Xywav vs Xyrem

Xywav and Xyrem are brand names for prescription drugs used for the treatment of narcolepsy. Here we will explain how they work, their similarities and differences, their side effects, and more. This should provide you with the basics to better understand your options.

What is Xywav?

Xywav is an FDA (U.S. Food and Drug Administration) approved medication manufactured by Jazz Pharmaceuticals, Inc. It is a prescription medication containing calcium, magnesium, potassium, and sodium oxybates. Xywav is used as a central nervous system depressant for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy, and for idiopathic hypersomnia (a type of sleep disorder) in adult patients.

The active ingredient of Xywav is a form of gamma-hydroxybutyrate (GHB), that is classed as a CNS depressant. The exact mechanism of action of Xywav for the treatment of narcolepsy and idiopathic hypersomnia is not known.

Xywav is a controlled substance that can only be prescribed through a Risk Evaluation Mitigation Strategy (REMS) program. This means only certain doctors and pharmacies are able to prescribe and dispense this medication.

Xywav contains 92% less sodium than Xyrem.

Xywav dosage

Xywav is available in oral solution form, in the following doses: 0.5 g/mL total salts (equivalent to 0.413 g/mL of oxybate)

If you currently take Xyrem for narcolepsy, your starting dose of Xywav will likely match your current dosage of Xyrem. Your dose will be based on your age and the condition you are being treated for. Xywav contains 92% less sodium than Xyrem.

Please read the full prescribing information and medication guide for the complete boxed warning. Always speak with your prescriber about any changes to your dose so they can monitor and evaluate your condition.

What is Xyrem?

Xyrem is an FDA (U.S. Food and Drug Administration) approved medication manufactured by Jazz Pharmaceuticals, Inc. Xyrem is a prescription medication also used to treat narcolepsy. It is prescribed to adults and children 7 years of age and over to treat the symptoms of:

• The sudden onset of weak or paralyzed muscles (cataplexy)
• Excessive daytime sleepiness (EDS)

The active ingredient in Xyrem is sodium oxybate, a type of central nervous system depressant. Research has shown that sodium oxybate significantly reduces cataplexy and daytime sleepiness caused by narcolepsy.

It is not fully understood how sodium oxybate works, but it is thought that it binds to cells in your brain at sites called receptors. This stimulates the receptors and alters your brain function in a way that reduces cataplexy and daytime sleepiness. Xyrem is a schedule III controlled substance when prescribed to treat narcolepsy. There is a high risk of drug abuse associated with taking it.

Xyrem dosage

Xyrem is available in an oral solution formulation, in the following doses: 0.5 g per mL. Your dose will be based on your age and the condition you are being treated for.

Please read the full prescribing information, medication guide, and complete boxed warning. Always speak with your prescriber about any changes to your dose so they can monitor and evaluate your condition.

Common side effects of Xywav and Xyrem

The most common side effects of Xywav in clinical trials compared to placebo include:

• Headache, nausea, dizziness
• Decreased appetite, diarrhea
• Hyperhidrosis, anxiety, vomiting
• In pediatric studies, common adverse reactions include bedwetting, nausea, headache, vomiting, dry mouth, weight decreased, decreased appetite, and dizziness

In rare instances, Xywav can cause more serious side effects. These can include:

• CNS depression
• Parasomnia (talking in your sleep, sleep paralysis, sleepwalking)
• Somnolence, fatigue, and tremor
• Depression and suicidality
• Confusion, anxiety

The most common Xyrem side effects include:

• Headaches
• Dizziness
• Tremors
• Nausea, vomiting
• A decrease in appetite
• Weight loss
• Sleepwalking
• Wetting the bed

In rarer instances, Xyrem can cause more serious side effects, like:

• Severe allergic reactions to the medication
• Respiratory depression – slower breathing and stopping breathing for short periods of time
• A worsening of or new mental health (psychiatric) problems, including depression, anxiety, aggressive behaviors, hallucinations, mania, and suicidal thoughts and behaviors
• Falls and injuries caused by sleepwalking
• Sleepwalking, waking, and confused behavior at night

These aren’t all the side effects Xywav or Xyrem can cause. You can find more details in the patient leaflet that comes with your medication. If you have any concerns about side effects, talk to your physician or pharmacist.

Xywav and Xyrem drug interactions

Xywav can interact with other medications. These include:

• Divalproex sodium – an initial reduction in Xywav dose is recommended
• Central nervous system (CNS) depressants such as opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol, or street drugs

Xyrem can interact with other medications. Tell your prescribing doctor about all drugs you are taking, particularly any other central nervous system (CNS) depressants. These include:

• Antipsychotics, benzodiazepines, general anesthetics, muscle relaxants, opioid analgesics, sleeping pills, anti-anxiety medication, sedating antidepressants, street drugs/recreational drugs – heroin
• Any medications that contain divalproex sodium, like Depakote, Depakote DR, Depakote ER, or Depakote Sprinkles

Xywav and Xyrem can interact with other medications. This can change how Xywav and Xyrem and other medications work and can make side effects more likely. Tell your prescribing physician about all your drugs, including vitamins and dietary supplements.

Xywav and Xyrem contraindications

You should not use Xywav if you:

• Are allergic to the active ingredient, calcium oxybate, magnesium oxybate, potassium oxybate, or sodium oxybates
• Are allergic to any of the other ingredients in Xywav
• Are taking sedative-hypnotics or alcohol
• Have succinic semialdehyde dehydrogenase deficiency
• Are pregnant or are planning to become pregnant

Talk to your doctor before using Xywav  if you:

• Are taking any of the medications that could interact with Xywav
• Have liver disease
• Have breathing problems (such as sleep apnea, or asthma)
• Have a personal or family history of regular use or abuse of drugs and alcohol
• Have mental health problems such as depression
• Have a family or personal history of suicidal thoughts or attempts
• Are breastfeeding or are planning to breastfeed

You should not use Xyrem if you:

• Are allergic to the active ingredient sodium oxybate
• Are allergic to any of the other ingredients in Xyrem
• Drink alcohol
• Have a rare condition called succinic semialdehyde dehydrogenase deficiency

Talk to your doctor before taking Xyrem if you:

• Are taking any of the medications that could interact with Xyrem
• Have a history of mental health problems
• Have a history of drug or alcohol addiction/abuse
• Have heart failure
• Have sleep apnea (short periods of not breathing while sleeping) or any other breathing problems
• Have high blood pressure (hypertension)
• Have any liver problems
• Have any kidney problems
• Are pregnant or are planning to become pregnant
• Are breastfeeding or are planning to breastfeed

Other drugs for narcolepsy

• Sunosi
• Provigil
• Nuvigil

If you have any concerns about Xywav or Xyrem side effects, talk to your physician, or pharmacist for medical advice. Also inform your healthcare provider about any medical conditions, supplements, and over-the-counter meds you are taking. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.