Pear Therapeutics Inc. obtained FDA approval for Somryst, the first prescription digital therapeutic for chronic insomnia. The app provides structured cognitive behavior therapy (CBT) with clinical dashboards for physicians. While CBT is the recommended first-line therapy for insomnia, the U.S. has only 500 therapists certified to provide CBT for insomnia (CBTi) for the estimated 30 million Americans who suffer from chronic difficulty going to and staying asleep.

Somryst was the first product to receive approval through the FDA’s 510(k) pathway as well as its new Software Precertification Pilot Program. The Boston and San Francisco-based company was one of nine in the country selected to help the FDA develop a new precertification “framework that is able to develop more rapid ways to review software updates and define high quality software and wearables” without compromising on safety, so that companies and consumer can benefit more quickly from frequent updates characteristic of these products, Pear Therapeutics’ Chief Medical Officer Yuri Maricich told BioWorld.

“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,” said Charles Morin, professor of psychology and director of Sleppe Research Centre at the Université Laval in Quebec City, Canada.

The approval is a potential gamechanger for patients with insomnia and their providers. “A number of medications are available, but they are only approved for short-term use, have significant adverse effects, and pose increased risks as patients age and the risk of both insomnia and drug interactions goes up,” Maricich noted.

Commercial availability is expected by the end of 2020. A price has not been set yet, but will likely reflect the traditional approach for setting pricing based on the “medical value created,” Maricich suggested.

Somryst is recommended for people who have experienced at least three months of severe difficulty in going to sleep and staying asleep, though many patients in the clinical trials that led to its approval had suffered from insomnia for the better part of a decade.

The high rate of insomnia among Americans is compounded by the dearth of trained therapists. “Some states have no certified CBTi therapists and many therapists have waiting lists of one to two years,” he added. That creates challenges for primary care physicians who may have no one to whom they can realistically refer patients.

How it works

As a prescription digital therapeutic, Somryst is only available to patients through their health care provider. Providers send the prescription to the company’s patient service center which then issues a code that patients can use to download the app through Google Play or Apple’s Playstore.

The authorization code enables access for nine weeks, at which point the patient can get another prescription if they want to continue to use it. Providers receive a digital dashboard to monitor patient’s daily sleep diaries and assessments of both insomnia and depression.

The app has six cores that each last about one week and include an overview on insomnia and the therapy, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene and relapse prevention.

Sleep restriction and consolidation work together to help patients fall asleep more quickly once they go to bed and identify when to go to bed for their best sleep. Using feedback in the program, patients track when they go to bed, when they fall asleep, how often and for how long they awaken during the night, and when they arise. Using that information, the app helps them define and gradually expand the “sleep window” that will work best for them.

Stimulus control identifies and educates patients about habits that may be inadvertently sabotaging their efforts to obtain quality sleep, such as drinking caffeine too late in the day, leaving the television on, extending blue light exposure from electronic devices into the late evening, or having a sleep area that is too warm, bright or noisy.

Cognitive restructuring addresses the maladaptive ways many patients with chronic insomnia think about sleep and the anxiety often associated with sleep issues. Patients may “worry about the next day, wondering whether they will be able to function or perform their work or activities. They may develop ‘thought traps,’” said Maricich.

“Somryst presents various thought traps and patients identify which ones they have, then it helps them catch that negative thought and change it to learn new ways of behaving and build new neuronal pathways,” Maricich explained.

The larger of the two randomized controlled trials of Somryst enrolled 1,149 adults with insomnia and depressive symptoms and was published in Lancet Psychiatry. At the end of the nine-week trial, the majority of patients randomized to the treatment arm no longer met the clinical criteria for insomnia and those benefits persisted for at least one year.

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