Sodium Oxybate

Conditions Treated

Sodium oxybate is used to prevent attacks of cataplexy (episodes of muscle weakness that begin suddenly and last for a short time) in patients who have narcolepsy (a sleep disorder that may cause extreme sleepiness, sudden uncontrollable urge to sleep during daily activities, and cataplexy). Sodium oxybate is in a class of medications called central nervous system depressants. The way that sodium oxybate works to treat cataplexy is not known.

Possible Side Effects

What Side Effects Can This Cause?

Sodium oxybate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• bedwetting
• headache
• dizziness
• upset stomach
• vomiting
• diarrhea
• heartburn
• stomach pain
• back pain
• weakness
• difficulty falling asleep or staying asleep
• sweating
• flu-like symptoms
• ringing in the ears
• problems with vision
• painful or irregular menstrual periods
• abnormal sensitivity to touch or sound

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• sleepwalking
• abnormal dreams
• sore throat, fever, chills, and other signs of infection

Sodium oxybate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Usage Instructions

How Should This Medication Be Used

Sodium oxybate comes as a solution (liquid) to mix with water and take by mouth. It is usually taken twice each night because sodium oxybate wears off after a short time and the effects of one dose will not last for the entire night. The first dose is taken at bedtime, and a second dose is taken 2 1/2 to 4 hours after the first dose. Sodium oxybate must be taken on an empty stomach, so the first dose should be taken several hours after the evening meal. Try to allow the same amount of time between your evening meal and your first dose of sodium oxybate every night. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Do not take your bedtime dose of sodium oxybate until you are in bed and are ready to go to sleep for the night. Sodium oxybate begins to work very quickly and you may have an upset stomach or feel dizzy or lightheaded if you take the medication before you go to bed for the night. Place your second dose of sodium oxybate in a safe place near your bed before you go to sleep. Use an alarm clock to be sure that you will wake up in time to take the second dose. If you wake up before the alarm goes off and it has been at least 2 1/2 hours since you took your first dose, take your second dose, turn off the alarm, and go back to sleep. Your doctor will probably start you on a low dose of sodium oxybate and gradually increase your dose, not more often than once every 2 weeks. Sodium oxybate may help to control your symptoms but will not cure your condition. Continue to take sodium oxybate even if you feel well. Do not stop taking sodium oxybate without talking to your doctor. Your doctor will probably want to decrease your dose gradually. If you suddenly stop taking sodium oxybate, you may have more attacks of cataplexy and you may experience anxiety and difficulty falling asleep or staying asleep. To prepare doses of sodium oxybate, follow these steps:

Open the carton that your medicine came in and remove the bottle of medication and the measuring device.

Remove the measuring device from its wrapper.

Open the bottle by pushing down on the cap and turning the cap counterclockwise (to the left) at the same time.

Place the open bottle upright on a table.

Hold the bottle upright with one hand. Use your other hand to place the tip of the measuring device in the center opening on the top of the bottle. Press the tip firmly into the opening.

Hold the bottle and measuring device with one hand. Use your other hand to pull back on the plunger until it is even with the marking that matches the dose your doctor prescribed. Be sure to keep the bottle upright to allow the medication to flow into the measuring device.

Remove the measuring device from the top of the bottle. Place the tip of the measuring device in one of the dosing cups provided with the medication.

Press down on the plunger to empty the medication into the dosing cup.

Add 2 ounces (60 milliliters, 1/4 cup, or about 4 tablespoons) of tap water to the dosing cup. The medication will taste best if you mix it with cold water. Do not mix the medication with fruit juice, soft drinks, or any other liquid.

Repeat steps 5-9 to prepare a dose of sodium oxybate in the second dosing cup.

Place the caps on both dosing cups. Turn each cap clockwise (to the right) until it clicks and locks in place.

Rinse the measuring device with water

Replace the cap on the bottle of sodium oxybate and return the bottle and measuring device to the safe place where they are stored. Place both prepared dosing cups of medication in a safe place near your bed.

When it is time for you to take the first dose of sodium oxybate, press down on the cap and turn it counterclockwise (to the left). Drink all of the liquid while you are sitting on your bed. Put the cap back on the cup, turn it clockwise (to the right) to lock it in place, and lie down right away.

When you wake up 2 1/2 to 4 hours later to take the second dose, repeat step 14.

What Dietary Instructions Should I Follow

Unless your doctor tells you otherwise, continue your normal diet.

Are There Any Special Instructions

Before taking sodium oxybate, tell your doctor and pharmacist if you are allergic to sodium oxybate or any other medications. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention the medications listed in the IMPORTANT WARNING section and levodopa (Larodopa, in Sinemet). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. tell your doctor if you are following a low salt diet for medical reasons and if you have or have ever had succinic semialdehyde dehydrogenase deficiency (an inherited condition in which certain substances build up in the body and cause retardation and developmental delays), heart failure, high blood pressure, or liver or kidney disease. if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking sodium oxybate. you should know that you will be very sleepy for at least 6 hours after you take sodium oxybate, and you may also be drowsy during the daytime. Do not drive a car, operate machinery, or perform any other dangerous activities for at least 6 hours after you take your medication. Avoid dangerous activities at all times until you know how sodium oxybate affects you.