleep time without causing early awakenings.

Press here, for more on Slenyto clinical evidence .
(https://www.slenyto.com/slenyto-clinical-evidence)

Question 6

Does Slenyto have an impact on child’s behavior?

Accepted Answer

Slenyto was proven to significantly improve child's externalising behaviour, and has demonstrated improvement in social functioning as well as parents’ and child’s -quality of life.

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Question 7

Is it easy to swallow Slenyto?

Accepted Answer

Slenyto has been developed specifically for children, it is an extremely small (3mm diameter) minitablet, which is tasteless and odorless to fit children’s needs, even children as young as 2 years old, and children with swallowing difficulties. During clinical trials, nearly 100% of children were compliant with treatment.

Press here, for more on Slenyto Dosage & Administration (https://www.slenyto.com/dosing-and-administration).

Question 8

What dosages are available and how to choose the right dose?

Accepted Answer

Slenyto is available in two dosage forms - 1mg (Pink minitablet) and 5mg (Orange minitablet). The recommended starting dose is 1-2 mg (1-2 pink minitablets of 1mg). You may raise Slenyto dose to 5mg (1 x 5mg orange minitablet) the maximum daily dose may be increased to 10mg (2 x 5mg orange minitablet). Slenyto dose should be adjusted according to patient’s individual response and regardless of the child’s weight and/or age.  The lowest effective dose should be taken for the shortest period.

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Question 9

Is Slenyto different from immediate release melatonin?

Accepted Answer

Yes, Slenyto is different from immediate release (IR) melatonin. Slenyto mimics endogenous melatonin secretion and maintains elevated melatonin levels throughout the night. By mimicking the endogenous melatonin secretion profile, only Slenyto is clinically proven to improve daytime externalizing behavior, all main sleep variables (sleep onset, sleep maintenance, total sleep time) and parents’ and child’s well-being, whereas immediate release (IR) melatonin shortens sleep onset latency and causes early awakening, however does not have influence on the behaviour.

Question 10

What would be the effect of taking Slenyto with stimulants typically used for ADHD?

Accepted Answer

Stimulants enhance the wake-promoting pathways, this is why insomnia is one of the most acute side effects of stimulants.

In Slenyto studies, about 30% of the children used concomitant medications such as stimulants and/or antidepressants.

Interactions with stimulants were not noticed when these two drugs were co-administered.

Question 11

How is Slenyto administered?

Accepted Answer

Slenyto should be taken daily, at night, 30-60 minutes before bedtime. 
Slenyto The tablets should be swallowed whole. The tablet should not be broken, crushed or chewed because it will lose the prolonged release properties. Tablets can be put into food such as yoghurt, orange juice or ice cream to facilitate swallowing and improve compliance. If the tablets are mixed with food or drink, they should be taken immediately and the mixture not stored.

If the child misses the window of 30-60 minutes before bedtime to take Slenyto, it could be taken before they go to sleep that night but after this time, no other tablet should be taken before the next evening.

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Question 12

How is Slenyto stored?

Accepted Answer

Slenyto should be stored below 30°C and out of the sight and reach of children.

For detailed information, please refer to the Product Information (SmPC). (https://www.ema.europa.eu/en/documents/product-information/slenyto-epar-product-information_en.pdf)

Question 13

Are there any drug-drug interactions with Slenyto?

Accepted Answer

Interaction studies have only been performed in adults. In the absence of specific studies in children, the listed drug interactions with Slenyto are the same as in adults:

a.       Concomitant use which is not recommended:

• fluvoxamine (increases melatonin levels), 
 • alcohol (reduces the effectiveness of melatonin on sleep), 
 • Benzodiazepines/non-benzodiazepine hypnotics (Melatonin may enhance their sedative properties)
 • Thioridazine and imipramine (studies have shown difficulty in performing tasks)

b.       Concomitant use to be considered with caution:

• 5- or 8-methoxypsoralen (increases melatonin levels by inhibiting its metabolism)
 • Cimetidine (increases plasma melatonin levels)
 • Oestrogens (increases melatonin levels)
 • CYP1A2 inhibitors such as quinolones (ciprofloxacin and norfloxacin) may increase melatonin exposure.
 • CYP1A2 inducers such as carbamazepine and rifampicin may reduce plasma concentrations of melatonin.
c.       Smoking - if patients stop or start smoking during treatment with melatonin, dose adjustment  
           may be required.

d.       NSAIDs - should be avoided in the evening; they may suppress endogenous melatonin levels in  
          the early part of the night by up to 75%.

e.       Beta-blockers - may suppress night-time release of endogenous melatonin and thus should be 
          administered in the morning.

For detailed information, please refer to the Product Information (SmPC)(chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https:/www.ema.europa.eu/en/documents/product-information/slenyto-epar-product-information_en.pdf)

Question 14

What are some possible adverse reactions of Slenyto?

Accepted Answer

Like all medicines, this medicine can cause side effects, although not everyone experiences them. The safety profile of Slenyto was established in the longest clinical trial program in Paediatric ASD. Slenyto offers favourable safety, both short and long term.

Fatigue, mood swings, headache, irritability, aggression and hangover occurred in 1:10-1:100 children. Overall, similar treatment-related side effects were observed in the Slenyto and the placebo groups, except for 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 Product Information (SmPC)(https://www.ema.europa.eu/en/documents/product-information/slenyto-epar-product-information_en.pdf)

Useful Resources

Slenyto Publications l FAQ l Useful ADHD & Insomnia Links

Frequently Asked Questions