Digital therapy for sleep disorders: “somnio” receives approval as digital health application (DiGA)

Leipzig, 22 October 2020 – The digital sleep training somnio for the treatment of sleep disorders was approved by the Federal Institute for Drugs and Medical Devices (BfArM) as a Digital Health Application (DiGA) and thus included in the list of prescribable products. The program, which treats sleep disorders on the basis of cognitive behavioral therapy, is thus one of the first digital health applications in Germany that can be prescribed by health insurance companies. somnio was developed by mementor DE GmbH. Its effectiveness has already been proven in a randomized controlled study.

According to independent surveys, about one in ten Europeans suffers from problems falling asleep and sleeping through the night. Since 2010, the proportion among professionals in Germany has even risen by more than 60 percent, as the DAK Health Report from 2017 shows. Although treatment guidelines in Europe and the U.S. clearly recommend cognitive-behavioral therapy for initial treatment, in the real world of care, drug therapy is used much more frequently. With corresponding risks: In addition to habituation or even dependency, certain drugs can cause confusion or even falls, especially in older patients.

Noah Lorenz, psychologist and founder of mementor: “The recommendations from the guidelines and the reality of medical care diverge greatly. According to various health insurance companies, less than 10 percent of patients with an initial diagnosis of insomnia receive cognitive behavioral therapy. With somnio, we want to make a significant contribution to improving care for those affected. The approval as DiGA now enables millions of insured persons to receive easily accessible treatment for their sleep disorders. And it opens an additional and, above all, a guideline-compliant treatment option for physicians.”

Guideline-compliant and evidence-based digital treatment

The digital training with the application somnio was developed based on the guidelines of the German Society for Sleep Research and Sleep Medicine. With the help of a sleep journal or a digital sleep tracker, sleep and behavioral data of the patients are recorded. On the basis of this data, the patients receive individual instructions and exercises to improve their own sleep situation. The exercises are based on methods of cognitive behavioral therapy. With these exercises, the users learn, for example, how to optimize their sleep-wake rhythm, how to handle sleep-inhibiting thoughts or how to get themselves into the right state of mind for sleep with the help of relaxation techniques.

The effectiveness of the digital sleep training has been proven in a randomized controlled study at the University of Zürich: Over a study period of six weeks, a reduction in sleep problems of 50 percent on average was achieved. (Details of the study can be found on the website www.somn.io).

Dr. Hans-Günter Weeß, Member of the board of the German society for sleep research and sleep medicine and director/conductor of the interdisciplinary sleep center at the Pfalzklinikum in Klingenmünster: “Sleep is the most important human regeneration and repair program. Chronic lack of sleep is accompanied by an increased health risk. In our 24-hour non-stop society, many people suffer from sleep disorders requiring treatment. Today, we regard cognitive behavioral therapy for insomnia with its self-effective techniques as first-line therapy for insomnia in many cases. Drug therapy for insomnia is considered a symptomatic therapy and is generally not regarded to have a causal, i.e. remedial, effect. Cognitive behavioral therapy of insomnia, on the other hand, is considered a causal treatment for many insomnia disorders. Digital health applications like somnio can help make these effective techniques widely available in the field of sleep medicine”.

Prof. Dr. med. Christoph Schöbel, Head of the Center for Sleep and Telemedicine at the Ruhrland Clinic of the University Medical Center Essen: “Health Apps that have shown a positive effect can be reimbursed as “apps on prescription” by the statutory health insurance after appropriate examination. We hope that these new possibilities can help us help our patients even better than before”.

somnio is available as a web application directly from the browser and as an app for smartphones and tablets with the iOS and Android operating systems.

somnio can now be prescribed by a doctor. The prescription is made through medical prescription form 16. The prescription must contain the product name “somnio”, the PZN 16898724 and the prescription period. From 2 November 2020, somnio can also be prescribed directly from the PVS.

About mementor

The digital health company mementor develops digital medical products in the sleep medicine field and related areas. mementor was founded in Switzerland in 2014 by Noah Lorenz (CEO), Jan Kühni (CTO) and Alexander Rötger (CMO) and has been represented with a German spin-off in Leipzig since January 2020. mementor’s first product is the digital, guideline-based sleep training somnio, which is used for the treatment of insomnia. Based on individual sleep data, the therapy teaches exercises and methods of cognitive behavioral therapy that lead to improved sleep. The effectiveness of the program has been proven by a randomized controlled study. somnio is approved as a Class I medical device and as a Digital Health Application (DiGA) and is therefore free of charge for those insured by statutory health insurance companies. The training is available as an online application in web browsers or as an app for iOS or Android. More information is available at: www.somn.io

Press contact:

mementor DE GmbH
Noah Lorenz
e-mail: noah.lorenz@mementor.de
Phone: *49 (0) 341 98995945