FM/CFS/ME RESOURCES - Drug Database - Sodium Oxybate

 

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Drug Database - Sodium Oxybate Xyrem Liquid

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

Brand Names: Xyrem®

Classification: Central Nervous System Depressant

Issue Date: 2000

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.

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, Sodium Oxybate is a Schedule III federally controlled substance.

  • Before Using This Medicine
  • How To Use This Medicine
  • Precautions While on this Medicine
  • Side Effects
  • Overdosage
  • Drug Interactions
  • Divider
    Before Using This Medicine

    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.

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

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

    Sodium oxybate 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 sodium oxybate. 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.

    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, 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

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    How To Use This Medicine

    Sodium oxybate is habit-forming and you can become physically and psychologically dependent on it. Sodium oxybate should be used exactly as your doctor has prescribed it for you. Do not use more of the medication than recommended. Do not take sodium oxybate 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 sodium oxybate on an empty stomach several 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, 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 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.

    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 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 through a special program. Your doctor will explain the risks and benefits of using sodium oxybate, 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 sodium oxybate suddenly or you may have withdrawal effects. Your doctor may recommend a gradual reduction in dose.

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    Precautions While on this Medicine

    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.

    Do not take sodium oxybate if you:

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

    Before taking sodium oxybate, 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 sodium oxybate, or you may require a dosage adjustment or special monitoring during treatment.

    Sodium oxybate 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 sodium oxybate passes into breast milk. Do not take Sodium Oxybate without telling your doctor if you are breast-feeding a baby.

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    Overdosage

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

    Symptoms of a sodium oxybate overdose may include:

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

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    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 sodium oxybate 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.

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    Drug Interactions

    The sedative effects of sodium oxybate 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 sodium oxybate. 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.

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