Sleepio is the first-ever digital therapeutic to receive NICE guidance, confirming clinical and cost effectiveness

Big Health has become the first digital therapeutics company to receive guidance from the National Institute for Health and Care Excellence (NICE), which has recommended Sleepio as a cost-saving option for treating insomnia in a move that heralds a new era in digital medicine.

The NICE guidance states that Sleepio, Big Health’s digital therapeutic for insomnia, is a safe and effective treatment for people who would otherwise only have access to the current standard of care, which includes sleep hygiene advice and medication. In addition, NICE confirms Sleepio as cost-saving for the National Health Service (NHS), with evidence showing Sleepio reduces GP appointments and prescribing costs by providing instant access to cognitive behavioural therapy for insomnia (CBT-I) where face-to-face CBT-I is unavailable.

Studies show that nearly one-third of adults in the United Kingdom (UK) experience insomnia symptoms each week. NICE recommends CBT-I as the first-line treatment for insomnia, offered before or alongside medication. However, due to a lack of trained therapists, CBT-I is unfortunately not routinely available in the NHS for most people living with insomnia.

The NICE Medical Technologies Advisory Committee evaluated Sleepio’s industry-leading evidence base of 28 studies including 12 randomised controlled trials, featuring thousands of patients who had a diagnosis or symptoms of insomnia. Peer-reviewed clinical trials show Sleepio helps 76% of patients to achieve clinical improvement in insomnia. The Committee concluded that Sleepio is more effective than treatment as usual (sleep hygiene and medication) in reducing symptoms of insomnia in adults and is a cost-saving option, as demonstrated by an independent health economic evaluation of NHS services in the Thames Valley.

“This is a significant moment for the NHS and UK healthcare innovation as a whole,” said Dr. Nick Broughton, CEO of Oxford Health NHS Foundation Trust and Board Member of the Oxford Academic Health and Science Network (AHSN). “Sleepio has the potential to transform current mental health pathways by expanding access to guideline-recommended care for everyone in England. The Oxford AHSN and Oxford Health are delighted to have played a key role in Sleepio’s flagship implementation in the Thames Valley, where Innovate UK funding helped generate rich real-world evidence that made NICE’s evaluation possible. We hope that Sleepio will now be made available across the country.”

Big Health co-founder and Chief Scientist Professor Colin Espie said: “We are delighted that Sleepio has become the first-ever digital therapeutic to receive NICE guidance after rigorous evaluation. Digital therapeutics aren’t wellness apps; they are proper treatments backed by data and clinical evidence, fit for assessment by world-leading bodies like NICE.”

“With the surge in demand for mental health support over the past two years, scalable and clinically-proven digital technologies simply must be part of the solution. Positive outcomes through NICE guidance are a significant step towards that goal, helping to reduce the NHS care backlog and provide safe, evidence-based, accessible support for everyone who needs it.”

Sleepio is a clinically-evidenced digital therapeutic for insomnia developed by world-renowned clinical psychologist and sleep expert Professor Colin Espie. The programme is fully automated and highly personalised, with an algorithm tailoring behavioural interventions including CBT to each individual’s symptoms and needs. It is accessed via smartphone or web browser, meaning people can engage with Sleepio wherever and whenever they wish, without the need for clinician involvement. NICE guidance is a key step in increasing patient access to Sleepio, since it gives NHS commissioners and clinicians added confidence in funding and prescribing Sleepio to their populations.

Sleepio is not yet available via the NHS in England. To register your interest in accessing Sleepio, please visit www.sleepio.com/waitinglist.

Sleepio is available to all adults living in Scotland. To get started, please visit www.sleepio.com/nhs.

For more information about commissioning Sleepio, please visit: https://www.bighealth.co.uk/lp/primarycare/

About Big Health

Big Health’s mission is to help millions back to good mental health by providing safe and effective non-drug alternatives for the most common mental health conditions. Designed by leading clinical experts and backed by 13 RCTs, Sleepio™ for insomnia and Daylight™ for worry and anxiety are among the world’s most evidenced digital mental health solutions. These programmes seamlessly integrate into primary care, enabling clinically effective self-management of mental health. With offices in London and San Francisco, Big Health’s digital therapeutics are used by leading health systems like the NHS and large multinational employers. For more information, please visit https://www.bighealth.co.uk/

¹ Disclaimer: In the UK, Sleepio and Daylight are CE marked medical devices available for the treatment of Insomnia Disorder and Generalized Anxiety Disorder, respectively.

In the US, in accordance with FDA’s Current Enforcement Discretion Policy for Digital Health Devices for Psychiatric Disorders, for patients aged 18 years and older, who are followed by and diagnosed with Insomnia Disorder or Generalized Anxiety Disorder by a medical provider, Sleepio and Daylight can be made available as an adjunct to their usual medical care for Insomnia Disorder or Generalized Anxiety Disorder, respectively. Sleepio and Daylight do not replace the care of a medical provider or the patient’s medication. Sleepio and Daylight have not been cleared by the U.S. Food and Drug Administration (FDA) for these indications.

For media inquiries, please contact press@bighealth.com.

¹ In accordance with FDA’s Current Enforcement Discretion Policy for Digital Health Devices for Psychiatric Disorders, for patients aged 18 years and older, who are followed by and diagnosed with Insomnia Disorder or Generalized Anxiety Disorder by a medical provider, Sleepio and Daylight can be made available as an adjunct to their usual medical care for Insomnia Disorder or Generalized Anxiety Disorder, respectively. Sleepio and Daylight do not replace the care of a medical provider or the patient’s medication. Sleepio and Daylight have not been cleared by the U.S. Food and Drug Administration (FDA) for these indications.