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 in patients with narcolepsy.
Sodium oxybate may also be used for other purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking sodium oxybate?
It is dangerous to try and purchase sodium oxybate on the Internet or from vendors outside of
the United States. The sale and distribution of sodium oxybate outside of the U.S. does not comply
with the regulations of the Food and Drug Administration (FDA) for the safe use of this medication.
Do not take sodium oxybate if you:
If you have any of these other conditions, you may need a dose adjustment
or special tests to safely take this medication:
-
liver disease;
-
heart disease, high blood pressure, or kidney disease;
-
a history of alcohol or drug abuse;
-
a lung disorder such as asthma, emphysema, or bronchitis;
-
sleep apnea (breathing stops during sleep);
-
depression or suicidal thoughts; or
-
mental illness such as bipolar disorder or schizophrenia.
Sodium oxybate may be habit-forming and
should be used
only by the person it was prescribed for
. Sodium oxybate should never be given to
another person, especially someone who has a history of drug abuse or addiction. Keep the
medication in a secure place where others cannot get to it.
FDA pregnancy category B. Sodium oxybate is not expected to be harmful to an unborn
baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether sodium oxybate passes into breast milk or if it could harm a nursing
baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I take sodium oxybate?
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or
for longer than recommended. Follow the directions on your prescription label.
Never take more than your prescribed dose of sodium oxybate.
Tell
your doctor if the medicine seems to stop working as well in relieving your pain.
This medication comes with patient instructions for safe and effective use. Follow these
directions carefully. Do not allow anyone else to use your medication.
Take sodium oxybate on an empty stomach several 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 two and a half to four 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, so that you will not have to get up to prepare the
second dose. 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.
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.
Sodium oxybate is also known as GHB, a known street drug of abuse. Because of the potential
for abuse and the serious side effects that may occur, sodium oxybate is available only through a special
program. Your doctor will explain the risks and benefits of using sodium oxybate, and the medication
will be delivered to you from a central pharmacy.
To be sure this medication is helping your condition, your doctor will need to see you on a
regular basis. Do not miss any scheduled appointments.
Do not stop using sodium oxybate suddenly or you may have withdrawal effects. Your doctor
may recommend a gradual reduction in dose.
Store sodium oxybate at room temperature away from moisture and heat.
Keep track of how much of this medicine has been used from each new bottle. Sodium
oxybate is a drug of abuse and you should be aware if any person in the household is using this
medicine improperly or without a prescription.
What happens if I miss a dose of sodium oxybate?
Take the missed dose as soon as you remember, but only at bedtime or during your normal
sleeping hours. If it is almost time for the next dose, skip the missed dose and take only the next
regularly scheduled dose.
Do not
take extra medicine to make up the missed dose.
Where can I get more information about sodium oxybate?
Your pharmacist has information about sodium oxybate written for health professionals that you may read.
What are the possible side effects of sodium oxybate?
Stop using sodium oxybate and get emergency medical help if you have any of these
signs of an allergic reaction:
hives; difficulty breathing; swelling of your face, lips,
tongue, or throat.
Stop using sodium oxybate and call your doctor at once if you have any of these serious
side effects:
Less serious side effects may include:
-
agitation or paranoia;
-
problems with bladder or bowel control;
-
depression;
-
nausea, vomiting, loss of appetite;
-
runny or stuffy nose and sore throat;
-
numbness or tingling;
-
tremors (uncontrolled shaking); or
-
blurred vision.
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 is the most important information I should know about sodium oxybate?
It is dangerous to try and purchase sodium oxybate on the Internet or from vendors outside of
the United States. The sale and distribution of sodium oxybate outside of the U.S. does not comply
with the regulations of the Food and Drug Administration (FDA) for the safe use of this medication.
Sodium oxybate is also known as GHB, a known street drug of abuse. Because of the potential
for abuse and the serious side effects that may occur, sodium oxybate is available only through a special
program. Your doctor will explain the risks and benefits of using sodium oxybate, and the medication
will be delivered to you from a central pharmacy.
Sodium oxybate may be habit-forming and
should be used only by the person it
was prescribed for
. Sodium oxybate should never be given to another person, especially
someone who has a history of drug abuse or addiction. Keep the medication in a secure place where
others cannot get to it.
Never take more than your prescribed dose of sodium oxybate.
Tell
your doctor if the medicine seems to stop working as well.
Sodium oxybate will cause drowsiness and must be taken while you are in bed. Do not
drive, operate machinery, or perform other hazardous activities for at least 6 hours after taking sodium
oxybate. You may still feel sleepy the morning after taking the medication. Use caution when driving or
doing anything else that requires you to be alert and awake.
Sodium oxybate must be taken at bedtime and again two and a half to four 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, so that you will not have to get up to prepare the
second dose. 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.
Do not take
other medicines that make you sleepy (such as alcohol, cold
medicine, pain medication, muscle relaxants, and medicine for depression or anxiety).
What should I avoid while taking sodium oxybate?
Sodium oxybate must not be taken with other drugs that are used for sleep or sedation.
Avoid drinking alcohol while taking sodium oxybate. Alcohol may increase drowsiness and
dizziness caused by sodium oxybate.
Sodium oxybate can cause side effects that may impair your thinking or reactions. Do not
drive, operate machinery, or perform other hazardous activities for at least 6 hours after taking sodium
oxybate. You may still feel sleepy the morning after taking the medication. Use caution when driving or
doing anything else that requires you to be alert and awake
What other drugs will affect sodium oxybate?
Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers,
and medicine for seizures, depression or anxiety can add to sleepiness caused by sodium oxybate. Tell
your doctor if you regularly use any of these medicines.
This list is not complete and there may be other drugs that can interact with sodium oxybate.
Tell your doctor about all the prescription and over-the-counter medications you use. This includes
vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new
medication without telling your doctor.
What happens if I have an overdose of sodium oxybate?