Insomnia treatment APP to be permitted as therapeutic device

The government has approved using a smartphone application (app) that treats insomnia. This app is one of the digital therapeutic devices, software forms of medical devices that treat diseases or disorders. This is the first time a digital treatment device has been clinically verified and approved in Korea.

On Wednesday, the Ministry of Food and Drug Safety announced that it has approved the use of ‘Somzz,' a cognitive treatment software for insomnia developed by Aimmed, a Korean company. With this approval, Korea became the fourth country in the world to permit the use of a digital therapeutic device for insomnia treatment, following the United States, Germany, and the United Kingdom. “The era of digital treatment devices has begun in Korea as well,” Food and Drug Safety Minister Oh Yoo-kyung said.

Somzz implemented ‘Insomnia Cognitive Behavioral Therapy,’ one of the methods to treat insomnia patients, in a smartphone app. Insomnia patients can download the app according to the doctor's prescription and then follow an insomnia improvement program that includes training on sleep habits, writing a sleep diary, and abdominal breathing for six to nine weeks. “A clinical trial was conducted at three domestic clinical trial institutions for six months. A statistically significant improvement was observed after using Somzz,” an official from the Ministry of Food and Drug Safety said. The safety of the application was also confirmed through a medical device committee composed of psychiatry and family medicine experts. If a patient with insomnia does not show sign of improvement even after using the software, the doctor will apply drug treatment.

Despite the approval, it seems it will take some time before actual insomnia patients can use Somzz. The Ministry of Health and Welfare will need to designate a medical institution that can prescribe the app. Also, the applicability of the app to health insurance needs to be reviewed. Currently, digital therapeutic devices that treat not only insomnia but also depression, attention deficit behavior disorder (ADHD), and mild cognitive impairment are under development in Korea.


ksy@donga.com