Effective management of sleep problems with Slenyto® improves next day behaviour in children with autism with, or without, comorbid ADHD5
SDQ, Strengths and Difficulties Questionnaire
- Improvement in child externalising behaviour correlates with improvement in total sleep time and longest sleep episode5
- Slenyto improves total sleep time and longest sleep episode6,7
- Immediate-release melatonin conveys no significant effect on child behaviour8
5. Schroder CM, et al. J Autism Dev Disord. 2019;49(8):3218–30.
6. Schroder CM, et al. Expert Opin Pharmacother. 2021;22(18):2445–5.
7. Gringras P, et al. J Am Acad Child Adolesc Psychiatry. 2017;56(11):948–57.
8. Gringras P, et al. BMJ. 2012;345:e6664.
Effective management of sleep problems in children with autism with, or without, comorbid ADHD, can improve the overall health of the family9
*A change of 10% in WHO-5 score.
CSDI, Composite Sleep Disturbance Index Score; WHO-5, World Health Organisation Wellbeing Index-5
9. Maras A, et al. J Child Adolesc Psychopharmacol. 2018;28(10):699–710.
Slenyto® delivers a clinically meaningful* reduction in sleep onset7
- Children fell asleep on average 40 minutes earlier7
- Number needed to treat = 3.2 for clinical response*
- Improves sleep onset without causing earlier wakening7,9
*Clinically meaningful reduction = reduction in sleep latency ≥15 mins versus baseline.
7. Gringras P, et al. J Am Acad Child Adolesc Psychiatry. 2017;56(11):948–57.
9. Maras A, et al. J Child Adolesc Psychopharmacol. 2018;28(10):699–710.
Slenyto® increases longest uninterrupted sleep episode (continuous sleep) in the short and long term6
- Slenyto increased longest sleep episode:
- significantly after 3 weeks7
- by an average of 78 mins after 13 weeks7
- by an average of 89 mins after 1 year9 - Longest sleep episode correlates with changes in the child’s behaviours and parent’s quality of life6
6. Schroder CM, et al. Expert Opin Pharmacother. 2021;22(18):2445–54.
7. Gringras P, et al. J Am Acad Child Adolesc Psychiatry. 2017;56(11):948–57.
9. Maras A, et al. J Child Adolesc Psychopharmacol. 2018;28(10):699–710.
Slenyto® delivers a clinically meaningful* improvement in total sleep time7
- When used for an initial period of 13 weeks, Slenyto-treated children slept an average of 58 minutes longer per night7
- Number needed to treat = 4.7 for clinical response* to Slenyto7
- Improvement in total sleep time correlates with improvements in externalising behaviour5
*Clinically meaningful improvement = increase in total sleep time ≥45 mins versus baseline
5. Schroder CM, et al. J Autism Dev Disord. 2019;49(8):3218–30.
7. Gringras P, et al. J Am Acad Child Adolesc Psychiatry. 2017;56(11):948–57.
Slenyto® has safety data from a 2-year clinical trial14
- No observed detrimental effects on children’s growth and pubertal development14
- No withdrawal issues related to the use or discontinuation of the drug14
- No ‘very common’ (≥1/10) adverse reactions13
- Common adverse reactions: somnolence, fatigue, mood swings, headache, irritability, aggression, hangover, sinusitis and sudden onset of sleep13
13. Slenyto SmPC (Accessed October 2025).
14. Malow BA, et al. J Am Acad Child Adolesc Psychiatry. 2021;60(2):252-61.
How to take Slenyto®13
- Slenyto should be taken once daily, 30 mins to 1 hr before bedtime, with or after food
- The minitablet should not be chewed, crushed or broken as it will lose its prolonged-release properties
- Slenyto can be added to food such as yoghurt, orange juice or ice cream to facilitate swallowing
- If mixed with food or drink, the dose should be taken immediately, and the mixture not stored
Designed with the patient in mind
- Paediatric-appropriate minitablet, just 3mm in diameter
- Flavourless and odourless
- Easy to swallow, with or without water. No need to crush
- Provides early release of melatonin which is then sustained throughout the night
