Warnings:

This medication 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. This medication 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 product 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).

For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

How to use Xywav 0.5 Gram/Ml Oral Solution Anti-Narcolepsy And Anti-Cataplexy Agents - Sedative-Type

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth at least 2 hours after eating in 2 separate doses as directed by your doctor. Prepare your 2 doses as directed. The doses must each be mixed 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 2-and-a-half hours to 4 hours. 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, weight (for children), 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 often, 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.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as anxiety, psychosis, fast heartbeat, trouble sleeping). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used this product for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Tell your doctor if your condition lasts or gets worse.

Side Effects

See also Warning section.

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

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 (such as confusion, hallucinations, agitation, depression, thoughts of suicide), numb/tingling skin, shaking (tremor), 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.

Precautions

Before taking this medication, tell your doctor or pharmacist if you are allergic to sodium oxybate, calcium oxybate, magnesium oxybate, or potassium oxybate; 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, breathing problems (such as sleep apnea, asthma), personal/family history of regular use/abuse of drugs/alcohol, mental/mood problems (such as depression, family/personal history of suicidal thoughts/attempts).

Sleep disorders may decrease your ability to react quickly. Though this medication helps keep you awake during the day, you still may not be able to safely do 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 at least 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).

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.

Consult your pharmacist or physician.

Interactions

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.

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Overdose

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.

Notes

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

Missed Dose

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 that you missed, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Prepare both doses just before bedtime. Properly discard prepared doses if not used 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.

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.