Xyrem (Sodium Oxybate) – Oral

What Is Xyrem?

Xyrem (sodium oxybate) is an oral prescription drug used to treat cataplexy (muscle weakness) or excessive daytime sleepiness (EDS) in adults and children aged 7 years and older with narcolepsy.

Xyrem is in a drug class called central nervous system (CNS) depressants. It works by reducing brain activity.

Xyrem is a controlled substance because it contains the ingredient sodium oxybate, which is the salt of gamma-hydroxybutyrate, or GHB. GHB is another controlled substance that is illegal and is frequently illegally sold and abused.

Xyrem is not available at retail pharmacies. You can only get Xyrem through the Xywav and Xyrem REMS program, a program to distribute the medication. Your medication will be mailed to you after you have read the information and talked to a pharmacist. It is available as an oral solution.

What Is Xyrem Used For?

The Food and Drug Administration (FDA) approved Xyrem to treat cataplexy (muscle weakness) or excessive daytime sleepiness in adults and children (7 years and older) with narcolepsy. Narcolepsy is a sleep disorder characterized by overwhelming daytime drowsiness and falling asleep suddenly. 

Xyrem is categorized as a Schedule III controlled substance.

Before taking Xyrem, tell your provider if you use or have ever used street drugs or have overused prescription drugs. Xyrem is dangerous when taken by someone other than the person for whom it was prescribed. 

Do not sell your Xyrem medication or give it to someone else. This is against the law. Xyrem can cause serious and dangerous side effects, and cannot be mixed with alcohol and certain medications. Abusing illegal GHB, alone or in combination with other drugs that depress the central nervous system, can cause serious problems, including seizures, drowsiness, dangerous breathing problems, coma, or death.

How to Take Xyrem

If you are prescribed Xyrem, make sure to read the prescription label and information leaflet given to you by your healthcare provider. Use it exactly as directed and do not skip or change doses, unless your provider tells you to do so.

Xyrem is usually taken in two doses. Take it on an empty stomach, at least two hours after eating. Prepare both doses before bedtime. Dilute each dose with 60 milliliters, or ¼ cup, of water in the containers provided with the prescription. After mixing, store Xyrem in child-resistant containers and keep it out of reach of children and pets.

Adults:

• Take the first dose at bedtime, while in bed. Lie down as soon as you take the first dose.
• Take the second dose 2.5 to four hours after the first dose. Set an alarm to make sure you wake up to take the second dose. Remain in bed after taking the first and second doses.

Children:

• Give the first dose at bedtime, while the child is in bed. Have the child lie down as soon as they take the first dose. 
• Give the second dose 2.5 to four hours after the first dose. Set an alarm to make sure you wake up to give your child the second dose. The child should remain in bed after taking the first and second doses.

When using Xyrem, remember the following:

• Xyrem can cause your body to crave or depend on it if you do not take it as directed.
• Xyrem can cause sleep very quickly, and without warning. You may fall asleep as quickly as five minutes, and usually within 15 minutes. It may take a different amount of time to fall asleep on different nights. 
• Falling asleep quickly, including while standing up or getting up, has caused falls with injuries that have required hospitalization in some people. Xyrem should always be taken while in bed, and you should lie down as soon as you take it. 
• When you have finished using a Xyrem bottle, empty any remaining liquid down the drain, cross out the label on the bottle with a marker, and place the empty bottle in the trash.

Ask your healthcare provider if you have any questions or concerns about Xyrem.

Storage

Store at room temperature, away from heat, direct light, and moisture. Keep this medication in a safe place, such as a locked cabinet, and make sure no one else can get to it. Keep track of how much liquid is left in the bottle so you will know right away if any is missing. Keep the bottle tightly closed when not in use.

What Are the Side Effects of Xyrem?

This is not a complete list of side effects and others may occur. A medical professional can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at www.fda.gov/medwatch or 800-FDA-1088.

Like other medications, Xyrem can cause side effects. Tell your healthcare provider about any side effects you experience while taking this medication.

