You may recommend smartphone apps for mindfulness, symptom tracking, or medication reminders, but do you prescribe apps? FDA-authorized “prescription digital therapeutics” are already available for ADHD (EndeavorRx), traumatic nightmares (Nightware), and opioid use disorder (reSET-O). Now Somryst, a prescription app for insomnia, joins them. It is designed to provide adults with a personalized, six- to nine-week course of cognitive behavioral therapy for insomnia (CBT-I). Should we recommend more phone time for patients who already can’t sleep well? And if so, how are apps prescribed?

CBT-I: What the evidence shows
CBT-I includes standard sleep hygiene measures but takes that basic therapy one step further by adding in “bed restriction.” In this step, patients calculate the average time they spend asleep in bed over a week and then limit their time in bed to that average (plus a 30-minute buffer to fall asleep). At first, bed restriction leaves patients drowsy, but as that drowsiness builds up over time it helps them fall asleep faster, and as their sleep improves, they are allotted more time in bed.

Over 20 randomized controlled trials (RCTs) have evaluated CBT-I. Together, they find that CBT-I helps patients fall asleep 19 minutes earlier and wake up 26 minutes less overnight, in addition to improving sleep efficiency (time spent in bed asleep vs awake) by about 10% compared to controls (Trauer JM et al, Ann Intern Med 2015;163(3):191–204). Other trials show that CBT-I is more effective than sleep hygiene, and even has an edge over sleep medications. Several medical groups, including the American Academy of Sleep Medicine and the American College of Physicians, recommend it first line for insomnia.

Therapists who practice CBT-I are hard to find, which is where digital adaptations of CBT-I come in. Digital CBT-I generally works as well as the face-to-face format, though patients who struggle with motivation may do better with a personal therapist. A 2017 Dutch RCT comparing a proprietary CBT-I app to a waitlist control found that insomnia severity, waking after falling asleep, total sleep time, and sleep efficiency improved over the course of six weeks for the app users compared to controls (Horsch CH et al, J Med Internet Res 2017;19(4):e70).

Is there any evidence for the new Somryst app? Not directly, but an earlier web-based version of Somryst, called SHUTi, was tested in several controlled trials. For example, a 2016 randomized trial that compared SHUTi to an online educational control found both immediate and one-year improvements with SHUTi in sleep efficiency, overnight wakefulness, and sleep quality, although total sleep time was not statistically different from controls (Ritterband LM et al, JAMA Psychiatry 2017;74(1):68–75). The SHUTi data were impressive enough to eventually earn FDA authorization for Somryst.

How Somryst works
Somryst consists of a nightly sleep diary and six weekly “cores.” These are sequential CBT-I lessons that present, review, and summarize concepts, as well as assign and review homework. Graphs, animations, vignettes, and quizzes keep patients engaged. As long as patients complete the prior week’s material, they unlock new cores each week, starting with an overview and working through sleep behavior, sleep education, sleep thoughts, and problem prevention. As patients provide Somryst with their sleep diaries and complete the cores, the program algorithmically generates nightly sleep schedules, without input from a therapist. The app also graphs sleep data and rating scales (Thorndike FP et al, E J Appl Psychol 2008;4(2):32–42).

The main competitor to Somryst is CBT-i Coach, a free app developed for the Veterans Administration (www.tinyurl.com/2p8v3x9y). Unlike Somryst, CBT-i Coach was intended to be used with guidance from a therapist, but motivated patients can also use it on their own. CBTi Coach improved insomnia and sleep quality in two prospective but uncontrolled studies (Reilly ED et al, JMIR Form Res 2021;5(12):e29573).

Risks
Because CBT-I restricts time in bed, Somryst lists contraindications for conditions that might worsen with sleep deprivation: epilepsy, bipolar disorder, parasomnias, untreated obstructive sleep apnea, and jobs involving heavy machinery, among others. However, CBT-I has been used successfully in treated sleep apnea, and a controlled trial showed that a modified form of CBT-I improved insomnia in euthymic bipolar disorder. CBT-I also improved mood and augmented antidepressants in controlled trials of unipolar depression.

Somryst is only available to patients 22 or older, likely in recognition that youths are particularly vulnerable to the risks of phone addiction. In a recent survey of 1,000 university students, one in three reported that excessive smartphone use impaired their sleep (Sohn SY et al, Front Psychiatry 2021;12).

How to use Somryst
Providers can prescribe Somryst after setting up an online account in Pear Therapeutic’s Pear Connect system at www.somrysthcp.com or 833-697-3738, or through digital pharmacies like Truepill, if their EHR interfaces with it. Alternatively, patients can obtain a prescription directly through www.somryst.com, which connects them to a Pear Therapeutics–contracted telemedicine provider who ensures the patient has a diagnosis of insomnia and no ­contraindications.

Patients then download Somryst from their app store and use the prescription code to unlock the app. From that point, they have nine weeks to use Somryst before the code deactivates.

Some insurers cover Somryst, including Optum and Serve You Rx, but only for a diagnosis of chronic insomnia. Patients whose insurance does not cover Somryst may be eligible for a “Somryst Savings Card” from Pear, which brings the cost to $100 from the out-of-pocket cost of $900.

TCPR Verdict:
For a long time, the first-line treatment for insomnia (CBT-I) has not been available for most patients. Digital apps like Somryst and CBT-i Coach bring this therapy closer to home.