- Scientists developed sulthiame, an oral drug reducing breathing pauses in sleep apnea patients
- The phase 2 trial showed 47% apnea reduction and improved oxygenation with sulthiame doses
- Sulthiame stabilises respiratory brain signals and increases airway muscle activity during sleep
Scientists have developed a promising oral medication that significantly reduces breathing pauses in people with obstructive sleep apnea (OSA). This medicine can be a potential alternative to CPAP machines. The study was published in The Lancet and included researchers from the University of Gothenburg. The drug, sulthiame, which is already approved in some countries for epilepsy, showed fewer breathing interruptions in people with sleep apnea.
Obstructive sleep apnea affects millions of people across the globe. It happens when the muscles in your throat relax while you're asleep, causing surrounding tissue to press on your windpipe. This eventually blocks air movement, causing repeated breathing pauses that starve the body of oxygen. Current treatments like CPAP deliver continuous air pressure through a mask, however, people find it difficult to wear while asleep.
Sulthiame, which has been used as an anticonvulsant, helps to stabilise brain respiratory signals and boosts upper airway muscle drive. This helps to tackle sleep apnea mechanisms without relying on mechanical aids. The medicine addresses a critical gap as a majority of sleep apnea patients abandon CPAP due to discomfort. Sleep apnea, if not treated, can increase the risk of heart disease, stroke, and diabetes due to untreated interrupted breathing.
Study Overview
The trial was a multicenter, randomised, double-blind, placebo-controlled phase 2 study. It enrolled 298 adults with moderate-to-severe OSA across Belgium, Czechia, France, Germany, and Spain. Participants received daily doses of sulthiame (100 mg, 200 mg, or 300 mg) or placebo one hour before bed for 12 weeks. The efficacy was measured by polysomnography assessing apnea-hypopnea index (AHI); the number of breathing pauses per hour.
Study Results
Higher doses gave the best results. 200 mg and 300 mg reduced AHI by 30-50%, with the top dose achieving a 47% drop in pauses and better overnight oxygenation compared to placebo. Daytime sleepiness scores improved significantly, and side effects were mostly mild (e.g., headache, nausea), dose-dependent, and temporary. There were no serious safety issues among the participants. The 200 mg dose hit the optimal balance of efficacy and tolerability. Jan Hedner, senior professor of pulmonary medicine at the Sahlgrenska Academy, University of Gothenburg called it a "breakthrough," noting pharmacological influence on OSA after years of effort.
"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.
How Sulthiame Works
Sulthiame improves respiratory control by modulating brain signals that regulate breathing, increasing upper airway dilator muscle activity to prevent collapse. Unlike weight-loss drugs, this directly addresses neuromuscular instability and loop gain. A prior 2024 pilot study confirmed these effects, paving the way for this larger trial.
Current Treatments and Limitations
CPAP remains one of the best treatment options for sleep apnea. However, adherence is only at 50% after one year due to mask claustrophobia, dry mouth, or travel inconvenience.
Weight loss and diabetes drug, Tirzepatide was approved in 2024 for obese moderate-severe OSA cases. The drug helps to shrink neck fat for larger airways, however, it overlooks non-obese patients or those needing immediate muscle/respiratory fixes.
Future Implications
If phase 3 confirms results, sulthiame could be launched as the first direct OSA pill. This could transform management for millions of potential sufferers.
Disclaimer: This content including advice provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. NDTV does not claim responsibility for this information.
