A new medication called sulthiame may offer sleep apnea patients a pill-based alternative to CPAP machines. In a European clinical trial, patients taking higher doses experienced up to 47% fewer breathing interruptions during sleep and improved oxygen levels overnight, according to research published in The Lancet . The findings suggest that obstructive sleep apnea, a condition affecting millions worldwide, could be treated with medication rather than relying solely on uncomfortable breathing masks.

What Is Sleep Apnea and Why Is Current Treatment So Challenging?

Obstructive sleep apnea occurs when the upper airway repeatedly collapses during sleep, causing breathing to stop temporarily and reducing oxygen levels. These interruptions disrupt sleep quality and, over time, can increase the risk of serious health complications . The most common treatment is continuous positive airway pressure, or CPAP, which uses a mask to keep the airway open during sleep. While CPAP is highly effective, many patients struggle with it. Up to half of CPAP users stop using the device within a year because the mask feels uncomfortable or interferes with sleep .

This gap in treatment options has left researchers searching for alternatives that patients might tolerate better. Sulthiame, an existing medication already approved to treat a form of childhood epilepsy, emerged as a promising candidate for addressing the underlying cause of sleep apnea rather than just managing its symptoms.

How Does Sulthiame Work to Improve Breathing During Sleep?

The drug works through a different mechanism than CPAP. Sulthiame appears to stabilize the body's control of breathing and increase respiratory drive, which helps lower the likelihood that the upper airway will collapse during sleep . By addressing the brain's breathing signals rather than physically holding the airway open, the medication targets the root cause of obstructive sleep apnea.

The clinical trial involved 298 people with moderate to severe sleep apnea across four European countries . The study used a double-blind design, meaning neither the participants nor the researchers knew who was receiving the active drug versus a placebo. This rigorous approach helps ensure the results reflect the drug's true effectiveness rather than the placebo effect.

What Did the Trial Results Show?

The results were striking. Patients who received higher doses of sulthiame experienced up to 47% fewer breathing interruptions during sleep compared with those given a placebo . Beyond reducing breathing pauses, participants also showed improved oxygen levels overnight, a critical measure of sleep quality and overall health. Most side effects reported during the trial were mild and temporary, suggesting the medication could be a safe option for broader patient populations .

"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," said Jan Hedner.

Jan Hedner, Senior Professor of Pulmonary Medicine at the Sahlgrenska Academy, University of Gothenburg

What Are the Health Risks of Untreated Sleep Apnea?

Understanding why sleep apnea treatment matters is crucial. When left untreated, obstructive sleep apnea raises the risk of several serious health problems over time:

• High Blood Pressure: Repeated breathing interruptions and oxygen drops strain the cardiovascular system, causing blood pressure to rise.
• Cardiovascular Disease: The stress on the heart from repeated oxygen deprivation increases the risk of heart disease and related complications.
• Stroke: The combination of high blood pressure and reduced oxygen levels elevates stroke risk significantly.
• Type 2 Diabetes: Sleep apnea disrupts metabolic function and increases the risk of developing diabetes.

These complications underscore why finding effective, tolerable treatments is so important for public health.

What Happens Next for Sulthiame as a Sleep Apnea Treatment?

While the phase 2 trial results are encouraging, sulthiame is not yet approved as a sleep apnea treatment. Researchers emphasize the need for larger and longer studies to confirm that the drug's benefits persist over extended use and to determine whether it is safe for a wider range of patient groups . The University of Gothenburg, along with collaborators Ludger Grote and Kaj Stenlöf, played important roles in this research and will likely continue investigating the medication's potential.

The path from clinical trial to approved medication typically takes several years and involves additional phases of testing. However, the strong results from this European trial suggest that sulthiame could eventually offer patients a meaningful alternative to CPAP machines, particularly for those who have struggled with mask-based therapy. For the millions of people living with sleep apnea, a pill-based option could be life-changing.