Xyrem

Generic name: Sodium Oxybate
Dosage form: oral solution, 0.5 g per mL.
Drug class: Miscellaneous anxiolytics , Antineoplastic Agents

Usage of Xyrem

Xyrem is used to prevent attacks of cataplexy (episodes of muscle weakness that begin suddenly and last for a short time).

Xyrem is also used to treat excessive daytime sleepiness in adults and children 7 years of age and older who have narcolepsy (a sleep disorder that may cause extreme sleepiness, sudden uncontrollable urge to sleep during daily activities, and cataplexy).

Xyrem belongs to a class of medications called central nervous system depressants. Sodium oxybate works to treat narcolepsy and cataplexy by reducing activity in the brain.

Xyrem is available only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Xyrem side effects

Get emergency medical help if you have signs of an allergic reaction to Xyrem: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Sodium oxybate may cause serious side effects. Call your doctor at once if you have:

weak or shallow breathing, breathing that stops for short periods of time;

sleepwalking;

confusion, paranoia, hallucinations, increased tiredness;

depression, anxiety, unusual or unpleasant thoughts, feeling of guilt or low self-worth; or

suicidal thoughts or actions.

Common Xyrem side effects may include:

sleepwalking;

weight loss, loss of appetite;

headache;

drowsiness, dizziness;

bedwetting;

nausea, vomiting; or

tremors.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Xyrem

Do not drink alcohol or take other sleep medicines together with Xyrem.

Do not give Xyrem to anyone who has a rare metabolic disorder called succinic semialdehyde dehydrogenase deficiency.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

breathing or lung problems;

sleep apnea (breathing stops during sleep);

depression or suicidal thoughts;

mental illness or unusual behaviors (anxiety, agitation, paranoia, aggression, hallucinations);

a drug or alcohol addiction;

heart failure or high blood pressure;

if you are on a low-salt diet;

if you also take divalproex sodium; or

kidney or liver disease.

You may need to be on a low-salt diet while you are using Xyrem, especially if you have high blood pressure, kidney disease, or heart disease.

Tell your doctor if you are pregnant or breastfeeding.

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How to use Xyrem

Usual Adult Dose for Narcolepsy:

Initial dose: 4.5 g orally per day, divided and given as 2 equal doses with the first dose taken at bedtime and the second dose taken between 2.5 to 4 hours later -The dose may be increased by 1.5 g (OR 0.75 g/dose) orally per night in weekly intervals Maintenance dose: 6 to 9 g/day Maximum dose: 9 g/day.

Usual Adult Dose for Idiopathic Hypersomnia:

2 times a night regimen: -Initial dose: 4.5 g orally per day, divided and given as 2 equal doses ---The dose may be increased by 1.5 g (OR 0.75 g/dose) orally per night in weekly intervals -Maintenance dose: 6 to 9 g/day -Maximum dose: 9 g/day Once a night regimen: -Initial dose: 3 g orally per day, divided and given as 2 equal doses ---The dose may be increased by 1.5 g (OR 0.75 g/dose) orally per night in weekly intervals -Maintenance dose: 3 to 6 g/day -Maximum dose: 6 g/day.

Usual Pediatric Dose for Narcolepsy:

7 years and older: Less than 20 kg: Specific dosing recommendations are not available. 20 to less than 30 kg: -Initial dose: Up to 2 g orally per day, divided and given as 2 equal doses with the first dose taken at bedtime and the second dose taken between 2.5 to 4 hours later -Maintenance dose: The dose may be increased by 1 g (OR 0.5 g/dose) orally per night at 1 to 2-week intervals up to 6 g/day. -Maximum dose: 6 g/day 30 to less than 45 kg: -Initial dose: Up to 3 g orally per day, divided and given as 2 equal doses with the first dose taken at bedtime and the second dose taken between 2.5 to 4 hours later -Maintenance dose: The dose may be increased by 1 g (OR 0.5 g/dose) orally per night at 1 to 2-week intervals up to 7.5 g/day. -Maximum dose: 7.5 g/day 45 kg and greater: -Initial dose: Up to 4.5 g orally per day, divided and given as 2 equal doses with the first dose taken at bedtime and the second dose taken between 2.5 to 4 hours later -Maintenance dose: The dose may be increased by 1.5 g (OR 0.75 g/dose) orally per night at 1 to 2-week intervals up to 9 g/day. -Maximum dose: 9 g/day.

Warnings

Sodium oxybate can slow or stop your breathing, even at regular doses or if you are also taking stimulant medicines.

Misuse of Xyrem can cause breathing problems, seizure, loss of consciousness, or death. Xyrem is available only from a certified pharmacy. Do not allow anyone else to use your medication.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Avoid taking other medicines that make you sleepy or slow your breathing. This includes cold or allergy medicine, opioid pain medicine, sedatives, muscle relaxants, seizure medicine, or medicine for depression, anxiety, or mental illness. Your doctor may need to change your treatment plan if you need to use any of these other medicines.

What other drugs will affect Xyrem

Using Xyrem with other drugs that make you drowsy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures. Your doctor may need to change your treatment plan if you need to use any of these other medicines.

Other drugs may interact with sodium oxybate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

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