Quick Answer: SleepioRx and Somryst are FDA-cleared prescription digital therapeutics (PDTs) that deliver Cognitive Behavioural Therapy for Insomnia (CBT-I) through a smartphone app. Both are primarily US-focused as of 2026, with limited formal availability in Canada. CBT-I remains the first-line treatment for chronic insomnia. A comfortable, supportive mattress is a foundational sleep environment factor that CBT-I practitioners universally recommend addressing alongside therapy.
In This Guide
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What Are Prescription Digital Therapeutics for Insomnia?
Prescription digital therapeutics (PDTs), sometimes categorised as Software as a Medical Device (SaMD), are software applications that deliver evidence-based treatments and carry the same regulatory status as physical medical devices. Unlike wellness apps that suggest good sleep habits, PDTs must demonstrate clinical efficacy through controlled trials and receive regulatory clearance before they can be prescribed by healthcare providers.
For insomnia, the established first-line treatment is Cognitive Behavioural Therapy for Insomnia (CBT-I), a structured multi-week intervention that targets the thoughts, behaviours, and beliefs that perpetuate chronic insomnia. CBT-I has a stronger long-term evidence base than sleep medications and is specifically recommended as the first-line treatment by the American Academy of Sleep Medicine, the Canadian Sleep Society, and the European guidelines.
The problem with CBT-I has always been access. Trained CBT-I therapists are relatively few in Canada, wait times are long, and the cost of multiple therapy sessions is significant without insurance coverage. Digital CBT-I attempts to solve this access problem by delivering the therapy through a structured app experience.
What the Evidence Shows for Digital CBT-I
A 2022 meta-analysis in Sleep Medicine Reviews by Ye et al. analysed 22 randomised controlled trials of digital CBT-I interventions and found significant improvements in sleep onset latency, wake after sleep onset, sleep efficiency, and insomnia severity index scores compared to control conditions. The effect sizes were smaller than in-person CBT-I but meaningfully larger than waitlist or self-help control conditions. Digital CBT-I is not a substitute for skilled therapist-delivered CBT-I, but it's substantially better than no treatment.
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SleepioRx: FDA-Cleared Digital CBT-I
SleepioRx, developed by Big Health, received FDA clearance in August 2024 for treatment of chronic insomnia and insomnia disorder in adults aged 18 and older. It is prescribed as an adjunct to usual care (not a standalone replacement for all treatment).
The programme runs over 6 weeks and includes several core CBT-I components: sleep restriction therapy (controlled narrowing of time in bed to consolidate sleep), stimulus control (rebuilding the association between bed and sleep), cognitive restructuring (challenging catastrophic beliefs about sleep), and relaxation techniques. A virtual sleep therapist called "The Prof" guides patients through the content in weekly sessions.
In the US, SleepioRx is reimbursed under Medicare's new Digital Mental Health Treatment (DMHT) codes effective January 2025, making it covered for Medicare patients when prescribed by a physician. Commercial insurance coverage varies by plan.
For Canadians: as of 2026, SleepioRx is not formally listed as available through Canadian provincial health systems. Big Health's marketing for SleepioRx targets US healthcare providers and payers. Canadians may be able to access the non-prescription version (Sleepio) as a standalone app, though the prescription version's regulatory pathway in Canada remains unclear.
Somryst: The First FDA-Cleared Digital Insomnia Treatment
Somryst (developed by Pear Therapeutics and subsequently acquired) was the first FDA-cleared prescription digital therapeutic for chronic insomnia, cleared in 2020. It is indicated for adults aged 22 and older with chronic insomnia.
Like SleepioRx, Somryst delivers CBT-I over a 9-week programme. The programme structure includes sleep restriction, stimulus control, relaxation, and cognitive restructuring components. Clinical trial data supporting clearance showed significant improvements in insomnia severity and sleep efficiency scores.
Pear Therapeutics, the original developer, filed for bankruptcy in 2023, which created uncertainty about Somryst's ongoing commercial availability. As of 2026, Somryst's status in the US market should be confirmed directly with the current holder of the product. For Canadian patients, this makes Somryst a less reliable option to plan around compared to SleepioRx.
Free and Lower-Cost CBT-I Options in Canada
While formal prescription PDTs are primarily US-focused, Canadians with insomnia have access to several evidence-based digital CBT-I resources. The Sleepio app (non-prescription version of SleepioRx) has been used in some Canadian employer benefits programmes. The Sleep Healthy Using the Internet (SHUTi) programme has been studied in Canadian populations. Some Ontario Employee Assistance Programmes (EAPs) include digital CBT-I tools through their mental health benefit providers. Your family physician can also provide a referral to a psychologist or registered therapist trained in CBT-I, which may be partially covered under extended health benefits.
Canada Availability in 2026
The Canadian regulatory pathway for SaMD (Software as a Medical Device) runs through Health Canada under the Medical Devices Regulations. As of 2026, neither SleepioRx nor Somryst has received Health Canada medical device approval for prescription use in Canada, based on available public information. Health Canada's SaMD guidance framework was updated in recent years, and the pathway exists for digital therapeutics to receive approval, but uptake has been slow compared to the US FDA clearance trajectory.
