Pear Therapeutics has launched its prescription smartphone app for chronic insomnia, designed to help train the brain and body to get a better night’s sleep.
The Somryst app received a green light from the FDA this past March, as one of the first products to make it through the agency’s pilot program that aims to certify software and developers while they are under development.
Available to patients age 22 and older, the app applies cognitive behavioral therapy to treat insomnia, similar to the first-line care offered by an in-person specialist. The program tailors lessons and challenges over a period of six to nine weeks, based on an algorithm designed to help restrict sleep to a specific schedule and improve sleep quality over time.
In clinical studies of more than 1,400 adults with insomnia, the program reduced the amount of time it took to fall asleep by 45% while cutting the amount of time awake at night by 52%. In addition, the severity of insomnia symptoms lowered by 45%, with continued improvements seen at six and 12 months after therapy.
The former Fierce 15 winner previously developed prescription digital therapeutics for treating substance and opioid use—dubbed reSET and reSET-O—and previously worked with Novartis’ Sandoz division to market the apps to addiction treatment specialists.
However, that partnership came to an end in October of last year. Now, Pear will launch Somryst through a virtual, direct-to-patient model that combines telemedicine visits with the digital delivery of the app.
The PearConnect patient service portal aims to reach the estimated 30 million people in the U.S. suffering from chronic insomnia, and connect them with a prescribing physician and case worker without them needing to leave home.
“We’re excited to offer patients who have been struggling to find a long-term solution for chronic insomnia with a meaningful, first-line treatment that is accessible via an end-to-end care model, to support patients and healthcare providers during the virtual onboarding process,” President and CEO Corey McCann said in a statement. In addition, the app recently received the Prix Galien USA award for best digital health product.
“The availability of Somryst demonstrates our ongoing commitment to developing [prescription digital therapeutics] to deliver easily-accessible treatment options to patients for their chronic conditions, important now, more than ever as we continue to navigate the COVID-19 pandemic,” McCann added, with the company citing a recent survey that showed nearly half of adults have lost sleep this year as the coronavirus has spread across the country.
Insomnia has also been linked to chronic pain, high blood pressure, gastrointestinal problems and heart disease, as well as psychiatric conditions such as depression, anxiety, substance use disorder and suicidal thoughts.