Safety Information
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 that 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 or 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 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.
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.
Download the complete XYREM Medication Guide.
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.
