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Drug Notebook

FDA Alerts

    Abuse Potential
  • A known drug of abuse. (See Misuse and Abuse Potential under Cautions.)
  • Recreational use associated with serious adverse CNS effects, including seizures, respiratory depression, profound decreases in level of consciousness, coma, and death; circumstances surrounding these events (e.g., dose ingested, amount of alcohol or other drugs ingested concomitantly) often unclear.

    Adverse CNS and Respiratory Effects
  • Risk of confusion, depression, and other neuropsychiatric events, even at recommended dosages. (See CNS Effects under Cautions.)
  • Respiratory depression reported in clinical trials. Most patients were receiving a CNS stimulant concomitantly; effect of such concomitant use on nocturnal respiration not known. (See Respiratory Effects under Cautions.)
  • Do not use concomitantly with alcohol or other CNS depressants.

    Restricted Distribution Program
  • Available only through the Xyrem Success Program®.
  • To order sodium oxybate, prescriber must first contact centralized pharmacy (866-997-3688), which will provide prescriber and patient with educational materials explaining the risks and appropriate use of the drug along with details of the program. Once it is documented that the patient has read and/or understood the materials, pharmacy will ship the drug to the patient.
  • Prescriber sees patient at least every 3 months and reports serious adverse effects to the manufacturer.
  • Information to help minimize risk of inadvertent use by others also available through this program.

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sodium oxybate
(SOE dee um OX i bate)

What is this medicine?
SODIUM OXYBATE (SOE dee um OX i bate) is used to treat excessive sleepiness and cataplexy in patients with narcolepsy. Cataplexy causes a sudden muscle weakness due to a strong emotional response. This medicine is not available in retail pharmacies. Your doctor will enroll you in a program that will provide the drug to you.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • confusion
  • fast, irregular heartbeat
  • increased blood pressure, particularly if you already have high blood pressure
  • memory loss
  • seizures
  • sleepwalking
  • tremors or shaking movements
  • urinary incontinence

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • dizziness
  • drowsiness
  • headache
  • increased urination
  • nausea, vomiting or stomach upset
  • unusual dreams

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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How should I use this medicine?
Take this medicine by mouth. Follow the directions on the prescription label. Take this medicine on an empty stomach, at least 30 minutes before or 2 hours after food. Do not take with food. Do not take your medicine more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

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What if I miss a dose?
Skip the missed dose. If it is almost time for your next dose, take only that dose. Allow at least two and one-half hours between each nightly dose. Do not take double or extra doses.

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What may interact with this medicine?
Do not take this medicine with any of the following medications:

  • alcohol
  • barbiturates, like phenobarbital
  • medicines commonly used for anxiety, sedation or insomnia

This medicine may also interact with the following medications:

  • bupropion
  • dronabinol or marijuana
  • medicines for psychosis or severe mood disturbances
  • muscle relaxants
  • other stimulants, although these are commonly used with sodium oxybate
  • prescription pain medicines, including tramadol

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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Who should NOT use this medication?

  • Concomitant therapy with sedative-hypnotic agents.
  • Succinate-semialdehyde dehydrogenase deficiency.

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What should I watch for while using this medicine?
The use of this medicine requires careful supervision. Visit your doctor or health care professional for regular checks on your progress. Do not suddenly stop taking this medicine if you have been taking it for a long time. Withdrawal symptoms may occur. Your doctor or health care professional may need to slowly stop your doses.

This medicine may affect your concentration or function. Let your doctor or health care professional know if you have increased sleepiness or confusion during the day.

This medicine causes sleep very quickly. You should only take this drug at bedtime, while in bed. Do not drive a car, operate heavy machinery or perform any activities that require mental alertness for at least 6 hours after taking this drug. Use extreme care in any such daily activities until you know how this medicine affects you.

Because alcohol may interfere with this medicine and may cause serious side effects, you must avoid alcohol-containing beverages while on this medicine. Do not take this medicine along with sleep medicines or other drugs with strong sedative effects, serious side effects may occur.

This medicine can be dangerous in overdose. If you take more than prescribed or take it by accident, get emergency medical help right away.

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What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:

  • depression, psychosis, or other mood disorders
  • heart disease or high blood pressure
  • if you frequently drink alcohol containing beverages
  • if you have a history of drug or alcohol abuse
  • liver disease
  • lung disease or difficulty breathing
  • seizures
  • succinic semialdehyde dehydrogenase deficiency
  • thoughts of suicide
  • an unusual or allergic reaction to sodium oxybate, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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