The Food and Drug Administration (FDA) has approved Somryst™ (Pear Therapeutics), a prescription digital therapeutic (PDT) intended for the treatment of patients 22 years of age and older with chronic insomnia.

Used on a mobile device, Somryst improves insomnia symptoms through neurobehavioral interventions, specifically Cognitive Behavioral Therapy for insomnia (CBTi) over 9 weeks, through 3 mechanisms: sleep restriction and consolidation, stimulus control, and personalized cognitive restructuring. Healthcare providers can track patient treatment progress with a clinician-facing dashboard, which displays information regarding Insomnia Severity Index (ISI), Patient Health Questionnaire 8 (PHQ-8) scores, and sleep metrics from sleep diaries.

The approval was supported by data from 2 clinical trials (Trial 1 and Trial 2) that evaluated the efficacy of the therapeutic in adult patients with chronic insomnia. Trial 1 randomized 1149 adult patients with chronic insomnia and depressive symptoms to receive either the PDT or an attention-matched digital placebo along with usual care. Trial 2 randomized 303 patients with chronic insomnia to receive either PDT or to complete an online patient education program.

Results from Trial 1 showed that at the end of 9 weeks, patients in the PDT arm demonstrated a reduction in mean Insomnia Severity Index (ISI) score to 7.27, from a baseline of mean 15.92, while those in the placebo group showed a reduction in ISI score to a mean of 13.17, from a baseline of mean 16.23 (LS mean difference: -5.90, (95% CI, -6.68, -5.11); P <.0001). Treatment with PDT was also associated with a reduction in depression severity as measured by the Patient Health Questionnaire 9 (PHQ9). Full study results have been published in Lancet Psychiatry.

Additionally, findings from Trial 2 demonstrated statistically significant improvements in insomnia severity, sleep onset latency and wake after sleep onset at 9 weeks of treatment. Treatment effects were maintained at 6 and 12 months with 56.6% of patients (n=69/122) achieving remission status and 69.7% (n=85/122) of patients deemed treatment responders at 1 year based on ISI data. Full study results have been published in JAMA Psychiatry.

In certain patients, Somryst use is contraindicated. These conditions or disorders include any disorder exacerbated by sleep restriction (eg, bipolar disorder, schizophrenia, other psychotic spectrum disorders), untreated obstructive sleep apnea, parasomnias, epilepsy, patients at high risk of falls, patients who are pregnant, and patients who have any other unstable or degenerative illness that may be worsened by sleep restriction. 

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Patient access to Somryst will automatically discontinue after 9 weeks (63 days); the prescription will end automatically based on the start date. The app will be available for download in the third quarter 2020 in the Apple App Store and through Google Play. 

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