New Pill Could Finally Treat Sleep Apnea Without a Mask

A clinical trial has found that a drug may significantly reduce breathing disruptions in obstructive sleep apnea. Credit: Stock

Sulthiame reduced breathing interruptions in sleep apnea patients, pointing toward a viable drug treatment.

A European clinical trial has found that the drug sulthiame can reduce breathing pauses and improve sleep quality in people with obstructive sleep apnea, with researchers from the University of Gothenburg playing a key role in the work. The results suggest a potential medication based option for patients who are unable to tolerate breathing masks.

The findings, published in The Lancet, are based on a study of 298 individuals with moderate to severe sleep apnea. About one quarter of the participants received a placebo, while the rest were treated with sulthiame at different dose levels.

The trial was carried out in four European countries and used a double blind design, meaning that neither the patients nor the research teams knew who was receiving the drug during the study.

A possible breakthrough

The researchers reported that patients given the higher doses of sulthiame experienced up to a 47 percent reduction in breathing interruptions during sleep and showed improved oxygen levels compared with those taking placebo. The drug appears to act by stabilizing the body’s breathing regulation and boosting respiratory drive, which lowers the chance that the upper airway will collapse during sleep. Most of the side effects observed during the trial were mild and temporary.

Jan Hedner, senior professor of pulmonary medicine at the Sahlgrenska Academy, University of Gothenburg, has played a leading role in the study.

Ludger Grote, Jan Hedner and Kaj Stenlöf. Credit: Göteborgs universitet

“We have been working on this treatment strategy for a long time, and the results show that sleep apnea can indeed be influenced pharmacologically. 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,” says Jan Hedner.

Ludger Grote and Kaj Stenlöf from the University of Gothenburg have also made significant contributions to the study.

Many struggle with CPAP

Sleep apnea occurs when the upper airways collapse during sleep, causing repeated breathing pauses, oxygen deprivation, and disrupted sleep. Over time, untreated sleep apnea increases the risk of high blood pressure, cardiovascular disease, stroke, and type 2 diabetes.

Although the condition is common, there is still no drug that treats the underlying cause. The standard treatment – continuous positive airway pressure (CPAP) – is highly effective but difficult for many to tolerate. Up to half of all patients discontinue CPAP within a year, as the mask can feel uncomfortable or disturb sleep.

Sulthiame is an existing medication previously approved for treating a form of childhood epilepsy, and is now being evaluated for sleep apnea.

Reference: “Sultiame once per day in obstructive sleep apnoea (FLOW): a multicentre, randomised, double-blind, placebo-controlled, dose-finding, phase 2 trial” by Winfried Randerath, Ludger Grote, Kaj Stenlöf, Ingo Fietze, Julia Chevts, Erik Buntinx, Javier Albares, Katrin Kuhn, Corinna Hansen, Andreas Völp, Jan Hedner, Dries Testelmans, Jean-Benoit Martinot, Farhad Baharloo, Benny Gimbada Mwenge, Erik Buntinx, Pierre Philip, Jean Louis Pepin, Frederic Gagnadoux, Maxime Patout, Maria Fernanda Troncoso Acevedo, Alejandro Iranzo de Riquer, Francisco Martinez-Orozco, Francisco Javier Puertas Cuesta, Ainhoa Alvarez Ruiz de Larrinaga, Francisco Javier Albares Tendero, Christian Viniol, Winfried Randerath, Heike Benes, Ingo Fietze, Geert Mayer, Katrin Gade, Christian Deckert, Peter Heymer, Frank Kaessner, Julia Chevts, Henning Candler, Zbysek Pavelek and Samuel Genzor, 9 October 2025, The Lancet.

DOI: 10.1016/S0140-6736(25)01196-1

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