This doesn't mean Canadians cannot access digital CBT-I. It means the formal prescription-and-coverage model that exists in the US (where a physician prescribes the app and insurance covers it) is not yet operational in Canada. Canadian patients can:
Use non-prescription CBT-I apps like Sleepio, which are available on a subscription or employer-benefit basis. Access online CBT-I programmes through licensed therapists offering telehealth services in Ontario. Contact the Ontario Psychological Association for referrals to CBT-I trained therapists who offer sliding-scale or insured sessions. Discuss pharmacotherapy with their physician as a short-term bridge while waitlisting for CBT-I, with the understanding that medication does not address the behavioural patterns that CBT-I targets.
What CBT-I Says About Your Sleep Environment
CBT-I practitioners universally include sleep environment assessment as part of the programme. The sleep hygiene components of CBT-I specifically address:
Sleep Environment Factors in CBT-I
- Bedroom temperature: Cooler rooms support sleep onset. Target 16-19 degrees Celsius.
- Darkness and light control: Blackout curtains or eye masks recommended.
- Noise management: White noise, earplugs, or addressing noise sources.
- Bed and mattress comfort: The bed should be associated with sleep and relaxation only. If the mattress is uncomfortable, this association is repeatedly disrupted.
- Stimulus control: This CBT-I technique specifically aims to strengthen the bed-equals-sleep association by limiting bed use to sleep and intimacy only, avoiding devices, reading, or working in bed.
The stimulus control component of CBT-I, which is one of the most evidence-supported individual techniques in the entire CBT-I framework, requires that the bed itself be a comfort cue rather than an anxiety cue. If a patient's mattress is uncomfortable enough that lying in bed immediately triggers awareness of discomfort, it undermines stimulus control from the start.
Brad at Mattress Miracle encounters this connection occasionally in customer conversations. Someone who has been through CBT-I and improved their sleep behaviours but still isn't sleeping well will sometimes describe lying in bed and noticing hip pressure or shoulder soreness as the first thing they're aware of. That's a different problem than insomnia, and it won't be resolved by therapy.
Complementary, Not Competing
CBT-I and a good mattress address different things. CBT-I addresses the thoughts, behaviours, and schedules that perpetuate insomnia. A good mattress addresses the physical sleep surface that determines comfort and support. For someone with both sleep schedule dysfunction and an uncomfortable mattress, both need attention. Doing CBT-I on an uncomfortable bed, or buying a great mattress while maintaining sleep-disrupting behaviours, gets only part of the way. We'd rather send you to a CBT-I therapist and sell you a mattress than suggest either one alone is sufficient if both are contributing to poor sleep.
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Call 519-770-0001Frequently Asked Questions
Is SleepioRx available in Canada?
As of 2026, SleepioRx is primarily available in the US, where it received FDA clearance in August 2024. Health Canada has not yet approved SleepioRx as a prescribed medical device in Canada. The non-prescription Sleepio app may be available through some Canadian employer benefits programmes.
What is CBT-I and why is it recommended for insomnia?
CBT-I (Cognitive Behavioural Therapy for Insomnia) is a structured therapy targeting the thoughts, behaviours, and beliefs that maintain chronic insomnia. It is the first-line treatment recommended by the Canadian Sleep Society and American Academy of Sleep Medicine because it produces durable improvements without medication side effects or dependence. Digital CBT-I programmes like SleepioRx deliver this therapy through a smartphone app.
Is Somryst still available in 2026?
Somryst's availability is uncertain following Pear Therapeutics' 2023 bankruptcy filing. Patients in Canada interested in digital CBT-I should focus on SleepioRx (if and when it becomes available in Canada) or non-prescription digital CBT-I options like Sleepio, or seek a referral to a CBT-I trained therapist through their family physician.
Does a good mattress help with insomnia?
It depends on the cause. If insomnia is primarily driven by dysfunctional sleep thoughts and schedules (which CBT-I addresses), a mattress change alone won't cure it. However, an uncomfortable mattress that creates physical discomfort throughout the night can contribute to sleep fragmentation and conditioned arousal at bedtime, which reinforces insomnia. A quality, comfortable mattress is a necessary baseline for effective sleep, and CBT-I practitioners include mattress and sleep environment assessment in their programmes.
Where can Canadians get CBT-I treatment?
Through referral to a psychologist or registered therapist trained in CBT-I (ask your family physician), through some Employee Assistance Programmes that include mental health benefits with CBT-I capabilities, or through the non-prescription Sleepio app. Some Canadian telehealth platforms are beginning to offer CBT-I through licensed therapists. The Canadian Sleep Society website lists accredited sleep centres by province.
Sources
- Ye, Y.Y., et al. (2022). Is internet-based cognitive behavioural therapy as effective as face-to-face CBT for insomnia? A systematic review and meta-analysis. Sleep Medicine Reviews, 61, 101560. doi.org/10.1016/j.smrv.2021.101560
- Qaseem, A., et al. (2016). Management of chronic insomnia disorder in adults: a clinical practice guideline from the American College of Physicians. Annals of Internal Medicine, 165(2), 125-133. doi.org/10.7326/M15-2175
- Big Health. (2024). FDA clearance of SleepioRx for prescription use in adults 18+. Retrieved from bighealth.com/sleepio-rx.
- Jacobson, B.H., et al. (2008). Grouped comparisons of sleep quality for new and personal bedding systems. Journal of Chiropractic Medicine, 7(4), 132-139. doi.org/10.1016/j.jcme.2008.09.002
- Morin, C.M., et al. (2021). Cognitive behavior therapy singly and combined with medication for persistent insomnia: impact on psychological and daytime functioning. Behaviour Research and Therapy, 140, 103847. doi.org/10.1016/j.brat.2021.103847
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