Last reviewed · How we verify
Xyrem
At a glance
| Generic name | Xyrem |
|---|---|
| Also known as | Sodium Oxybate, Sodium Oxybate Placebo, gamma-hydroxybutyrate |
| Sponsor | Jazz Pharmaceuticals |
| Target | Calcium/calmodulin-dependent protein kinase type II subunit alpha, GABA-B receptor, Gamma-hydroxybutyrate receptor |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
- Cataplexy and narcolepsy
- Narcolepsy
Common side effects
- Nausea
- Dizziness
- Vomiting
- Somnolence
- Enuresis
- Tremor
- Feeling drunk
- Disturbance in attention
- Disorientation
- Sleepwalking
- Irritability
- Sleep paralysis
Serious adverse events
- Treatment discontinuation due to adverse reactions
- Respiratory depression
- Abuse and dependence
- CNS depression
Key clinical trials
- Stimulating Amyloid Clearance in Cerebral Amyloid Angiopathy (PHASE2)
- Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ) (PHASE3)
- Sodium Oxybate Versus Midazolam for Comfort Sedation (PHASE4)
- Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor (PHASE2, PHASE3)
- Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor (PHASE1)
- Efficacy, Safety and Tolerability of Low Sodium Oxybate for Nocturnal Cluster Headache Attacks (PHASE2)
- Extended-release Sodium Oxybate in Children (PHASE2)
- An Open Label Study of FT218 in Subjects With Narcolepsy (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Xyrem CI brief — competitive landscape report
- Xyrem updates RSS · CI watch RSS
- Jazz Pharmaceuticals portfolio CI