FDA Approves Prescription Digital Therapeutic for Chronic Insomnia

Pear Therapeutics recently announced that FDA granted authorization for Somryst, the first prescription digital therapeutic (PDT) to treat adult patients with chronic insomnia.

Somryst is a nine-week PDT intended for patients 22 years old and older. It is the first product submitted through FDA’s traditional 510(k) pathway while also reviewed as part of FDA’s Software Precertification Pilot Program to help build and test FDA’s Digital Health Precertification Working Model 1.0.

“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. 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,” Charles M. Morin, MD, PhD, professor of psychology, director the Sleep Research Centre at Université Laval in Quebec City, said in the announcement.

“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.”

Somryst is the third PDT to receive authorization from FDA, following Pear reSET and reset-0.

Pear reSET is a 90-day PDT for substance use disorder (SUD) intended to provide cognitive behavioral therapy (CBT), simultaneously with a contingency management system, Pear Therapeutics said in an article. It is meant for patients 18 and older who are enrolled in outpatient treatment under clinician supervision.

reset-O is an 84-day PDT for opioid use disorder (OUD) to increase retention of patients in outpatient treatment by providing cognitive behavioral therapy (CBT) along with outpatient treatment. This includes transmucosal buprenorphine and contingency management for adult patients under clinician supervision, the article stated.

Somryst will provide neurobehavioral interventions, focusing on Cognitive Behavioral Therapy for insomnia (CBT) and sleep restrictions to greatly improve insomnia symptoms. The PDT is personalized to the patients’ needs, such as their ability to set a sleep window.

The PDT is the only FDA-authorized therapeutic that delivered guidance recommended first-line treatment for chronic insomnia. Previously, the American Academy of Sleep Medicine and the American College of Physicians clinical guidance recommend CBTi as first-line treatment for the disorder.

The FDA submission was supported by two randomized clinical trials evaluating the effectiveness of the therapeutic, the announcement highlighted. The studies enrolled over 1,400 adults with chronic insomnia. The study published in JAMA Psychiatry found that out of 303 patients, those on treatment showed notable improvements in insomnia severity, sleep onset latency, wake after sleep onset at the time of treatment, and six to 12 months follow-up compared to active control.

Published in Lancet Psychiatry, the second study of 1,149 patients with the disorder and depressive symptoms uncovered that individuals on treatment for nine weeks saw a great reduction in insomnia severity measurements compared to controls. The benefits lasted greater than 12 months and most patients no longer met clinical criteria for insomnia after the 9-week treatment period.

Pear Therapeutics is one of nine companies taking part in the FDA’s Pilot Program. The company has been working closely with the FDA and volunteered to undergo the first-ever Excellence Appraisal in May 2019, which consisted of an onsite evaluation of the company’s commitment and execution across product quality, patient safety, cybersecurity responsibility, clinical responsibility, and a proactive culture, the announcement stated.

“The FDA’s authorization of our third PDT, Somryst, demonstrates our ongoing commitment to redefine disease treatment through the development of PDTs,” said Corey McCann, MD, PhD, president and CEO of Pear Therapeutics. “Now, more than ever, easily-accessible treatment options are imperative for patients suffering from chronic conditions. Pear has built the capabilities, pipeline, and platform to allow us to build PDTs that help patients across a variety of disease areas.”