Curr Med Res Opin. 2022 Aug 8:1-36. doi: 10.1080/03007995.2022.2108616. Online ahead of print.
ABSTRACT
OBJECTIVE: The purpose of this study was to compare the effectiveness of the only Food and Drug Administration-authorized prescription digital therapeutic (PDT) Somryst* versus cognitive behavioral therapy for insomnia (CBT-I), or FDA-approved prescription medications for insomnia.
METHODS: A systematic literature review was undertaken to identify relevant studies. A Bayesian network meta-analysis (NMA) was conducted to examine (1) mean change in insomnia severity index (ISI); (2) proportional change in ISI remitters; (3) mean change in wake after sleep onset (WASO); and (4) mean change in sleep onset latency (SOL).
RESULTS: Twenty studies provided data on the PDT, CBT-I, CBT-I in combination with self-help (SH), or two prescription medications (eszopiclone and zolpidem). The PDT was associated with significant mean change in ISI (-5.77, 95% Credible Interval [CI] -8.53, -3.07) and ISI remitters (OR 12.33; 95% CI 2.28, 155.91) compared to placebo, and had the highest probability of being the most effective treatment overall for ISI mean change (56%), and ISI remitters (64%). All evaluated interventions significantly outperformed placebo for WASO but no significant differences were observed for SOL (five interventions). Sensitivity analyses excluding medications and meta-regression (assessing type, duration, delivery method for CBT-I) did not affect NMA results.
CONCLUSIONS: This network meta-analysis demonstrated that a PDT delivering CBT-I had the highest probability of being most effective compared to face-to-face CBT-I, prescription sleep medications, or placebo, as measured by reductions in mean ISI score from baseline and ISI-determined remittance.* Somryst is the registered trademark for a prescription digital therapeutics for insomnia developed by Pear Therapeutics (US), Inc.
PMID:35938209 | DOI:10.1080/03007995.2022.2108616