Your spouse says your snoring is driving her nuts. You wake up feeling unrested and irritable. These are common signs that you may have obstructive sleep apnea (OSA), a sleep disorder that—left untreated—can take its toll on the body and mind.

Untreated OSA has been linked to high blood pressure, heart attacks, strokes, car accidents, work-related accidents and depression. According to the American Sleep Association, OSA affects more than 12 million Americans.

The Food and Drug Administration ensures the safety and effectiveness of medical devices, including the device most often used by those affected by OSA – the Continuous Positive Airway Pressure machine, commonly known as CPAP – and a new device, the Inspire Upper Airway Stimulation (UAS) System.

What is Sleep Apnea?

The Greek word “apnea” literally means “without breath.” With sleep apnea, your breathing pauses multiple times during sleep. The pauses can last from a few seconds to minutes and can occur more than five times per hour, to as high as 100 times per hour. (Fewer than five times per hour is normal). Sometimes when you start breathing again, you make a loud snort or choking sound.

Obstructive sleep apnea, the most common type, is caused by a blockage of the airway, usually when the soft tissue in the back of the throat collapses. The less common form, central sleep apnea, happens if the area of your brain that controls breathing doesn’t send the correct signals to your breathing muscles.

According to Eric Mann, M.D., Ph.D., deputy director of FDA’s Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices, you may be unaware of these events since they happen while you’re sleeping. Because you partially wake up when your breathing pauses, your sleep is interrupted, and you often feel tired and irritable the next day.

Sleep apnea is almost twice as common in men as it is in women. Other risk factors include:

• being overweight, as extra fat tissue around the neck makes it harder to keep the airway open,
• being over age 40,
• smoking,
• having a family history of sleep apnea, and
• having a nasal obstruction due to a deviated septum, allergies or sinus problem.

Children also get sleep apnea, most commonly between ages 3 and 6. The most common cause is enlarged tonsils and adenoids in the upper airway.

“You should certainly tell your physician if you think you, or your child, is experiencing symptoms of sleep apnea,” Mann says. “But the diagnosis of sleep disorders such as obstructive sleep apnea requires a formal sleep study.”

Polysomnogram (PSG) is the most common sleep study for sleep apnea and often takes place in a sleep center or lab to record brain activity, eye movement, blood pressure and the amount of air that moves in and out of your lungs.

Getting Treatment

The first line of defense can be behavioral. Weight loss may go a long way toward improving OSA. It may also help to stop using alcohol or medicines that make you sleepy, because they can make it harder for you to breathe.

The most common treatment is a CPAP machine. CPAPs use mild air pressure to keep your airways open. The air is delivered through a mask that fits over your nose and mouth, or only your nose.

Consumers may call 1-800-FDA-1088 or visit MedWatch to report any problems they are having with their CPAP.

CPAP is not the only medical device approved for treatment of OSA. On May 1, 2014, FDA approved the first implanted medical device for the treatment of this disorder. The Inspire Upper Airway System (UAS) is intended for consumers with moderate to severe OSA who have specific characteristics (a Body Mass Index under 32 and the absence of complete collapse in the back of the throat) and were not helped by a CPAP device, or could not tolerate the CPAP treatment. The Inspire device is surgically implanted below the collarbone and works with electrical impulses to stimulate the patient’s tongue muscles and keep airways open.

The Inspire UAS consists of an electrical impulse generator, with leads and sensors that stimulate the nerve that controls the tongue and that sense the patient’s breathing.

After the surgical site has healed (about a month), the physician turns the unit on and sets up the pulse generator. Patients may need to undergo one or more sleep studies before the UAS configuration is optimized for use. The patient turns the system on before going to sleep and off upon waking, using a remote control.

There are no drugs that are approved by the FDA to treat sleep apnea. Ronald Farkas, M.D., Ph.D., at FDA’s Center for Drug Evaluation and Research, says that doctors sometimes prescribe drugs that promote wakefulness such as Provigil and Nuvigil for patients suffering from the daytime sleepiness caused by sleep apnea—but that these drugs do not treat the nighttime breathing problem.

Moreover, Farkas recommends that if you’ve been diagnosed with sleep apnea and are taking other medications, you should let your doctor know what those medications are. “A number of drugs can actually make sleep apnea worse, including many for insomnia, anxiety or severe pain,” he says. [TLS]