XYREM (sodium oxybate)
XYREM is indicated for the treatment of Cataplexy; Excessive Daytime Sleepiness; Narcolepsy.
How XYREM Works
The exact mechanism of action of Xyrem in the treatment of narcolepsy has not been fully established. Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB), which is an endogenous metabolite of the neurotransmitter GABA. It is hypothesized that the drug's therapeutic effects are mediated through GABA B actions at noradrenergic, dopaminergic, and thalamocortical neurons.
Details
- Status
- Prescription
- First Approved
- 2002-07-17
- Patent Cliff
- 2033
- Revenue
- $38M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- SOLUTION
XYREM Approval History
What XYREM Treats
3 indicationsXYREM is approved for 3 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cataplexy
- Excessive Daytime Sleepiness
- Narcolepsy
XYREM Boxed Warning
CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE. • Central Nervous System Depression Xyrem (sodium oxybate) is a CNS depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in adult patients treated with Xyrem [see Warnings and Precautions ( 5.1 )]. Many patients who received Xyrem during clinical trials in narcolepsy were receiving central nervous system stimulants [see Clinical Trials ( 14 )]. • Abuse and Misuse Xyrem ®...
WARNING: CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE. • Central Nervous System Depression Xyrem (sodium oxybate) is a CNS depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in adult patients treated with Xyrem [see Warnings and Precautions ( 5.1 )]. Many patients who received Xyrem during clinical trials in narcolepsy were receiving central nervous system stimulants [see Clinical Trials ( 14 )]. • Abuse and Misuse Xyrem ® (sodium oxybate) is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death [see Warnings and Precautions ( 5.2 )]. Because of the risks of CNS depression and abuse and misuse, Xyrem is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYWAV and XYREM REMS [see Warnings and Precautions ( 5.3 )]. WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION and ABUSE AND MISUSE. See full prescribing information for complete boxed warning. Central Nervous System Depression • Xyrem is a CNS depressant, and respiratory depression can occur with Xyrem use ( 5.1 , 5.4 ) Abuse and Misuse • Xyrem is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB is associated with CNS adverse reactions, including seizure, respiratory depression, decreased consciousness, coma, and death ( 5.2 , 9.2 ) Xyrem is available only through a restricted program called the XYWAV and XYREM REMS ( 5.3 )
XYREM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to XYREM
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07041203 | 2025P000919 | Ph 1 | not yet recruiting | Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor |
| NCT03292458 results posted | 2019P001680 R01DC012545 | Ph 2, Ph 3 | completed | Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor |
| NCT04006925 results posted | 47852 | Ph 4 | completed | Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate |
| NCT01584934 | 2012/197 2011-006336-23 | Ph 4 | withdrawn | Sodium Oxybate in Patients With Chronic Fatigue Syndrome. |
| NCT02637076 results posted | 017-2014 | Ph 4 | completed | Xyrem and Brain Dopamine in Narcolepsy |
| NCT02111122 PD-Xyrem | KEK-ZH-Nr. 2013-0239 | Ph 2 | completed | Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease |
| NCT02055898 SAFFE results posted | SAFFE2012 2012-002969-35 | Ph 4 | completed | SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE) |
| NCT02221869 results posted | 13-005 | Ph 3 | completed | A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy |
| NCT00744393 | NEMC-8479 | Ph 2 | withdrawn | The Effect of Sodium Oxybate on Sleep Architecture |
| NCT01961297 results posted | GCO 09-1156 R01DC012545 | Ph 2 | completed | Voice Tremor in Spasmodic Dysphonia: Central Mechanisms and Treatment Response |
| NCT00594256 results posted | 07I/C36-0 | Ph 2 | completed | Sodium Oxybate in Schizophrenia With Insomnia |
| NCT02215499 | CP386.1001 | Ph 1 | completed | A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics |
| NCT00931164 AHC-SO results posted | 32164 103932 | Ph 1, Ph 2 | completed | Sodium Oxybate in Patients With Alternating Hemiplegia of Childhood (AHC-SO) |
| NCT00803023 results posted | 08-004 | Ph 3 | completed | Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
XYREM FDA Label Details
Indications & Usage
FDA Label (PDF)XYREM is indicated for the treatment of Cataplexy; Excessive Daytime Sleepiness; Narcolepsy.
WARNING: CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE. • Central Nervous System Depression Xyrem (sodium oxybate) is a CNS depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in adult patients treated with Xyrem [see W...
XYREM Patents & Exclusivity
Patents (13 active)
Exclusivity
Pro Intelligence Preview
Deep insights for XYREM
Revenue Insights
- • Q4-2025: $38M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 14 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.