US insomniacs have a new prescription DTx option

It is estimated that around one in four US adults suffer from insomnia, raising their risk of other health conditions, and the recent approval of a digital therapeutic gives them a treatment option that does not rely on drugs or scarce talking therapies.

Big Health has joined the select group of companies with FDA approval for a prescription digital therapeutic (DTx), getting the go-ahead for SleepioRx as a treatment for chronic insomnia and insomnia disorder as an adjunct to usual care in adults over 18.

It takes the form of a 90-day course of digital cognitive and behavioural therapy (CBT) designed to address the factors that maintain insomnia and chronic sleep problems and is an extension of Big Health's well-established Sleepio products.

That is a shorter, six-week course marketed directly to end-users, as well as to employers, health plans, and international health systems. One feature of the prescription version, which can be used only under the care of a licensed healthcare provider, is in-the-moment therapeutic content to help users fall asleep, according to the company.

"Approximately 25% of adults in the US suffer from insomnia, with a cost to US industry of $62.3 billion per year," said Big Health in a statement.

"Poor sleep has also been associated with increased risk for a number of health conditions, including diabetes, obesity, heart disease, and cancer," it added. "Individuals who do not get sufficient sleep are also at higher risk of stroke or dementia."

Chief executive Yael Berman described the FDA approval as a "landmark milestone" for Big Health that provides "accessible, guideline-recommended, first-line treatment for insomnia."

While some digital health companies have struggled to build a sustainable business from DTx products, Berman believes that the 2025 Medicare Physician Fee Schedule proposed rule, which includes a proposal to pay for FDA-cleared digital mental health treatments, establishes a promising pathway to scale access to SleepioRx.

"This clearance, coupled with the new proposed reimbursement codes, will for the first time motivate US healthcare providers to prescribe safe and effective treatment alternatives to traditional medication," he said.

In trials, SleepioRx has been shown to restore normal sleep to 76% of users, with an average 54% reduction in the time to fall asleep and 62% fall in time spent during the night awake, according to Big Health.

It offers an alternative to sleeping pills like zopiclone and zolpidem, which can be habit-forming and can have side effects including next-day sleepiness, as well as therapy, which in many parts of the US is scarce and means joining a long waiting list.

It's not the first prescription DTx to reach the US market, however. That accolade belongs to Somryst, originally developed by Pear Therapeutics – which went bankrupt last year – and was subsequently acquired by Nox Health in an asset sale.

The original version of Sleepio has been building traction in international markets, particularly the UK, where it became the first DTx to be recommended by health technology assessment (HTA) agency NICE for NHS use in 2022.