South Korea approves second local insomnia DTx

With a 96% increase in the number of patients with insomnia in the last decade, South Korea currently has at least 15% of its population dealing with chronic insomnia. Cognitive Behavioural Therapy is a proven first line of treatment for insomnia but access to it is limited due to the lack of providers. WELT-I’s mobile CBT-based app aims to bridge the gap in access and enable patients across South Korea. 

WELT-I requires a doctor’s prescription and was approved based on a clinical trial conducted on 120 patients where WELT-I demonstrated significant improvements in sleep efficiency. It is a six week programme that uses patients’ sleep diary data to provide personalised bedtime routine recommendations, analysis of sleep habits, behavioural interventions to improve sleep quality and relaxation therapy to reduce tension and anxiety. 

Aimmed’s insomnia digital therapeutic device “Somzz” was the first domestic digital therapeutic approved in February this year by South Korea’s Ministry of Food and Drug Safety. WELT-I’s latest clearance comes just two months after the ministry’s first approval and can be another new treatment option for insomnia patients with limited access to CBT options for insomnia locally.