Sulthiame, a drug traditionally used for epilepsy, has shown dose-dependent reductions in apneic episodes among patients with obstructive sleep apnea, according to a recent study presented at the 2024 European Respiratory Society Congress.
A randomized, double-blind, placebo-controlled trial led by Professor Jan Hedner from Sahlgrenska University Hospital suggests that sulthiame may offer therapeutic benefits for patients with obstructive sleep apnea (OSA) who cannot tolerate continuous positive airway pressure (CPAP) therapy. The study was conducted at 28 centers across Spain, France, Belgium, Germany, and the Czech Republic.
The trial enrolled 298 patients with OSA, who were randomized to receive either 100 mg, 200 mg, or 300 mg of sulthiame, or a placebo. All patients underwent polysomnography assessments at baseline and again at 4 and 12 weeks. The primary endpoint was the change in the apnea-hypopnea index (AHI3a) at week 12.
Results demonstrated a dose-dependent reduction in apneic episodes. Patients in the 300 mg group experienced a 39.9% reduction in AHI3a from baseline (P<0.0001), while those in the 100 mg and 200 mg groups saw reductions of 17.8% and 34.8%, respectively. Additionally, when measured using AHI4, the treatment resulted in an approximately 50% reduction in respiratory pauses. Sulthiame also improved overnight oxygen saturation and reduced daytime sleepiness, as measured by the Epworth Sleepiness Scale.
Side effects, including paresthesia, headache, fatigue, and nausea, were generally mild to moderate and dose-dependent, with no significant cardiovascular adverse events reported.
Professor Hedner noted, “This suggests that sulthiame could be an effective treatment for OSA, especially for those who find they cannot use the existing mechanical treatments. Although sulthiame is already available as a treatment for childhood epilepsy, further studies are required to confirm these effects in a larger cohort of patients.”
The study, funded in part by Desitin GmbH, involved researchers with no significant conflicts of interest. Further phase III trials are planned to confirm sulthiame's long-term safety and efficacy.
