0337 24-Month Patterns of Sleep Medication Use with a Prescription Digital Therapeutic for Chronic Insomnia – A Retrospective Analysis

Abstract

Abstract Introduction Cognitive-behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment, but sedative-hypnotic medications are often used first, despite contraindications and risk of misuse. This study assessed change in sedative/hypnotic use/dosage in patients with chronic insomnia treated with Somryst® (tested as SHUTi), a prescription digital therapeutic (PDT) delivering CBT-I. Methods A retrospective claims data analysis was conducted with chronic use of prescribed sedatives/hypnotics (days’ supply: 8-200; units dispensed: >12) in patients with self-identified sleep problems who initiated the PDT (index) between June 2016 and December 2018, and who had available closed claims data 24 months pre- and post-index. Eligible medications were used at least once in the year prior to initiation of the PDT, or 90 days after PDT initiation. Outcomes evaluated: dose change, stoppage/initiation, or medication switch, using nearest pre-index medication and furthest post-index medication. Dose change was evaluated using total strength per day: medication dose quantity dispensed/day's supply. Medication switch was evaluated as post-index cessation of a pre-index medication, accompanied by a post-index initiation of a different sedative/hypnotic. Results Of the 248 individuals observed, 131 (52.8%) utilized an eligible sedative/hypnotic medication. On average, individuals were on 1.5 (median of 2, range 1-6) sedative/hypnotic medications. In 59 individuals (45% of the cohort), there was either a decrease in dosage (13 patients, 9.9%), a full stopping of a medication (52 patients, 39.7%), or a stopping of all medications (41 patients, 31.3%). In 32 individuals (24% of the cohort), there was either an increase in dosage (8 patients, 6.1%) or an initiation of a new medication (28 patients, 21.3%). Twenty-two patients (16.7%) switched to a different medication in the post-index period. Forty-three patients (32%) experienced no changes in a specific medication and its dosage, including 25 (19%) patients who had another medication already counted in the groups described above, and 18 (13.7%) patients not counted elsewhere. Conclusion Real-world evidence from a PDT delivering digital CBT-I demonstrated dose reduction and/or stoppage of sedative/hypnotic medications in almost half of the population, with almost a third of patients stopping all such medications. Support (if any) This study was funded by Pear Therapeutics (US), Inc.