Full Prescribing Information Important Safety Information Medication Guide

How Should I Take XYREM®?

Read the Instructions for Use in the Medication Guide for detailed instructions on how to take Xyrem.

  • Take Xyrem exactly as your doctor tells you to take it.
  • Never change your Xyrem dose without talking to your doctor.
  • Xyrem can cause sleep very quickly. You should fall asleep soon. Some patients fall asleep within 5 minutes and most fall asleep within 15 minutes. Some patients take less time to fall asleep and some take more time. The time it takes you to fall asleep might be different from night to night.
  • Take your first Xyrem dose at bedtime while you are in bed. Take your second Xyrem dose 2 ½ to 4 hours after you take your first Xyrem dose. You may want to set an alarm clock to make sure you wake up to take your second Xyrem dose.
  • If you miss your second Xyrem dose, skip that dose and do not take Xyrem again until the next night. Never take 2 Xyrem doses at 1 time.
  • Wait at least 2 hours after eating before you take Xyrem.
  • You should see your doctor every 3 months for a check-up while taking Xyrem. Your doctor should check to see if Xyrem is helping to lessen your symptoms and if you feel any side effects while you take Xyrem.

If you take too much Xyrem, call your doctor or go to the nearest hospital emergency room right away.

How do I prepare my XYREM doses?

Figure A

Step 1. Take the Xyrem bottle, press-in-bottle adaptor, and syringe out of the box.
Step 2. Remove the bottle cap from the Xyrem bottle by pushing down while turning the cap counterclockwise (to the left). See Figure B.

Figure B

Step 3.

  • The press-in-bottle adaptor may already be put in place by the pharmacy. If it is not already in place, you will have to do it yourself. After removing the cap from the Xyrem bottle, set the bottle upright on a tabletop.
  • While holding the Xyrem bottle in its upright position, insert the press-in-bottle-adaptor into the neck of the Xyrem bottle. See Figure C.

Figure C

  • Tilt the straw toward the edge of the bottom of the bottle to be sure you can draw out your dose of the medicine. You only need to do this the first time you open the bottle. See Figure D.

Figure D

  • After you draw out your dose of the medicine, leave the adaptor in the bottle for all your future uses. See Figure E.

Figure E

Step 4.

  • Take the syringe out of the plastic wrapper. Use only the syringe provided with your Xyrem prescription.
  • While holding the Xyrem bottle upright on the tabletop, insert the tip of the syringe into the opening on top of the Xyrem bottle and press down firmly. See Figure F.

Figure F

Step 5.

  • Hold the bottle and syringe down with one hand, and draw up one-half (1/2) of your total prescribed nightly dose with the other hand by pulling up on the plunger. For example, if your total nightly dose of Xyrem is 4.5 grams a night, you will need to draw up 2 separate doses of 2.25 grams each, one for each pharmacy container. See Figure G.

Note: The Xyrem medicine will not flow into the syringe unless you keep the bottle upright.

Figure G

Step 6.

  • After you draw up each separate Xyrem dose, remove the syringe from the opening of the Xyrem bottle. Put the tip into 1 of the empty containers with child-resistant caps provided by the pharmacy.
  • Make sure the pharmacy container is empty and does not contain any medicine from your previous night’s dose.
    • Empty each separate Xyrem dose into 1 of the empty pharmacy containers by pushing down on the plunger. (See Figure H).
  • Using a measuring cup, pour about ¼ cup of water into each container. Be careful to add only water to each container and not more Xyrem. All shipped bottles of Xyrem contain the concentrated medicine. Water for mixing the medicine is not provided in the shipment.

Figure H

Step 7.

  • Place the child-resistant caps provided on the filled pharmacy containers and turn each cap clockwise (to the right) until it clicks and locks into its child-resistant position. See Figure I.

Figure I

  • Put the cap back on the Xyrem bottle and store it in a safe and secure place. Store in a locked place if needed. Keep Xyrem out of the reach of children and pets.
  • Rinse the syringe out with water and squirt the liquid into the sink drain.

Step 8.

