![]() ![]() Breathing problems, including slower breathing, trouble breathing, and/or short periods of not breathing while sleeping (sleep apnea).XYREM can cause serious side effects, including the following: Those activities should not be done until you know how XYREM affects you or your child.įalling asleep quickly, including while standing or while getting up from the bed, has led to falls with injuries that have required some people to be hospitalized. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.Īnyone who takes XYREM should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery, or flying an airplane, for at least 6 hours after taking XYREM. Selling or giving away XYREM may harm others, and is against the law. Keep XYREM in a safe place to prevent abuse and misuse. You or your child must be enrolled in the XYWAV and XYREM REMS to receive XYREM.ĭo not take XYREM if you take or your child takes other sleep medicines or sedatives (medicines that cause sleepiness), drink alcohol, or have a rare problem called succinic semialdehyde dehydrogenase deficiency. Call your doctor right away if you or your child has any of these serious side effects.īecause of these risks, you have to go through the XYWAV and XYREM REMS. These effects include seizures, trouble breathing (respiratory depression), changes in alertness (drowsiness), coma, and death. Abuse or misuse of illegal GHB alone or with other CNS depressants (drugs that cause changes in alertness or consciousness) have caused serious side effects. The active ingredient of XYREM is a form of gamma hydroxybutyrate (GHB). You can also report negative side effects to Harmony Biosciences at 1-80.WARNING: Taking XYREM with other Central Nervous System (CNS) depressants such as medicines used to make you or your child fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol, or street drugs, may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), fainting (syncope), and death. You are encouraged to report negative side effects of prescription drugs to the FDA. The safety and effectiveness of WAKIX have not been established in patients less than 18 years of age. To enroll or obtain information from the registry, call 1-80. You are encouraged to enroll in the WAKIX pregnancy registry if you become pregnant while taking WAKIX. There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. Tell your healthcare provider if you are pregnant or planning to become pregnant. You should use an alternative non-hormonal birth control method during treatment with WAKIX and for at least 21 days after discontinuation of treatment. WAKIX can also decrease the effectiveness of some medicines, including hormonal birth control methods. The dosage of WAKIX may need to be adjusted if you are taking these medicines. Some medicines can increase the amount of WAKIX that gets into your blood and some medicines can decrease the amount of WAKIX that gets into your blood. Tell your healthcare provider about all the medicines you take or plan to take, including prescription and over-the-counter medicines. Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of WAKIX. ![]() Other side effects included headache, upper respiratory infection, musculoskeletal pain, heart rate increased, and decreased appetite. The most common side effects seen with WAKIX were insomnia, nausea, and anxiety. WAKIX is not recommended in patients with end-stage kidney disease. ![]() The risk of QT prolongation may be greater in patients with liver or kidney disease. Tell your healthcare provider about all the other medicines you take. Medicines with this effect can lead to disturbances in heart rhythm, which are more likely in patients with risk factors such as certain heart conditions, or when taken in combination with other medicines that affect QT. WAKIX has an effect on the electrical activity of the heart known as QT/QTc prolongation. Tell your healthcare provider about all your medical conditions, including if you have heart rhythm irregularities, were born with a heart condition, or the levels of electrolytes in your blood are too high or too low. Do not take WAKIX if you are allergic to pitolisant or any ingredient in WAKIX, or if you have severe liver disease. ![]()
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