Diclegis (Doxylamine/Pyridoxine) Discontinuation: Safety Concerns

Diclegis (doxylamine succinate 10 mg + pyridoxine HCl 10 mg) was FDA‑approved (2013) for nausea/vomiting of pregnancy (NVP). It was voluntarily discontinued by the manufacturer (Duchesnay) in 2023, not due to new safety signals but as a business decision. The components remain available separately (Unisom SleepTabs + vitamin B6). No increased birth‑defect risk was confirmed in post‑marketing surveillance; doxylamine is Category A (Australia) / B (older FDA). Clinicians now prescribe the combination off‑label or use generic components.