Sleepio is an evidence-based digital therapeutic that delivers cognitive behavioural therapy for insomnia (CBTi), the recommended first-line treatment for insomnia in international clinical guidelines, including both England and the US.

In the US, FDA clearance of SleepioRx (the US version of the treatment) comes alongside a proposal by the Government’s Centers for Medicare & Medicaid Services (CMS) to introduce new reimbursement codes for FDA-approved digital mental health therapies paving the way for millions of patients to be offered help consistent with clinical guidelines in 2025.

Meanwhile in England, although NICE recommends CBTi as the first-line treatment for insomnia – either delivered face-to-face by a qualified therapist or digitally through Sleepio – in practice neither option is available to most people. Face-to-face CBTi is very limited due to a shortage of trained therapists, and NHS England has not yet funded digital CBTi through Sleepio