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Sodium Oxybate

Also known as: Xyrem

Route: Oral

4 interactions on record⛔ Black Box Warning

Sodium Oxybate has 4 known drug interactions based on U.S. FDA drug labeling data. Of these, 2 are contraindicated combinations that should be avoided entirely. 2 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Alcohol, Sedative-Hypnotics, Cns Depressants. Patients taking Sodium Oxybate should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 4
Contraindicated: 2
Major: 2

Contraindicated (2)

Sodium Oxybate + Alcohol— Sodium oxybate oral solution is contraindicated for use in combination with alcohol due to potentiation of CNS-depressan…
Sodium Oxybate + Sedative-Hypnotics— Sodium oxybate oral solution is contraindicated for use in combination with sedative hypnotics due to potentiation of CN…

Major (2)

Sodium Oxybate + Cns Depressants— May potentiate the CNS-depressant effects of sodium oxybate; use caution.
Sodium Oxybate + Divalproex Sodium— Concomitant use increases systemic exposure to GHB, causing greater impairment on tests of attention and working memory.…

Sodium Oxybate + Alcohol⛔Contraindicated

Sodium oxybate oral solution is contraindicated for use in combination with alcohol due to potentiation of CNS-depressant effects.

Sodium Oxybate + Sedative-Hypnotics⛔Contraindicated

Sodium oxybate oral solution is contraindicated for use in combination with sedative hypnotics due to potentiation of CNS-depressant effects.

Sodium Oxybate + Cns Depressants⚠️Major

May potentiate the CNS-depressant effects of sodium oxybate; use caution.

Sodium Oxybate + Divalproex Sodium⚠️Major

Concomitant use increases systemic exposure to GHB, causing greater impairment on tests of attention and working memory. An initial dose reduction of at least 20% is recommended.

⛔ FDA Black Box Warning

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 )

Contraindications

4 CONTRAINDICATIONS Xyrem 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 )] . • In combination with sedative hypnotics or alcohol ( 4 ) • Succinic semialdehyde dehydrogenase deficiency ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of sodium oxybate in pregnant women. Oral administration of sodium oxybate to pregnant rats (150, 350, or 1,000 mg/kg/day) or rabbits (300, 600, or 1,200 mg/kg/day) throughout organogenesis produced no clear evidence of developmental toxicity; however, oral administration to rats throughout pregnancy and lactation resulted in increased stillbirths and decreased offspring postnatal viability and growth, at a clinically relevant dose [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Clinical Considerations Labor or Delivery Xyrem has not been studied in labor or delivery. In obstetric anesthesia using an injectable formulation of sodium oxybate, newborns had stable cardiovascular and respiratory measures but were very sleepy, causing a slight decrease in Apgar scores. There was a fall in the rate of uterine contractions 20 minutes after injection. Placental transfer is rapid and gamma-hydroxybutyrate (GHB) has been detected in newborns at delivery after intravenous administration of GHB to mothers. Subsequent effects of sodium oxybate on later growth, development, and maturation in humans are unknown. Data Animal Data Oral administration of sodium oxybate to pregnant rats (150, 350, or 1,000 mg/kg/day) or rabbits (300, 600, or 1,200 mg/kg/day) throughout organogenesis produced no clear evidence of developmental toxicity. The highest doses tested in rats and rabbits were approximately 1 and 3 times, respectively, the maximum recommended human dose (MRHD) of 9 g per night on a body surface area (mg/m 2 ) basis. Oral administration of sodium oxybate (150, 350, or 1,000 mg/kg/day) to rats throughout pregnancy and lactation resulted in incr

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.