Somryst Digital Prescription Therapeutic Gets Market Authorization for Insomnia

Charles M. Morin, PhD, professor of psychology, and director, Sleep Research Centre, Universite Laval

Charles M. Morin, PhD

The FDA has granted market authorization to Somryst, the first digital prescription therapeutic (DPT) designed for the treatment of patients with chronic insomnia aged 22 years and older, according to an announcement by its developer, Pear Therapeutics.¹

Somryst works by providing tailored neurobehavioral interventions intended to improve the symptoms of insomnia, most specifically via cognitive behavioral therapy for insomnia (CBTi) and sleep restriction, driven by an algorithm evaluation. The product offers personalization features that enable patients to set sleep windows depending on their schedules.

“More than 30 million adults suffer from chronic insomnia, which can seriously impact one’s quality of life and can lead to depression, suicidality, hypertension, and even heart attacks,” Charles M. Morin, PhD, professor of psychology, and director, Sleep Research Centre, Université Laval, said in a statement. “Treatment options for chronic insomnia are limited as most available sleep medications are only recommended for short term use, can lead to problems with tolerance, and can have unwanted side-effects, including next-day cognitive impairments.”

Overall, the intervention offers a 9-week therapeutic program, which can be accessed on mobile devices like smartphones and tablets. The decision from the FDA was supported by a pair of randomized controlled trials that included a total of 1400 adults with chronic insomnia.

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The first, which featured 303 participants, reported a significant improvement of sleep for those who used the study intervention (n = 151) compared to those who utilized an online patient education program (n = 152), with 56% achieving remission of insomnia and 69.7% deemed responders at the 1-year mark. Additionally, all of the 3 primary sleep outcomes showed significant overall group&thinsp;× time interaction for all variables in favor of the intervention. The outcomes were the Insomnia Severity Index (F_3,1063&thinsp;=&thinsp;20.65; P&thinsp;<.001), sleep-onset latency (F_3,1042&thinsp;=&thinsp;6.01; P&thinsp;<.001), and wake after sleep onset (F_3,1042&thinsp;=&thinsp;12.68; P&thinsp;<.001).²

The second study included 1149 adult patients with chronic insomnia and depressive symptoms, those on treatment for 9 weeks saw a significant reduction in insomnia severity measurements compared to controls. These benefits persisted over a 12-month period. The majority of patients randomized to the treatment arm for the PDT candidate no longer met clinical criteria for insomnia at the end of the 9-week treatment.³

“The authorization of Somryst by the FDA provides patients suffering from chronic insomnia with a digitally-delivered CBTi therapeutic, where CBTi is the guideline-recommended long-term, first-line treatment for chronic insomnia,” Morin added. The American Academy of Sleep Medicine (AASM) and the American College of Physicians (ACP) clinical guidelines recommend CBTi as first-line treatment for people with chronic insomnia.^4,5

Somryst is the only FDA-authorized therapeutic that delivers guideline-recommended first-line treatment for chronic insomnia, according to Pear. It follows Pear’s other PDT products, reSET and reSET-O, as the third such therapeutic to receive agency authorization. The CBTi product was the first to be submitted through the FDA’s traditional 501(k) pathway at the same time as the agency’s Software Precertification Pilot Program—in which Pear is 1 of 0 companies taking part&mdash;intended to build and assess its Digital Health Precertification Working Model 1.0.

REFERENCES

1. Pear Therapeutics Obtains FDA Authorization for Somryst, a Prescription Digital Therapeutic for the treatment of Adults With Chronic Insomnia [press release]. Boston, MA, and San Francisco, CA: Pear Therapeutics; Published March 26, 2020. Accessed March 26, 2020. peartherapeutics.com/pear-therapeutics-obtains-fda-authorization-for-somryst-a-prescription-digital-therapeutic-for-the-treatment-of-adults-with-chronic-insomnia

2. Ritterband LM, Thorndike, FP, Ingersoll, KS, et al. Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial. JAMA Psychiatry. 2017;74(1),68-75. doi:10.1001/jamapsychiatry.2016.3249

3. Christensen H, Batterham PJ, Gosling JA, et al. Effectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): a randomised controlled trial. Lancet Psychiatry. 2016;3(4):333-341. doi: 10.1016/S2215-0366(15)00536-2

4. Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008;4(5):487-504.

5. Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD. Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016; 165:125—133. doi: 10.7326/M15-2175