History of XYREM | What is XYREM? | Patient FAQs | Common Side Effects | Safety Information

Patient Frequently Asked Questions (FAQs)

1. What is XYREM^®?
2. Why do I have to be in bed, ready to go to sleep, while taking my XYREM dose?
3. Why do I need to take two nightly doses of XYREM?
4. How do I wake up to take the second dose of XYREM?
5. What if I miss the second dose?
6. Why did my doctor prescribe XYREM for me?
7. Who should not take XYREM?
8. How long will it take to see a change in my symptoms while taking XYREM?
9. Possible side effects with XYREM
10. What things should I NOT do while taking XYREM?
11. Can I take XYREM with food?
12. Can I drink alcohol (for example beer, wine, and hard liquor) while taking XYREM?
13. Can I take XYREM with other medicines?
14. What does it mean that XYREM is a controlled substance?
15. What is the difference between Xyrem and illegal GHB?

1. What is XYREM?

Xyrem is a prescription medicine used to treat the following symptoms in people who fall asleep frequently during the day, often at unexpected times (narcolepsy):

• suddenly weak or paralyzed muscles when they feel strong emotions (cataplexy)
• excessive daytime sleepiness (EDS) in people who have narcolepsy

Xyrem may only be given to patients enrolled in the Xyrem Success Program. Before you receive XYREM your doctor or pharmacist will make sure that you understand how to use XYREM safely and effectively. If you have any questions about XYREM, ask your doctor or call the Xyrem Success Program^® at 1-866-997-3688.

XYREM is approved in adults. It is not known if it is safe and effective in children. It is very important to keep XYREM out of reach of children and pets.

2. Why do I have to be in bed, ready to go to sleep, while taking my XYREM dose?

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.

3. Why do I need to take two nightly doses of XYREM?

XYREM leaves your body quickly. Therefore, you should take both doses each night. Do this exactly as your doctor tells you to.
Never take both XYREM doses at once. This could cause additional side effects or safety issues.

4. How do I wake up to take the second dose of XYREM?

Take your second dose of XYREM between 2½ and 4 hours after the first dose. Take the first dose at bedtime, while you are in bed. Set an alarm clock (one is provided to you by SDS pharmacy) to wake yourself for your second nightly dose.
Because XYREM is short acting, you might wake up before the alarm goes off. If this happens, take your second dose while in bed and between 2½ and 4 hours after the first dose.

5. What if I miss the second dose?

It is very important that you take both doses each night, exactly as your doctor has prescribed. However, if you miss the second dose, skip that dose and do not take XYREM again until the next night. Never take both XYREM doses at once.

6. Why did my doctor prescribe XYREM for me?

XYREM is a prescription medicine used to treat the following symptoms in people who fall asleep frequently during the day, often at unexpected times (narcolepsy): suddenly weak or paralyzed muscles when they feel strong emotions (cataplexy) or excessive daytime sleepiness (EDS) in people who have narcolepsy.

Patients can only have their Xyrem^® prescriptions filled through the Xyrem Success Program^®.

7. Who should not take 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 is a kind of GHB. GHB has been abused and misused (used illegally and not for medical reasons). Abuse and misuse of Xyrem can cause serious medical problems, including seizures, trouble breathing, changes in alertness, coma and death.
• Do not drive a car, use heavy machinery, fly an airplane, or do anything that is dangerous or that requires you to be fully awake for at least 6 hours after you take Xyrem. You should not do those activities until you know how Xyrem affects you.
• Xyrem is available only by prescription and filled through the central pharmacy in the Xyrem Success Program. Before you receive Xyrem, your doctor or pharmacist will make sure that you understand how to use Xyrem safely and effectively. If you have any questions about Xyrem, ask your doctor or call the Xyrem Success Program^® at 1-866-997-3688
• It is not known if Xyrem is safe and effective in children.
• Xyrem is a controlled substance (CIII) because it contains sodium oxybate that can be a target for people who abuse prescription medicines or street drugs. Keep your Xyrem in a safe place to protect it from theft. Never give your Xyrem to anyone else because it may cause death or harm them. Selling or giving away this medicine is against the law.
• Do not take Xyrem if you take other sleep medicines or sedatives (medicines can cause sleepiness), drink alcohol, or have a rare problem called succinic semialdehyde dehydrogenase deficiency.

Before you take Xyrem, tell your doctor if you:

• have short periods of not breathing while you sleep (sleep apnea).
• snore, have trouble breathing, or have lung problems. You may have a higher chance of having serious breathing problems when you take Xyrem.
• have or had depression or have tried to harm yourself. You should be watched carefully for new symptoms of depression.
• have liver problems.
• are on a salt-restricted diet. Xyrem contains a lot of sodium (salt) and may not be right for you.
• have high blood pressure, heart failure, or kidney problems.
• are pregnant or plan to become pregnant. It is not known if Xyrem can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Xyrem passes into your breast milk. You and your doctor should decide if you will take Xyrem of breastfeed.

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.

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 doctos 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.

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, and 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.

8. 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.

9. 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.

10. What things should I NOT do while taking XYREM?

Do not drive a car, use heavy machinery, fly an airplane, or do anything that is dangerous or that requires you to be fully awake for at least 6 hours after you take Xyrem. You should not do those activities until you know how Xyrem affects you.

11. Can I take XYREM with food?

No. Food will cause your body to take in XYREM more slowly. It is very important to wait at least 2 hours after eating before taking your first dose. It is best to eat your evening meal at about the same time each day before taking your first nightly XYREM dose.

12. Can I drink alcohol (for example beer, wine, and hard liquor) while taking XYREM?

No. Combining them can result in very severe sleepiness and trouble breathing.

13. Can I take XYREM with other medicines?

Do not take XYREM with other medicines that help you sleep or cause drowsiness. Taking XYREM with these medicines can result in very severe sleepiness and trouble breathing.
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 and pharmacist about all your other medicines. This includes medicines and vitamins you get without a prescription. It also includes herbal, nutritional, or dietary supplements.

Make sure to tell all of your doctors that you are taking XYREM. Do this before you start or change any medicines.

14. What does it mean that XYREM is a controlled substance?

The FDA determines which medicines are controlled substances. These are medicines that may lead to physical or psychological dependence (emotional need to take the drugs) if you abuse them. XYREM is a Schedule III drug — which means that it has a moderate likelihood of causing dependence. Do not sell, distribute, or give your XYREM to anyone else. Do not use your XYREM for any other purpose than what it was prescribed for. If you do so, you may be punished under federal and state law by jail and fines.
Remember, your XYREM must be:

• Used only by you.
• Used only as directed by your doctor.
• Stored in a safe and secure place and at room temperature.

15. What is the difference between Xyrem and illegal GHB?

While XYREM is sodium oxybate, a form of GHB, there can be important differences between XYREM and illegal GHB. XYREM is approved by the FDA. It has been carefully studied in clinical trials in 781 people with narcolepsy. XYREM is manufactured under strictly controlled conditions. The content and strength of XYREM are regulated by the FDA. Because XYREM has a known concentration, an appropriate dose can be determined for you by your doctor. By contrast, illegal GHB is made under uncontrolled conditions and can contain chemicals whose content, strength, and harmfulness are unknown. GHB occurs naturally in the body at very low levels, most often in the brain and spine.