Susmed Inc has obtained regulatory approval from the Ministry of Health, Labour and Welfare of Japan for its Susmed CBT-I app for insomnia, a prescription-only digital therapeutic intended to assist physicians providing cognitive behavioral therapy for insomnia (CBT-I) to patients in the treatment of insomnia.

Susmed is in the process of applying for insurance coverage and market launch.

The app has therapeutic effects on insomnia symptoms by following instructions prompted by the product over a nine-week period. In addition, the progress of insomnia treatment can be shared with physicians through the management system that supports the treatment process.

Currently, drug therapy with sleeping pills is widely used to treat insomnia in Japan. Although sleeping pills have the advantage of immediate effects, such as shortening the latency to fall asleep and improving difficulty staying asleep, they have side effects such as physical symptoms of lightheadedness or falling down, carryover effects of headache or fatigue, and carry drug dependence, according to a release from Susmed. 

In addition to drug treatment, there are other treatment options like sleep hygiene instruction or CBT-I. In the United States, CBT-I is recommended as the first choice for insomnia treatment. In the UK, where evidence for the treatment of insomnia with smartphone applications has been accumulated, the National Institute for Health and Clinical Excellence has recommended the use of CBT-I-based applications for insomnia treatment in its 2022 guidelines.

However, implementing CBT-I requires time-consuming instruction, and CBT-I is not widely used in Japan due to a lack of medical professionals.

With this regulatory approval, the Susmed CBT-I app for insomnia can be prescribed in the form of a smartphone application, and it becomes a treatment option for insomnia other than drug therapy in the country. 

Susmed entered into a marketing alliance agreement with Shionogi & Co in December 2021 to promote the product to medical institutions.

Photo caption: Susmed CBT-I app

Photo credit: Susmed