Sodium Oxybate

Sodium Oxybate is a prescription medication used to treat cataplexy (sudden loss of muscle strength) and reduce daytime sleepiness in patients with narcolepsy.

• Sodium Oxybate is available under various brand names: Xyrem 

Common side effects of Sodium Oxybate include:

• drowsiness, dizziness.
• bed-wetting.
• nausea, vomiting; or
• tremors.

Serious side effects of Sodium Oxybate include:

hives. 

• difficult breathing. 
• swelling of the face, lips, tongue, or throat.
• weak or shallow breathing, breathing that stops for short periods of time.
• aggression, paranoia, hallucinations (seeing or hearing things).
• sleepwalking, waking, and confused behavior at night.
• depression, agitation, unusual or unpleasant thoughts; or
• suicidal thoughts or actions.

Rare side effects of Sodium Oxybate include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Oral solution, Schedule III

• 500 mg/mL

Narcolepsy

Adult dosage

• Initial: 2.25 g at bedtime after the patient is in bed, and 2.25 g administered 2.5 to 4 hours later (4.5 g/night). 
• May increase the nightly dose by 1.5 g (0.75 g at bedtime and 0.75 g administered 2.5 to 4 hours later) at weekly intervals based on efficacy and tolerability; usual effective dosage range: 6 to 9 g per night. 
• Maximum dose: 9 g/night.

Pediatric dosage

• Children above 7 years and Adolescents:
• Children below 20 kg: Oral: Limited data available:
  • Initial: 60 to 90 mg/kg/night (total dose) in 2 divided doses; the first dose administered at bedtime after the patient is in bed, then 2.5 to 4 hours later, administer the second dose; titrate every 1 to 2 weeks until efficacy or development of intolerable side effects. Reported maximum daily dose: 180 mg/kg/night
• Children 20 to below 30 kg: 
  • Oral: Initial: below 1 g at bedtime after the patient is in bed, then 2.5 to 4 hours later, administer a second dose of above 1 g. After 1 week, titrate dose based on efficacy and tolerability at weekly intervals; increase the dose in below 0.5 g/dose (below 1 g/night) increments per week; maximum single dose: 3 g/dose; maximum daily dose: 6 g/night.
• Children 30 to below 45 kg: 
  • Oral: Initial: below 1.5 g at bedtime after the patient is in bed, then 2.5 to 4 hours later, administer a second dose of below 1.5 g. After 1 week, titrate dose based on efficacy and tolerability at weekly intervals; increase the dose in below 0.5 g/dose (below 1 g/night) increments per week; maximum single dose: 3.75 g/dose; maximum daily dose: 7.5 g/ night.
• Children below 45 kg: 
  • Oral: Initial: below 2.25 g at bedtime after the patient is in bed, then 2.5 to 4 hours later, administer a second dose of below 2.25 g. After 1 week, titrate dose based on efficacy and tolerability at weekly intervals; increase the dose in below 0.75 g/dose (1.5 g/night) increments per week. 
  • maximum single dose: 4.5 g/dose; maximum daily dose: 9 g/night.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Sodium Oxybate has severe interactions with the following drugs:
  • amobarbital
  • azelastine
  • butabarbital
  • chloral hydrate
  • estazolam
  • eszopiclone
  • ethanol
  • flurazepam
  • phenobarbital
  • quazepam
  • ramelteon
  • sufentanil SL
  • temazepam
  • zaleplon
  • zolpidem
• Sodium Oxybate has serious interactions with at least 126 other drugs.
• Sodium Oxybate has moderate interactions with the following drugs:
  • brexanolone
  • cenobamate
  • daridorexant
  • difelikefalin
  • esketamine intranasal
  • food
  • ganaxolone
  • lasmiditan
  • lemborexant
  • midazolam intranasal
  • oliceridine
  • remimazolam
  • stiripentol
• Sodium Oxybate has minor interactions with the following drugs:
  • eucalyptus
  • sage

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity
• Concomitant sedative-hypnotic drugs or other drugs used for insomnia
• Coadministration with alcohol
• Succinic semialdehyde dehydrogenase deficiency 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Sodium Oxybate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Sodium Oxybate?”

Cautions

• Sodium Oxybate can slow or stop your breathing, even at regular doses or if you are also taking stimulant medicines.
• Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
• Avoid taking other medicines that make you sleepy or slow your breathing. This includes cold or allergy medicine, opioid pain medicine, sedatives, muscle relaxants, seizure medicine, or medicine for depression, anxiety, or mental illness. Your doctor may need to change your treatment plan if you need to use any of these other medicines.
• Misuse of sodium Oxybate can cause breathing problems, seizures, loss of consciousness, or death. Sodium Oxybate is available only from a certified pharmacy. Do not allow anyone else to use your medication.
• Do not drink alcohol or take other sleep medicines together with sodium Oxybate. Dangerous side effects or death could occur.
• Do not give sodium Oxybate to anyone who has a rare metabolic disorder called succinic semialdehyde dehydrogenase deficiency (which can cause mental or physical impairment).
• It is dangerous to purchase sodium Oxybate on the Internet or outside the United States. The sale and distribution of medicines outside the U.S. does not comply with safe-use regulations of the Food and Drug Administration (FDA). These medications may contain dangerous ingredients, or may not be distributed by a licensed pharmacy.
• Do not drink alcohol. Dangerous side effects or death could occur.
• Sodium Oxybate will cause drowsiness and can impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine. Wait at least 6 hours or until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.
• Do not take other sleep medicines together with sodium Oxybate.

Pregnancy and Lactation

• It is not known whether sodium Oxybate will harm an unborn baby. Tell your doctor if you are pregnant.
• Lactation
  • It may not be safe to breastfeed a baby while you are using this Sodium Oxybate. Ask your doctor about any risks.