  • At bedtime, and before you take your first Xyrem dose, put your second Xyrem dose in a safe place near your bed.
  • You may want to set an alarm clock to make sure you wake up to take the second dose.
  • When it is time to take your first Xyrem dose, remove the cap from the container by pressing down on the child-resistant locking tab and turning the cap counterclockwise (to the left).
  • Drink all of your first Xyrem dose at bedtime. Put the cap back on the first container before lying down to sleep.
  • You should fall asleep soon. Some patients fall asleep within 5 minutes and most fall asleep within 15 minutes. Some patients take less time to fall asleep, and some take more time. The time it takes you to fall asleep might be different from night to night.

Step 9.

  • When you wake up 2½ to 4 hours later, take the cap off the second pharmacy container.
  • If you wake up before the alarm and it has been at least 2½ hours since your first Xyrem dose, turn off your alarm and take your second Xyrem dose.
  • While sitting in bed, drink all of the second Xyrem dose and put the cap back on the second pharmacy container before lying down to continue sleeping.

What if I miss or skip the second dose?

If you miss your second XYREM dose, skip that dose and do not take XYREM again until the next night. Never take 2 XYREM doses at 1 time.

Can I mix XYREM with liquids other than water?

XYREM has only been studied when it’s mixed with water.

Do I need to mix my XYREM with more water if my dose increases?

2 oz. or approximately ¼ cup of water is enough to add to each XYREM dose. This is true even if your XYREM dose is raised.

How long will it take to see a change in my symptoms while taking XYREM?

Your symptoms may improve in the first few weeks after you start XYREM. However, it may take longer to find the dose that is right for you.

Is XYREM available in a pill or capsule?

XYREM only comes in liquid form. There is no pill or capsule form of XYREM.

Will I be able to wake up in an emergency?

Speak to your Doctor about starting Xyrem therapy. Discuss how you can safely evaluate your response to Xyrem.

Possible side effects with XYREM

Xyrem can cause serious side effects, including slow breathing or changes in your alertness. Do not drink alcohol or take medicines intended to make you fall asleep while you are taking Xyrem because they can make these side effects worse. Call your doctor right away if you have any of these serious side effects.

Xyrem can cause serious side effects, including:

  • Breathing problems, including:

    • slower breathing
    • trouble breathing
    • short periods of not breathing while sleeping (sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they use Xyrem.
  • Mental health problems, including:
    • confusion
    • seeing or hearing things that are not real (hallucinations)
    • unusual or disturbing thoughts (abnormal thinking)
    • feeling anxious or upset
    • depression
    • thoughts of killing yourself or trying to kill yourself

    Call your doctor right away if you have symptoms of mental health problems.

  • Sleepwalking. Sleepwalking can cause injuries. Call your doctor if you start sleepwalking. Your doctor should check you.

The most common side effects of XYREM include:

  • nausea
  • dizziness
  • vomiting
  • bedwetting
  • diarrhea

Your side effects may increase when you take higher doses of XYREM.
Xyrem can cause physical dependence and craving for the medicine when it is not taken as directed.

These are not all the possible side effects of XYREM. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In all clinical studies, 10.3% of patients dropped out because of side effects compared with 2.8% of patients taking placebo. The most common side effect leading to drop out was nausea (2.8%). The majority of side effects leading to drop out began during the first few weeks of treatment.

Can I take XYREM with other medicines?

Do not take Xyrem if you take other sleep medicines or sedatives (medicines that cause sleepiness), drink alcohol, or have a rare problem called succinic semialdehyde dehydrogenase deficiency.

Do not start or stop any medicine unless you check with your doctor first. Check with your doctor before you change the dose of any medicine.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially, tell your doctor if you take other medicines to help you sleep (sedatives). Do not take medicines that make you sleepy with Xyrem.

To reach the pharmacy by phone please call:

 1-866-997-3688

To report a side effect
please call:

 1-800-520-5568


Jake S - Mentor

Talk with a XYREM Patient Connection Mentor

The XYREM Patient Connection program provides an opportunity for you to talk one-on-one with a mentor who has been diagnosed with excessive daytime sleepiness and/or cataplexy with narcolepsy, and has been treated with XYREM.

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