A medication originally used to treat childhood epilepsy may soon offer a new way to treat obstructive sleep apnea, one of the most common sleep disorders worldwide.
A European clinical trial has found that the drug sulthiame significantly reduced breathing interruptions during sleep, raising the possibility of a pill-based alternative to CPAP machines.
The findings, published in The Lancet, come from a multicountry clinical trial involving 298 people with moderate to severe obstructive sleep apnea (OSA). Researchers say the results suggest that pharmacological treatment for the condition, which was long considered difficult, may finally be within reach.
Obstructive sleep apnea occurs when the upper airway repeatedly collapses during sleep, temporarily blocking airflow. These pauses in breathing can last for several seconds and may occur dozens of times an hour, leading to fragmented sleep and drops in oxygen levels.
Over time, untreated sleep apnea is linked to high blood pressure, heart disease, stroke, and type 2 diabetes.
Currently, the most widely prescribed treatment is continuous positive airway pressure (CPAP) therapy. The device delivers pressurised air through a mask worn during sleep to keep the airway open.
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While highly effective, many patients struggle to tolerate the mask, and studies suggest up to half discontinue CPAP within a year. The new trial explored whether sulthiame could address the underlying breathing instability that contributes to airway collapse during sleep.
The clinical trial was conducted across four European countries. Participants were randomly assigned either a placebo or different doses of sulthiame, ensuring that neither the researchers nor the participants knew who received the active drug.
Results showed that patients receiving higher doses of sulthiame experienced up to 47 percent fewer breathing interruptions compared to those given a placebo. The treatment group also showed improved oxygen levels overnight, indicating more stable breathing during sleep.
Researchers believe the drug works by stabilising the brain’s control of breathing and increasing respiratory drive. This reduces the likelihood that the airway will collapse during sleep, addressing one of the core mechanisms behind obstructive sleep apnea.
Most side effects reported in the trial were mild and temporary, according to the research team. Jan Hedner, senior professor of pulmonary medicine at the Sahlgrenska Academy at the University of Gothenburg and a lead investigator in the study, described the results as an important step forward.
Dr Harish Chafle, Senior Consultant, Chest Physician, Bronchoscopist, Intensivist and Sleep Disorders specialist, Gleneagles Hospitals, Mumbai, explains why sulthiame could represent a breakthrough in pharmacological treatment for sleep apnea. "Many patients diagnosed with obstructive sleep apnea struggle to tolerate CPAP masks even after knowing their effectiveness and avoid using them. So, emerging pill-based therapies such as sulthiame may offer hope when it comes to patients having mild to moderate disease. If proven effective in larger studies, such medications could provide a simpler, more convenient treatment option and improve long-term adherence. However, currently, there is not much known about the sulthiame drug and we will have to wait and watch the results."
Sulthiame is not a new drug. It has long been approved in several countries for the treatment of certain forms of childhood epilepsy. Researchers say its existing safety profile made it a promising candidate for repurposing in sleep apnea research.
Despite the promising results, scientists caution that more research is needed before the medication can become a standard treatment.
Experts say a drug therapy for sleep apnea could be especially helpful for patients who cannot tolerate CPAP machines or other devices.
For now, the researchers are planning larger and longer studies to determine whether the benefits of sulthiame persist over time and whether the treatment is safe for all kinds of patients.
If future trials confirm these results, the discovery could mark a significant shift in the management of sleep apnea, potentially offering millions of patients a simpler alternative to nightly masks and machines.