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 cause serious side effects. Tell your doctor if you take antidepressants; medications for anxiety, mental illness, or seizures; muscle relaxants; sedatives; sleeping pills; or tranquilizers. You doctor will probably tell you not to take sodium oxybate while you are taking these medications. 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 Xyrem REMS Program. It is a special program 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: Web Site.
Keep all appointments with your doctor. You should see your doctor at least every 3 months.
Talk to your doctor about the risks of taking sodium oxybate.
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. The way that sodium oxybate works to treat narcolepsy is not known.
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 the 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 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 doses 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. Place your second dose of sodium oxybate 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. 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.
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:
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking sodium oxybate,
Unless your doctor tells you otherwise, continue your normal diet.
If you miss the first dose of sodium oxybate, you may take a dose when the second dose is scheduled; do not take a second dose of sodium oxybate that night. If you miss the second dose, 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.
Sodium oxybate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
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:
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 ( Web Site ) or by phone (1-800-332-1088).
Keep this medication 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. 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.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. Web Site
Symptoms of overdose may include the following:
Ask your doctor or call the central pharmacy if you have any questions about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: December 15, 2018.