Magnesium Oxybate (1 brand name, 1 dosage form, 1 route)
Available dosage forms: SOLUTION.
Routes of administration: ORAL.
Brand Names
- XYWAV
Boxed Warning
• Central Nervous System Depression XYWAV is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with XYWAV at recommended doses [see Warnings and Precautions (5.1, 5.4)]. Many patients who received XYWAV during clinical trials in narcolepsy and idiopathic hypersomnia were receiving central nervous system stimulants [see Clinical Studies (14.1, 14.2, 14.3)]. • Abuse and Misuse The active moiety of XYWAV is oxybate or 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, XYWAV 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)].
Contraindications
XYWAV is contraindicated for use in: •combination with sedative hypnotics [see Warnings and Precautions (5.1)]. •combination with alcohol [see Warnings and Precautions (5.1 , 5.2)]. •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)]
Mechanism of Action
XYWAV is a CNS depressant. The exact mechanism of action of XYWAV in the treatment of narcolepsy and idiopathic hypersomnia is unknown. XYWAV is a mixture of calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate (gamma-hydroxybutyrate). Gamma-hydroxybutyrate (GHB) is an endogenous compound and metabolite of the neurotransmitter GABA. It is hypothesized that the therapeutic effects of XYWAV are mediated through GABAB actions during sleep at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons.