Xyrem

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Sodium oxybate is a very powerful central nervous system (CNS) depressant with a high risk of abuse. It may cause slow/shallow breathing or severe drowsiness at recommended doses. 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 or misuse of this drug can result in seizures, severe difficulty breathing, loss of consciousness, and even death. It must not be used with alcohol or other CNS depressants (see also Drug Interactions section).

To receive this medication in the United States, you must understand, agree to, and carefully follow the requirements of the Xywav and Xyrem REMS Program. In Canada, a similar program is called the Xyrem Success Program. If you live in any other country, consult your doctor and pharmacist for your country's regulations.

See also Warning section.

Drowsiness, dizziness, nausea, vomiting, bedwetting, stomach pain, diarrhea, increased sweating, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 (such as confusion, psychosis, hallucinations, agitation, depression, thoughts of suicide), 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 MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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 (such as sleep apnea, asthma), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), heart problems (such as heart failure, high blood pressure), mental/mood problems (such as 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 tasks that require alertness (such as driving, flying). This drug may also make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. For these reasons, do not drive, use machinery, or do anything that needs alertness until you can do it safely. 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. Talk to your doctor if you are using marijuana (cannabis).

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 (such as 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 headaches.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.

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 cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are using other products such as other opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

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, seizures.

Do not share this medication with others. Sharing it is against the law.

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. Take your next dose at the regular time. 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. For more details, read the Medication Guide, or consult your pharmacist or local waste disposal company.