We're here to help.
We welcome your
inquiries.
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 much time do I need between the two nightly doses? How will 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 for me to feel the effects of XYREM?
- What are the most common side effects?
- Are there activities I should avoid while taking XYREM?
- May I take XYREM with food?
- What about interactions with other medications?
1. What is XYREM?
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. 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.[1]
Important Safety Information[1][2]
- XYREM is a controlled substance. Controlled substances are medicines that, if abused, may lead to varying degrees of physical or psychological dependence. XYREM is a Schedule III drug - which means that it has a moderate risk of dependence. If you sell, distribute, or give your XYREM to anyone else or use it for purposes other than what it was prescribed for, you may be punished under federal and state law by jail and fines.
- It is very important to keep XYREM out of reach of children and pets.
- XYREM can cause serious side effects including trouble breathing while asleep, confusion, abnormal thinking, depression and loss of consciousness. Tell your doctor if you have any of these problems while taking XYREM.
- The active ingredient of XYREM is a form of gamma-hydroxybutyrate (GHB). GHB is a chemical that have been abused and misused. Abuse and misuse of XYREM can cause serious medical problems, including seizures, loss of consciousness, coma, and death. Abuse of XYREM can lead to dependence, which may include craving for the medicine and severe withdrawal symptoms.
2. Why do I have to be in bed, ready to go to sleep, while taking my XYREM dose?[2]
XYREM is a medicine that produces sleepiness; therefore, as a safety precaution, it is best to be in bed when you take your first dose. As with any medicine that causes sleepiness, if you continue evening activities after taking your dose, such as watching television or walking around, you may experience light-headedness, dizziness, nausea, confusion or other unpleasant feelings.
3. Why do I need to take two nightly doses of XYREM?[2]
XYREM is cleared from your body very quickly, so it is important to take both doses each night, exactly as prescribed by your doctor. Never take both XYREM doses at once. This could result in side effects or safety issues.
4. How much time do I need between the two nightly doses? How will I wake up to take the second dose of XYREM?[2]
You must leave a minimum of 2½ hours and a maximum of 4 hours between XYREM doses. Set an alarm clock to wake yourself for your second nightly dose. Take your first nightly dose immediately before sleeping, while in bed. XYREM is short-acting so it should be relatively easy to wake up when you hear the alarm. If you wake before the alarm, you can take your second dose as long as it is at least 2½ to 4 hours after your first dose.
5. What if I miss the second dose?[2]
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?[1]
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?[1]
Do not take XYREM if you:
- Take other sleep medications or sedatives (medicines that cause sleepiness).
- Have a rare condition called succinic semialdehyde dehydrogenase deficiency.
Tell your doctor if you:
- Have or had depression or tried to harm yourself.
- Have liver problems.
- Have sleep apnea, snoring, breathing, or lung problems.
- Are on a salt-restricted diet, have high blood pressure, heart failure, or kidney problems.
- Are pregnant or plan to become pregnant.
- Are breastfeeding.
8. How long will it take for me to feel the effects of XYREM?[1][2]
Most patients can expect to see some improvement within the first weeks of XYREM therapy. However, it may take up to 8 weeks after you begin using XYREM to find the dose that is right for you. Be sure to talk to your doctor about any side effects or if you don't feel any benefits while taking XYREM. This is especially important during the first 1-2 months of beginning XYREM therapy.
9. What are the most common side effects?[2]
The most common side effects with XYREM are nausea, dizziness, headache, vomiting, sleepiness and bed-wetting. An increase in side effects may happen with higher doses. 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.
10. Are there activities I should avoid while taking XYREM?[2]
For at least 6 hours after taking a dose of XYREM, do not drive a car, operate heavy machinery, or perform any activity that is dangerous or requires mental alertness. In addition, until you know whether XYREM will have any carryover effect on you the next day, use extreme care during activities that require mental alertness.
11. May I take XYREM with food?[2]
Food will decrease the amount of XYREM that your body absorbs so you should wait at least 2 hours after eating before taking your first dose. It is also best to eat your evening meal at a consistent time prior to taking the first nightly XYREM dose.
12. What about interactions with other medications?[2]
It is very important for your doctor to be aware of any other medications you are taking, including non-prescription medicines, vitamins or herbal, nutritional, or dietary supplements. XYREM should not be used in combination with medications that cause drowsiness and should never be taken with alcohol. Combining XYREM with alcohol or medications that cause drowsiness can result in very severe sleepiness and trouble breathing.
Important Safety Information
1. XYREM® is a controlled substance. Controlled substances are medicines that, if abused, may lead to varying degrees of physical or psychological dependence. XYREM is a Schedule III drug — which means that it has a moderate dependence liability. If you sell, distribute, or give your XYREM to anyone else or use it for purposes other than what it was prescribed for, you may be punished under federal and state law by jail and fines.
2. It is very important to keep XYREM out of reach of children and pets.
3. XYREM can cause serious side effects including trouble breathing while asleep, confusion, abnormal thinking, depression and loss of consciousness. Tell your doctor if you have any of these problems while taking XYREM.
BOXED WARNING:
!Warning
Central Nervous System Depressant with Abuse Potential. Should not be used with alcohol or other CNS depressants. Sodium oxybate is a form of GHB, a known drug of abuse. Abuse has been associated with some important central nervous system (CNS) adverse events (including death). Even at recommended doses, use has been associated with confusion, depression, and other neuropsychiatric events. Reports of respiratory depression occurred in clinical trials. Almost all of the patients who received sodium oxybate during clinical trials were receiving CNS stimulants.
Important CNS adverse events associated with abuse of GHB include seizure, respiratory depression and profound decreases in level of consciousness, with instances of coma and death. For events that occurred outside of clinical trials, in people taking GHB for recreational purposes, the circumstances surrounding the events are often unclear (e.g., dose of GHB taken, the nature and amount of alcohol or any concomitant drugs).
XYREM is available through the XYREM Success Program®, using a centralized pharmacy 1-866-XYREM88® (1-866-997-3688). The Success Program provides educational materials to the prescriber and the patient explaining the risks and proper use of sodium oxybate, and the required prescription form. Once it is documented that the patient has read and/or understood the materials, the drug will be shipped to the patient. The XYREM Success Program also recommends patient follow-up every 3 months. Physicians are expected to report all serious adverse events to the manufacturer.
