Sleepio®

Overview

Medical condition:

Insomnia

Target patient population:

Patients who desire recovery from insomnia.

What to expect:

Sleepio demonstrated in a placebo-controlled RCT and a further 11 published RCTs that Sleepio helped 76% of patients achieve clinical improvement in insomnia.
Health economic data also suggest that Sleepio is associated with $1,677 reductions in healthcare costs.

Note: for more information, please visit https://www.bighealth.com/sleepio/.

Clinical Overview

Indications for use:

Sleepio is a digital therapeutic intended for the improvement of poor sleep and the management of insomnia disorder in adults aged 18 years and older, as an adjunct to their usual medical care.
For adults diagnosed with insomnia disorder, Sleepio should be used under the supervision of a healthcare professional.
For otherwise healthy adults who have difficulty sleeping, Sleepio may be used as a non-prescription self-help tool to improve sleep health.

Outcomes:

Sleepio helped 76% of patients achieve clinical improvement in insomnia.

Directions:

The Sleepio program consists of six sessions (each 20 minutes on average) which can be completed in weeks, and daily Sleep Diary entries (<5 minutes each).

Each of Sleepio’s six sessions builds on the last, guiding users step by step through methods proven to help them quiet their racing mind, reshape their behaviors, and get better sleep — all in about 20 minutes per week. Sleep Diary entries enable Sleepio to help the user track their progress over the course of the program.

Risks & warnings:

Sleepio may not be suitable for people without internet, wifi, or a mobile device. Sleepio is a digital therapeutic intended for the improvement of poor sleep and the management of insomnia disorder in adults aged 18 years and older, as an adjunct to their usual medical care.

Place in therapy:

Complementary to current therapy and effective as a standalone solution.

Product Access

Product description:

Sleepio is a digital sleep improvement program accessible through mobile and web, and clinically proven to help you clear your mind, improve your sleep, and have better days.

Prescription status:

No prescription is required.

Patient access:

Eligible users can sign up for Sleepio on web (desktop or mobile), at which point they can start the program by either downloading the mobile app (currently iOS users only) and logging in, or continuing on web (desktop or mobile).Use of this product requires access to:

• Internet or WiFi
• a mobile phone, tablet, or computer

Provider access:

Sleepio provides a non-drug alternative for insomnia without needing a prescription. In the UK, Sleepio is available for eligible individuals through self-referral or by visiting their GP.

Coverage options:

In the US, Sleepio is offered through large payers including self-insured employers. Sleepio is offered to millions of people in the UK through their NHS services.

Product availability:

Sleepio is available in:

• USA: FDA enforcement discretion
• UK: Class I CE mark

Clinical Trials

The provided set of evidence represents a sample of conducted studies. For a comprehensive collection contact manufacturers directly.

• Study Title: Does adjunctive digital CBT for insomnia improve clinical outcomes in an improving access to psychological therapies service? – Stott et al., 2021
  Study Design: Observational Trial
  Outcomes: Patients who used Sleepio alongside usual care experienced signficantly greater improvements in anxiety and depressive symptoms, and work and social functioning compared to matched controls who did not use Sleepio but received usual care. The recovery rates achieved for Sleepio were greater than those experienced in the control group.
• Study Title: Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial – Espie et al. 2019
  Study Design: Randomized Controlled Trial
  Outcomes: Sleepio led to significant improvements in sleep, functional health, psychological well-being and sleep-related quality of life. Improvements in sleep resulting from Sleepio mediated benefits to functional health, psychological well-being and sleep-related quality of life.
• Study Title: The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis – Freeman et al., 2017
  Study Design: Randomized Controlled Trial
  Outcomes: Sleepio led to significant reductions in insomnia, paranoia and hallucinations amongst other areas of mental health. Improvements in insomnia symptoms mediated reductions in paranoia and hallucinations.
• Study Title: A Randomized, Placebo-Controlled Trial of Online Cognitive Behavioral Therapy for Chronic Insomnia Disorder Delivered via an Automated Media-Rich Web Application – Espie et al. 2012
  Study Design: Placebo controlled Randomized Controlled Trial
  Outcomes: 76% of participants achieved healthy sleep efficiency.

Note: for more research, please visit https://www.bighealth.com/research/.