Introducing Somryst

Somryst™ is an investigational Prescription Digital Therapeutic (PDT), intended to treat adults with chronic insomnia and depression.

Somryst:
  • 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).

The FDA submission is supported by data from two randomized controlled clinical trials that evaluated more than 1,400 adults with chronic insomnia, approximately 1,100 of whom also had depression.

Read more here. 

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.

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(1)  Khurshid KA. Comorbid Insomnia and Psychiatric Disorders: An Update. Innov Clin Neurosci. 2018;15(3-4):28–32. Ohayon MM. Insomnia: a ticking clock for depression? J Psychiatr Res. 2007;41(11):893-894. doi:10.1016/j.jpsychires.2007.07.008. Baglioni C, Battagliese G, Feige B, etal. Insomnia as a predictor of depression: A meta-analytic evaluation of longitudinal epidemiological studies. J Affect Disord. 2011. doi:10.1016/j.jad.2011.01.011