Consumer Health Information

www.fda.gov/consumer

Always Tired? You May

Have Sleep Apnea
Y
our 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 thatleft
untreatedcan 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.

CPAP machines, the most common treatment for sleep apnea, use mild air pressure
to keep your airways open.

Obst r uc t ive sleep apnea, t he

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 doesnt send the correct
signals to your breathing muscles.
According to Eric Mann, M.D., Ph.D.,
deputy director of FDAs Division of
Ophthalmic, Neurological, and Ear,
Nose and Throat Devices, you may

1 / FDA Consumer Health Infor mat ion / U. S. Food and Drug Administrat ion

be unaware of these events since

they happen while youre 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,
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Consumer Health Information

www.fda.gov/consumer

You should certainly tell your physician if you think you,

or your child, is experiencing symptoms of sleep apnea...
But the diagnosis of sleep disorders such as obstructive
sleep apnea requires a formal sleep study.
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-FDA1088 or visit MedWatch (http://www.

fda.gov/Safety/MedWatch/default.htm)
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
patients 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 patients 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

2 / FDA Consumer Health Infor mat ion / U. S. Food and Drug Administrat ion

Farkas, M.D., Ph.D., at FDAs 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 apneabut that these
drugs do not treat the nighttime
breathing problem.
Moreover, Farkas recommends that
if youve 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.

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