Scientists have identified an existing drug that could be the long-awaited cure for obstructive sleep apnea, a condition that afflicts 84 million Americans yet has no medication to treat it.
Obstructive sleep apnea (OSA) occurs when the upper airway collapses during sleep, causing breathing to repeatedly stop and start. In the short term, this leads to excessive snoring and sleep deprivation that undermines focus, productivity and daily functioning.
In the long term, untreated OSA — which affects an estimated 30 million Americans who have the condition but are not receiving treatment —dramatically raises the risk of high blood pressure, heart disease, stroke, Type 2 diabetes, cognitive decline, depression and fatal accidents.
The only current standard treatment for OSA is a CPAP machine, which uses a mask to deliver a steady stream of pressurized air, keeping the airway open during sleep.
Around eight to 10 million Americans use one, but many find the mask uncomfortable, with up to half choosing to stop using the device within a year of getting it, noting that it gets in the way of a good night’s sleep.
However, in a recent European trial of roughly 300 people, researchers discovered that sultiame, an already-existing epilepsy medication, cut nighttime breathing pauses by almost half.
It works by stabilizing the body’s control of breathing and increasing respiratory drive. This helps lower the likelihood that the upper airway will collapse during sleep.
Jan Hedner, a pulmonary specialist at the Sahlgrenska University Hospital in Gothenburg, Sweden, said: ‘It feels like a breakthrough, and we now look forward to larger and longer studies to determine whether the effect is sustained over time and whether the treatment is safe for broader patient groups.’
Obstructive sleep apnea (OSA) occurs when the upper airway collapses during sleep, causing breathing to repeatedly stop and start. In the short term, this sleep disruption causes snoring, makes it hard to focus, work and handle daily tasks (stock)
Hedner added: ‘We have been working on this treatment strategy for a long time, and the results show that sleep apnea can indeed be influenced pharmacologically.’
The research team designed a double-blind clinical trial including 298 participants with moderate to severe OSA who were divided into four groups.
Three groups received different daily doses of the study drug, 100mg, 200mg or 300mg, while the fourth group received a placebo with no active medication.
The core of the investigation, published in The Lancet, relied on high-quality data from polysomnography, or overnight sleep studies.
To get an accurate baseline, each participant underwent two consecutive nights of sleep monitoring before the treatment began.
The sleep studies were repeated at the four-week and 15-week marks of the trial.
All of the data from these thousands of hours of patient monitoring across four countries were sent to a central lab and scored by technicians who were not told which treatment group a patient belonged to.
Researchers not only counted breathing stoppages but also used questionnaires to track how patients felt when awake, tracking changes in their quality of life and levels of daytime sleepiness — key symptoms of OSA.
The standard treatment for OSA is a CPAP machine, which delivers a steady stream of pressurized air through a mask to keep the airway open. While an estimated eight to 10 million Americans use one, many struggle with the mask’s discomfort
They wanted to see whether sultiame could cause a greater reduction in the Apnoea-Hypopnea Index (AHI), which measures the severity of sleep apnea by counting breathing pauses per hour of sleep, compared to a placebo after 15 weeks.
After 15 weeks, the results were clear: researchers concluded that patients’ sleep apnea improved significantly while taking sultiame, which has not been approved for patient use in US by the Food and Drug Administration.
Several other countries including the UK, Australia, Switzerland and Romania have approved the drug to treat epilepsy by prescription only.
While the placebo group saw a slight worsening of their condition, each dose of sultiame reduced the frequency of breathing pauses — the AHI score — compared to their starting point.
This improvement followed a clear dose-response pattern, meaning the higher the dose, the greater the benefit. Patients on the lowest dose, 100mg, saw their AHI score drop by an average of five events per hour.
This reduction nearly doubled for the 200mg group, with a drop of about nine events per hour, and the 300mg group saw the most dramatic improvement with a reduction of over 10 events per hour.
The 200mg and 300mg doses were highly effective, reducing the severity of sleep apnea by roughly 30 percent to 40 percent more than the placebo, a clinically meaningful change.
The drug proved effective regardless of how severe a person’s OSA was at the start of the study.
The graph shows the absolute change in AHI3a (number of breathing pauses per hour) from baseline to week 15. While the placebo group experienced a slight increase in AHI3a, all sultiame doses produced reductions
The graph shows the change in average oxygen saturation throughout the night, a key measure of how well the body maintains oxygen levels while sleeping. Both the 200 mg and 300 mg doses of sultiame outperformed placebo, meaning patients on these doses spent less time with dangerously low oxygen levels while sleeping
Whether participants began with moderate or severe cases, those taking the 200mg or 300mg doses saw significant improvements.
Nearly half of the patients in these two groups experienced a dramatic turnaround.
Specifically, 45 percent of the 200mg group and 49 percent of the 300mg group either cut their breathing disturbances in half or reduced them to a level that is no longer considered a problem, which means fewer than 15 events per hour.
The drug also tackled oxygen drops. Throughout the night, people with the condition experience repeated dips in their blood oxygen levels.
The study found that the 200mg and 300mg doses of sultiame significantly reduced the frequency of dangerous oxygen drops.
Patients on these doses also had higher average oxygen levels throughout the night, meaning their bodies were getting the oxygen they needed to function properly while they slept.
Beyond just breathing and oxygen levels, the drug helped people sleep more soundly without being aroused awake by choking for air.
The data clearly showed that the drug was consistently beating the placebo, providing strong evidence that the improvement in breathing was due to the medication.
