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Sodium oxybate (Oral)

Generic Name: sodium oxybate (SOE-dee-um OX-i-bate)

Oral route(Solution)

Central Nervous System (CNS) Depression and Abuse and MisuseCentral Nervous System DepressionSodium oxybate is a CNS depressant, and respiratory depression can occur with sodium oxybate use.Abuse and MisuseSodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB is associated with CNS adverse reactions, including seizure, respiratory depression, decreased consciousness, coma, and death.Sodium oxybate is available only through a restricted program called the Xywav and Xyrem REMS .

Medically reviewed by Drugs.com. Last updated on Sep 4, 2020.

Commonly used brand name(s)

In the U.S.

  • Xyrem

Available Dosage Forms:

  • Solution

Therapeutic Class: Central Nervous System Agent

Uses for sodium oxybate

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.

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

Before using sodium oxybate

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 sodium oxybate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sodium oxybate 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.

Pediatric

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

Geriatric

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.

Breastfeeding

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.

Interactions with 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 sodium oxybate, 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 sodium oxybate 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 sodium oxybate 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
  • Carisoprodol
  • Carphenazine
  • Cetirizine
  • Chlordiazepoxide
  • Chlorpromazine
  • Chlorzoxazone
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Clozapine
  • Codeine
  • Cyclobenzaprine
  • Dantrolene
  • 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
  • Lemborexant
  • 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
  • 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

Interactions with food/tobacco/alcohol

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 sodium oxybate 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 sodium oxybate. 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 sodium oxybate 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 sodium oxybate

Take sodium oxybate 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 sodium oxybate 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® REMS program, and become familiar with the Xyrem® Medication Guide and patient instructions. Ask your doctor if you have any questions.

Sodium oxybate is divided into 2 nightly doses. The first nightly dose should be taken at least 2 hours after you eat.

Sodium oxybate 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.

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.

Take sodium oxybate 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 sodium oxybate 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 sodium oxybate. 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 (solution):
    • For treatment of excessive daytime sleepiness and cataplexy:
      • 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.

Missed dose

If you miss a dose of sodium oxybate, 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 sodium oxybate

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 sodium oxybate if you are also taking another sedative or hypnotic medicine (eg, Ambien®, Phenergan®, Seconal®). Also, do not drink alcohol while you are using sodium oxybate. 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 sodium oxybate.

Sodium oxybate 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 sodium oxybate.

Sodium oxybate 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 sodium oxybate 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.

Sodium oxybate may cause feelings of sadness or hopelessness, change in weight or appetite, loss of interest or pleasure in usual activities, increased tiredness or weakness, or have suicidal thoughts and tendencies. If you notice any of these side effects, call your doctor right away.

Sodium oxybate 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 sodium oxybate 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.

Sodium oxybate side effects

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Frequently Asked Questions