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.
REMS:
FDA approved a REMS for sodium oxybate to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of sodium oxybate and consists of the following: medication guide, elements to assure safe use, and implementation system. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
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.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
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.
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.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
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.
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.
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:
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.
Where should I keep my medicine?
Keep out of reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
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.
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