Proper Use

Drug information provided by: Merative, Micromedex®

Take this medicine 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. If too much is taken, it may become habit-forming. If you think this medicine is not working properly after you have taken it for several weeks, check with your doctor first and do not increase the dose.

It is very important that you understand the requirements of the Xyrem® and Lumryz™ REMS program, and become familiar with the Xyrem® Medication Guide and patient instructions. Ask your doctor if you have any questions.

Sodium oxybate oral solution is divided into 2 nightly doses.

Take this medicine at least 2 hours after you eat.

This medicine can make you sleep very quickly (within 5 to 15 minutes) without feeling drowsy. It is best to take the medicine only at bedtime or when you are ready to fall asleep.

To use the solution: You must first mix each dose with 2 ounces (60 milliliters [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 liquid within 24 hours after mixing.

To use the extended-release suspension (packet):

  • Open the mixing cup and fill it with water up to fill line A. Put the mixing cup down on a flat surface.
  • Use scissors to cut the packet open along the cutting line or tear the packet open with your hands.
  • Empty the entire contents of a packet into the mixing cup. Shake the mixture well for at least 60 seconds. The mixture will look slightly milky with some lumps.
  • Drink the mixture within 30 minutes of mixing while sitting in bed.
  • If some medicine remains in the cup, add more water up to fill line B, shake for 10 seconds, and drink immediately.
  • Leave the mixing cup at your bedside and lie down immediately to go to sleep.

Take this medicine 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.

Dosing

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 treatment of excessive daytime sleepiness and cataplexy:
    • For oral dosage form (solution):
      • Adults—At first, 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 g per night.
      • Children 7 years of age and older—Dose is based on body weight and must be determined by your doctor:
        • Weighing 45 kilograms (kg) or more—At first, 2.25 grams (g) or less 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 and tolerated. However, the dose is usually not more than 4.5 g per night.
        • Weighing 30 to less than 45 kg—At first, 1.5 g or less 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 3.75 g per night.
        • Weighing 20 to less than 30 kg—At first, 1.0 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 3 g per night.
      • Children younger than 7 years of age or weighing less than 20 kilograms (kg)—Use and dose must be determined by your doctor.
    • For oral dosage form (extended-release suspension):
      • Adults—At first, 4.5 grams (g) given once at bedtime. Your doctor may adjust your dose as needed. However, the dose is usually not more than 9 g per night.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

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.

Storage

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Pour any unused medicine down the sink drain. Use a marker to cross out the label on the bottle, then throw it in the trash.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm