Sodium Oxybate Solution

What is this medication?

SODIUM OXYBATE (SOE dee um OX i bate) treats narcolepsy. It works by decreasing daytime sleepiness, which can help you sleep better at night. It also reduces the number of episodes of sudden muscle weakness (cataplexy).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Xyrem

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Depression
• Diet low in salt
• Heart disease
• High blood pressure
• History of substance or alcohol abuse problem
• If you drink alcohol
• Kidney disease
• Liver disease
• Lung or breathing disease, like sleep apnea
• Mental illness
• Succinic semialdehyde dehydrogenase deficiency
• Suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• An unusual or allergic reaction to oxybate, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Follow the directions on the prescription label. Use a specially marked oral syringe, spoon, or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Mix the dose with water as directed. Take this medication on an empty stomach, at least 2 hours after food. Take your medication at regular intervals. Do not take it more often than directed. Do not stop taking except on your care team's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 7 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medication with any of the following:

• Alcohol
• Medications for sleep

This medication may also interact with the following:

• Antihistamines for allergy, cough, and cold
• Certain medications for depression, like amitriptyline, fluoxetine, sertraline
• Certain medications for seizures like phenobarbital, primidone
• Divalproex sodium
• General anesthetics like halothane, isoflurane, methoxyflurane, propofol
• Medications that relax muscles for surgery
• Narcotic medications for pain
• Phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• Valproate or valproic acid

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. This medication has a risk of abuse and dependence. Your care team will check you for this while you take this medication.

You may get drowsy or dizzy. This medication causes sleep very quickly. You should only take your first dose at bedtime, while in bed. The second dose should be taken 2.5 to 4 hours after your first dose. Do not drive, use machinery, or do anything that needs mental alertness for at least 6 hours after taking this medication. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medication. Avoid alcoholic drinks.

After taking this medication, you may get up out of bed and do an activity that you do not know you are doing. The next morning, you may have no memory of this. Activities include driving a car ("sleep-driving"), making and eating food, talking on the phone, sexual activity, and sleep-walking. Serious injuries have occurred. Call your care team right away if you find out you have done any of these activities. Do not take this medication if you have used alcohol that evening. Do not take it if you have taken another medication for sleep. The risk of doing these sleep-related activities is higher.

If you or your family notice any changes in your behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your care team right away.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Sleep apnea—loud snoring, gasping or choking during sleep, daytime sleepiness
• Sleepwalking

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Bedwetting
• Dizziness
• Headache
• Loss of appetite
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children. This medication can be abused. Keep your medication in a safe place to protect it from theft. Do not share this medication with anyone. Selling or giving away this medication is dangerous and against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep this medication in the original container. Throw away any unused medication after the expiration date.

This medication may cause accidental overdose and death if it is taken by other adults, children, or pets. Flush any unused medication down the toilet or empty down the sink drain to reduce the chance of harm. Do not use the medication after the expiration date.

After preparing a dose of this medication with water, the medication should be taken within 24 hours or emptied down the sink drain.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.