What is Xyrem?Xyrem is a medicine used for the treatment of narcolepsy (a sleep disorder characterized by excessive daytime sleepiness) to reduce too much daytime sleepiness and reduce cataplexy (weak or paralyzed muscles) attacks.
Xyrem is a federally controlled substance because it has abuse potential.
What is the most important information I should know about Xyrem?Xyrem has abuse potential. Do not sell or give your Xyrem to anyone else or use it for purposes other than what your doctor has prescribed it for. If you take Xyrem in the wrong way, you can develop seizures, loss of consciousness, other life-threatening effects, or dependence or craving for this medication. Tell your doctor if you experience any of these symptoms while you are taking Xyrem.
Xyrem can cause serious side effects, including trouble breathing while you are asleep, confusion, abnormal thinking, depression, loss of consciousness, urinary incontinence (inability to control urination), inability to control voiding of feces, or sleepwalking. Tell your doctor if you experience any of these problems while you are taking Xyrem.
Xyrem can cause sleep very quickly. You should take Xyrem only at bedtime and while you are in bed. Do not drive, operate heavy machinery, or perform any activities that require mental alertness for at least 6 hours after you take Xyrem. Perform these activities with caution until you know how Xyrem affects you the next day. Also, do not drink alcohol or take other medicines that cause sleepiness while you are taking Xyrem.
Xyrem contains a sodium (salt) content that should be watched when you are on a salt-restricted diet. Tell your doctor if you have high blood pressure, heart failure, or kidney problems.
Who should not take Xyrem?Do not take Xyrem if you are allergic to it or any of its ingredients, or if you are taking other medicines that cause sleepiness. Also, do not take Xyrem if you have a rare condition called succinic semialdehyde dehydrogenase deficiency (an inherited condition in which certain substances build up in your body and cause retardation and developmental delays).
What should I tell my doctor before I take the first dose of Xyrem?Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Xyrem. Also, talk to your doctor about your complete medical history, especially if you have or had depression or tried to harm yourself; have liver problems; have sleep apnea (stopping breathing temporarily during sleep), snoring, or lung problems; or are on a salt-restricted diet, have high blood pressure, heart failure, or kidney problems. Also, tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.
What is the usual dosage?The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.
Adults and adolescents ≥16 years: The recommended starting dose is 4.5 grams (g) a day at night, divided into 2 equal doses of 2.25 g. Your doctor may increase your dose as needed.
If you have liver impairment, your doctor will adjust your dose appropriately.
How should I take Xyrem?Take Xyrem exactly as prescribed by your doctor. Prepare both of your Xyrem oral solution doses before going to bed. Take the first dose at bedtime while you are seated in bed, and set your alarm clock to take the second dose 2.5-4 hours later while you are seated in bed. You can take Xyrem at least 2 hours after eating.
Please review the instructions that came with your prescription on how to properly prepare and take Xyrem oral solution.
What should I avoid while taking Xyrem?Do not drive, operate heavy machinery, or perform any activities that require mental alertness for at least 6 hours after you take Xyrem.
Do not drink alcohol or take other medicines that cause sleepiness while you are taking Xyrem.
What are possible food and drug interactions associated with Xyrem?If Xyrem is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Xyrem with alcohol or other medicines that cause sleepiness.
What are the possible side effects of Xyrem?Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.
Side effects may include: abnormal thinking, agitation, bed-wetting, breathing problems, confusion, depression, dizziness, headache, inflammation of your nose, nausea, psychosis, sleepiness, sleepwalking, sore throat, thoughts of killing yourself or trying to kill yourself, urinary incontinence, vomiting
Can I receive Xyrem if I am pregnant or breastfeeding?The effects of Xyrem during pregnancy and breastfeeding are unknown. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding.
What should I do if I miss a dose of Xyrem?If you miss a dose of Xyrem, skip the one you missed and return to your regular dosing schedule. Do not take two doses at once.
How should I store Xyrem?Store at room temperature.