sodium oxybate

Generic Name: sodium oxybate (SO dee um OX i bate)
Brand Name: Xyrem

What is sodium oxybate?

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.

Sodium oxybate 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, sodium oxybate 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 sodium oxybate for you.

Sodium oxybate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about sodium oxybate?

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

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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 may occur.

What should I discuss with my healthcare provider before taking sodium oxybate?

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 may occur.

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

To make sure sodium oxybate 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 are on a low-salt diet.

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

Sodium oxybate may be habit forming. Never share sodium oxybate 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 sodium oxybate on the Internet or from vendors outside of the United States. The sale and distribution of sodium oxybate outside of the U.S. does not comply with the regulations of the Food and Drug Administration (FDA) for the safe use of this medication.

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

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 sodium oxybate?

Follow all directions on your prescription label. Never take more than your prescribed dose of sodium oxybate. This medication can slow your breathing. If you take too much, your breathing may stop.

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

Sodium oxybate 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 of sodium oxybate 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 sodium oxybate dose that has been mixed with water but not used within 24 hours of mixing.

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

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

Store at room temperature away from moisture and heat. After you have stopped using sodium oxybate, flush any unused medicine down the toilet.

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

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 sodium oxybate can be fatal.

What should I avoid while taking sodium oxybate?

Do not drink alcohol. Dangerous side effects or death may occur. Check your food and medicine labels to be sure these products do not contain alcohol.

Sodium oxybate 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.

Sodium oxybate side effects

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

Stop using sodium oxybate 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 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)

Sodium oxybate dosing information

Usual Adult Dose for Narcolepsy:

Initial: 4.5 grams orally per day, divided into equal 2.25 gram doses, which are administered twice daily, 2.5 to 4 hours apart.

Maintenance: 6 to 9 grams orally each day (in patients with normal hepatic function), administered in 2 equally divided doses, 2.5 to 4 hours apart. Patients with decreased hepatic function may respond to lower maintenance doses, e.g. 4.5 grams per day.

When a higher maintenance dose is necessary, the dose should be increased by increments of 1.5 grams per day (0.75 grams per dose), at intervals no more frequently than once every 2 weeks.

Doses greater than 9 grams per day are not recommended.

Both doses for the day should be prepared at bedtime prior to ingesting any sodium oxybate. This is accomplished by diluting the sodium oxybate oral solution with 2 ounces (60 mL, 1/4 cup, or 4 tablespoonfuls) of water in the child resistant dosing cups. Each prepared dose of medication should be placed in a location that allows the patient to retrieve and administer the drug while remaining seated in bed. The patient may need to use an alarm clock to awaken for the second dose. After receiving each dose, the patient should lie down and remain in bed.

What other drugs will affect sodium oxybate?

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.

Where can I get more information?

  • Your pharmacist can provide more information about sodium oxybate.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 8.02. Revision Date: 2014-01-23, 11:20:58 AM.