xyrem

Xyrem (sodium oxybate) is a central nervous system depressant. It is used to treat cataplexy (sudden loss of muscle strength) and reduce daytime sleepiness in patients with narcolepsy.

Xyrem is also known as GHB, a known street drug of abuse. Because of the potential for abuse and the serious side effects that may occur, Xyrem is available only from a certified pharmacy under a special program called Xyrem Success Program. Your doctor must be registered in the program in order to prescribe this medicine for you.

Important information

Xyrem can slow or stop your breathing, even at regular doses or if you are also taking stimulant medicines.

Do not drink alcohol or take other sleep medicines. Dangerous side effects or death could occur.

Avoid taking other medicines that make you sleepy or slow your breathing. This includes cold or allergy medicine, narcotic pain medicine, sedatives, muscle relaxants, seizure medicine, or medicine for depression, anxiety, or mental illness. Your doctor may need to change your treatment plan if you need to use any of these other medicines. Misuse of Xyrem can cause breathing problems, seizure, loss of consciousness, or death.

Because of the potential for abuse and the serious side effects that may occur, Xyrem is available only from a certified pharmacy. Do not allow anyone else to use your medication.

Before taking this medicine

Do not drink alcohol or take other medicines that make you sleepy or slow your breathing (such as cold medicine, pain medication, muscle relaxants, sleep medication, or medicine for depression or anxiety). Dangerous side effects or death could occur.

Do not give Xyrem to anyone who has a rare metabolic disorder called succinic semialdehyde dehydrogenase deficiency (which can cause mental or physical impairment).

To make sure Xyrem is safe for you, tell your doctor if you have:

• a breathing disorder such as asthma, emphysema, or bronchitis;

• snoring, or sleep apnea (breathing stops during sleep);

• kidney or liver disease;

• heart disease, high blood pressure;

• a history of alcohol or drug abuse;

• a history of depression or suicidal thoughts;

• mental illness such as bipolar disorder or schizophrenia; or

• if you also take divalproex sodium (Depakote).

You may need to be on a low-salt diet while you are using Xyrem, especially if you have high blood pressure, kidney disease, or heart disease.

Xyrem may be habit forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

It is dangerous to try and purchase Xyrem on the Internet or from vendors outside of the United States. The sale and distribution of this medicine outside of the U.S.A. does not comply with the regulations of the Food and Drug Administration (FDA) for the safe use of this medication.

FDA pregnancy category B. Xyrem is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether sodium oxybate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medication to anyone under 18 years old without medical advice.

How should I take Xyrem?

Take Xyrem exactly as prescribed by your doctor. Follow all directions on your prescription label.

Xyrem can slow or stop your breathing, even at regular doses or if you are also taking stimulant medicine. Never use this medicine in larger amounts, or for longer than prescribed.

Xyrem may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Misuse of this medicine can cause breathing problems, seizure, loss of consciousness, or death. Selling or giving away this medicine is against the law.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Do not allow anyone else to use your medication.

Take Xyrem on an empty stomach at least 2 hours after a meal. It is important to take the dose at the same time each night.

Xyrem must be taken at bedtime and again two and a half to four hours later. This medicine works very fast and should be taken while you are sitting in bed ready for sleep. Prepare both doses while you are getting ready for bed. Place the second dose next to your bed so you can take it without getting up. You will most likely need to set an alarm to awaken for the second dose.

Each dose must be mixed with two ounces (one quarter cup) of water in the child-resistant dosing cups provided with the medication. Both doses must be used within the same night. Throw away any dose that has been mixed with water but not used within 24 hours of mixing.

Do not stop using Xyrem suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Your doctor will need to check your progress every 3 months.

If you need surgery, tell the surgeon ahead of time that you are using sodium oxybate.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Xyrem is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover Xyrem liquid. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused liquid medicine down the toilet. Disposal of medicines by flushing is recommended to reduce the danger of accidental overdose causing death. This advice applies to a very small number of medicines only. The FDA, working with the manufacturer, has determined this method to be the most appropriate route of disposal and presents the least risk to human safety.

Xyrem dosing information

Usual Adult Dose for Narcolepsy:

Initial dose: 4.5 grams orally per night administered in two equal, divided doses of 2.25 g at bedtime and 2.25 g administered 2.5 to 4 hours later.
Maintenance dose: Increase the dose by 1.5 g orally per night at weekly intervals (additional 0.75 g at bedtime and 0.75 g administered 2.5 to 4 hours later) to the dose range of 6 g to 9 g per night.
Maximum dose: 9 g orally per night

Uses: Treatment of cataplexy in narcolepsy and excessive daytime sleepiness (EDS) in narcolepsy

What happens if I miss a dose?

Take the missed dose as soon as you remember, but only at bedtime or during your normal sleeping hours. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Xyrem can be fatal.

What should I avoid?

Xyrem will cause drowsiness and can impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine. Wait at least 6 hours or until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Do not take other sleep medicines together with Xyrem.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with sodium oxybate. Check your food and medicine labels to be sure these products do not contain alcohol.

Xyrem side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Xyrem: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Xyrem and call your doctor at once if you have:

• weak or shallow breathing, breathing that stops for short periods of time;

• hallucinations (seeing or hearing things), severe confusion, seizure (convulsions);

• sleepwalking, waking and confused behavior at night;

• depression, agitation, unusual or unpleasant thoughts; or

• suicidal thoughts or actions;

Common Xyrem side effects may include:

• dizziness, tremors;

• bed-wetting;

• nausea, vomiting; or

• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Xyrem?

Avoid taking other medicines that make you sleepy or slow your breathing. This includes cold or allergy medicine, narcotic pain medicine, sedatives, muscle relaxants, seizure medicine, or medicine for depression, anxiety, or mental illness. Your doctor may need to change your treatment plan if you need to use any of these other medicines.

Other drugs may interact with sodium oxybate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.