Profile of Somryst Prescription Digital Therapeutic for Chronic Insomnia: Overview of Safety and Efficacy.

Publication Type:

Journal Article


Expert Rev Med Devices, Volume 17, Issue 12, p.1239-1248 (2020)


Chronic Disease, Cognitive Behavioral Therapy, COVID-19, Humans, Prescriptions, SARS-CoV-2, Sleep Initiation and Maintenance Disorders


<p>: Prescription digital therapeutics (PDTs) represent a new class of software-based medical devices authorized by the Food and Drug Administration (FDA) to treat disease. Somryst™, the first PDT for treating chronic insomnia, delivers cognitive behavioral therapy for insomnia (CBT-I) via a mobile application. CBT-I is the guideline-recommended, first-line treatment for chronic insomnia, but availability of CBT-I therapists is limited. Somryst addresses this need by providing asynchronous access to CBT-I treatment. As a contactless therapeutic medium, Somryst is also an ideal option when face-to-face therapy is not available or recommended for safety reasons (e.g. because of possible exposure to the SARS-CoV-2 virus). : This review summarizes the mechanisms of action and technical features of Somryst, and describes safety and effectiveness data from the randomized trials on which FDA clearance was based. : Somryst demonstrates robust clinical efficacy with a favorable benefit-to-risk profile for treating adults with chronic insomnia. FDA clearance was based on data from 2 clinical trials of the first-generation web-based CBT-I platform Sleep Healthy Using the Internet (SHUTi). Somryst, and PDTs in general, are promising devices to address the need for greater accessibility to effective therapies.</p>

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