Last update July 10, 2023

Sodium Oxybate

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

Gamma-Hydroxybutyric acid (GHB) is a natural substance in the body normally found in the central nervous system and also in milk with levels of 0.1 - 1.03 mg/L. (Busardò 2016).Its sodium salt, sodium oxybate, and other salts (calcium, potassium) are used in the treatment of narcolepsy and alcohol withdrawal syndrome. Oral administration in two nightly doses 4 hours apart.

Used as a drug of abuse because of its central nervous system depressant effects. (Felmlee 2021, Busardò 2015). Gamma butyro lactone (GBL) and 1,4-butanediol are precursors of Gamma-HydroxyButyric acid (GHB) and have the same effects as GHB.

Limited data indicate that it is excreted in breast milk in clinically insignificant amount (Barker 2017, Busardò 2017 and 2016 ) and no problems have been observed in two infants whose mothers were taking it (Barker 2017, Busardò 2016, Gashlin 2016). Two mothers breastfed just before each dose and then waited 4 hours to breastfeed again. (Barker 2017, Gashlin 2016)

Given its rapid half-life, at 4 - 5 hours oxybate milk levels are back in the normal range. (Barker 2017, Busardò 2016)

Intestinal absorption of the drug and plasma levels decrease significantly (up to 58%) with simultaneous administration of a meal, especially if it is fatty in content (Jazz Ph 2022), which would protect the infant. 

Oxybate may increase prolactin levels. (Donjacour 2011, Van Cauter 1997)

The use of this drug in high doses as a drug of abuse has risks of very serious side effects (Busardò 2015) and is not compatible with breastfeeding.
 
Monitor drowsiness and adequate infant feeding.
Bed-sharing with the infant (co-sleeping) is not recommended if taking this drug.


See below the information of this related product:

  • Narcolepsy. Narkolepsy. (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)

Alternatives

  • Fluoxetine Hydrochloride (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)
  • Methylphenidate (Safe substance and/or breastfeeding is the best option.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Tradenames

Main tradenames from several countries containing Sodium Oxybate in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 88 %
Molecular weight 126 daltons
Protein Binding < 1 %
VD 0.2 - 0.4 l/Kg
pKa 4.44 -
Tmax 0.5 - 2 hours
0.5 - 1 hours
M/P ratio 0.2 - 0.6 -

References

  1. Jazz Ph. Ireland. Sodium Oxybate. Drug Summary. 2022 Full text (in our servers)
  2. Felmlee MA, Morse BL, Morris ME. γ-Hydroxybutyric Acid: Pharmacokinetics, Pharmacodynamics, and Toxicology. AAPS J. 2021 Jan 8;23(1):22. Abstract Full text (link to original source)
  3. Barker EC, Puchowicz M, Letterio J, Higgins K, Sharkey KM. GHB levels in breast milk of women with narcolepsy with cataplexy treated with sodium oxybate. Sleep Med. 2017 Aug;36:172-177. Abstract
  4. Busardò FP, Bertol E, Mannocchi G, Tittarelli R, Pantano F, Vaiano F, Baglio G, Kyriakou C, Marinelli E. Determination of GHB levels in breast milk and correlation with blood concentrations. Forensic Sci Int. 2016 Abstract
  5. Gashlin LZ, Sullo D, Lawrence RA, Rosen-Carole C. Treatment of Narcolepsy with Sodium Oxybate While Breastfeeding: A Case Report. Breastfeed Med. 2016 Jun;11:261-3. Abstract Full text (link to original source)
  6. Busardò FP, Jones AW. GHB pharmacology and toxicology: acute intoxication, concentrations in blood and urine in forensic cases and treatment of the withdrawal syndrome. Curr Neuropharmacol. 2015 Jan;13(1):47-70. Abstract Full text (link to original source)
  7. EMA. Oxibato sódico. Ficha técnica. 2015 Full text (in our servers)
  8. Donjacour CE, Aziz NA, Frölich M, Roelfsema F, Overeem S, Lammers GJ, Pijl H. Sodium oxybate increases prolactin secretion in narcolepsy patients and healthy controls. Eur J Endocrinol. 2011 Mar;164(3):363-70. Abstract
  9. Wise MS, Arand DL, Auger RR, Brooks SN, Watson NF; American Academy of Sleep Medicine. Treatment of narcolepsy and other hypersomnias of central origin. Sleep. 2007 Abstract Full text (link to original source) Full text (in our servers)
  10. Borgen LA, Okerholm R, Morrison D, Lai A. The influence of gender and food on the pharmacokinetics of sodium oxybate oral solution in healthy subjects. J Clin Pharmacol. 2003 Abstract
  11. Van Cauter E, Plat L, Scharf MB, Leproult R, Cespedes S, L'Hermite-Balériaux M, Copinschi G. Simultaneous stimulation of slow-wave sleep and growth hormone secretion by gamma-hydroxybutyrate in normal young Men. J Clin Invest. 1997 Aug 1;100(3):745-53. Abstract
  12. Levy MI, Davis BM, Mohs RC, Trigos GC, Mathé AA, Davis KL. Gamma-hydroxybutyrate in the treatment of schizophrenia. Psychiatry Res. 1983 Abstract

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