Data emphasize effectiveness of FDA-authorized digital therapeutic for insomnia

Pear Therapeutics reported new data that reinforce the effectiveness of Somryst, its prescription digital therapeutic for chronic insomnia in adults.

The app-based therapeutic includes self-paced lessons and activities that deliver cognitive behavioral therapy for insomnia and require 45 to 60 minutes per week, over the course of 6 to 9 weeks.

“Today, many people face barriers to accessing care, so the opportunity to provide patients with 24/7 virtual access to proven treatment options is more important than ever,” Yuri Maricich, MD, chief medical officer and head of development at Pear Therapeutics, said in a released statement.

“It’s critical to examine the impact of prescription digital therapeutics among people with chronic insomnia, particularly given the toll lack of sleep can take on day-to-day activities and overall quality of life, including leading to depression, suicidality, hypertension and even heart attacks.”

According to the press release, 991 participants were initially enrolled in a remote, virtual, open-label, decentralized clinical trial to evaluate Somryst. At baseline, the mean insomnia severity score among participants was 18.8, which dropped to 11.3 at 9 weeks (n = 779; Cohen’s d = 1.4; 95% CI, 1.3-1.5) and 12.1 (n = 193; Cohen’s d = 1.2; 95% CI, 1-1.4) at 6 months (P < .0001).

After the initial 9-week period, 78.7% of participants achieved the American Academy of Sleep Medicine clinical definition of sleep onset latency remission, and 73.3% achieved WASO remission (waking up during the night for 30 minutes or less).

“The ability to capture real-world data in a fully remote setting due to the COVID-19 pandemic allowed us to really understand the value that access to remote treatment options have in successfully treating chronic insomnia,” study author Charles M. Morin, PhD, professor of psychology at Laval University in Quebec, said in the release. “These results demonstrate that cognitive behavioral therapy, the recommended first line treatment of care for chronic insomnia, can be effectively delivered through a [prescription digital therapeutic] like Somryst, helping patients treat their chronic insomnia.”