The Food and Drug Administration (FDA) has approved Bonjesta (doxylamine succinate and pyridoxine HCl extended-release tablets; Duchesnay), a fixed-dose combination drug product for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. This product has not been studied in women with hyperemesis gravidarum.

Each tablet of Bonjesta contains 20mg of doxylamine succinate, an antihistamine, and 20mg of pyridoxine HCl, a vitamin B6 analog. The combination of doxylamine succinate and pyridoxine HCl has been the subject of many epidemiological studies designed to detect possible teratogenicity. No increased risk for congenital malformations has been reported based on these studies.

Bonjesta will be available in extended-release tablets in 100-count bottles. The tablet should be taken on an empty stomach as food may delay the onset of action.

Duchesnay also markets Diclegis, which contains doxylamine succinate 10mg and pyridoxine HCl 10mg, for a similar indication.

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