Sodium Oxybate (Oral Route)

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. Narcolepsy is an uncontrollable desire for sleep or a sudden attack of deep sleep.

This medicine 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 this medicine. You cannot get the medicine until you have read the information the pharmacy will send you about sodium oxybate.

This product is available in the following dosage forms:

• Solution

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 the pediatric population. Safety and efficacy have not been established.

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.

The dose of this medicine 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 this medicine. 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.

• For oral dosage form (solution):
  • For treatment of excessive daytime sleepiness and cataplexy:
    • Adults—2.25 grams (g) given at bedtime and repeated one time during the night. The first dose should be taken at bedtime and the second dose taken 2.5 to 4 hours later. Your doctor may adjust your dose as needed. However, the dose is usually not more than 9 grams per night.
    • Children—Use and dose must be determined by your doctor.

If you miss a dose of this medicine, 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.

If you miss the second dose, skip that dose and do not take any more medicine until the next night. Do not use extra medicine to make up for a missed dose.