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.

Sleepio may be suitable for you if:

• You are 18 years or older
• You are experiencing sleep difficulties or insomnia symptoms
• You have been diagnosed with Insomnia Disorder and are under the care of a doctor
• You have stable physical and mental health
• You are able to read, hear, and understand English
• You have regular access to a computer or mobile device
• You have periodic access to the internet

Please read the Instructions for Use (IFU) document to review Sleepio’s intended use, safety information, and further resources. The IFU document is provided during the signup process. If you have been previously diagnosed with Insomnia Disorder, you should contact your doctor before using Sleepio.

Sleepio is a fully automated digital sleep improvement program based on Cognitive Behavioral Therapy (CBT)

Sleepio is a fully automated digital sleep improvement program based on CBT. Over the course of six sessions, a virtual sleep expert -- The Prof -- will teach you evidence-based cognitive and behavioral skills to tackle even the most stubborn of sleep problems. Each session is fully automated, yet the content is tailored to your particular problems based on your answers from the onboarding questions completed prior to starting the program. The program also adapts based on your week-to-week progress in improving your sleep and the choices you make during the sessions. Although suggestions are made throughout the program, you are ultimately in control of what techniques you put into practice and how, and it's your responsibility to decide how best to apply the therapeutic content. Think of it as a serious computer game - one that helps you learn how to sleep better.

Sleepio is used alongside a support network and expert knowledge bank

The Sleepio Community is a warm and welcoming place where you can share your experiences with others about the program, and get support from program graduates who have been there before. In addition, the Library contains over 100 articles covering every topic introduced in the program, including details on putting techniques into practice and the science behind them. 

Sleepio is not a replacement or substitute for other medical or mental health treatment.

Sleepio is not a replacement for other medical or mental health care and should not be solely or primarily relied upon to treat psychiatric conditions. Do not disregard professional medical advice or delay seeking care because of information you encounter within Sleepio. We do not advise making any changes to your current treatment (e.g., changes to therapy or medication) before or while using Sleepio without the consultation of your doctor. If you are currently taking sleep medication, there is no need to make any changes prior to using Sleepio. If you are interested in decreasing or stopping sleep medication use, speak to your doctor about a medication tapering plan. Always seek advice from your doctor before making any changes to your current treatments. We strongly recommend that you consult a doctor if at any time you are concerned about your physical or mental health.

Sleepio is not intended for crisis support

Sleepio is not intended to provide crisis support. If you are experiencing a crisis or medical emergency, including suicidal thoughts: 

• In the United States, call 911 or go to your nearest emergency room. For the National Suicide Lifeline, call 988.
• In the United Kingdom, call NHS 111, call your GP, or go to your nearest A&E department.
• For other regions, please contact your local emergency services, or go to your nearest hospital emergency room.

Sleepio may not be suitable for everyone

Sleep restriction is a core component of the Sleepio program. Sleep restriction increases sleep quality by reducing time in bed to the amount of time spent asleep. Sleep restriction is not appropriate for everyone. Please consult your doctor prior to initiating Sleepio if you: 

• Have a diagnosis of bipolar disorder, schizophrenia, or have a history of psychotic symptoms or suicidal thoughts
• Have a diagnosis of epilepsy or a history of seizures
• Have a sleep-related breathing disorder / sleep apnea
• Experience excessive daytime sleepiness (e.g., fall asleep unintentionally during the day)
• Are at high risk for falls
• If you have other unstable or degenerative disorders that may be exacerbated by sleep restriction
• Are pregnant

In general, if you feel like you need more than self-help, have questions about your sleep, or questions about Sleepio suitability, we recommend that you speak to your doctor before using Sleepio.

Sleepio program sessions are delivered in a visual and auditory format. If you have vision or hearing impairment, you may need to arrange appropriate assistance to help you complete sessions.

Sleepio is not a 'magic bullet' solution for poor sleep

The CBT techniques within Sleepio have been shown to be highly effective for providing long-term relief from even very persistent poor sleep. Many Sleepio users see benefits within weeks or even days. However, it is not a 'passive' solution; the program requires sustained and significant effort in order for improvements to be achieved. Many users manage to make this effort on their own, while others do it with support from others in the Sleepio Community. We recommend starting Sleepio when you are prepared to make a commitment to the program.

Insomnia symptoms are very common across a range of medical and mental health conditions including cancer, pain, depression and endocrine or hormonal changes (for example, menopause). There is good evidence that the approaches used in the Sleepio program can improve sleep even in the context of medical or mental health conditions. However, it is recommended that you consult with a doctor before using Sleepio if you have an existing medical or mental health condition, or are pregnant or recently have been pregnant.

Sleep restriction may result in temporarily increased daytime sleepiness. Individuals who experience excessive daytime sleepiness should speak to their doctor before starting Sleepio. Examples include individuals who:

• Have untreated sleep apnea / an untreated sleep-related breathing disorder
• Have narcolepsy
• Have parasomnias
• Are shift workers
• Are on medications that cause drowsiness

Sleep restriction also should not be used if daytime sleepiness imposes a risk to you or others. Examples include:

• Bus or delivery vehicle drivers
• Air traffic controllers
• Operators of heavy machinery
• Assembly line workers

Sleepio is generally safe for most individuals who drive. However, if you are feeling sleepy while driving, pull over and take a nap until the sleepiness subsides.

While sleep restriction may not be appropriate for everyone, most people will still benefit from the other parts of the program, especially the lifestyle advice and the cognitive and behavioral tools and techniques.

The techniques taught in Sleepio have been shown to be useful for the improvement of sleep in individuals who experience chronic pain and/or physical limitations. However, some of the techniques may require some modifications.

The quarter of an hour rule encourages individuals to get out of bed if they are unable to fall asleep or return to sleep within approximately 15 minutes. Getting out of bed in the middle of the night may be challenging for individuals with pain or mobility limitations. If this is your experience, you may want to consider not applying the quarter of an hour rule. Please speak to your doctor before using the quarter of an hour rule if you experience pain or physical limitations. 

Progressive muscle relaxation requires you to tense and relax your muscles. If you experience pain while tensing your muscles, you can use an alternative exercise that does not involve muscle tensing.

Do not make changes to your medication before consulting a doctor. 

For some, sleep medications may increase the likelihood of experiencing falls, especially in older adults. Therefore, the quarter of an hour rule may not be appropriate for some individuals taking sleep medications. Please consult your doctor before using the quarter of an hour rule if you are taking sleep medications and are over the age of 65.

The Sleepio program is not recommended for people under the age of 18. This is because sleep restriction may not be suitable for those who biologically require more sleep, such as children and adolescents.

Clinical trials (Felder et al., 2020; Kalmbach et al., 2020) have indicated that Sleepio is safe and effective to use during pregnancy. However, as there may be a biologically greater need for sleep during pregnancy, it is recommended that pregnant individuals do not restrict time in bed to fewer than 6 hours. For more information about sleep during pregnancy and how to adapt the Sleepio program during pregnancy, see this Sleepio guide.

You can access Sleepio through your web browser and on iOS or Android devices. Supported web browsers include Chrome, Safari, and MS Edge. Sleepio supports import of sleep data through FitBit devices.

If you have any questions, please contact our team at hello@sleepio.com.

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 by a medical provider, Sleepio is available as an adjunct to their usual medical care for Insomnia Disorder. Sleepio does not replace the care of a medical provider or the patient’s medication. Sleepio has not been cleared by the U.S. Food and Drug Administration (FDA) for this indication.