Drug updated on 4/16/2024
| Dosage Form | Solution (oral; 0.5 g/mL) |
| Drug Class | Central nervous system depressants |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
- Treatment of idiopathic hypersomnia (IH) in adults.
Summary
- Calcium, magnesium, potassium, and sodium oxybates (Xywav) is indicated for the treatment of cataplexy or excessive daytime sleepiness in patients aged 7 years and older with narcolepsy as well as idiopathic hypersomnia in adults.
- The information provided was derived from one document which was a Randomized Controlled Trial.
- In this trial involving adults aged between 18-70 years diagnosed with narcolepsy with cataplexy, Xywav demonstrated efficacy in treating symptoms of both conditions after transitioning from previous medications used for the same purpose during a 12-week open-label optimized treatment period followed by a two-week stable-dose period.
- During the double-blind randomized withdrawal phase of the study where participants were either continued on Xywav or switched to placebo, those who received placebo experienced statistically significant worsening of symptoms including an increase in weekly number of cataplexy attacks and higher Epworth Sleepiness Scale scores compared to those who remained on Xywav therapy.
- Safety assessment revealed that common adverse events associated with Xywaw included headache (20.4%), nausea (12.9%) and dizziness (10.4%).
- Xywaw's safety profile was found consistent with sodium oxybate (SXB), another medication commonly used for similar indications but contains significantly more sodium than Xyawav (92% less).
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Xywav (calcium, magnesium, potassium, and sodium oxybates) Prescribing Information. | 2023 | Jazz Pharmaceuticals, Inc., Palo Alto, CA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Efficacy and safety of calcium, magnesium, potassium, and sodium oxybates (lower-sodium oxybate [LXB]; JZP-258) in a placebo-controlled, double-blind, randomized withdrawal study in adults with narcolepsy with cataplexy. | 201Subjects F: 61% M: 39% | 2021 | Sleep |
| Quality of life in a phase 3, placebo-controlled, double-blind, randomized withdrawal study of lower-sodium oxybate in adults with narcolepsy with cataplexy (2044). | Data not availableSubjects F: null% M: null% | 2021 | Neurology: American Academy of Neurology |
Sex Distribution:
F:61%
M:39%
201Subjects
Year:
2021
Source:Sleep
Sex Distribution:
Year:
2021
Source:Neurology: American Academy of Neurology
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Calcium, magnesium, potassium and sodium oxybates (Xywav®) in sleep disorders: a profile of its use. | 2022 | CNS Drugs |
| Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline. | 2021 | Journal of Clinical Sleep Medicine |