Somryst™ is an investigational Prescription Digital Therapeutic (PDT), intended to treat adults with chronic insomnia and depression.
- Is an investigational PDT that offers Cognitive Behavioral Therapy for insomnia (CBTi) and sleep restriction algorithms to reduce the severity of insomnia and symptoms of depression
- Is the first product submitted to the FDA Software Pre-certification Pilot program, as part of the 2019 Test Plan released by the FDA in January 2019
Pear Therapeutics has filed a submission with the U.S. Food and Drug Administration (FDA) seeking marketing authorization for Somryst™, a prescription digital therapeutic (PDT) intended for use in the treatment of adults with chronic insomnia and depression. Depression is the most common co-occurring disorder with insomnia (1).
About Pear Therapeutics
Pear Therapeutics is the leader in prescription digital therapeutics. PDTs are a new therapeutic class that use software to directly treat serious diseases.
Similar to traditional biologics or drugs, PDTs are prescribed by a physician and backed by clinical data that has been validated by the FDA.