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Slenyto (melatonin)
Australian Prescription Medicine Decision Summary
Slenyto has been approved for the treatment of insomnia in children and adolescents with neurogenetic disorders and/or attention-deficit hyperactivity disorder (ADHD). Slenyto contains the active ingredient prolonged-release melatonin.
Published
Product name
Slenyto
Active ingredient
Melatonin
Submission type
Type C - Extension of Indications
Decision
Approved for registration in the Australian Register of Therapeutic Goods (ARTG)
Decision date
Registration date
What this medicine was approved for
In this extension of indication submission, Slenyto has been approved to treat:
- Insomnia in children and adolescents aged 2-18 years with neurogenetic disorders with aberrant diurnal melatonin secretion and/or nocturnal awakenings, where sleep hygiene measures have been insufficient.
- Insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient.
Neurogenetic disorders are those of the central and peripheral nervous systems clearly associated with a characteristic set of symptoms and signs, which are caused by molecular defects in heritable material (usually DNA). Examples include Smith-Magenis syndrome, Angelman syndrome, Rett syndrome, Tuberous sclerosis complex, and Williams syndrome.
Insomnia is a common sleep disorder in children with ADHD, Autism Spectrum Disorder (ASD) and/or other heritable neurodevelopmental disorders. These children may have difficulty falling asleep, staying asleep, or waking too early.
Sleep is important for healthy brain development in childhood. It supports learning, memory, emotional regulation, and overall thinking and behaviour. Poor sleep may worsen the symptoms of these underlying conditions.
Sleep problems can be a challenging aspect of these disorders, improving sleep is often an important treatment goal for both children and their caregivers.
How this medicine works
Melatonin is a naturally occurring hormone produced by the pineal gland in the brain that helps regulate the sleep–wake cycle. Melatonin levels usually start to rise soon after it gets dark and signal that it is time to sleep.
Some children with ASD, ADHD and other neurogenetic disorders may not regulate melatonin properly, which may contribute to problems with sleep onset and sleep maintenance.
Slenyto is a ‘prolonged release’ form of melatonin, made to release melatonin slowly over time. Slenyto treatment may help improve sleep and support a more regular sleep pattern in some children with these disorders.
Why the TGA approved or did not approve this medicine
The effectiveness and safety of Slenyto were assessed in a single study that included 125 children aged 2 to 17 years whose sleep had not improved with behavioural treatment alone. Most had ASD (96.8%), and a small number had Smith-Magenis syndrome (3.2%). About 29% had been diagnosed with ADHD and 77% had abnormal hyperactivity/inattention scores.
The study had 2 important stages: a 13-week randomised placebo-controlled treatment period (where patients were randomly assigned to be given melatonin or a placebo) and a 91-week open-label treatment period (where all children received melatonin). The main goal of the study was to measure how much the total time spent asleep changed after the 13 week-treatment phase.
Well-established tracking surveys and diaries were used to measure sleep and behavioural outcomes in children and quality of life outcomes in caregivers.
In addition to the clinical study data, the sponsor company submitted published medical literature to support their application.
Key findings from the clinical study
- After 13 weeks:
- Children taking Slenyto slept longer than those taking placebo. The total sleep time increased by about 51 minutes with Slenyto compared with about 19 minutes with placebo.
- For children taking Slenyto, the time taken to fall asleep from full wakefulness decreased by about 38 minutes, compared with about 13 minutes with placebo, without making children wake earlier.
- Better sleep in the Slenyto group was associated with improved caregivers’ well-being and higher satisfaction with their child’s sleep.
- A similar improvement in total sleep time was measured in the 36 children in the study who also had ADHD, compared to children without ADHD. The use of melatonin for children with ADHD was supported by other published medical studies submitted by the sponsor.
- After 91 weeks of treatment, the improvements seen during the 13 week study period were maintained.
- Evidence for using Slenyto in children and adolescents aged 2 to 18 years with neurogenetic disorders was derived from this clinical trial and by published medical studies submitted by the sponsor. Melatonin works by regulating sleep in a way that is not thought to depend on the underlying disorder, so children with neurogenetic disorders linked to abnormal melatonin patterns may also benefit from Slenyto treatment.
- The safety results from this trial did not show any important new safety concerns beyond what is already known about Slenyto from other studies. In this trial, compared with placebo, children taking melatonin had increased sleepiness, tiredness and headache.
The TGA decided that the application provided sufficient evidence supporting the safety and effectiveness of Slenyto for the approved indications.
More detailed information on why the TGA approved Slenyto will be published in the upcoming Australian Public Assessment Reports (AusPAR).
For comprehensive information on potential side effects and risks, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document.
This decision summary will not be updated to reflect any subsequent changes and may therefore not contain the most current information about the medicine. For the latest information, refer to the medicine’s CMI or PI.
Consumer Medicine Information (CMI)
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMI for Slenyto can be accessed through the searchable TGA eBusiness Services or ARTG databases
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PI for Slenyto can be accessed through the searchable TGA eBusiness Services or ARTG databases.
Sponsor
Other resources
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For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.