What is the most important information I should know about sodium oxybate?
Sodium oxybate can slow or stop your breathing, even at regular doses or if you are also taking stimulant medicines.
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 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 is sodium oxybate?
Sodium oxybate is a central nervous system depressant. It is used to treat cataplexy (sudden loss of muscle strength) and reduce daytime sleepiness caused by narcolepsy in adults and children at least 7 years old.
Sodium oxybate is also known as GHB, a known street drug of abuse. Because of the potential for abuse and serious side effects, sodium oxybate is available only from a certified pharmacy under a special program. Your doctor must be registered in the program in order to prescribe sodium oxybate for you.
Sodium oxybate may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking sodium oxybate?
Do not drink alcohol or take other sleep medicines together with sodium oxybate. Dangerous side effects or death could occur.
Do not give sodium oxybate to anyone who has a rare metabolic disorder called succinic semialdehyde dehydrogenase deficiency (which can cause mental or physical impairment).
Tell your doctor if you have ever had:
- a breathing disorder such as asthma, emphysema, or bronchitis;
- snoring, or 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;
- kidney or liver disease;
- heart failure;
- if you are on a low-salt diet; or
- if you also take divalproex sodium (Depakote).
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.
How should I take sodium oxybate?
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 in a place where others cannot get to it. Selling or giving away this medicine is against the law.
Do not allow anyone else to use this medicine.
Take sodium oxybate at least 2 hours after a meal. It is important to take sodium oxybate at the same time each night.
Sodium oxybate must be taken at bedtime and again 2.5 to 4 hours later. This medicine works very fast and should be taken while you are sitting in bed ready for sleep. 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 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.
Do not stop using sodium oxybate suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using sodium oxybate.
Your doctor will need to check your progress every 3 months.
Store at room temperature away from moisture and heat.
Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.
Do not keep leftover sodium oxybate liquid. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, pour any unused liquid medicine down a sink drain.
What happens if I miss a dose?
Take the medicine as soon as you can, but only during your normal sleeping hours (wait at least 2 hours after eating). Do not take two doses at one time.
What happens if I overdose?
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 sweating, vomiting, severe confusion, loss of balance or coordination, or seizure (convulsions).
What should I avoid while taking sodium oxybate?
Do not drink alcohol. Dangerous side effects or death could occur.
Sodium oxybate will cause drowsiness and can impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine. 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.
Do not take other sleep medicines together with sodium oxybate.
What are the possible side effects of sodium oxybate?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- weak or shallow breathing, breathing that stops for short periods of time;
- sleepwalking, waking and confused behavior at night;
- confusion, paranoia, hallucinations (seeing or hearing things);
- depression, anxiety, unusual or unpleasant thoughts; or
- suicidal thoughts or actions.
Common side effects may include:
- weight loss;
- loss of appetite;
- drowsiness, dizziness;
- nausea, vomiting; or
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.
What other drugs will affect sodium oxybate?
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 your current medicines and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about sodium oxybate.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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