Introducing Somryst

Somryst™ is a Prescription Digital Therapeutic (PDT) candidate, designed to treat adults with insomnia and symptoms of depression.

Somryst™:
  • Is designed to offer Cognitive Behavioral Therapy for insomnia (CBTi) and sleep restriction algorithms designed 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 510(k) submission with the U.S. Food and Drug Administration (FDA) seeking clearance for Somryst™, using data from the SHUTi precursor product to support the submission.

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. (1)
 
Somryst is not available for sale in the U.S.

About Pear Therapeutics

Pear Therapeutics is the leader in prescription digital therapeutics. PDTs are a new therapeutic class that use software to treat serious diseases.

PDTs are authorized by the FDA, prescribed by a physician, and backed by clinical data.

Apart from Somryst, Pear is continuing to investigate new intended uses of PDTs for insomnia.  If you are interested in participating in an upcoming trial, please click “Notify Me of Upcoming Trials” below.

(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