Common Side Effects

The most common side effects of Xyrem are:

• Stomach problems: nausea, vomiting, diarrhea, stomach pain
• Headache 
• Bedwetting 
• Dizziness 
• Sleepiness/tiredness 
• Appetite loss (and weight loss in children)
• Sleepwalking
• Sleep paralysis (not being able to speak or move when waking up or falling asleep)
• Excess sweating
• Tremor 
• Anxiety
• Dry mouth 
• Attention disturbance
• Confusion/disorientation
• Depression 
• Irritability 
• Pain
• Muscle spasm  
• Numbness and tingling

Severe Side Effects

Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• CNS depression (slowing down of brain activity, which can cause various effects from drowsiness in mild cases to unconsciousness, coma, or death in severe cases) 
• Respiratory depression (slowed breathing)
• Abuse/dependence
• Depression 
• Suicidal thoughts  
• Psychosis 
• Paranoia
• Hallucinations 
• Apnea (a serious sleep disorder in which breathing starts and stops)
  

Long-Term Side Effects

While many people tolerate Xyrem well, long-term or delayed side effects are possible. Some long-term side effects can be mild, such as:

• Appetite and weight loss 
• Anxiety 
• Numbness and tingling 
• Irritability 
• Excess sweating
• Muscle cramps 
• Joint pain 
• Increased desire for sex

Moderate long-term side effects can include:

• Depression 
• Sleep paralysis
• Peripheral edema (swelling of the extremities)
• Cataplexy (muscle weakness and loss of muscle control)
• Memory problems 
• Tolerance/dependence 
• Nystagmus (involuntary eye movements)

Severe long-term side effects may include:

• Suicidal thoughts 
• Apnea 
• Seizures 
• Serotonin syndrome (a life-threatening disorder caused by the buildup of too much serotonin)

Dosage: How Much Xyrem Should I Take?

Modifications

In certain situations, your healthcare provider may change your dosing or decide to prescribe you a different medication.

Age

You may need to use caution when taking Xyrem if you are 65 years or older. Older adults tend to experience a higher frequency of side effects such as headaches. Dosing for older adults should start low. 

Regarding use in children, Xyrem can be used in children ages 7 years and older. However, serious side effects are still possible in this age group, so your healthcare provider will weigh risks and benefits before prescribing Xyrem to a child 7 years or older. Xyrem is not indicated for use in children under 7 years old.

Liver Problems

People with liver problems also will require a lower dose. The prescribing information recommends the starting dose should be reduced by half in this group.

Pregnancy and Breastfeeding

There is no data on pregnant people and Xyrem. However, Xyrem caused harm and death to the fetus in animal studies. If you are pregnant or plan to become pregnant, talk to your healthcare provider. If you are taking Xyrem and find out you are pregnant, contact your provider right away for medical advice.

Xyrem is generally not recommended for use while breastfeeding. Consult your healthcare provider for medical guidance. If a breastfeeding person must take Xyrem, avoid breastfeeding for at least four or five hours after each dose, and the baby should be carefully monitored.

Missed Dose

If the second dose of Xyrem is missed, skip the dose. Do not take or give Xyrem again until the following night. Never take or give two doses at the same time.

Overdose: What Happens If I Take Too Much Xyrem?

Taking too much Xyrem can cause a variety of possible effects, including:

• Confusion 
• Agitation 
• Coma 
• Impaired coordination 
• Vomiting 
• Sweating 
• Headache
• Blurred vision 
• Seizures 
• Muscle jerks
• Breathing problems 
• Apnea or alternating apnea and hyperventilation
• Slow heart rate
• Unconsciousness 
• Hypothermia (a dangerous drop in body temperature)

Precautions

What Are Reasons I Shouldn’t Take Xyrem?

Xyrem is not appropriate for everyone. You should not take this medication if you are allergic to sodium oxybate or any of the inactive ingredients in Xyrem. 

Other people who should not take Xyrem include people who take other CNS depressants (such as opioid pain medicines, anxiety medicines, sleep medicines) or consume alcohol. People with a succinic semialdehyde dehydrogenase deficiency (a rare, inherited metabolism disorder that causes various delays) should not take Xyrem. 

Xyrem may be prescribed with caution in some people and only if the healthcare provider determines it is safe. This includes people with:

• Liver, kidney, or lung problems
• Heart disease or heart failure
• High blood pressure
• A risk of suicide
• Psychiatric disorders
• Sodium restrictions
• History of depression
• History of drug abuse
• History of incontinence (loss of bladder control)
  

What Other Medications May Interact With Xyrem?

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, and vitamins or supplements. 

