Central nervous system (CNS) depressant with abuse potential. Should not be used with alcohol or other CNS depressants.
Sodium oxybate is GHB, a known drug of abuse. Abuse has been associated with some important CNS adverse events (including death). Even at recommended doses, use has been associated with confusion, depression and other neuropsychiatric events. Reports of respiratory depression occurred in clinical trials. Almost all of the patients who received sodium oxybate during clinical trials were receiving CNS stimulants; whether this affected respiration during the night is unknown.
Important CNS adverse events associated with abuse GHB include seizure, respiratory depression and profound decreases in level of consciousness, with instances of coma and death. For events that occurred outside of clinical trials, in people taking GHB for recreational purposes, the circumstances surrounding the events are often unclear (eg, dose of GHB taken, the nature and amount of alcohol or any concomitant drugs).
Sodium oxybate is available through the Xyrem Success Program, using a centralized pharmacy 1-866-XYREM88 (1-866-997-3688). The Success Program provides educational materials to the prescriber and the patient explaining the risks and proper use of sodium oxybate, and the required prescription form. Once it is documented that the patient has read and/or understood the materials, the drug will be shipped to the patient. The Xyrem Success Program also recommends patient follow-up every 3 months. Physicians are expected to report all serious events to the manufacturer .
Sodium oxybate is GHB (gamma hydroxybutyrate), a known drug of abuse. Do not use with alcohol or other CNS depressants. Use at recommended doses has been associated with confusion, depression, and other neuropsychiatric events. Reports of respiratory depression occurred in clinical trials. Profound decreases in level of consciousness, with instances of coma and death; respiratory depression; and seizures have been associated with abuse of GHB. Available only through the Xyrem Success Program, call 1-866-XYREM88 .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Central Nervous System Agent
Sodium oxybate is used to treat excessive daytime sleepiness and to reduce the number of cataplexy (weak or paralyzed muscles) attacks in people with narcolepsy. sodium oxybate is a narcotic agent that is used for sedation.
sodium oxybate is available only with your doctor's prescription, and you can only get it from one central pharmacy. Before you use sodium oxybate your doctor should teach you about the safe and effective use of sodium oxybate. You cannot get the medicine until you have read the information the pharmacy will send you about sodium oxybate.
Note: Sodium oxybate is a Schedule III, federally controlled substance. This means that if you sell, distribute, or give your medicine to anyone else, or if you use your sodium oxybate for purposes other than what it was prescribed for, you may be punished under federal and state law by jail and fines. Your sodium oxybate should be used only by you, as prescribed by your doctor.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For sodium oxybate, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to sodium oxybate or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of sodium oxybate in children below 16 years of age. Safety and efficacy have not been established.
Appropriate studies on the relationship of age to the effects of sodium oxybate have not been performed in the geriatric population. However, elderly patients are more likely to have unwanted effects (e.g., clumsiness or memory loss) or age-related liver disease, which may require caution in patients receiving sodium oxybate.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Using sodium oxybate with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of sodium oxybate. Make sure you tell your doctor if you have any other medical problems, especially:
Take sodium oxybate only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
sodium oxybate will come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
Food will decrease the amount of sodium oxybate that is absorbed by your body. It is best to take sodium oxybate at least 2 hours after a meal.
To take sodium oxybate, you must first mix it with 2 ounces (60 mL) of water. Prepare both doses before bedtime. Place the caps provided on the dosing cups and turn each cap so it locks in its child resistant position. Use the oral solution within 24 hours after mixing.
Sodium oxybate causes sleep very quickly. Take it only at bedtime and while in bed. Drink all of the first dose while sitting in bed, recap the cup, and then lie down right away. Right before going to sleep place your second dose in a secure place near your bed. You might need to set an alarm to wake up to take the second dose. When you wake up to take the second dose, remove the cap from the second dosing cup. While sitting in bed, drink all of the second dose right before lying down to continue sleeping. Recap the second cup.
The dose of sodium oxybate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of sodium oxybate. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of sodium oxybate, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Never take two doses of sodium oxybate at the same time. If you have any questions about this, ask your doctor.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Do not throw any unused medicine in the trash. Flush it down the toilet or take it to a community take-back program when available.
It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects. This is especially important for elderly patients who may be more sensitive to the effects of sodium oxybate.
Do not take other medicines unless they have been discussed with your doctor. sodium oxybate will add to the effects of CNS depressants (medicines that make you drowsy or less alert). Check with your doctor or dentist before taking any of the above medicines while you are taking sodium oxybate.
While you are taking sodium oxybate, you should not drink alcohol. The effects of alcohol can increase the chance of dangerous side effects of sodium oxybate.
Other people living in your house should monitor you for the possibility of urinary or fecal incontinence (loss of bladder or bowel control), or sleepwalking. Tell your doctor if these symptoms occur.
Make sure you know how you react to sodium oxybate before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert. Do not drive a car, operate heavy machinery, or perform any activity that is dangerous or requires mental alertness for at least 6 hours after taking sodium oxybate. When you first start taking sodium oxybate, until you know whether it makes you sleepy the next day, use extreme care while driving a car or doing anything else that could be dangerous or needs you to be fully mentally alert.
Do not stop using sodium oxybate suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More Common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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