Question 1

What is Slenyto?

Accepted Answer

Slenyto is a prescription medicine used to treat insomnia in children with ASD and/or neurogenetic disorders aged 2-18 years with aberrant diurnal melatonin secretion and /or nocturnal awakenings, where sleep hygiene measures have been insufficient. 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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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 neurogenetic disorders and insomnia?

Accepted Answer

Slenyto was proven to be safe and effective for short- and long-term treatment of children at 2-18 years with ASD and / or NGDs and insomnia.

Slenyto has a prolonged release formulation that mimics endogenous melatonin secretion throughout the night, therefore itis 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, odourless and tasteless. Slenyto has a well-defined pharmaceutical characterization and is manufactured in accordance with the highest requirements.

A variety of sleep problems are observed, including difficulty initiating and maintaining sleep, multiple nocturnal awakenings, difficulties falling asleep, reduced total sleep time, sleep-wake rhythm disorders, nocturnal movement disorders, enuresis, bruxism, sleep terrors, sleep walking, sleep paralysis, excessive daytime sleepiness, and sleep related breathing difficulties.

Question 4

What do you need to know prior to initiating treatment for insomnia?

Accepted Answer

Slenyto dose may be adjusted to optimize treatment response. To monitor treatment response a simple questionnaire i(https://pmc.ncbi.nlm.nih.gov/articles/PMC9296438/)s available for you) to fill in  for each patient / caregiver before starting treatment and 2-4 weeks after treatment initiation  (https://pmc.ncbi.nlm.nih.gov/articles/PMC9296438/)or dose change.  It will assist you to evaluate if the benefit to the patient is sufficient and treatment goals are met, or if dose escalation is needed.

Question 5

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 stated 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 caution when purchasing medicines from overseas websites.

Needless to say that medicinal products are strictly regulated providing high standard of manufacturing practices (GMP certification), 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.

Question 6

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. 
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(https://www.slenyto.com/slenyto-clinical-evidence)

Question 7

Does Slenyto have an impact on child’s behavior?

Accepted Answer

Slenyto was proven to significantly improve child's externalizing behaviour and has demonstrated improvement in social functioning . 
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Question 8

Is it easy to swallow Slenyto?

Accepted Answer

Slenyto has been developed specifically for children,  it is extremely small (3mm diameter) minitablet, which is tasteless and odorless to fit children, 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 9

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 2mg (2 x 1mg). You may raise Slenyto dose to 5mg (1 x 5mg orange minitablets). If an inadequate response has been observed, the dose should be increased to 5 mg, with a maximal dose of  10mg (2 x 5mg orange minitablets). Slenyto dose may be adjusted  according to patient’s individual response and regardless of the child’s age or weight.  
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Question 10

Is Slenyto different from immediate release melatonin?

Accepted Answer

Yes, Slenyto is different from immediate release melatonin. Slenyto mimics endogenous melatonin secretion and maintains elevated melatonin levels throughout the night. By mimicking the endogenous melatonin secretion profile, Slenyto is clinically proven to improve daytime behavior, all main sleep variables (sleep onset, sleep maintenance ,total sleep time) and parents’  and child's quality of life, whereas immediate release melatonin shortens sleep onset latency and causes early awakening.

Question 11

How is Slenyto administered?

Accepted Answer

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 broken, crushed or chewed, in order to retain the prolonged-release properties of the tablet responsible for sleep maintenance.

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.

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 Pediatric ASD. Slenyto offers favorable 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 Patient Information Leaflet.(https://www.ema.europa.eu/en/documents/product-information/slenyto-epar-product-information_en.pdf)

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