Alcohol should never be consumed while taking Xyrem. The combination of alcohol and Xyrem can cause low blood pressure, fainting, and serious CNS and respiratory depression, which could cause unconsciousness, coma, or death. 

Xyrem should not be combined with other drugs that depress the CNS. Some examples include:

• Anticonvulsants such as Depakote (divalproex), Dilantin (phenytoin), Lyrica (pregabalin), Neurontin (gabapentin), and phenobarbital
• Antidepressants such as Celexa (citalopram), Cymbalta (duloxetine), Effexor (venlafaxine), Elavil (amitriptyline), Lexapro (escitalopram), Pamelor (nortriptyline), Paxil (paroxetine), Prozac (fluoxetine), and Zoloft (sertraline)
• Benzodiazepines such as Klonopin (clonazepam), Valium (diazepam), and Xanax (alprazolam)
• Cannabidiol or cannabis
• Muscle relaxants such as Flexeril (cyclobenzaprine), Lioresal (baclofen), Skelaxin (metaxalone), and Soma (carisoprodol)  
• Opioid pain medicines such as codeine, Dilaudid (hydromorphone), Duragesic (fentanyl), oxycodone, OxyContin (oxycodone), Percocet (oxycodone/acetaminophen), and Vicodin (hydrocodone/acetaminophen)  
• Sleeping medications such as Ambien (zolpidem), Lunesta (eszopiclone), and Sonata (zaleplon)
• Triptans for migraine such as Imitrex (sumatriptan), Maxalt (rizatriptan), and Zomig (zolmitriptan)

Other drug interactions may occur with Xyrem. Consult your healthcare provider for a complete list of drug interactions.

What Medications Are Similar?

Xyrem is prescribed to adults and children 7 years and older to treat muscle weakness and excessive daytime sleepiness due to narcolepsy. It contains the ingredient sodium oxybate.

Xywav is an oral solution that contains calcium, magnesium, potassium, and sodium oxybates. It is also indicated to treat adults and children 7 years and older with muscle weakness and excessive daytime sleepiness due to narcolepsy. It can also be used to treat idiopathic hypersomnia (IH). People with IH are very sleepy during the day. Xywav is a lower-sodium (lower-salt) version of Xyrem. 

Other drugs that are indicated to treat excessive daytime sleepiness due to narcolepsy include:

• Nuvigil (armodafinil)
• Provigil (modafinil)
• Sunosi (solriamfetol)
• Wakix (pitolisant)

This is a list of drugs also prescribed for narcolepsy. It is not a list of drugs recommended to take with Xyrem. Ask your pharmacist or a healthcare practitioner if you have questions.

How Can I Stay Healthy While Taking Xyrem?

Before taking Xyrem, discuss your medical history and all medication you take with your healthcare provider. 

When taking Xyrem, follow your healthcare provider’s instructions for use. Read the patient information leaflet that comes with your prescription and ask your provider if you have any questions.

Here are some tips for staying safe and healthy while taking Xyrem:

• Do not drink alcohol while taking Xyrem.
• Take Xyrem exactly as directed by your healthcare provider. Xyrem can cause dependence and craving for the medication if you do not take it as directed.
• Take Xyrem just before you are ready to go to sleep while sitting in bed, and lie down immediately after you take the medicine. Do not get out of bed after you take the first or second dose of Xyrem. 
• Xyrem interacts with various drugs. Tell your healthcare provider about all of the medications you take, including prescription and OTC drugs, vitamins, and supplements, before taking Xyrem. While taking Xyrem, do not start any new medications unless your provider says it is safe to do so. 
• Do not perform activities that require you to be fully awake and alert such as driving a car or flying an airplane, for at least six hours after taking the second dose of Xyrem. You should not perform these activities at all until you know how Xyrem affects you (or your child). 
• Xyrem contains sodium. People who are sensitive to sodium intake (for example, those with heart failure, high blood pressure, or kidney problems) should consult their healthcare provider for instructions on limiting sodium intake. 
• Xyrem can cause mental health problems, such as confusion, hallucinations, abnormal thinking, anxiety, and depression. It can also cause you to think about suicide or attempt suicide. Call your healthcare provider immediately if you or your child has any changes in mood or behavior, or changes in appetite or weight. 
• Xyrem can cause sleepwalking, which can cause injuries. Call your healthcare provider if you or your child starts to sleepwalk.