Pronunciation:

SOE-dee-um OX-i-bate

Brand Names:

• Xyrem

Dosage Forms:

• Powder for Suspension, Extended Release
• Solution

Warnings:

Warning: Central Nervous System (CNS) Depression and Abuse and MisuseCentral Nervous System DepressionSodium oxybate is a CNS depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in adult patients treated with sodium oxybate. Many patients who received sodium oxybate during clinical trials in narcolepsy were receiving central nervous system stimulants.Abuse and MisuseSodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death.Because of the risks of CNS depression and abuse and misuse, sodium oxybate is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Xywav and Xyrem REMS .

Warning: Central Nervous System Depression and Misuse and AbuseCentral Nervous System (CNS) DepressionSodium oxybate is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with sodium oxybate. Many patients who received sodium oxybate during clinical trials in narcolepsy were receiving central nervous system stimulants.Abuse and MisuseSodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death.Because of the risks of CNS depression and abuse and misuse, sodium oxybate is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Lumryz REMS .

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 or excessive daytime sleepiness (EDS) in patients with narcolepsy. Narcolepsy is an uncontrollable desire for sleep or a sudden attack of deep sleep.

This medicine is available only under a restricted distribution program called Xyrem® and Lumryz™ REMS (Risk Evaluation and Mitigation Strategy) Program. You can only get it from one central pharmacy.

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—

Appropriate studies have not been performed on the relationship of age to the effects of Lumryz™ in the pediatric population. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Xyrem® in children younger than 7 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of sodium oxybate have not been performed in the geriatric population. However, elderly patients are more likely to have unwanted effects (eg, headache) or age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving sodium oxybate.

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—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Carbinoxamine
• Chloral Hydrate
• Diphenhydramine
• Doxylamine
• Eszopiclone
• Ethchlorvynol
• Hydroxyzine
• Promethazine
• Ramelteon
• Zaleplon
• Zolpidem
• Zopiclone

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.

• Acepromazine
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aprobarbital
• Aripiprazole
• Asenapine
• Baclofen
• Benperidol
• Benzhydrocodone
• Bromazepam
• Buprenorphine
• Buspirone
• Butabarbital
• Butalbital
• Butorphanol
• Cannabidiol
• Cannabis
• Carisoprodol
• Carphenazine
• Cetirizine
• Chlordiazepoxide
• Chlorpromazine
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Clozapine
• Codeine
• Cyclobenzaprine
• Dantrolene
• Daridorexant
• Dexmedetomidine
• Diacetylmorphine
• Diazepam
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Droperidol
• Enflurane
• Esketamine
• Estazolam
• Ethopropazine
• Ethylmorphine
• Fentanyl
• Flibanserin
• Flunitrazepam
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Isoflurane
• Ketamine
• Ketazolam
• Ketobemidone
• Lacosamide
• Lemborexant
• Levocetirizine
• Levorphanol
• Lofexidine
• Lorazepam
• Lormetazepam
• Loxapine
• Meclizine
• Medazepam
• Melperone
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Metoclopramide
• Midazolam
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nicomorphine
• Nitrazepam
• Nitrous Oxide
• Olanzapine
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenobarbital
• Pimozide
• Piperacetazine
• Pipotiazine
• Piritramide
• Prazepam
• Pregabalin
• Primidone
• Prochlorperazine
• Promazine
• Propofol
• Quazepam
• Quetiapine
• Remifentanil
• Remimazolam
• Remoxipride
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Sertindole
• Sufentanil
• Sulpiride
• Suvorexant
• Tapentadol
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Valproic Acid
• Zotepine
• Zuranolone

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

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:

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

• Breathing or lung problems (eg, hypopnea or sleep apnea) or
• Depression, history of or
• Suicidal ideation, history of—Use with caution. May make these conditions worse.

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

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Obesity—Use with caution. May increase risk for sleep-related breathing problems (eg, respiratory depression).

• Succinic semialdehyde dehydrogenase deficiency (rare inborn metabolism disorder)—Should not be used in patients with this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming. If you think this medicine is not working properly after you have taken it for several weeks, check with your doctor first and do not increase the dose.

It is very important that you understand the requirements of the Xyrem® and Lumryz™ REMS program, and become familiar with the Xyrem® Medication Guide and patient instructions. Ask your doctor if you have any questions.

Sodium oxybate oral solution is divided into 2 nightly doses.

Take this medicine at least 2 hours after you eat.

This medicine can make you sleep very quickly (within 5 to 15 minutes) without feeling drowsy. It is best to take the medicine only at bedtime or when you are ready to fall asleep.

