The following lists contain some of the key side effects that may occur while taking Xyrem. Xyrem can cause mild or serious side effects. They can help you choose a treatment plan that’s best for you. If you have questions about the risk of misusing Xyrem, talk with your doctor. You can learn more about this at the program website. This allows their doctor to be sure that Xyrem isn’t being misused. And Xyrem can only be dispensed to people who are enrolled in the REMS program with documentation of safe use of the drug.įor people who may have misused drugs in the past, their doctor may monitor them closely during Xyrem treatment. Xyrem can also only be dispensed by pharmacies that are registered with the REMS program. With the REMS program, Xyrem can only be prescribed by doctors who are certified to offer Xyrem treatment. This program limits how freely Xyrem is prescribed (as well as a similar drug called Xywav). The Xywav and Xyrem REMS program is used to help decrease the risk of serious side effects of Xyrem, such as misuse and central nervous system (CNS) depression. See “REMS program” just below for details. And it was shown to be safe and effective in treating narcolepsy during clinical trials.ĭue to the risks associated with Xyrem treatment, the FDA requires that Xyrem only be prescribed through a Risk Evaluation and Mitigation Strategy (REMS) program. This means that it does have an approved medical use. However, Xyrem, which is a form of GHB, is a Schedule III (three) drug. Schedule I drugs also lack information on the safety of their use. And they have a high potential for misuse. In fact, Schedule I controlled substances have no accepted medical use. GHB is a Schedule I (one) controlled substance that’s commonly misused and is illegal. It’s a form of another drug called gamma-hydroxybutyrate (GHB). (With tolerance, you need to take more medication to have the same effect over time.) Some people may also have cravings for Xyrem. (With dependence, your body needs the drug in order to feel like usual.) It’s also possible to build up a tolerance to Xyrem. For example, some people taking the medication may become dependent on it. Xyrem is a controlled drug because it has the potential to be misused. This means the use of Xyrem is regulated by the federal government. And in 2018, Xyrem was FDA-approved to treat narcolepsy in children ages 7 and older. In 2002, Xyrem was approved by the Food and Drug Administration (FDA) for use in adults with narcolepsy. In comparison, about 22% of people taking a placebo had the same result.įor information about Xyrem’s effectiveness in children, see the “ Xyrem uses” section below. In this study, between 52% and 64% of people taking Xyrem had a significant reduction in their EDS. In one clinical study, a scale called the Clinical Global Impression of Change was used to measure the change in EDS that people had after taking Xyrem for 8 weeks. Xyrem also reduced EDS in adults using the drug. In comparison, people taking a placebo (no active drug) had 4 fewer cataplexy episodes each week. During treatment, adults who took either 6 g or 9 g of Xyrem each night had between 10 and 16 fewer cataplexy episodes each week. In clinical trials, Xyrem was effective in treating narcolepsy by reducing both EDS and cataplexy. Xyrem is available in one strength: 0.5 grams per milliliter (g/mL). It’s usually taken at bedtime and then again, 2.5 to 4 hours later. Xyrem comes as a solution that’s taken by mouth. This helps to decrease sleepiness when you’re not at rest. Xyrem is thought to work by increasing the amount of time that your body spends in a deep sleep when you’re resting. Xyrem contains the drug sodium oxybate, which belongs to a class of medications called central nervous system (CNS) depressants. It’s approved for this use in adults and children ages 7 years and older. Xyrem treats narcolepsy by reducing both cataplexy and excessive daytime sleepiness (EDS). It can also cause sleep paralysis (the inability to move while you’re sleeping). Narcolepsy may cause hallucinations or cataplexy (sudden muscle weakness or paralysis). And it can cause you to feel extremely tired when you’re not at rest. This condition is a sleep disorder that affects how well you’re able to sleep. Xyrem is a brand-name prescription drug that’s FDA-approved to treat narcolepsy.
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