OBJECTIVES: Despite high prevalence, chronic insomnia remains undertreated. Cognitive-behavioural therapy for insomnia (CBT-I) is the recommended first-line treatment; however, access to CBT-I is limited. A prescription digital therapeutic (PDT)—an FDA-authorized, software-based treatment—was developed to provide digital CBT-I (dCBTi) for adults with chronic insomnia. This secondary analysis evaluated the effectiveness of insomnia treatment response and remission (including number needed to treat [NNT]) of dCBTi (including this specific PDT) across multiple randomized clinical trials and real-world populations.

METHODS: Adults with chronic insomnia had access to dCBTi for 9 weeks in: a) 2 pivotal randomized controlled trials (GoodNight [n=1,149] and UVA Study [n=303]); b) a real-world ongoing study (DREAM; n=777); and c) a real-world population whose claims were followed for 24 months (n=248). Treatment response was Insomnia Severity Index (ISI) score improvement of >7 points; remission was an ISI score <8 by end of treatment (EOT). Effect sizes were estimated at EOT. NNTs were calculated vs control data or vs baseline data if no controls available.

RESULTS: In GoodNight, 62.8% (n=360/574) of patients achieved responder status (NNT: 2.0); 61.6% (n=354/574) achieved insomnia remission status (NNT: 2.1) by EOT. In the UVA study, 52.6% (n=70/133) were responders (NNT: 1.9); 40.6% (n=54/133) were remitters (NNT: 2.5). In DREAM, 45.9% (n=357/777) were responders (NNT: 2.2); 29.7% (n=231/777) were remitters (NNT: 3.4). In the 24-month real-world cohort, 58.9% (n=146/248) were responders (NNT:1.7); 26.6% (n=66/248) were remitters (NNT: 3.8) by EOT. Effect sizes for change in ISI scores were similar across GoodNight, UVA, DREAM, and 24-month cohorts, with Cohen’s d = 2.00, 1.62, 1.41, and 1.75, respectively.

CONCLUSIONS: Treatment with dCBTi is effective in reducing insomnia severity and helping patients achieve response and remission regardless of setting—real-world cohorts demonstrated similarly low NNTs, large effect sizes, high treatment response and remission rates as pivotal trial cohorts.