Jazz PharmaceuticalsJAZZ
Neurology40 cited findings · profile updated 2026-08-25
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About Jazz Pharmaceuticals
Jazz Pharmaceuticals (JAZZ) focuses on neurology. The company's drug Xyrem, originally approved on July 17, 2002, is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS). Xyrem has a minimum age for use of 7 years of age and a maximum recommended dose of 9 g/night. The most common side effects for Xyrem in adult patients include nausea, dizziness, vomiting, somnolence, enuresis, and tremor, while in pediatric patients, they include enuresis, nausea, headache, vomiting, weight decreased, decreased appetite, and dizziness. Xyrem is a Schedule III controlled substance and requires a REMS Program, which was approved on February 27, 2015. Unused prepared doses of Xyrem should be disposed of within 24 hours, and patients should avoid hazardous activities for 6 hours after dosing. Healthcare provider check-ups are recommended every 3 months after the dose is established. Epidyolex, another drug, showed an incidence of aggression and/or irritability of 9% in the CBD-OS treated population, with an increase in irritability of 5.5%.
Compiled from the cited findings below — figures are as stated in each company's published technical reports and filings.
Key figures — cited
| Original approval date | July 17, 2002 | JAZZ PHARMS — Xyrem FDA Review (NDA/BLA 021196, 2022), p.241 |
| Difference in percentage change in weekly cataplexy attacks | 40% | JAZZ PHARMS — Xyrem FDA Review (NDA/BLA 021196, 2022), p.247 |
| Incidence of aggression and/or irritability in CBD-OS treated population | 9 % | Jazz — Epidyolex EMA EPAR public assessment report (EMEA/H/C/004675, 2, p.173 |
| REMS Program approval date | February 27, 2015 | JAZZ PHARMS — Xyrem FDA Review (NDA/BLA 021196, 2022), p.241 |
| Minimum age for use | 7 years of age | JAZZ PHARMS — Xyrem FDA Review (NDA/BLA 021196, 2022), p.102 |
| XYREM maximum recommended dose | 9 g/night | JAZZ PHARMS — Xyrem FDA Review (NDA/BLA 021196, 2022), p.174 |
Key projects
- Xyrem (cataplexy or excessive daytime sleepiness (EDS))
Xyrem was originally approved on July 17, 2002.
- Xyrem (pediatric use for cataplexy in narcolepsy and excessive daytime sleepiness in narcolepsy) — US
The proposed indication expansion for Xyrem is for pediatric use for the treatment of cataplexy in narcolepsy and the treatment of excessive daytime sleepiness in narcolepsy for patients 7 years and older.
- Epidyolex
The incidence of aggression and/or irritability in the CBD-OS treated population for Epidyolex was 9%.
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