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Network meta-analysis comparing the effectiveness of a prescription digital therapeutic for chronic insomnia to medications and face-to-face cognitive behavioral therapy in adults

Chronic insomnia is the long-term inability to fall asleep easily or to stay asleep. This condition is much more serious than most people realize, raising the risk of many health problems including depression, heart disease, and injuries. Although sleep medications are commonly used to treat insomni...

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Published in:Current medical research and opinion 2022-10, Vol.38 (10), p.1727-1738
Main Authors: Forma, Felicia, Pratiwadi, Ramya, El-Moustaid, Fadoua, Smith, Nathaniel, Thorndike, Frances, Velez, Fulton
Format: Article
Language:English
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Summary:Chronic insomnia is the long-term inability to fall asleep easily or to stay asleep. This condition is much more serious than most people realize, raising the risk of many health problems including depression, heart disease, and injuries. Although sleep medications are commonly used to treat insomnia, these drugs may not be effective and can lead to harms such as accidents or clouded thinking. Clinical guidelines recommend a treatment called cognitive behavioral therapy for insomnia (CBT-I) that is safe and effective. Unfortunately, there is a shortage of clinicians trained to provide CBT-I. Prescription digital therapeutics (PDTs) are FDA-approved software programs available on mobile devices such as smartphones. A PDT for insomnia (Somryst) delivers CBT-I and can overcome barriers to access for this important type of therapy. To compare the effectiveness of this PDT with FDA-approved sleep medications and face-to-face CBT-I a special kind of study was conducted called a network meta-analysis. This is a statistical method of combining data from numerous studies in a way that allows the results to be fairly compared. This network meta-analysis of 20 studies found that the PDT was more effective at reducing insomnia symptoms than any of the sleep medications studied and was even more effective than face-to-face CBT-I as measured by scores on a clinically valid scale of insomnia symptoms. These results are encouraging because they suggest that digital delivery of CBT-I could help the millions of people who currently do not have access to this effective treatment. The purpose of this study was to compare the effectiveness of the only Food and Drug Administration-authorized prescription digital therapeutic (PDT) Somryst versus face-to-face cognitive behavioral therapy for insomnia (CBT-I), or FDA-approved prescription medications for insomnia. 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). 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 [CrI] − 8.53, −3.07) and ISI remitters (OR 12.33; 95% CrI
ISSN:0300-7995
1473-4877
DOI:10.1080/03007995.2022.2108616