The Food and Drug Administration (FDA) has granted authorization for a prescription digital therapeutic (PDT) (Somryst, Pear Therapeutics, Boston, MA) intended for treating individuals age 22 years or more with chronic insomnia.
The therapy is a 9-week PDT that can be used on a mobile device, such as a smartphone or tablet. It is intended to provide tailored Cognitive Behavioural Therapy for insomnia (CBTi) and sleep restriction driven by algorithms designed to improve symptoms.
The FDA submission was supported by 2 randomized controlled trials (NCT04325464) that evaluated the effectiveness of the therapy. Together, these studies enrolled more than 1,400 adults with chronic insomnia.
In 1 trial that enrolled 303 participants with chronic insomnia, those who received the therapy demonstrated clinically meaningful improvements in insomnia severity, sleep onset latency (time to fall asleep), and wake after sleep onset (time awake at night) at the end of treatment, as well as at 6-month and 12-month follow-ups compared to active control. Results of the study were published in JAMA Psychiatry.
In a second study of 1,149 adult participants with chronic insomnia and depressive symptoms, those on treatment for 9 weeks saw a significant reduction in insomnia severity measurements compared with controls.
These benefits persisted for more than 12 months. Most participants randomized to the treatment arm for the PDT no longer met clinical criteria for insomnia at the end of the 9-week treatment.
“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,” said Charles M. Morin, PhD, professor of psychology, director sleep research centre, Université Laval, Quebec City. “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.”
Jill M. Giordano Farmer, DO
Monideep Dutt, MD; Jamika Hallman-Cooper, MD; Ekta Bery, MD; Mohammed Shahnawaz, MD; and Grace Gombolay, MD
Fabio Fieni Toso, MD; Rene de Araújo Gleizer, MD; and Lívia Almeida Dutra, MD, PhD