To use the solution: You must first mix each dose with 2 ounces (60 milliliters [mL]) of water. 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. Use the oral liquid within 24 hours after mixing.

To use the extended-release suspension (packet):

• Open the mixing cup and fill it with water up to fill line A. Put the mixing cup down on a flat surface.
• Use scissors to cut the packet open along the cutting line or tear the packet open with your hands.
• Empty the entire contents of a packet into the mixing cup. Shake the mixture well for at least 60 seconds. The mixture will look slightly milky with some lumps.
• Drink the mixture within 30 minutes of mixing while sitting in bed.
• If some medicine remains in the cup, add more water up to fill line B, shake for 10 seconds, and drink immediately.
• Leave the mixing cup at your bedside and lie down immediately to go to sleep.

Take this medicine 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 in a secure place near your bed. You might 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.

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 treatment of excessive daytime sleepiness and cataplexy:
  • For oral dosage form (solution):
    • Adults—At first, 2.25 grams (g) 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. Your doctor may adjust your dose as needed. However, the dose is usually not more than 9 g per night.
    • Children 7 years of age and older—Dose is based on body weight and must be determined by your doctor:
      • Weighing 45 kilograms (kg) or more—At first, 2.25 grams (g) or less 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. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 4.5 g per night.
      • Weighing 30 to less than 45 kg—At first, 1.5 g or less 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. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3.75 g per night.
      • Weighing 20 to less than 30 kg—At first, 1.0 g 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. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3 g per night.
    • Children younger than 7 years of age or weighing less than 20 kilograms (kg)—Use and dose must be determined by your doctor.
  • For oral dosage form (extended-release suspension):
    • Adults—At first, 4.5 grams (g) given once at bedtime. Your doctor may adjust your dose as needed. However, the dose is usually not more than 9 g per night.
    • Children—Use and dose must be determined by your doctor.

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.

If you miss the second dose, skip that dose and do not take any more medicine until the next night. Do not use extra medicine to make up for a missed dose.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Pour any unused medicine down the sink drain. Use a marker to cross out the label on the bottle, then throw it in the trash.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects.

Do not use this medicine if you are also taking another sedative or hypnotic medicine (eg, Ambien®, Phenergan®, Seconal®). Also, do not drink alcohol while you are using this medicine. Doing so may increase the risk for serious unwanted effects.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused medicine in a safe and secure place. People who are addicted to drugs might want to steal this medicine.

This medicine will add to the effects of other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sleeping medicine, certain medicines for depression or anxiety, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are using this medicine.

This medicine may make you dizzy, drowsy, or less alert than you are normally. Do not drive or do anything else that could be dangerous for at least 6 hours after taking sodium oxybate.

Do not use more of this medicine or take it more often than your doctor tells you to. This can be life-threatening. Symptoms of an overdose include: extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, or cold, clammy skin. Call your doctor right away if you notice these symptoms.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause unusual behavior while you are sleeping. Other people living in your house should monitor you for the possibility of urinary or fecal incontinence (loss of bladder or bowel control), or sleepwalking. Tell your doctor if these symptoms occur.

Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

Bedwetting

sleep walking

Less common

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

changes in behavior

choking or gasping sounds

daytime sleepiness or tiredness

headache

lack of appetite

loud or frequent snoring

rapid weight gain

seeing, hearing, or feeling things that are not there

thoughts of killing oneself

trouble sleeping

unusual weight gain or loss

waking to urinate at night

Incidence not known

Being forgetful

blurred vision

decrease in the amount of urine

dizziness

fever

hives, itching, skin rash

hoarseness

increase urge to urinate at night

irritation

joint pain, stiffness, or swelling

nervousness

noisy, rattling breathing

pounding in the ears

redness of the skin

swelling of the face, fingers, hands, feet, or lower legs

tightness in the chest

trouble breathing or swallowing

weight gain

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

Symptoms of overdose

Agitation

bluish lips or skin, not breathing

chest pain or discomfort

clumsiness

confusional, agitated combative state

drowsiness

generalized slowing of mental and physical activity

inability to hold bowel movement or urine

increased sweating

lightheadedness, dizziness, or fainting

loss of consciousness

muscle aches or weakness

seizures

shakiness and unsteady walk

shivering

slow or irregular heartbeat

trembling or other problems with muscle control or coordination

unusual tiredness or weakness

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

Diarrhea

difficulty passing urine (dribbling)

increased frequency, urgency, or burning on urination

increased sweating

nausea

vomiting

Less common

Dry mouth

Incidence not known

Difficulty with moving

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.