Sodium Oxybate, Oral

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KEY POINTS

• This medicine is taken by mouth to treat loss of muscle control and excessive daytime sleepiness caused by narcolepsy. This medicine may be habit-forming. Take it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: anticataplectic (treats cataplexy)

Generic and brand names: sodium oxybate, oral; Xyrem

What is this medicine used for?

This medicine is taken by mouth to treat cataplexy (sudden loss of muscle control) and excessive daytime sleepiness in people who have narcolepsy (a condition where people fall asleep frequently during the day at unexpected times).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Depression, psychosis, or other mood disorders
• High blood pressure or heart failure
• Liver or kidney disease
• Lung or breathing problems such as asthma, COPD, or sleep apnea
• Problems with alcohol or drug abuse
• Seizures
• Succinic semialdehyde dehydrogenase deficiency (a rare metabolism problem you are born with)

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Read and follow these instructions carefully. Ask your healthcare provider or pharmacist if you have any questions. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

Take the medicine on an empty stomach. Wait at least 2 hours after eating before taking this medicine.

This medicine will make you drowsy very quickly. Take this medicine at bedtime while in bed. Take the second dose 2.5 to 4 hours after you take the first dose. You may need to set an alarm clock to wake you up so you can take the second dose on time.

Mix this medicine with 2 ounces (1/4 cup) of water before using. Mix it only in the child-resistant dosing cups that come with the medicine. Mix both doses of medicine before you go to bed, and store the second dose close to your bed. Keep out of the reach of children.

What if I miss a dose?

If you miss your doses at bedtime any day, skip the missed dose and take the next one as directed. If you miss the second dose, skip that dose and do not take any more medicine until the next night. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: Slow breathing, trouble breathing, confusion, aggressiveness, trouble walking, coma, sweating, nausea, vomiting, weakness.

What should I watch out for?

This medicine is a controlled substance. It is illegal for you to give it to anyone else. This medicine is not available in retail pharmacies. You must read, sign, and send in paperwork to have the medicine shipped to you from a central pharmacy. This medicine may be habit-forming. Take it exactly as directed by your healthcare provider. Do not take more of it or take it more often than directed. Taking too much of this medicine will increase the chances of side effects.

This medicine increases the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol or take sedatives or sleeping pills while taking this medicine.

If you have heart disease, high blood pressure, or renal (kidney) disease, you may need to limit your use of sodium (salt) while taking this medicine. Talk with your healthcare provider about this.

This medicine makes you sleepy, and you may still be sleepy the morning after taking this medicine. Do not drive a car, operate machinery, or do any activities that require mental alertness for at least 6 hours after taking this medicine.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, itching, rash, tightness in your chest, swelling of your lips, tongue or throat, trouble breathing).

Serious (Report these to your healthcare provider right away.): Shortness of breath, sleep apnea (brief periods of stopping breathing while asleep), severe confusion, disturbing or unusual thoughts, hallucinations (seeing or hearing things that are not there), nervousness, severe depression, thoughts of suicide, sleepwalking, loss of bladder control, unusually fast or slow heartbeat.

Other: Headache, dizziness, tremors, ringing in the ears, pain, fever, muscle or joint pain, nausea, vomiting, diarrhea, increased daytime sleepiness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antianxiety medicines such as alprazolam (Xanax), chlordiazepoxide, clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antidepressants such as amitriptyline, citalopram (Celexa), clomipramine, desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), protriptyline, sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Antihistamines such as azelastine (Astelin, Astepro), chlorpheniramine (Chlor-Trimeton), and diphenhydramine (Benadryl)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as ethosuximide (Zarontin), phenytoin (Dilantin, Phenytek), primidone (Mysoline), and valproic acid (Depacon, Depakene, Depakote)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Doxepin (Silenor)
• Levodopa/carbidopa (Duopa, Rytary, Sinemet)
• Methamphetamine (Desoxyn)
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), and pentazocine (Talwin)
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Sleeping pills such as flurazepam, temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)

Do NOT drink alcohol while you are taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light. After the medicine has been mixed with water, use it within 24 hours.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.