Sodium Oxybate

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, including serious or life-threatening breathing problems. 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: http://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 medication 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.

🔔 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) also 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, place your second dose of sodium oxybate (Xyrem) 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.

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.