Sulthiame Effective for Obstructive Sleep Apnea Symptoms

Sulthiame (STM) has shown promise in improving symptoms of obstructive sleep apnea (OSA), according to findings presented at the European Respiratory Society Congress, held in Vienna from September 7 to 11, 2024. The study was led by Jan A. Hedner, M.D., Ph.D., from Sahlgrenska Academy in Sweden.

The research involved a double-blind, randomized, placebo-controlled trial, which included patients with OSA who either did not accept or could not tolerate traditional treatments like continuous positive airway pressure (CPAP) or oral splints. Polysomnography, a comprehensive sleep study, was utilized to assess the effectiveness of three different doses of STM compared to a placebo.

A total of 298 participants were randomized into four groups, each receiving either 100 mg, 200 mg, or 300 mg of STM, or a placebo. Each group consisted of approximately 74 to 75 participants. The primary measure of efficacy was the change in the apnea/hypopnea index (AHI) from baseline to week 15. This index measures the number of apnea and hypopnea events per hour of sleep, where apnea refers to pauses in breathing and hypopnea to shallow breathing.

The results showed significant improvements in the AHI for all STM doses. Specifically, the apnea/hypopnea index decreased by 17.8 percent, 34.8 percent, and 39.9 percent for the 100 mg, 200 mg, and 300 mg doses, respectively. These reductions were associated with a ≥3 percent decrease in oxygen levels or an arousal from sleep. Additionally, there was a 47.1 percent reduction in apnea/hypopnea events involving ≥4 percent oxygen desaturation by the 15th week in a dose-dependent manner when adjusted for placebo.

The study also highlighted improvements in mean overnight oxygen saturation. At the 15-week mark, participants receiving 200 mg and 300 mg of STM showed mean improvements in oxygen desaturation levels of 0.95 percent and 0.87 percent, respectively. Furthermore, there was evidence of improvement in the total arousal index and overall sleep quality, although the effects on sleep structure were neutral.

For patients who reported significant daytime sleepiness, as indicated by an Epworth Sleepiness Scale score of 11 or higher, there was also a reduction in their scale scores. This suggests that STM not only helped with night-time symptoms but also improved daytime alertness.

"People taking sulthiame in the trial had a reduction in OSA symptoms such as stopping breathing during the night and feeling sleepy during the day. Their average levels of oxygen in the blood were also improved with the treatment," said Hedner.

In summary, the study demonstrated that sulthiame effectively reduces the severity of OSA symptoms, improves oxygen saturation, and enhances overall sleep quality. These findings could provide a new therapeutic option for patients who are unable to tolerate existing treatments like CPAP or oral splints.