Xyrem Oral

This medication is used to treat narcolepsy, a condition that causes severe daytime sleepiness. It can decrease symptoms such as daytime sleepiness, unwanted daytime naps/sleep attacks, and nighttime awakening. It also reduces the number of sudden short attacks of weak/paralyzed muscles (known as cataplexy) that can also occur in patients with narcolepsy. Sodium oxybate is a central nervous system depressant. It is also known as gamma hydroxybutyrate (GHB).

How to use Xyrem Oral
Read the Medication Guide provided by your pharmacist before you start using sodium oxybate and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
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.
Dosage is based on your medical condition and response to treatment. 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 immediately.
Tell your doctor if your condition persists or worsens.

See also Warning section.
Drowsiness, dizziness, nausea, vomiting, stomach pain, diarrhea, increased sweating, or headache may occur. If any of these effects persist or worsen, 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 immediately if any of these unlikely but serious side effects occur: difficult/slow/shallow breathing (especially during sleep), mental/mood changes (e.g., confusion, psychosis, hallucinations, agitation, depression, rare thoughts of suicide), bedwetting, weakness, ringing in the ears.
Tell your doctor immediately if any of these rare but very serious side effects occur: sleepwalking.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.
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.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain rare metabolic condition (succinic semialdehyde dehydrogenase deficiency).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, breathing problems (e.g., sleep apnea), 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., congestive heart failure, high blood pressure)
Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the 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.
It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.
This drug should not be used with the following medications because very serious interactions may occur: sedatives for sleep or anxiety (eszopiclone, zaleplon, zolpidem, benzodiazepines such as diazepam/temazepam, barbiturates such as pentobarbital).
If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting sodium oxybate.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.
Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), muscle relaxants, other narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: lack of response, trouble breathing, inability to control urine/stool.

NOTES:
Do not share this medication with others. It may harm them, and it is against the law.
Keep all medical appointments. It is recommended that you visit your doctor at least every 3 months while taking this medication.

MISSED DOSE:
If you miss a dose, take it as soon as you remember if it is before bedtime. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE:
Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Prepare each dose just before bedtime. Use or properly discard prepared doses within 24 hours. Do not store in the bathroom. Keep all medicines 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. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.