13. Slenyto SmPC (Accessed October 2025).
Sleep disorders exacerbate symptoms of ADHD and autism1,2
Sleep onset and maintenance issues are common in children with neurodevelopmental and neurogenetic disorders3,4
| Disorder | Sleep onset insomnia | Sleep maintenance insomnia |
| Autism3,4 |  |
 |
| ADHD4 | |
|
| Angelman syndrome3 | |
|
| Down syndrome3 | |
|
| Fragile X syndrome3 | |
|
| Rett syndrome3 | |
|
| Smith-Magenis syndrome3 | |
|
| Williams syndrome3 | |
|
Slenyto®, the only melatonin shown to improve the lives of children and adolescents with autism, with and without ADHD5,7‑13
 |
Improves child behaviour5,10,11 See how Slenyto® helps |
 |
|
Improves caregiver quality of life5,9,10,11 See how Slenyto® helps |
|
|
Improves sleep onset without causing earlier wakening7,8,9 See how Slenyto® helps |
|
|
Improves sleep maintenance (longest uninterrupted sleep episode)7,9,10,11 See how Slenyto® helps |
|
|
Improves total sleep time to a clinically noticeable extent7,9,10,11 See how Slenyto® helps |
|
|
Proven long-term (52 weeks) efficacy and safety data9 See how Slenyto® helps |
|
|
Mimics endogenous melatonin secretion12 | |
|
Minitablet (3mm diameter) developed for swallowing by children13 See how Slenyto® helps |
|
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Licensed from age 2 years13 | |
|
Equally effective in treating insomnia in autistic children with or without comorbid ADHD13 | |
Immediate-release melatonin has a rapid onset and rapid decline*12
Immediate-release melatonin improves sleep onset, but promotes earlier wakening8
Prolonged-release melatonin mimics the body’s endogenous production of melatonin*12
Prolonged-release melatonin confers extended sleep coverage throughout the night7,12
AUC, area under the curve
Slenyto® is now indicated to treat insomnia in children and adolescents with ADHD, autism and/or neurogenetic disorders13
Where sleep hygiene measures have been insufficient, Slenyto is now indicated in children and adolescents:
- Aged 2-18 years with autism and/or neurogenetic disorders with aberrant diurnal melatonin secretion and/or nocturnal awakenings
- Aged 6-17 years with ADHD
Recommended starting doses:13
| ADHD | 1-2mg | ≥6 years |
| ASD and/or NGD | 2mg | ≥2 years |
If required, the dose may be increased to 5mg and further to a maximum dose of 10mg/day
Slenyto® improves insomnia, behaviour and caregiver quality of life in children and adolescents with autism, with or without ADHD5,7,9,13
*Leads to favourable effects on daytime externalising behaviour.
References
1. Deliens G, et al. Rev J Autism Dev Disord. 2015;2:343–56.
2. Ipsiroglu OS, et al. Somnologie. 2024;28:189–200.
3. Shelton AR, et al. Neurotherapeutics. 2021;18(1):156–69.
4. Holingue C, et al. Sleep Health. 2021;7(3):375–83.
5. Schroder CM, et al. J Autism Dev Disord. 2019;49(8):3218–30.
6. Schroder CM, et al. Expert Opin Pharmacother. 2021;22(18):2445–54.
7. Gringras P, et al. J Am Acad Child Adolesc Psychiatry. 2017;56(11):948–57.
8. Gringras P, et al. BMJ. 2012;345:e6664.
9. Maras A, et al. J Child Adolesc Psychopharmacol. 2018;28(10):699–710.
10. Adaflex SmPC (Accessed October 2025).
11. Melatonin 1mg/ml oral solution SmPC (Accessed October 2025).
12. Zisapel N. Br J Pharmacol. 2018;175(16):3190–9.
13. Slenyto SmPC (Accessed October 2025).
14. Malow BA, et al. J Am Acad Child Adolesc Psychiatry. 2021;60(2):252-61.