South Korea approves second local insomnia DTx

Another digital therapeutics app for treating insomnia has been approved by the South Korean Ministry of Food and Drug Safety.

The mobile app called WELT-I by Welt Co. is the second insomnia DTx to be approved in the country.

WHAT IT DOES

WELT-I uses cognitive behavioural therapy (CBT), which is the first-line treatment for insomnia, to address the underlying causes of chronic insomnia.

It is a six-week programme that uses sleep data logged by patients themselves to provide personalised bedtime routine suggestions, analysis of sleep habits, behavioural interventions to improve sleep quality, and relaxation therapy to reduce tension and anxiety. 

WHY IT MATTERS

South Korea has seen a 96% increase in the number of patients with insomnia over the past decade. At least 15% of its population is dealing with chronic insomnia. 

While sleeping pills offer short-term relief, this only helps induce sleep and does not solve the underlying causes of insomnia. CBT provides first-line treatment for insomnia but access to it is limited and there are not many providers around. A mobile CBT-based app can potentially bridge this gap in access to more effective treatments for insomnia. 

THE LARGER TREND

This latest MFDS clearance for an insomnia DTx comes just two months after the ministry’s first approval. Somzz by Aimmed, which was cleared in February, also delivers CBT to help increase sleep duration in users with insomnia.