SODIUM OXYBATE
Sodium oxybate is a central nervous system depressant used to manage symptoms in patients living with narcolepsy. It specifically helps patients with cataplexy and excessive daytime sleepiness. This medication is prescribed to address these core neurological challenges, though certain pediatric labeling information is restricted due to marketing exclusivity.
How SODIUM OXYBATE Works
Although its exact mechanism is unknown, this drug works by acting as a central nervous system depressant and is the sodium salt of a GABA metabolite called gamma-hydroxybutyrate. It is hypothesized to produce its effects through GABA B actions at specific neurons, including those that are noradrenergic, dopaminergic, and thalamocortical.
Details
- Status
- Prescription
- First Approved
- 2017-01-17
- Routes
- ORAL
- Dosage Forms
- SOLUTION
SODIUM OXYBATE Approval History
What SODIUM OXYBATE Treats
2 indicationsSODIUM OXYBATE is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cataplexy
- Narcolepsy
SODIUM OXYBATE Boxed Warning
CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION and ABUSE AND MISUSE. Central Nervous System Depression Sodium oxybate oral solution is a CNS depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in adult patients treated with sodium oxybate oral solution [see Warnings and Precautions (5.1) ] . Many patients who received sodium oxybate oral solution during clinical trials in narcolepsy were receiving central nervous system stimulants ...
WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION and ABUSE AND MISUSE. Central Nervous System Depression Sodium oxybate oral solution is a CNS depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in adult patients treated with sodium oxybate oral solution [see Warnings and Precautions (5.1) ] . Many patients who received sodium oxybate oral solution during clinical trials in narcolepsy were receiving central nervous system stimulants [see Clinical Trials (14) ] . Abuse and Misuse Sodium oxybate oral solution 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, sodium oxybate oral solution is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Sodium Oxybate REMS Program [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 Sodium oxybate oral solution is a CNS depressant, and respiratory depression can occur with sodium oxybate oral solution use (5.1 , 5.4) Abuse and Misuse Sodium oxybate oral solution 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) Sodium oxybate oral solution is available only through a restricted program called the Sodium Oxybate REMS Program (5.3)
SODIUM OXYBATE 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 SODIUM OXYBATE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 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. |
| 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) |
| 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.
SODIUM OXYBATE FDA Label Details
Indications & Usage
FDA Label (PDF)SODIUM OXYBATE is indicated for the treatment of Cataplexy; Narcolepsy.
WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION and ABUSE AND MISUSE. Central Nervous System Depression Sodium oxybate oral solution is a CNS depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in adult patients treated with so...
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Full clinical data, patents, trials, and competitive landscape for sodium oxybate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.