Sodium oxybate is used to treat sudden weak or paralyzed muscles (cataplexy) and excessive daytime sleepiness caused by narcolepsy in adults and children at least 7 years old.

Sodium oxybate oral suspension is not approved for use by anyone younger than 18 years old.

Sodium oxybate is available only under a special program. You must be registered in the program and understand the risks and benefits of sodium oxybate.

Sodium oxybate may also be used for purposes not listed in this medication guide.

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

Fatal side effects may occur if you also drink alcohol or use other drugs that cause drowsiness or slow 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.

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. Use the medicine exactly as directed.

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

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

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

Oral solution: It 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.

Oral solution: Each dose of sodium oxybate 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 sodium oxybate dose that has been mixed with water but not used within 24 hours of mixing.

Oral suspension: It is taken once at bedtime. Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon). Do not use hot water. Take this medicine within 30 minutes after mixing.

You may have withdrawal symptoms if you stop using sodium oxybate 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.

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

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

Tell your doctor if you have or 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 sodium oxybate, especially if you have high blood pressure, kidney disease, or heart disease.

Tell your doctor if you are pregnant or breastfeeding.

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

Oral suspension: Skip the missed dose and do not take another dose until the next day at bedtime.

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 sodium oxybate 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.

Sodium oxybate 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: 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 side effects of sodium oxybate 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 sodium oxybate 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 affect sodium oxybate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.