Brand Name Formulations of Doxylamine
Doxylamine succinate is available under several brand names, most notably as Unisom SleepTabs (as a single-ingredient sleep aid) and as Diclegis/Diclectin (in combination with pyridoxine for pregnancy-related nausea and vomiting).
Single-Ingredient Formulations
Doxylamine succinate 25 mg is marketed as an over-the-counter sleep aid under multiple brand names 1:
- Unisom SleepTabs - the most widely recognized brand name in the United States 1
- Donormyl - available in France and other markets 2
- Lidene - another European brand name 2
- Generic formulations are also widely available 1, 2
These products are indicated for occasional insomnia in adults and are available without prescription 1, 2.
Combination Formulations with Pyridoxine
The delayed-release combination of doxylamine succinate 10 mg and pyridoxine hydrochloride (vitamin B6) 10 mg is available under two primary brand names 3, 4:
- Diclegis - FDA-approved in the United States in April 2013 specifically for nausea and vomiting of pregnancy (NVP) 5, 3, 4
- Diclectin - available in Canada since 1979 for the same indication 3, 4
This combination represents the only FDA-approved medication specifically indicated for nausea and vomiting of pregnancy 4. The formulation is available in 10 mg/10 mg and 20 mg/20 mg combinations 6, 7.
Clinical Context
The doxylamine-pyridoxine combination is recommended by the American College of Obstetricians and Gynecologists (ACOG) as first-line pharmacologic therapy for persistent NVP refractory to non-pharmacologic interventions 6. The dosing typically starts with 20 mg/20 mg at bedtime, with potential titration to additional doses in the morning (10 mg/10 mg) and at lunchtime (10 mg/10 mg) based on symptom response 7.
The extensive safety profile of this combination, with studies involving over 200,000 women exposed during the first trimester showing no increased risk of congenital malformations, has earned it FDA Pregnancy Category A status 3, 4.