Sodium Oxybate (4 brand names, 2 dosage forms, 1 route)
Available dosage forms: SOLUTION, FOR SUSPENSION, EXTENDED RELEASE.
Routes of administration: ORAL.
Brand Names
- LUMRYZ
- SODIUM OXYBATE
- XYREM
- XYWAV
Related Health Topics
Boxed Warning
Central Nervous System Depression Sodium oxybate 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 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)].
Indications and Usage
Sodium oxybate oral solution is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy. Pediatric use information is approved for Jazz Pharmaceuticals Inc.’s XYREM (sodium oxybate) Oral Solution. However, due to Jazz Pharmaceuticals Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Contraindications
Sodium oxybate oral solution is contraindicated for use in: combination with sedative hypnotics [see Warnings and Precautions (5.1)]. combination with alcohol [see Warnings and Precautions (5.1)]. patients with succinic semialdehyde dehydrogenase deficiency [see Clinical Pharmacology (12.3)].
Adverse Reactions
The following clinically significant adverse reactions appear in other sections of the labeling: CNS depression [see Warnings and Precautions (5.1)] Abuse and Misuse [see Warnings and Precautions (5.2)] Respiratory Depression and Sleep-Disordered Breathing [see Warnings and Precautions (5.4)] Depression and Suicidality [see Warnings and Precautions (5.5)] Other Behavioral or Psychiatric Adverse Reactions [see Warnings and Precautions (5.6)] Parasomnias [see Warnings and Precautions (5.7)] Use in Patients Sensitive to High Sodium Intake [see Warnings and Precautions (5.8)]
Mechanism of Action
Sodium oxybate oral solution is a CNS depressant. The mechanism of action of sodium oxybate oral solution in the treatment of narcolepsy is unknown. Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB), an endogenous compound and metabolite of the neurotransmitter GABA. It is hypothesized that the therapeutic effects of sodium oxybate oral solution on cataplexy and excessive daytime sleepiness are mediated through GABAB actions at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons.