Mobile Phone App that Treats Insomnia and Depression Files for FDA Approval

Pear Therapeutics has recently filed a submission to the US Food and Drug Administration (FDA) for a prescription digital therapeutic (PDT) oriented towards insomnia and depression. The company created the first FDA-approved PDT last year when they teamed up with Novartis’s Sandoz to develop a smartphone app prescribed to treat substance abuse disorders. Now, Pear is looking to get the same approval for their latest mobile health innovation, Somryst.

“One in three adults suffer from symptoms of insomnia in a given week and more than 30 million adults have chronic insomnia,” said Charles M. Morin, PhD, Professor of Psychology, Director Sleep Research Centre at Université Laval in Quebec City. “Chronic insomnia can have an impact on quality of life – and can put people at risk long-term for depression, hypertension, and even heart attack.”

Somryst is designed to create cognitive behavioral therapy for insomnia (CBTi) and sleep restriction windows that are both made unique to each user via an algorithm. The goal of this system is to reduce the symptoms of both insomnia and depression in each user. CBTi is commonly used in treating patients with chronic insomnia, however, many patients don’t have access to this recommended treatment. In addition, there are currently no means of CBTi delivery that are approved by the FDA.

CBTi refers to several techniques that help aid those with insomnia. Popular techniques include stimulus control, which strengthens the bed as a cue for sleep by eliminating its use for other activities, and sleep restriction. The latter involves limiting the number of hours spent laying unnecessarily in bed. For example, if one were only getting five hours of sleep at night despite laying there for seven hours, their sleep restriction therapy would limit them to five hours in bed a night. Though they will likely get less than five hours of sleep a night, this will help them eventually establish a healthier sleep schedule.

“Most adults with insomnia receive medication intended for short-term use or struggle with insomnia without receiving effective, lasting treatment,” explained Morin. “Somryst could facilitate patient access to CBTi treatment with appropriate clinical oversight and management from clinicians.”

The Research Behind Somryst

Pear submitted two randomized controlled trials to the FDA that evaluate the efficacy of Somryst. These works included over 1,400 adults with chronic insomnia, with 1,100 of these participants having depression. These individuals with both conditions were randomly assigned to either receive Somryst intervention or an “attention-matched digital placebo”. These groups received therapy for nine weeks and had their results compared at baseline and nine weeks, with post treatment measurements recorded at six months, a year, and a year and a half.

After 9 weeks of treatment, those who used Somryst showed significantly reduced Insomnia Severity Index scores, dropping from an average of 15.92 to 7.27, whereas the control group dropped from 16.23 to 13.17. In addition, those who received the treatment also showed reduced depression severity based on their Patient Health Questionnaire 9 (PHQ9) scores. The treatment group’s PHQ9 scores decreased from 8.03 to 3.78, whereas the control only from 7.84 to 6.20. After 9 weeks of using Somryst, most of the participants no longer met the inclusion criteria for insomnia or depression, in these improvements were still seen at 18 months follow up. This study also found the PDT alleviated symptoms of anxiety and thoughts of suicide in the treatment group as well. These findings can be found in Lancet Psychiatry.

“Prescription digital therapeutics are a new treatment class that use software applications to directly treat serious disease,” said Corey McCann, MD, PhD, President and CEO of Pear Therapeutics. “PDTs are designed to deliver evidence-based treatment anytime, anywhere, while also providing clinicians with real-time data on patient progress. Pear Therapeutics is the leader in this emerging space. If authorized, Somryst could become our third FDA-authorized PDT, representing a new wave of innovation for patients and physicians.”