Sodium Oxybate

IMPORTANT WARNING:

Sodium oxybate is another name for GHB, a substance that is often illegally sold and abused, especially by young adults in social settings such as nightclubs. Tell your doctor if you use or have ever used street drugs, or if you have overused prescription medications. Sodium oxybate may be harmful when taken by people other than the person for whom it was prescribed. Do not sell or give your sodium oxybate to anyone else; selling or sharing it is against the law. Store sodium oxybate in a safe place, such as a locked cabinet or box, so that no one else can take it accidentally or on purpose. Keep track of how much liquid is left in your bottle so you will know if any is missing.

Sodium oxybate may be habit forming. If you take too much sodium oxybate, you may experience life-threatening symptoms including seizures, slowed or stopped breathing, loss of consciousness, and coma. You may also develop a craving for sodium oxybate, feel a need to take larger and larger doses, or want to continue taking sodium oxybate even though it causes unpleasant symptoms. If you have taken sodium oxybate in amounts larger than prescribed by your doctor, and you suddenly stop taking it, you may experience withdrawal symptoms such as difficulty falling asleep or staying asleep, restlessness, anxiety, abnormal thinking, loss of contact with reality, sleepiness, upset stomach, shaking of a part of your body that you cannot control, sweating, muscle cramps, and fast heartbeat.

Some medications should not be taken with sodium oxybate. Make sure you have discussed any medications you are currently taking or plan to take before starting sodium oxybate with your doctor and pharmacist. Be sure to mention if you take sleeping pills. Before starting, stopping, or changing any medications while taking sodium oxybate, please get the advice of your doctor or pharmacist. Do not drink alcoholic beverages while you are taking sodium oxybate.

Sodium oxybate is not available at retail pharmacies. Sodium oxybate is available only through a restricted distribution program called the Xywav^® and Xyrem^® REMS Program or the Lumryz^® REMS Program. These are special programs to distribute the medication and provide information about the medication. Your medication will be mailed to you from a central pharmacy after you have read the information and talked to a pharmacist. Ask your doctor if you have any questions about how you will receive your medication.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with sodium oxybate and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also obtain the Medication Guide from the FDA website: https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

Keep all appointments with your doctor.

Talk to your doctor about the risks of taking sodium oxybate.

WHY is this medicine prescribed?

Sodium oxybate is used to prevent attacks of cataplexy (episodes of muscle weakness that begin suddenly and last for a short time) and excessive daytime sleepiness in adults and children 7 years of age and older 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. Sodium oxybate works to treat narcolepsy and cataplexy by reducing activity in the brain.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Sodium oxybate (Xyrem^®) comes as an immediate-release solution (liquid) to mix with water and take by mouth. Sodium oxybate (Lumryz^®) comes as an extended-release (long-acting) powder for oral suspension to be mixed with water and take by mouth. Sodium oxybate (Xyrem^®) immediate-release oral solution 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 the second dose is taken 2 1/2 to 4 hours after the first dose. Sodium oxybate (Lumryz^®) extended-release powder for oral suspension is usually taken once daily at bedtime. Sodium oxybate must be taken on an empty stomach, so the first dose should be taken at least 2 hours after eating. 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(s) of sodium oxybate until you or your child are in bed and are ready to go to sleep for the night. Sodium oxybate begins to work very quickly, within 5 to 15 minutes after taking it.

If you are taking the oral solution (Xyrem^®), place your second dose in a safe place near your bed (or in an safe place to give to your child) before sleep. Use an alarm clock to be sure that you will wake up in time to take the second dose. If you or your child 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 week.

Sodium oxybate may be habit forming. Do not take more of it or take it more often than prescribed by your doctor.

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.

If you are taking the immediate-release oral solution, you will need to split the dose that your doctor prescribed into 2 different dosing containers. Using a dosing syringe, remove the prescribed amount of the first dose from the prescription bottle and place in one of the dosing containers. Add 1/4 cup (or 4 tablespoonsful or 60 milliliters) of tap water to the container. Repeat this procedure to prepare a dose of sodium oxybate in the 2nd container. Carefully read the manufacturer's instructions that describe how to mix and take a dose of sodium oxybate immediate-release solution. Be sure to ask your pharmacist or doctor if you have any questions about how to mix or take this medication.

