What is Xyrem (Sodium Oxybate) used for?
Xyrem (Sodium Oxybate) 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).
How should I take Xyrem (Sodium Oxybate)?
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 directed. The doses must 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 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.
How do I store Xyrem (Sodium Oxybate)?
Xyrem (Sodium Oxybate) is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Xyrem (Sodium Oxybate) in the bathroom or the freezer. There may be different brands of Xyrem (Sodium Oxybate) that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.
You should not flush Xyrem (Sodium Oxybate) down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.
Precautions & warnings
What should I know before using Xyrem (Sodium Oxybate)?
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. Alcohol or marijuana 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.
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.
This drug passes into breast milk. Consult your doctor before breast-feeding.
Is it safe during pregnancy or breast-feeding?
There are no adequate studies in women for determining risk when using this Xyrem (Sodium Oxybate) during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Xyrem (Sodium Oxybate). Xyrem (Sodium Oxybate) is pregnancy risk category C according to the US Food and Drug Administration (FDA).
FDA pregnancy risk category reference below:
- A=No risk,
- B=No risk in some studies,
- C=There may be some risk,
- D=Positive evidence of risk,
What side effects can occur from Xyrem (Sodium Oxybate)?
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 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.
Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.
What drugs may interact with Xyrem (Sodium Oxybate)?
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, marijuana, 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).
Xyrem (Sodium Oxybate) may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.
Does food or alcohol interact with Xyrem (Sodium Oxybate)?
Xyrem (Sodium Oxybate) may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.
What health conditions may interact with Xyrem (Sodium Oxybate)?
Xyrem (Sodium Oxybate) may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.
The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Xyrem (Sodium Oxybate).
What is the dose of Xyrem (Sodium Oxybate) for an adult?
Usual Adult Dose for Narcolepsy
Initial dose: 4.5 grams orally per night administered in two equal, divided doses of 2.25 g at bedtime and 2.25 g administered 2.5 to 4 hours later.
Maintenance dose: Increase the dose by 1.5 g orally per night at weekly intervals (additional 0.75 g at bedtime and 0.75 g administered 2.5 to 4 hours later) to the dose range of 6 g to 9 g per night.
Maximum dose: 9 g orally per night
Uses: Treatment of cataplexy in narcolepsy and excessive daytime sleepiness (EDS) in narcolepsy
Liver Dose Adjustments
Initial dose: 2.25 g orally per night administered in two equal, divided doses of approximately 1.13 g at bedtime and approximately 1.13 g administered 2.5 to 4 hours later.
Co-administration of Divalproex Sodium: For patients already stabilized on sodium oxybate, the addition of divalproex sodium should be accompanied by an initial reduction in the nightly dose of sodium oxybate by at least 20%. For patients already taking divalproex sodium, prescribers should use a lower starting sodium oxybate dose. Additionally, prescribers should monitor patient response and adjust dose as needed.
What is the dose of Xyrem (Sodium Oxybate) for a child?
The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.
How is Xyrem (Sodium Oxybate) available?
Xyrem (Sodium Oxybate) is available in the following dosage forms and strengths:
- Oral liquid.
What should I do in case of an emergency or overdose?
In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.
What should I do if I miss a dose?
If you miss a dose of Xyrem (Sodium Oxybate), take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.
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