Pronunciation:

SOE-dee-um OX-i-bate

Brand Names:

• Xyrem

Dosage Forms:

• Solution

Warnings:

Central nervous system (CNS) depressant with abuse potential. Should not be used with alcohol or other CNS depressants.

Sodium oxybate is GHB, a known drug of abuse. Abuse has been associated with some important CNS adverse events (including death). Even at recommended doses, use has been associated with confusion, depression and other neuropsychiatric events. Reports of respiratory depression occurred in clinical trials. Almost all of the patients who received sodium oxybate during clinical trials were receiving CNS stimulants; whether this affected respiration during the night is unknown.

Important CNS adverse events associated with abuse GHB include seizure, respiratory depression and profound decreases in level of consciousness, with instances of coma and death. For events that occurred outside of clinical trials, in people taking GHB for recreational purposes, the circumstances surrounding the events are often unclear (eg, dose of GHB taken, the nature and amount of alcohol or any concomitant drugs).

Sodium oxybate is available through the Xyrem Success Program, using a centralized pharmacy 1-866-XYREM88 (1-866-997-3688). The Success Program provides educational materials to the prescriber and the patient explaining the risks and proper use of sodium oxybate, and the required prescription form. Once it is documented that the patient has read and/or understood the materials, the drug will be shipped to the patient. The Xyrem Success Program also recommends patient follow-up every 3 months. Physicians are expected to report all serious events to the manufacturer .

Sodium oxybate is GHB (gamma hydroxybutyrate), a known drug of abuse. Do not use with alcohol or other CNS depressants. Use at recommended doses has been associated with confusion, depression, and other neuropsychiatric events. Reports of respiratory depression occurred in clinical trials. Profound decreases in level of consciousness, with instances of coma and death; respiratory depression; and seizures have been associated with abuse of GHB. Available only through the Xyrem Success Program, call 1-866-XYREM88 .

Classifications:

Therapeutic—

Central Nervous System Agent

Uses of This Medicine:

Sodium oxybate is used to reduce the number of cataplexy (weak or paralyzed muscles) attacks in people with narcolepsy. This medicine is available only with your healthcare professional's prescription, and you can only get it from one central pharmacy. Before you use sodium oxybate your healthcare professional should teach you about the safe and effective use of this medicine. You cannot get the medicine until you have read the information the pharmacy will send you about sodium oxybate.

Note: Sodium oxybate is a Schedule III, federally controlled substance. This means that if you sell, distribute, or give your medicine to anyone else, or if you use your sodium oxybate for purposes other than what it was prescribed for, you may be punished under federal and state law by jail and fines. Your sodium oxybate should be used only by you, as prescribed by your healthcare professional.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Studies in this medicine have only been done in adult patients, and there is no specific information comparing the use of sodium oxybate in children with other age groups.

Older adults—

Elderly patients may be sensitive to the effects of sodium oxybate. This may increase the chance of side effects during treatment especially difficulty in movement or in thinking.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adinazolam
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aprobarbital
• Bromazepam
• Brotizolam
• Butabarbital
• Butalbital
• Carisoprodol
• Chlordiazepoxide
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Codeine
• Dantrolene
• Diazepam
• Estazolam
• Fentanyl
• Flunitrazepam
• Flurazepam
• Halazepam
• Hydrocodone
• Hydromorphone
• Ketazolam
• Levorphanol
• Lorazepam
• Lormetazepam
• Medazepam
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methocarbamol
• Methohexital
• Midazolam
• Morphine
• Morphine Sulfate Liposome
• Nitrazepam
• Nordazepam
• Oxazepam
• Oxycodone
• Oxymorphone
• Pentobarbital
• Phenobarbital
• Prazepam
• Primidone
• Propoxyphene
• Quazepam
• Remifentanil
• Secobarbital
• Sufentanil
• Temazepam
• Thiopental
• Triazolam

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Breathing problems such as:
  • Hypopnea (abnormally slow, shallow breathing) or
  • Sleep apnea (stopping breathing during sleep)—Use of sodium oxybate may make these conditions worse

• Depression, history of, or
• Suicide, attempted—Use of sodium oxybate may worsen these conditions

• Drug abuse or dependence, history of—Dependence on sodium oxybate may be more likely to develop.

• Heart failure, history, or
• Hypertension (high blood pressure) or
• Kidney problems—The amount of sodium in this medicine may make these conditions worse.

• Liver problems—May increase the amount of sodium oxybate in the body and a smaller dose may be needed

• Succinic semialdehyde dehydrogenase deficiency (a rare, inborn metabolism deficiency)—Sodium oxybate should not be taken.

