Breakthrough in the treatment of nausea and vomiting of pregnancy; the first dual release combination of doxylamine-pyridoxine

Gideon Koren, Manon Vranderick


Nausea and vomiting of pregnancy (NVP) affect up to 85 % of all pregnancies. Effective treatment can improve  woman’s quality of life, reduce the risk for maternal and fetal complications, and reduce healthcare costs. Because women tend to date to postpone the start of their family into their thirties, increasing numbers of them suffer from chronic conditions necessitating internal medicine specialists, and hence NVP is increasingly a clinical issue the internist needs to deal with. The only agent approved by the FDA and other countries for the management of NVP symptoms and recommended by leading healthcare and professional organizations, has been the delayed release combination of doxylamine and pyridoxine. This combination, formulated as a 10 mg/10 mg delayed release tablet, was approved by the US Food and Drug Administration (FDA) for the treatment of NVP in April 2013 (Diclegis® ).  

Due to its delayed release properties, Diclegis® begins to exert its antiemetic properties 6-8 hours after ingestion, and hence symptom relief may be delayed and necessitate the use of an immediate release medication. In November 2016 the FDA approved Bonjesta®, a novel, dual- release combination of doxylamine and pyridoxine, whereby a rapid release phase is followed by a delayed release phase, thus overcoming the time delay in action of Diclegis® . In this article we review the unique properties of this new drug which is only the second FDA- approved agent for the treatment of NVP.





nausea and vomiting of pregnancy, doxylamine, pyridoxine, Bonjesta, antiemetic drugs

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