Published in The Lancet, the trial involved 298 participants with moderate to severe sleep apnea. Roughly one-quarter received a placebo, while the remaining participants were administered varying doses of sulthiame. Conducted across four European countries using a double-blind design, neither participants nor researchers knew who was receiving the active drug during the study.
Significant Reduction in Breathing Pauses
Participants receiving higher doses of sulthiame experienced up to 47 percent fewer breathing interruptions during sleep compared with the placebo group. The medication also improved oxygen levels overnight.
Sulthiame is believed to work by stabilizing the body’s breathing control and enhancing respiratory drive, reducing the likelihood of upper airway collapse—the primary cause of obstructive sleep apnea. Most reported side effects were mild and temporary.
Jan Hedner, senior professor of pulmonary medicine at the Sahlgrenska Academy, University of Gothenburg, who led the study, described the findings as a potential breakthrough.
"We have been working on this treatment strategy for a long time, and the results show that sleep apnea can indeed be influenced pharmacologically. 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," Hedner said.
Research colleagues Ludger Grote and Kaj Stenlöf also contributed significantly to the project.
Addressing a Major Treatment Gap
Obstructive sleep apnea occurs when the upper airway repeatedly collapses during sleep, temporarily stopping breathing, lowering oxygen levels, and disrupting rest. Over time, untreated sleep apnea increases the risk of serious health issues, including high blood pressure, cardiovascular disease, stroke, and type 2 diabetes.
Currently, continuous positive airway pressure (CPAP) is the most widely used therapy. CPAP keeps the airway open through a mask worn during sleep and is highly effective. However, many patients struggle with the device, and up to half discontinue use within a year due to discomfort or interference with sleep.
According to the researchers, sulthiame could fill this unmet need by offering a drug-based approach that directly targets the underlying cause of obstructive sleep apnea.
The study’s results mark an important step toward alternative treatments for the millions of patients worldwide who cannot tolerate conventional CPAP therapy. Larger trials are expected to further evaluate the long-term effectiveness and safety of sulthiame in diverse patient populations.