Epilepsy drug could beat dangerous sleep disorder affecting 10 million Britons

A pill used to treat epilepsy could help treat sleep apnea, a disabling sleep disorder that causes temporary interruptions in breathing.

Swedish experts found that patients taking sulthiame experienced up to a 40% reduction in symptoms, including restless nights and loud snoring.

In addition to causing exhaustion, sleep apnea can increase the risk of life-threatening diseases such as high blood pressure, stroke and type 2 diabetes.

Current treatment involves patients using an uncomfortable mechanical mask while they sleep that pumps cool air into their nose and mouth.

But many patients find the machines uncomfortable and difficult to use, prompting experts to look for alternative treatments.

One of these is sulthiame, which, although primarily used as an epilepsy medication, also improves breathing by stimulating the muscles of the upper airway.

Professor Jan Hedner of Sahlgrenska University Hospital and the University of Gothenburg in Sweden presented the results of a landmark clinical trial of the drug in nearly 300 patients with obstructive sleep apnea.

The patients, from Spain, France, Belgium, Germany and the Czech Republic, were all unable to continue using the special masks typically used for patients with obstructive sleep apnea.

At the start of the trial, participants underwent tests to look at their breathing, blood oxygen levels, eye movements, and brain and muscle activity during sleep to establish a baseline.

They were then divided into three groups. Three of them received a daily tablet of sulthiame at one of three doses: 100 mg, 200 mg or 300 mg.

The last group received a placebo as a control.

Participants then underwent the same sleep tests at four weeks and at the end of the 12-week trial to explore the impact of the drug.

Researchers found that people taking the drug had fewer nighttime breathing pauses and higher oxygen levels in their blood while they slept.

The effect seen was stronger at higher doses, with patients taking the 300 mg tablet experiencing a nearly 40% reduction in these breathing pauses, compared with 18% at the lowest dose.

Patients on the treatment also reported feeling more rested in a survey conducted by researchers.

The trial results, which have not yet been peer-reviewed, also found that sulthiame’s side effects, including tingling, fatigue and nausea, were generally mild to moderate among the groups taking the drug.

Professor Hedner said the findings opened the way to a possible treatment for patients who previously had no alternative to standard masks.

“Many people find these machines difficult to use in the long term, so there is a need to find alternative treatments,” he said.

“Although sulthiame is already available as a treatment for childhood epilepsy, we still need to perform a phase III study to confirm the beneficial respiratory effects of this drug in a larger group of patients with OSA (obstructive sleep apnea).”

Professor Sophia Schiza, director of the European Respiratory Society on Sleep Disordered Breathing and an expert in respiratory and sleep medicine at the University of Crete who was not involved in the study, welcomed the findings.

“Many of us know that we or our partner snores. If snoring is accompanied by other symptoms, such as waking up frequently during the night, feeling tired and/or sleepy during the day, it’s time to see a doctor,” she said.

“This is one of the first studies to suggest that drug treatment might help some patients, and the results are promising.

“We need to continue testing sulthiame and other treatments to understand their long-term effects, including possible side effects. For example, we would like to see if the treatment can help lower blood pressure and prevent cardiovascular disease in people with OSA.”

Although estimates vary, charities have said obstructive sleep apnoea affects up to 10 million people in the UK, with men twice as likely to be affected as women.

They add, however, that less than a million of this total are actually diagnosed with the disease.

Although more commonly used in Europe, sulthiame is not routinely used in the NHS as the drug is an unlicensed medicine in the UK.

This means that even if it can be used, doctors who want to prescribe it must go through additional approval processes and it is only deployed where other drugs have failed.

OpenPrescribing, a data source supported by the NHS, shows that sulthiame was prescribed 100 times in England between January and June this year, according to the latest available figures.

The average cost of the drug was just under £260 per packet, or around £4 per tablet.