Millions of people in the U.S. have sleep apnea, most of whom aren’t getting treated for it. But a simple daily pill of an old drug just might help people with the condition, recent trial data shows.
Scientists in Sweden and elsewhere have been studying the anti-seizure medication sultiame as a treatment for obstructive sleep apnea. In their latest Phase II trial, they found that people on sultiame experienced a significant improvement in their apnea symptoms and sleep quality compared to those taking a placebo. The results suggest sultiame could become an effective option for sleep apnea, particularly for those unable to tolerate continuous positive airway pressure (CPAP) machines, the researchers say.
“These findings offer perspectives for a pharmaceutical approach to treatment of patients with obstructive sleep apnea,” they wrote in their paper, published in The Lancet.
A pill for apnea?
Obstructive sleep apnea, or OSA, is the most common form of sleep apnea, affecting roughly 12% of U.S. adults. It happens when airway muscles physically block a person’s breathing during sleep. This pause causes the body to wake up just enough to start breathing again, only for the cycle to restart throughout the night—anywhere from five to 100 times an hour. These episodes cause low oxygen levels and disturb people’s sleep and, over time, can raise the risk of other long-term health problems, including heart disease and possibly even dementia.
CPAP machines use air pressure to keep the airways open during sleep and can be a highly effective apnea treatment. Though these machines have gotten easier to wear over time, many people still have trouble using them long-term or have a medical condition that prevents their use. And that’s led some companies to pursue less cumbersome interventions, including medications.
Bayger AG first launched sultiame (also called sulthiame) in the 1960s as an anticonvulsant, and it’s still used as such in many European countries (the drug was never approved in America). The drug works by inhibiting carbonic anhydrase, an enzyme that plays a role in regulating our breathing. And early research has suggested the drug can stabilize the breathing of people with apnea during sleep, thus preventing airway collapse. The U.S.-based Apnimed, in conjunction with the Japanese company Shionogi & Co., Ltd., have been looking to develop sultiame as a sleep apnea treatment.
The phase II trial involved 298 patients with untreated, moderate to severe sleep apnea. Over a 15-week period, half were randomized to a placebo pill taken right before bed, while the rest were given varying doses of sultiame. People taking sultiame saw a noticeable decrease of apnea episodes, the researchers found, along with improvements in their sleep quality and daytime sleepiness. People in the highest dose group saw the largest improvement, up to a 47% reduction in apnea events.
“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,” said study researcher Jan Hedner, a senior professor of pulmonary medicine at the University of Gothenburg, in a statement from the university released on Wednesday.
The future of apnea treatment
Sultiame isn’t the only pill-based treatment being studied for apnea.
In late 2024, Eli Lilly secured an expanded approval of its GLP-1 medication tirzepatide to treat sleep apnea as well (obesity is a major risk factor of OSA, and weight loss can reduce its symptoms). Apnimed is also developing other drugs that it hopes can tackle the root causes of apnea. Its top candidate, code-named AD109, has already shown positive results in Phase III trial data, and the company plans to formally seek FDA approval for AD109 sometime this year.
Hopefully, in the near future, people with apnea will have a bevy of options available to chase away their sleepless nights.
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