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Sodium Oxybate
Specialty Drug

Xyrem

SODIUM OXYBATE is used to treat excessive sleepiness and cataplexy in patients with narcolepsy. Cataplexy causes a sudden muscle weakness due to a strong emotional response. This medicine is not available in retail pharmacies. Your doctor will enroll you in a program that will provide the drug to you. Compare central nervous system depressants.
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Sodium Oxybate Side Effects

What should I watch for?

The use of this medicine requires careful supervision. Visit your doctor or health care professional for regular checks on your progress. Do not suddenly stop taking this medicine if you have been taking it for a long time. Withdrawal symptoms may occur. Your doctor or health care professional may need to slowly stop your doses.

This medicine may affect your concentration or function. Let your doctor or health care professional know if you have increased sleepiness or confusion during the day.

This medicine causes sleep very quickly. You should only take your first dose at bedtime, while in bed. The second dose should be taken 2.5 to 4 hours after your first dose. Do not drive a car, operate heavy machinery or perform any activities that require mental alertness for at least 6 hours after taking this drug. Use extreme care in any such daily activities until you know how this medicine affects you.

Because alcohol may interfere with this medicine and may cause serious side effects, you must avoid alcohol-containing beverages while on this medicine. Do not take this medicine along with sleep medicines or other drugs with strong sedative effects, serious side effects may occur.

This medicine can be dangerous in overdose. If you take more than prescribed or take it by accident, get emergency medical help right away.

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Common and Rare Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Bloating or swelling of the face, arms, hands, lower legs, or feet

rapid weight gain

tingling of the hands or feet

unusual weight gain or loss

Incidence not known

Anxiety

blurred vision

chest pain or discomfort

decrease in the amount of urine

dizziness

fast or pounding heartbeat

fever

headache

hives, itching, or rash

hoarseness

irritation

joint pain, stiffness, or swelling

noisy, rattling breathing

pounding in the ears

redness of the skin

slow heartbeat

sweating

tightness in the chest

troubled breathing at rest

troubled breathing or swallowing

weight gain

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Alternating periods of shallow and deep breathing

bluish lips or skin, not breathing

clumsiness

coma

confusional, agitated combative state

consciousness, depressed

convulsions

drowsiness

generalized slowing of mental and physical activity

inability to hold bowel movement or urine

increased sweating

lightheadedness, dizziness, or fainting

muscle aches or weakness

shakiness and unsteady walk

shivering

sleepiness

slow or irregular heartbeat

trembling or other problems with muscle control or coordination

unusual tiredness or weakness

vomiting

weak or feeble pulse

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

confusion about identity, place, and time

diarrhea

feeling drunk

irritability

upper abdominal or stomach pain

Incidence not known

Being forgetful

decreased appetite

difficulty with moving

muscle pain or stiffness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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