Drug Database - Xyrem

Generic Name: sodium oxybate (SO-dee-um / OX-i-bate)

Brand Names: Xyrem®

Classification: Central Nervous System Depressant

Issue Date: 2000

Xyrem 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.

Some people already take Xyrem, off label, for fibromyalgia and anecdotal evidence supports its use. Clinical trials have shown that the drug can significantly improve sleep quality and reduce pain in people with this condition. The first 2 Phase III trials have been wrapped up but the findings are not yet released. Jazz Pharmaceuticals submitted a New Drug Application to the FDA in late 2009.

Note: Because of its potential for abuse, Xyrem is a Schedule III federally controlled substance.

It is dangerous to try and purchase Xyrem on the Internet or from vendors outside of the United States. The sale and distribution of Xyrem 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.

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 through a special program. Your doctor will explain the risks and benefits of using Xyrem, and the medication will be delivered to you from a central pharmacy.

Xyrem is habit-forming and you can become physically and psychologically dependent on it. Xyrem should be used exactly as your doctor has prescribed it for you. Do not use more of the medication than recommended. Do not take Xyrem for longer than your doctor has prescribed. Talk with your doctor if you feel that the medication is not working.

Xyrem will cause drowsiness and must be taken while you are in bed. Do not drive, operate machinery, or perform other hazardous activities for at least 6 hours after taking Xyrem. You may still feel sleepy the morning after taking the medication. Use caution when driving or doing anything else that requires you to be alert and awake.

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, so that you will not have to get up to prepare the second dose. 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.

Do not take other medicines that make you sleepy such as:

• alcohol
• cold medicine
• pain medication
• muscle relaxants
• medicine for depression or anxiety

Xyrem is habit-forming and you can become physically and psychologically dependent on it. Xyrem should be used exactly as your doctor has prescribed it for you. Do not use more of the medication than recommended. Do not take Xyrem for longer than your doctor has prescribed. Talk with your doctor if you feel that the medication is not working.

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 several hours after a meal. It is important to take Xyrem 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, so that you will not have to get up to prepare the second dose. 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 Xyrem 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 Xyrem dose that has been mixed with water but not used within 24 hours of mixing.

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 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 through a special program. Your doctor will explain the risks and benefits of using Xyrem, and the medication will be delivered to you from a central pharmacy.

To be sure this medication is helping your condition, your doctor will need to see you on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Do not stop using Xyrem suddenly or you may have withdrawal effects. Your doctor may recommend a gradual reduction in dose.

It is dangerous to try and purchase Xyrem on the Internet or from vendors outside of the United States. The sale and distribution of Xyrem 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.

Do not take Xyrem if you:

• are taking another medication that causes drowsiness
• have the rare metabolic disorder - succinic semialdehyde dehydrogenase deficiency

Before taking Xyrem, tell your doctor if you have:

• liver disease
• heart disease
• high blood pressure
• kidney disease
• history of alcohol or drug abuse
• lung disorder such as asthma, emphysema, or bronchitis
• sleep apnea (breathing stops during sleep)
• depression or suicidal thoughts
• mental illness such as bipolar disorder or schizophrenia

If you have any of the conditions listed above, you may not be able to take Xyrem, or you may require a dosage adjustment or special monitoring during treatment.

Xyrem is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not use this medication without telling your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether Xyrem passes into breast milk. Do not take Sodium Oxybate without telling your doctor if you are breast-feeding a baby.

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a Xyrem overdose may include:

• extreme sleepiness or confusion
• fainting
• vomiting
• sweating
• difficulty breathing
• muscle weakness
• slow heartbeat
• seizure (convulsions)

Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction:

• hives
• difficulty breathing
• swelling of your face, lips, tongue, or throat

STOP using Xyrem and call your doctor at once if you have any of these SERIOUS side effects:

• hallucinations
• severe confusion
• shallow breathing
• sleepwalking
• waking and confused behavior at night

Other, less serious side effects may be more likely to occur. Continue to take sodium oxybate and talk to your doctor if you have:

• agitation or paranoia
• problems with bladder or bowel control
• depression
• nausea, vomiting, loss of appetite
• runny or stuffy nose and sore throat
• numbness or tingling
• tremors (uncontrolled shaking)
• blurred vision

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

The sedative effects of Xyrem can be made worse by also taking other medicines that make you sleepy such as:

• alcohol
• cold medicine
• pain medication
• muscle relaxants
• medicine for depression or anxiety

There may be other drugs that can affect Xyrem. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.