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Is it safe? · Pregnancy Smart

Is doxylamine + vitamin B6 safe during pregnancy?

Assigned clinical reviewerMatt Stahl· PharmDDraft · pending clinical reviewUpdated

What does the evidence say about doxylamine + vitamin B6 during pregnancy?

  1. Studies covering hundreds of thousands of pregnancies exposed to doxylamine and B6 together have not found an increased risk of birth defects. 1
  2. Doxylamine plus B6 is the first medication ACOG recommends trying once non-drug measures for nausea aren't enough on their own. 2
  3. The over-the-counter version is Unisom SleepTabs (doxylamine succinate 25 mg) paired with 10 to 25 mg of vitamin B6, and Unisom SleepGels are a different product made with diphenhydramine, so they're not a substitute. 3
  4. Drowsiness is the most common side effect, which is why many dosing plans put more of the dose in the evening, with a smaller morning dose added only if daytime nausea needs it too. 1

Is doxylamine + vitamin B6 safe in each trimester?

  • First trimester. This is when most people start using it, since nausea and vomiting peak in the first trimester. A typical approach splits the 25 mg Unisom tablet with 10 to 25 mg of B6, adjusting the dose until it helps.
  • Second trimester. If nausea continues into the second trimester, keep using the lowest dose that helps. Your provider can guide you on tapering down once symptoms ease.
  • Third trimester. Some people still need it occasionally in the third trimester if nausea comes back. Keep in mind doxylamine can make you sleepy, which matters when your energy is already up and down late in pregnancy.

Frequently asked questions

How does the OTC combo compare with Diclegis?

They use the same active ingredients. Diclegis is a delayed-release version designed to cover morning nausea from a bedtime dose. OTC Unisom plus B6 gives you the same molecules at a lower price, with more manual timing on your part. Your provider can help you decide which fits best.

Is Unisom SleepGels the same as Unisom SleepTabs?

No. SleepGels contain diphenhydramine, not doxylamine. Only Unisom SleepTabs, the pill labeled doxylamine succinate 25 mg, is the right substitute for the ACOG-recommended combination.

Can I take this if I'm also on ginger for nausea?

Yes. Many people combine ginger with the doxylamine-B6 combination. Just review your full regimen with your provider so your total B6 stays under the 100 mg per day upper limit.

What about the daytime drowsiness?

Start with a half-tablet at bedtime, and only add a morning half-tablet if you still need it. Avoid driving or operating heavy machinery while you're getting used to how sleepy it makes you.

References

  1. Doxylamine Succinate-Pyridoxine Hydrochloride (Diclegis/Diclectin): MotherToBaby Fact Sheet

    MotherToBaby · https://mothertobaby.org/fact-sheets/doxylamine-succinate-pyridoxine-hydrochloride-diclegisdiclectin-pregnancy/

  2. ACOG Practice Bulletin: Nausea and Vomiting of Pregnancy

    ACOG · https://www.acog.org/clinical/clinical-guidance/practice-bulletin/articles/2018/01/nausea-and-vomiting-of-pregnancy

  3. Doxylamine: MotherToBaby Fact Sheet

    MotherToBaby · https://mothertobaby.org/fact-sheet-reference/doxylamine/

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.