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Prescription Insomnia App Okayed by FDA

Insomnia

(Ajay Kumar Singh, Pixabay)

27 Mar. 2020. A mobile app prescribed by physicians to treat chronic insomnia is cleared by the Food and Drug Administration for marketing in the U.S. Somryst is the latest app designed as treatment for nervous systems disorders by its developer Pear Therapeutics in Boston and San Francisco, to be authorized by FDA.

Pear Therapeutics develops what it calls prescription digital therapeutics that harness capabilities of electronic technologies to treat disease. The company says that even in digital form, its therapies are designed to treat serious disorders, evaluated with human clinical trials, subject to FDA review, and require a prescription. As reported by Science & Enterprise in December 2018, a mobile app made by Pear Therapeutics was the first such software cleared by FDA for opioid use disorder. A reSET app was earlier cleared to help treat other forms of substance abuse, the first of its kind authorized by FDA.

Insomnia is a common disorder marked by interrupted sleep, which can last for days at a time. When the condition lasts for a month or more, it’s considered chronic insomnia and may be the result of underlying stress that requires more intensive and professional interventions. Pear Therapeutics designed its Somryst software as part of a personalized cognitive behavioral therapy program, administered by a clinician, for chronic insomnia, experienced by up to 30 million people in the U.S., according to the company.

Cognitive behavioral therapy is a form of psychotherapy that seeks to change attitudes and behavior by concentrating on a person’s cognitive processes — thoughts, images, and beliefs — related to that individual’s behavior. And while this therapy is considered a first line treatment for insomnia, the number of clinicians trained in its use are limited.

Somryst, says Pear, sets specific times for going to bed and waking, called a sleep window, then identifies behavior by the individual to change to achieve that sleep window goal. The software also helps the individual learn to identify and shift thought patterns that contribute to sleeplessness. In addition, Somryst helps identify lifestyle and environmental changes to achieve better sleep, and provides guidance for the future, including handling a relapse.

FDA cleared Somryst for treating patients age 22 and older. The software runs on a smartphone or tablet, running either iOS/Apple or Android operating systems. The therapy is divided into six sections or cores, with individuals expected to complete each core in seven days. After nine weeks, the software automatically discontinues, but the prescription can be renewed, if requested by the physician. Pear Therapeutics lists a number of restrictions on using Somryst, including some occupations where interrupted sleep is a safety hazard, such as long-haul truckers, heavy equipment operators, and air traffic controllers.

FDA based its decision in part on results from two clinical trials testing Somryst among a total of 1,400 individuals with chronic insomnia. In both studies, a majority of participants experienced reductions in their insomnia severity, with improvements continuing six or 12 months following the treatments. The studies were published in the journals JAMA Psychiatry and Lancet Psychiatry.

Pear Therapeutics is also taking part in FDA’s Software Precertification Pilot Program that helps the agency design a regulatory environment for automated medical devices reflecting the systems’ unique properties as well as the risks they pose for users.

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