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Patient Frequently Asked Questions (FAQs)
- What is XYREM®?
- Why do I have to be in bed, ready to go to sleep, while taking my XYREM dose?
- Why do I need to take two nightly doses of XYREM?
- How do I wake up to take the second dose of XYREM?
- What if I miss the second dose?
- Why did my doctor prescribe XYREM for me?
- Who should not take XYREM?
- How long will it take to see a change in my symptoms while taking XYREM?
- What are some of the possible side effects with XYREM?
- What things should I NOT do while taking XYREM?
- Can I take XYREM with food?
- Can I drink alcohol (for example beer, wine, and hard liquor) while taking XYREM?
- Can I take XYREM with other medicines?
- What does it mean that XYREM is a controlled substance?
- What is the difference between Xyrem and illegal GHB?
1. What is XYREM?
XYREM is a medication approved for the treatment of excessive (too much) daytime sleepiness and the treatment of cataplexy (weak or paralyzed muscles), both in patients with narcolepsy. In studies with XYREM, about 80 percent of patients were also taking stimulants (medicines that help keep you alert). ( See BOXED WARNING)
XYREM is approved by the FDA (Food and Drug Administration).
You can get XYREM only by prescription. You must get it through the SDS Pharmacy. Before you first receive XYREM, your doctor or SDS Pharmacy will confirm that you understand how to use the drug safely and effectively.
XYREM is approved for adults. XYREM has not been studied in patients younger than 16 years old. 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?
Patients usually fall asleep in about 15 minutes, although some patients have reported falling asleep more quickly. In some instances sleep may come on very quickly (without first feeling drowsy). You should take each dose of XYREM while in bed.
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 for the treatment of narcolepsy to reduce too much daytime sleepiness and reduce cataplexy (weak or paralyzed muscles) attacks in people with narcolepsy. XYREM taken at night has been proven to help people with narcolepsy to stay awake better during the day and to have fewer cataplexy attacks.
7. Who should not take XYREM?
Do not take XYREM if you are taking sedatives (medicines that calm you down) or sleep medicines (medicines that cause sleepiness). Do not take XYREM if you have a rare condition called succinic semialdehyde dehydrogenase deficiency.
Tell your doctor if you:
- Have or have had depression.
- Have tried to hurt yourself or have thoughts about hurting yourself.
- Have liver problems.
- Have sleep apnea (short periods of not breathing while sleeping).
- Have snoring, breathing, or lung problems.
- Are on a low-salt diet or have high blood pressure, heart failure, or kidney problems.
- Are pregnant or plan to become pregnant.
- Are breast-feeding.
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. What are some of the possible side effects with XYREM?
In clinical trials, the most common side effects with XYREM were:
- Nausea
- Dizziness
- Headache
- Throwing up
- Sleepiness
- Bed-wetting
- Sore throat
In all clinical studies ten percent of patients dropped out of the study early because of side effects. The most common reasons for dropping out were feeling nauseous, feeling dizzy and throwing up. These side effects may get worse at higher doses.
If you experience the following side effects while using XYREM, you should call your doctor immediately:
- Breathing problems. These can include decreased breathing or trouble breathing. They can also include sleep apnea, which means short periods of not breathing while asleep. Patients who already have breathing or lung problems have a higher chance of breathing problems with XYREM.
- Mental health problems. These can include confusion, psychosis (believing, seeing, or hearing things that are not real), abnormal thinking, agitation (being emotionally very disturbed or upset), or depression. They can also include thoughts of killing yourself or an attempt to kill yourself.
- Bed-wetting or sleepwalking. Call your doctor if you experience these side effects. He or she may need to rule out some other illness.
These are not the only possible side effects with XYREM. If you are concerned about any possible side effects with XYREM, talk with your doctor.
You are encouraged to report any side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
To report a medical issue or side effect when taking XYREM, please call Jazz Pharmaceuticals’ Drug Safety & Medical Information toll-free number at 1-800-520-5568.
10. What things should I NOT do while taking XYREM?
For at least 6 hours after you take XYREM, do not:
- Drive a car.
- Operate heavy machines.
- Do anything dangerous.
- Do anything that requires mental alertness until you know how XYREM will affect 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 717 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.
