Xywav

What is Xywav?

• XYWAV® is the brand name anti-cataplexy prescription drug with the generic name of calcium, magnesium, potassium, and sodium oxybates oral solution.
• It is an improved version(specifically, less sodium) of the sodium oxybate sold under the brand name xyrem.

What are the warnings and precautions for Xywav?

• XYWAV is a CNS depressant, and respiratory depression can occur with XYWAV use.
• Caution patients against hazardous activities requiring complete mental alertness or motor coordination within the first 6 hours of dosing or after first initiating treatment until certain that XYWAV does not affect them adversely.
• Depression and suicidality: Monitor patients for emergent or increased depression and suicidality.
• Confusion/Anxiety: Monitor for impaired motor/cognitive function.
• Parasomnias: Evaluate episodes of sleepwalking.

What are the abuse and misuse precautions?

• The active moiety of XYWAV is oxybate or gamma-hydroxybutyrate (GHB).
• Abuse or misuse of illicit GHB is associated with CNS adverse reactions, including seizure, respiratory depression, decreased consciousness, coma, and death

How is Xywav dispensed

XYWAV is available only through a restricted program called the XYWAV REMS and XYREM REMS

What are the uses of Xywav?

XYWAV is a central nervous system depressant indicated for the treatment of:

• Cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy
• Idiopathic Hypersomnia (IH) in adults

What is the recommended dosage for Xywav?

• For adults, start the medication at 4.5 g per night orally, divided into two doses.
• Titrate to effect in increments of up to 1.5 g per night per week.
• Recommended dosage range: 6 g to 9 g per night orally, divided into two doses.
• Doses may be divided equally or unequally and the first dose taken at bedtime and the second dose taken 2.5 to 4 hours later.

What is dosage for pediatric patients?

• The recommended starting dosage, titration regimen, and maximum total nightly dosage are based on body weight.

What is the dosage for Idiopathic Hypersomnia?

• XYWAV can be administered as a twice or once nightly regimen in adults

Twice nightly

• Initiate dosage at 4.5 g or less per night orally, divided into two doses.
• Titrate to effect in increments of up to 1.5 g per night per week, up to 9 g total nightly dose.

Once nightly

• Initiate dosage at 3 g or less per night orally, as one dose.
• Titrate to effect in increments of up to 1.5 g per night per week, up to 6 g total nightly dose.
• Take XYWAV at least 2 hours after eating.

How do you prepare Xywav for administration?

• Prepare XYWAV prior to bedtime; dilute with approximately ¼ cup of water in pharmacy-provided containers.
• Take XYWAV while in bed and lie down after dosing.

How to transition from taking Xyrem to Xywav?

For Patients Transitioning from Xyrem to XYWAV: Initiate at the same dose and regimen as Xyrem (gram for gram). Titrate as needed based on efficacy and tolerability.

What dosage adjustments are needed for patients with liver impairment?

Recommended starting dosage is one-half of the original dosage per night administered orally, divided into two doses

What dosages are available?

• Oral solution: 0.5 g/mL total salts (equivalent to 0.413 g/mL of oxybate)
• Take orally, divided into two doses

What dosages does this medicine come in?

Oral solution: 0.5 g/mL total salts (equivalent to 0.413 g/mL of oxybate)

Who should not use this medicine?

• Do not take this medicine in combination with sedative hypnotics or alcohol
• Do not take this medicine if you have succinic semialdehyde dehydrogenase deficiency

What side effects can Xywav cause?

• Most common adverse reactions in adults with narcolepsy or IH (≥5%) were nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor.
• In a pediatric study with sodium oxybate (same active moiety as XYWAV), the most common adverse reactions (≥5%) were nausea, enuresis, vomiting, headache, weight decreased, decreased appetite, dizziness, and sleepwalking.

What drug to drug interactions can this medication cause?

• Concomitant use with divalproex sodium: An initial reduction in XYWAV dose of at least 20% is recommended.

Can this medication be used in pregnancy?

• Pregnancy: Based on animal data, may cause fetal harm.
• Geriatric patients: Monitor for impairement

Can this medication be used by nursing mothers?

• GHB is excreted in human milk. There is insufficient data regarding the administration to breastfed infants and milk production in nursing mothers.

How to store Xywav?

• Store at room temperature.
• Each dose should be diluted with ¼ cup of water in provided empty pharmacy containers.
• Diluted solution should be used within 24 hours.

How does Xywav work?

• The exact mechanism of action of oxybate salts to treat narcolepsy with cataplexy is unknown
• It is likely to be mediated through its actions of GABAB on noradrenergic, dopaminergic, and thalamocortical neurons during sleep.

What studies are done to demonstrate safety and effectiveness?

Clinical safety and efficacy outcomes are based on a phase 3 trial, 16 weeks in duration with two weeks of data comparing lower-sodium oxybate (LXB) vs placebo. Six individuals included in study were ≥ 65 years of age. Sodium oxybate (SXB) is recommended for the treatment of cataplexy in several Clinical Practice Guidelines based on Class 1 evidence. 16-17 Lower-sodium oxybate (LBX) is also effective in treating cataplexy.

What are the main benefits of Xywav compared Xyrem?

• The American Heart Association recommends limiting sodium intake to 2,300 mg per day, with an even more strict limit of 1,500 mg per day for most adults, especially those with high blood pressure.
• Since LBX has 92% lower sodium content compared to SXB, it offers another treatment option for treating cataplexy in patients with NT1 and cardiovascular/renal disease or other health condition/valid medical reason requiring a lower daily sodium consumption. 

Who manufactures Xywav?

• Xywav, and Xyrem are manufactured and distributed by Jazz Pharmaceuticals

What is the cost of Xywav?

• While the cash pay or self pay cost is $5843.12 for 180 ml bottle, most insurances do cover this medication.

How is it like to live with narcolepsy?

Watch patient stories below

What are the frequently asked questions about Xywav?

Here are some of the most commonly asked questions about Xywav and their answers.

Is Xywav a narcotic?

No, it is not. It is a controlled substance, however.

Is Xywav a stimulant?

No, it is not. Xywav is a central nervous system depressant.

Is Xywav a tablet?

No, it is supplied as an oral solution.

Does Xywav cause anxiety?

Although rare, Xywav can cause confusion and anxiety in some patients.

What is the difference between Xywav and Xyrem?

The difference between Xywav and Xyrem is that Xyrem, being a sodium salt, gives a significant load of sodium while Xywav, being a mixture of sodium, potassium, calcium and magnesium salt, reduces the sodium load by as much as 92%.

Can you overdose on Xywav?

Yes, you can overdose on Xywav

Does Xywav work as well as Xyrem?

Yes, clinical studies have shown that these two medications are therapeutically equivalent.

How is Xywav supplied?

It is supplied as an oval solution

How do you get sodium oxybate?

It is a controlled prescription medication usually prescribed by physicians and healthcare providers for a specific medical problem such as narcolepsy or idiopathic hypersomnia

Is Xyrem covered by insurance?

Yes, most insurances cover Xyrem and Xywav.

How is idiopathic hypersomnia treated?

• Xywav is one of the FDA approved medications to treat idiopathic hypersomnia.
• Other treatments include stimulants, such as Adderall, wakefulness promoting agents such as armodafanil (Nuvigil) and modafinil (Provigil), pitolisant

(Wakix), solriamfetol (Sunosi) etc.

How to find a sleep doctor near me?

► Sleep medicine providers

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• Dailymed label info on Xywav
• FDA Xywav

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