Sodium oxybate is used to treat cataplexy (sudden muscle weakness after strong emotions) and excessive daytime sleepiness (EDS) in people with narcolepsy. Common side effects of the medication include nausea, dizziness, and bedwetting (especially in children). Sodium oxybate is a controlled substance because it has the potential for misuse and dependence. Sodium oxybate is available as brand-name Xyrem and lower-cost generic that are taken twice at night for people age 7 years and older. There's also a newly-approved, extended-release version for adults called Lumryz that's taken only once at night (expected to be available in summer 2023).
Excessive daytime sleepiness (EDS) or cataplexy in people with narcolepsy
Sodium oxybate is a central nervous system (CNS) depressant. It's not entirely clear how the medication works. But researchers think that it works on proteins in the brain known as gamma-aminobutyric acid (GABA) receptors to help with cataplexy and EDS in people with narcolepsy.
Sodium oxybate can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: Personal or family history of substance or alcohol use disorder | History of mental health conditions | Taking more of sodium oxybate than prescribed
Sodium oxybate is a schedule III controlled substance because it has a risk of misuse. This can lead to serious, life-threatening problems, such as seizure, extremely slowed breathing, and overdose. Misuse of sodium oxybate can sometimes also lead to addiction. Because of these risks, the FDA requires this medication to be distributed under the Xyrem REMS and Lumryz REMS programs. You, your provider, and the pharmacy must all enroll in this program to make sure you're taking this medication safely.
Risk factors: Drinking alcohol | Taking other CNS depressants | History of breathing problems (e.g., sleep apnea)
Sodium oxybate can slow your breathing down to the point where it's life-threatening. This can look like shortness of breath, slow and shallow breathing, and bluish-colored lips, fingers, or toes. If this change in your breathing isn't recognized and treated right away, it can lead to death. Get medical help right away if you or a loved one notices that you have symptoms of extremely slowed breathing.
Sodium oxybate can slow down your brain activity. This can make you very sleepy and have trouble thinking, focusing, and reacting. Don't drive or perform any activities that require you to be alert until you know how this medication affects you, and especially for at least 6 hours after taking it.
Changes in mental alertness and slowed breathing can happen at any time while you're taking sodium oxybate and even at recommended doses. But your risk is higher if you drink alcohol or take other CNS depressants, such as opioids, muscle relaxants, or antipsychotics, while you're taking sodium oxybate. Speak to your provider if you have concerns about these risks.
Risk factors: History of mental health conditions
Some people taking sodium oxybate had behavioral changes like confusion, seeing or hearing things that aren't there, paranoia, and aggression. Some people also reported having depression and thoughts of hurting themselves. Let your provider know if you have a history of mental health problems. They might want to follow up with you more often to make sure your mental health is okay while you're taking sodium oxybate. Tell your provider if you start to behave in ways that aren't normal for you or have new or worsening depression. Call a provider right away if you have thoughts of wanting to hurt yourself.
Some people taking sodium oxybate experienced sleepwalking (having confused behavior or wandering throughout the night) or other similar sleep disorder. This can raise the risk of injuring yourself. Make sure your family and loved ones know about this side effect so they can watch out for your safety. Tell your provider if you have sleepwalking episodes or if you wander throughout the night.
Risk factors: Heart failure | High blood pressure | Kidney problems | Low sodium diet
Sodium oxybate contains a high amount of sodium (salt). This can be especially dangerous for people who are sensitive to salt intake, such as those with congestive heart failure, high blood pressure, or kidney problems. Tell your provider about your full medical history before starting sodium oxybate.
Source: DailyMed
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
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
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
difficulty passing urine (dribbling)
increased frequency, urgency, or burning on urination
increased sweating
vomiting
Less common
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.
One of the first-choice medications to treat narcolepsy
Can use in children 7 years and older (immediate-release version only)
Is a liquid mixture, so you don't need to swallow a pill
Dose can be adjusted if needed
Need to wake up in the middle of the night to take the second dose (immediate-release version only)
Need to mix the doses with water before taking
Risk of dependence and misuse
Can't take with other sleep medications
Make sure to keep sodium oxybate in its original bottle until you're ready to use it.
Take your sodium oxybate dose(s) at your bedside at least 2 hours after eating. Food can affect how fast your body absorbs the medication and how well it works.
Lie down in bed right after taking sodium oxybate to avoid falling and injuring yourself. You'll probably fall asleep very soon after taking the medication (within 5 to 15 minutes).
Sodium oxybate can cause drowsiness that can last for many hours. Don't drive or operate machinery until you know how this medication affects you, especially during the 6 hours after taking it.
Let your provider know if you experience sleep walking or mood changes (e.g., depression, difficulty concentrating, suicidal thoughts) while taking sodium oxybate.
After you're finished with the medication bottle, pour any unused medication down the sink. You can throw away the empty bottle in the trash, but make sure to cross out your name or other personal information.
If you, your child, or someone you know overdoses on sodium oxybate, get medical attention or call a Poison Control Center right away at 1-800-222-1222.
For the immediate-release version (Xyrem and generic)
Review the Xyrem instructions on how to prepare and take the medication properly. Ask your provider or pharmacist if you have any questions.
Prepare your two doses before bedtime by mixing each dose with 60 mL (1/4 cup) of water in the provided containers. After you mix sodium oxybate with water, take it within 24 hours.
You'll need to space out your two doses by 2.5 to 4 hours. Don't take two doses at once because this can cause serious side effects. Set an alarm so that you'll wake up to take your second dose of the night.
If you miss your second dose of sodium oxybate, skip the missed dose and wait until the next night to take your next two doses.
For the extended-release version (Lumryz)
Review the Lumryz instructions on how to prepare and take the medication safely. Ask your provider or pharmacist if you have any questions.
Before bedtime, mix your Lumryz dose with 1/3 cup of water. Only use the mixing cup that was provided to you; don't use a household cup, and don't mix it with hot water. After you mix your dose with water, take it within 30 minutes; don't let it sit out for longer than that.
Dosage | Quantity | Price as low as | Price per unit |
---|---|---|---|
180ml of 500mg/ml | 3 bottles | $6830.28 | $2276.76 |
Immediate-release sodium oxybate (Xyrem and generic)
Adults: The typical starting dose is 2.25 grams by mouth at bedtime and 2.25 grams taken 2.5 to 4 hours later. Your provider will raise your dose every week to the usual dose of 6 to 9 grams by mouth per night, split into two doses.
Children age 7 years and older: Dosing will depend on your child's weight. The dose should be taken by mouth twice per night (at bedtime and 2.5 to 4 hours later). Your child's provider will raise your child's dose every week to a maximum dose of 6 to 9 grams per night.
Extended-release sodium oxybate (Lumryz)
Adults: The typical starting dose is 4.5 grams by mouth as a single dose each night at bedtime. Your provider will raise your dose every week to the usual dose of 6 to 9 grams per night.
Children: Talk to your child's provider because it's not known if this version is safe or will work well for them.
Your dose might differ if you have liver problems or if you're taking divalproex (Depakote).
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.
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.
Take other sedative medications
Drink alcohol
A genetic condition called succinic semialdehyde dehydrogenase deficiency
Excessive daytime sleepiness (EDS) or cataplexy in people with narcolepsy
Excessive daytime sleepiness or cataplexy (sudden muscle weakness) in adults with narcolepsy
Excessive daytime sleepiness in children ages 6 and older with narcolepsy
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