Proper Use of This Medicine:

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (oral solution):
  • For treatment of cataplexy
    • Adults—2.25 grams given at bedtime and repeated one time during the night. The first dose should be taken at bedtime and the second dose taken 2.5 to 4 hours later. The dose will be increased as needed by your healthcare professional up to a maximum of 9 grams. Food will decrease the amount of sodium oxybate that is absorbed by your body. It is best to take this medicine several hours after a meal.

Note: Sodium oxybate causes sleep very quickly. Take it only at bedtime and while in bed. Drink all of the first dose while sitting in bed, recap the cup, and then lie down right away. Right before going to sleep place your second dose (already prepared) in a secure location (locked if needed) near your bed. You may need to set an alarm to wake up to take the second dose. When you wake up to take the second dose, remove the cap from the second dosing cup. While sitting in bed, drink all of the second dose right before lying down to continue sleeping. Recap the second cup.

To take sodium oxybate, you must first mix it with water. Your healthcare professional and the medication guide that comes with your medicine will tell you how to prepare sodium oxybate. Prepare both doses before bedtime. Place the caps provided on the dosing cups and turn each cap so it locks in its child resistant position.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Never take two doses of sodium oxybate at the same time. If you have any questions about this ask your healthcare professional.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Pour any unused sodium oxybate down the drain. Destroy the drug name on the label with a marker when you are finished with the medicine. Place the empty bottle in the trash so it is not used for illegal purposes.

Precautions While Using This Medicine:

It is very important that your healthcare professional check your progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects. This is especially important for elderly patients who may be more sensitive to the effects of this medicine.

Do not take other medicines unless they have been discussed with your healthcare professional. This medicine will add to the effects of CNS depressants (medicines that make you drowsy or less alert). Check with your healthcare professional or dentist before taking any of the above medicines while you are taking sodium oxybate.

While you are taking sodium oxybate, you should not drink alcohol. The effects of alcohol can increase the chance of dangerous side effects of sodium oxybate.

Other people living in your house should monitor you for the possibility of sleepwalking. If this happens, tell your healthcare professional.

Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert. Do not drive a car, operate heavy machinery, or perform any activity that is dangerous or requires mental alertness for at least 6 hours after taking sodium oxybate. When you first start taking sodium oxybate, until you know whether it makes you sleepy the next day, use extreme care while driving a car or doing anything else that could be dangerous or needs you to be fully mentally alert.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles" or tingling feeling

change in vision

confusion

discouragement

dizziness

feeling sad or empty

headache

impaired vision

irritability

lack of appetite

lack or loss of strength

loss of bladder control

loss of interest or pleasure

loss of memory

loss of strength or energy

muscle pain or weakness

nervousness

pounding in the ears

problems with memory

sleepwalking

slow or fast heartbeat

tiredness

trouble concentrating

trouble sleeping

Symptoms of Overdose

Get emergency help immediately if any of the following symptoms of overdose occur:

Alternating periods of shallow and deep breathing

bluish lips or skin, not breathing

chest pain or discomfort

clumsiness

coma

confusion

confusional, agitated combative state

consciousness, depressed

convulsions

drowsiness

generalized slowing of mental and physical activity

headache

inability to hold bowel movement and/or urine

increased sweating

lightheadedness, dizziness or fainting

loss of strength or energy

low body temperature

muscle aches or weakness

muscle pain or weakness

shakiness and unsteady walk

shivering

shortness of breath

sleepiness

slow or irregular heartbeat

trembling, or other problems with muscle control or coordination

unusual tiredness

unusual weak feeling

vision, blurred

vomiting

weak or feeble pulse

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

Abdominal pain

abnormal thinking

acid or sour stomach

back pain

belching

body aches or pain

chills

congestion

cold

cough or hoarseness

cramps

diarrhea

dizziness

dreams, abnormal

dryness or soreness of throat

fear

fever

flu-like symptoms

general feeling of discomfort or illness

heartburn

heavy bleeding

hoarseness

indigestion

joint pain

lower back or side pain

nausea

pain

pain or tenderness around eyes and cheekbones

painful or difficult urination

runny nose

shivering

shortness of breath or troubled breathing

sleep disorder

sleepiness or unusual drowsiness

sneezing

sore throat

stomach discomfort, upset, or pain

stuffy nose

sweating

tender, swollen glands in neck

tightness of chest or wheezing

trouble in swallowing

unusual tiredness or weakness

voice changes

vomiting

Less common

Sleeplessness

unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.