Kuhnil Pharmaceutical has launched Slenyto SR Tablet, marking the first officially licensed insomnia treatment for children and adolescents in Korea. This development is drawing significant attention from industry insiders, given the previous lack of approved treatments for pediatric insomnia in the country.
Developed by Israel-based Neurim Pharmaceuticals, Slenyto was launched following its approval for treating insomnia in children and adolescents aged two to 18 years with Autism Spectrum Disorders (ASD) and Smith-Magenis syndrome (SMS), specifically when sleep hygiene improvements have proven insufficient.
Clinical Trial Results
According to a Kuhnil Pharm official, Slenyto's efficacy in treating pediatric insomnia has been demonstrated through clinical trials. In a phase 3 trial, Slenyto increased sleep duration by 40 minutes at week 3 compared to placebo. Over a longer period, the average increase in total sleep duration was 62.08 minutes across four measurements taken at weeks 13, 26, 39, and 52. Furthermore, after dose optimization, sleep maintenance saw an increase of 89.1 minutes at week 52. Sleep latency, or the time taken to fall asleep, decreased by an average of 48.6 minutes at week 52.
The study, conducted across 24 sites in Europe and the U.S., included 125 children and adolescents aged two to 17.5 with ASD and neurological disorders. Participants were divided into two groups: Slenyto (60) and placebo (65). The study assessed sleep onset, sleep duration, and total sleep time after 13 to 52 weeks of treatment. Notably, 28.5 percent of the children had comorbid ADHD, and 12.8 percent had comorbid epilepsy.
Impact on Caregivers
An interesting finding from the study was the improvement in the quality of life for caregivers of children treated with Slenyto. Parents in the Slenyto group reported an average increase of two points in child sleep satisfaction on a scale of one to five. Nearly 50 percent of caregivers reported a 10 percent or greater increase in quality-of-life scores compared to pre-treatment levels.
Safety Profile
The clinical trials revealed no significant adverse events associated with Slenyto. A two-year follow-up study indicated adherence to the tablets was nearly 100 percent over the 24-month study period, with only mild drowsiness reported. Importantly, there were no adverse events indicative of dependence, abuse, tolerance, or withdrawal after discontinuation of the treatment.
Expert Commentary
Choi Seok-hong, head of Marketing 1 Division at Kuhnil Pharm, emphasized the established safety of melatonin, the active ingredient in Slenyto, citing prior experience with Circadin. He stated, "We have already confirmed melatonin's short- and long-term safety with Circadin (the same ingredient as Slenyto). The drug has confirmed it is a treatment for insomnia without tolerance or dependence."
Choi also highlighted that European guidelines recommend melatonin as the first-line medication for pediatric patients with ASD and SMS, underscoring its safety profile.
Mechanism of Action and Formulation
Choi explained that many ASD patients experience sleep problems due to genetic disruptions in serotonin production, leading to decreased melatonin levels. He noted that studies have confirmed that symptoms such as nighttime seizures and mood instability can lead to sleep deprivation and reduced quality of life for caregivers. Chronic insomnia, he added, reduces REM sleep, leading to cognitive decline, increased aggression, hyperactivity, and fear, creating a detrimental cycle.
Slenyto's extended-release tablet form is designed to mimic normal sleep patterns by releasing melatonin over seven to eight hours. The tablets are small and nearly spherical, making them easy to swallow and can be mixed with yogurt, juice, or ice cream for easier administration to children with ASD.
Availability and Pricing
Slenyto is available in 1mg and 5mg formulations, priced at 1,600 won ($1.2) and 4,000 won, respectively, without insurance coverage.
