An anxiolytic - It is used to treat excessive sleepiness and cataplexy in patients with narcolepsy
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.
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.
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