Sodium oxybate is a very powerful central nervous system (CNS) depressant with a high risk of abuse. It must be used only for the purpose that your doctor prescribes. It is against the law to use this drug for any other purposes. Abuse and even approved use can result in seizures, severe difficulty breathing, confusion, depression, loss of consciousness, and even death. It must not be used with alcohol or other CNS depressants (see also Drug Interactions section).
In the US, only patients who take part in the Xyrem REMS Program may receive treatment with this medication. In Canada, a similar program is called the Xyrem Success Program. Before you receive your prescription, you must register with this program, and your doctor's office must provide educational materials to you. Your doctor must go over this material with you and instruct you how to use this medication safely and effectively. Only doctors enrolled in the Xyrem REMS Program may prescribe sodium oxybate, and only the central pharmacy (not your local pharmacy) may dispense it.Who should not take Xyrem?
This medication is used to treat narcolepsy, a condition that causes severe daytime sleepiness. Sodium oxybate can decrease daytime sleepiness and also reduce the number of sudden short attacks of weak/paralyzed muscles (known as cataplexy) that can occur in patients with narcolepsy. Sodium oxybate is a central nervous system depressant. It is also known as gamma hydroxybutyrate (GHB).
Take this medication by mouth in 2 separate doses at bedtime (at least 2 hours after eating) as directed by your doctor. Prepare your 2 doses as instructed in the Medication Guide. The doses must be diluted with 2 ounces (60 milliliters) of water. Take the first dose at bedtime while in bed. Set an alarm clock to awaken you for the second dose in 4 hours. If you wake up before the alarm and it has been at least 2-and-a-half hours after the first dose, then take the second dose while sitting in bed, and turn off the alarm. If you have children or pets in the house, be sure to use the child-resistant caps that come with the medication cups.
The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor will gradually increase your dose over 1 to 2 weeks to lessen the risk of side effects. This process will continue until your doctor has found the right dose for you. Follow your doctor's directions carefully. Do not increase your dose, take it more frequently, or use it for longer than prescribed.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each night.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as anxiety, psychosis, fast heartbeat, trouble sleeping) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.
Tell your doctor if your condition persists or worsens.
See also Warning section.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., confusion, psychosis, hallucinations, agitation, depression, thoughts of suicide), bedwetting, weakness, ringing in the ears, sleepwalking.
Get medical help right away if you have any very serious side effects, including: difficult/slow/shallow breathing (especially during sleep).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking sodium oxybate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain rare metabolic condition (succinic semialdehyde dehydrogenase deficiency), liver disease, kidney disease, breathing problems (e.g., sleep apnea, asthma), personal/family history of regular use/abuse of drugs/alcohol, heart problems (e.g., heart failure, high blood pressure), mental/mood problems (e.g., depression, family/personal history of suicidal thoughts/attempts).
Sleep disorders may decrease your ability to react quickly. Though sodium oxybate helps keep you awake during the day, you still may not be able to safely perform task that require alertness (e.g., driving, flying). This drug may also make you dizzy. For these reasons, do not drive, use machinery, or do any other activity that requires alertness until you know how this medication affects you. Always use great care when doing these activities, and avoid them completely during the first 6 hours after you take this medication. Avoid alcoholic beverages because they increase the risk of serious side effects.
This medication contains sodium. Consult your doctor for more information if you are on a salt-restricted diet or if you have a condition that could be worsened by increased salt intake (e.g., heart failure, high blood pressure)
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially the reduced ability to drive/use machinery.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
See also Warning section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, medicine for sleep or anxiety (eszopiclone, zaleplon, zolpidem, benzodiazepines such as diazepam/temazepam, barbiturates such as pentobarbital), muscle relaxants, and narcotic pain relievers (such as codeine).
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: lack of response, slow/shallow breathing, inability to control urine/stool.
Keep all medical appointments. It is recommended that you visit your doctor at least every 3 months while taking this medication.
If you miss your first dose of the night, take it as soon as you remember if it is before bedtime. If it is not at bedtime or if it is your second dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Prepare each dose just before bedtime. Use or properly discard prepared doses within 24 hours. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. In the US, the FDA recommends flushing this medication down the toilet or pouring into a drain. Consult your pharmacist or local waste disposal company.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.
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