If you are taking the extended-release powder for oral suspension, you will need to mix the medication powder with cool or room temperature water right before you take it. Do not mix the powder with any other liquid or food, except for water. Make sure that you take your dose of sodium oxybate extended-release suspension within 30 minutes of mixing it with water. The doctor will tell you how much water to mix the powder with and how to take a dose of sodium oxybate extended-release suspension. Carefully read the manufacturer's instructions that describe how to mix and take a dose of sodium oxybate extended-release suspension. Be sure to ask your pharmacist or doctor if you have any questions about how to mix or take this medication.

What SPECIAL PRECAUTIONS should I follow?

Before taking sodium oxybate,

• tell your doctor and pharmacist if you are allergic to sodium oxybate, any other medications, or any of the ingredients in the sodium oxybate solution or suspension. Ask your pharmacist or check the medication guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or ever had succinic semialdehyde dehydrogenase deficiency (an inherited condition in which certain substances build up in the body and cause retardation and developmental delays). Your doctor will probably tell you not to take sodium oxybate.

• tell your doctor if you are following a low salt diet for medical reasons. Also tell your doctor if you snore; if you have ever thought about harming or killing yourself or planned or tried to do so; and if you have or have ever had lung disease, difficulty breathing, sleep apnea (a sleep disorder that causes breathing to stop for short periods during sleep), seizures, depression or other mental illness, heart failure, high blood pressure, or liver or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking sodium oxybate, call your doctor.

• 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, fly an airplane, 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.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

If you miss the second dose of sodium oxybate immediate-release solution, skip the missed dose and continue your regular dosing schedule on the next night. Do not take a double dose to make up for a missed one. Always allow at least 2 1/2 hours between doses of sodium oxybate.

If you miss a dose of sodium oxybate extended-release oral suspension, skip the missed dose and continue your regular dosing schedule.

What SIDE EFFECTS can this medicine 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
• feeling drunk
• shaking of a part of your body that you cannot control
• feelings of numbness, tingling, pricking, burning, or creeping on the skin
• difficulty moving when sleeping or upon waking
• nausea
• vomiting
• diarrhea
• stomach pain
• back pain
• weakness
• swelling of the arms, hands, feet, ankles, or lower legs
• sweating

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 or get emergency medical treatment:

• sleepwalking
• abnormal dreams
• agitation
• aggression
• anxiety
• depression
• feeling unusually suspicious of others
• difficulty concentrating
• confusion or memory problems
• changes in weight or appetite
• feelings of guilt
• thoughts of harming or killing yourself
• feeling that others want to harm you
• hallucinations (seeing things or hearing voices that do not exist)
• loss of contact with reality
• breathing problems, snoring, or sleep apnea
• excessive drowsiness during the day

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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep sodium oxybate (Xyrem^®) in the container it came in, tightly closed, and out of reach of children and pets. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Pour any remaining medication down the sink if it is more than 24 hours after preparation. Cross out the label on the bottle with a marker and dispose of the empty bottle in the trash. Ask your doctor or call the central pharmacy if you have questions about the proper disposal of your medication if it is outdated or no longer needed.

Keep sodium oxybate (Lumryz^®) in the container it came in, tightly closed, and out of reach of children and pets. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Pour any remaining medication down the sink if it is more than 30 minutes after preparation. Ask your doctor or call the central pharmacy if you have questions about the proper disposal of your medication if it is outdated or no longer needed.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

What should I do in case of OVERDOSE?

Symptoms of overdose may include the following:

• confusion
• problems with coordination
• agitation
• loss of consciousness
• coma
• slow, shallow, or interrupted breathing
• loss of bladder control
• loss of bowel control
• vomiting
• sweating
• headache
• blurred vision
• muscle jerks or twitches
• seizure
• slow heartbeat
• low body temperature
• weak muscles

What OTHER INFORMATION should I know?

Ask your doctor or call the central pharmacy if you have any questions about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.