Sweet Dreams Ahead: Korea Unveils Slinyto, Groundbreaking Pediatric Insomnia Treatment
Breakthrough in Pediatric Insomnia Treatment: Geonil Pharmaceutical Launches Slinaito Mini Extended-Range Tablets
Geonil Pharmaceutical’s Innovative Solution for Pediatric Insomnia
Geonil Pharmaceutical has officially launched Slinaito Mini Extended-Range Tablets 1.5mg, a groundbreaking treatment for insomnia in children and adolescents.
The company received approval for two products, Slinaito, from the Ministry of Food and Drug Safety on November 15 and November 23 last year, respectively.
What is Slinaito?
Slinaito is the first insomnia treatment for children and adolescents in Korea, introduced from Neurim, Israel, and Kunil Pharmaceutical holds the exclusive development and distribution rights in Korea.
Slinaito is effective in treating insomnia in children and adolescents ages 2 to 18 years with autism spectrum disorder (ASD) or Smith-Magenis syndrome (SMS) whose symptoms have not improved with improved sleep hygiene.
Recommended Dosage and Efficacy
The recommended initial dose is 2 mg once daily, and if an inadequate response is observed, the dose may be increased to 5 mg, up to a maximum of 10 mg per day.
In a phase 3 clinical trial targeting children and adolescents with ASD and SMS, Slinaito was confirmed to improve sleep onset, sleep maintenance, and sleep duration.
Addressing the Unmet Needs of Pediatric Insomnia Patients
Children and adolescents suffering from insomnia have been using adult sleep disorder medications in excess of their approved dosages due to limitations in treatment.
A Geonil official stated, “We expect that the launch of this Slinyto Mini-SR tablet will meet the needs of clinical sites that require drugs to treat insomnia in children and adolescents.”
Future Prospects and Expansion of Indications
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) received a positive opinion on the recommendation to expand the existing indications to include the treatment of insomnia in children with neurogenetic disorders (NGD).
It is expected that Slinaito will also play a role as a treatment for insomnia in patients with neurogenetic disorders (NGD) who have sleep disorders related to melatonin secretion.
Kunil Pharmaceutical’s Comprehensive Insomnia Treatment Portfolio
With the launch of Circadin 2mg in 2014 and the recent launch of Slinyto, Kunil Pharmaceutical now possesses products that can treat insomnia in both children and adults.