18 July 2019 - The pending submission is supported by data from two randomised controlled clinical trials of more than 1,400 patients.

Pear Therapeutics today announced the filing of a submission to the U.S. 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.

Somryst is intended to provide tailored neurobehavioral interventions, specifically Cognitive Behavioral Therapy for insomnia (CBTi) and sleep restriction driven by learning algorithms to reduce the severity of insomnia and symptoms of depression. CBTi is considered first-line treatment for chronic insomnia, but most people do not have access to nor receive the recommended treatment, and there currently are no FDA authorised therapeutics that deliver CBTi.

Read Pear Therapeutics press release