FDA Authorizes a Prescription Digital Therapeutic for Insomnia

On Thursday, March 26, the FDA granted authorization for Somryst^TM, a prescription-only digital therapeutic that can be accessed on a smart phone or tablet for treatment of chronic insomnia in patients aged 22 years or older. Clinical guidelines from the American Academy of Sleep Medicine and the American College of Physicians recommend cognitive behavioral therapy for insomnia (CBTi) as first-line treatment for chronic insomnia. Somryst uses technology to digitally deliver CBTi to patients. Similar to person-to-person CBTi interventions, Somryst provides 3 primary mechanisms of action to improve symptoms: tailored sleep restriction and consolidation, stimulus control, and personalized cognitive restructuring.

The FDA authorization was based on two randomized controlled trials comprising more than 1400 adults with chronic insomnia. Findings from the first trial suggest that patients saw improvements in insomnia severity, sleep onset latency, and wake after sleep onset (time awake at night) by the end of treatment. Moreover, the effects of treatment were sustained at 6 and 12 months follow-up.1 In the second trial, which consisted of 1149 patients with insomnia and depression, a significant reduction in insomnia severity was seen after 9 weeks of treatment, and the benefits were still evident over 12 months follow up.2
Somryst should be used only under the supervised care of a clinician. Psychiatric Times Advisory Board member John Torous, MD, MBI, director of the digital psychiatry division, Department of Psychiatry, Beth Israel Deaconess Medical Center, a Harvard Medical School affiliated teaching hospital, warns that “The usage data collected in therapy lessons by Somryst are not intended to be used as a standalone assessment of treatment progress.”

Contraindication for use include:
• Any disorder exacerbated by sleep restriction (eg, bipolar disorder, schizophrenia, other psychotic spectrum disorders)
• Untreated obstructive sleep apnea
• Parasomnias
• Seizure disorders
• Individuals at high risk of falls
• Pregnant women
• Person with unstable of degenerative illness judged to be worsened by sleep restriction.

Torous noted, “The mental health field has a rich history of using technology as part of care for insomnia, so this news is of course welcome. But it remains to be seen whether this will actually increase access to quality of care. Real world data will be critical for psychiatrists about the implementation challenges and patient experiences with this new product.”

References:

1. Rittenband LM, Thorndike FP, Ingersoll KS, et al. Effect of a web-based cognitive behavior therapy for insomnia intervention with 1-year follow-up: a randomized clinical trial. JAMA Psychiatry. 2017;74:68-75.
2. Christensen H, Batterham PJ, Gosling JA, et al. Effectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): a randomised controlled trial. Lancet Psychiatry. 2016;3:333-341.