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.

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.

Take Xyrem oral solution exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Sodium oxybate can slow or stop your breathing, even at regular doses or if you are also taking stimulant medicine.

Xyrem may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away this medicine is against the law.

Take Xyrem at least 2 hours after a meal or snack. It is important to take this medicine at the same time each night.

This medicine works very fast and should be taken while you are sitting in bed ready for sleep.

Xyrem oral solution is taken at night divided into 2 doses. The first dose should be taken at bedtime and the second dose should be taken 2 1/2 to 4 hours later. Prepare both doses while you are getting ready for bed. Place the second dose next to your bed so you can take it without getting up. You will most likely need to set an alarm to awaken for the second dose.

Each dose of Xyrem oral solution must be mixed with two ounces (one quarter cup) of water in the child-resistant dosing cups provided with the medication. Both doses must be used within the same night. Throw away any oral solution that has been mixed with water but not used within 24 hours of mixing.

You may have withdrawal symptoms if you stop using Xyrem suddenly. Ask your doctor before stopping the medicine.

Your doctor will need to check your progress on a regular basis.

Do not keep leftover medicine. Ask your pharmacist about a drug take-back program or flush the unused medicine down the toilet.

Store at room temperature away from moisture and heat.

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.

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.

If the second dose is missed, skip this dose and do not take another dose until the next night.

Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Xyrem can be fatal.

Overdose symptoms may include headache, sweating, vomiting, severe confusion, agitation, loss of balance or coordination, drop in body temperature, coma, blurred vision, trouble breathing, slow heart rate, muscle weakness, or seizure (convulsions).

Do not drink alcohol. Dangerous side effects or death could occur.

Xyrem will cause drowsiness and can impair your thinking or reactions. Wait at least 6 hours or until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

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.

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.