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Doxylamine-Pyridoxine Fixed Dose Combinations

Preferred Drug - Diclegis (doxylamine succinate and pyridoxine tablet) [Duchesnay USA, Inc.]

Nonpreferred Drug - Bonjesta (doxylamine succinate and pyridoxine tablet) [Duchesnay USA, Inc.]

September 2019

Therapeutic area - Antiemetic/Antivertigo Agents

Approval criteria

  • Patient is at least 18 years or older AND
  • Patient has diagnosis of pregnancy-induced nausea or vomiting AND
  • Patient does NOT have a diagnosis of hyperemesis gravidarum AND
  • Patient has failed documented non-pharmacologic measures (e.g., dietary changes [eat smaller, more frequent meals and to avoid smells and food textures that cause nausea], trigger avoidance) AND
  • Patient does not have known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride, or any inactive ingredient in the formulation AND
  • Patient is not using a monoamine oxidase (MAO) inhibitor AND
  • Patient has documented failures to TWO of the following:
    • pyridoxine (vitamin B6)
    • doxylamine
    • diphenhydramine
    • meclizine
    • metoclopramide
    • promethazine
    • prochlorperazine
    • ondansetron
  • Documented maximum tolerated daily dosages and treatment duration (start and end dates) of TWO pharmacologic treatment failures above must be provided at time of request
  • If the request is for Bonjesta, patient has clinically valid reason as to why Diclegis cannot be used. A pill burden rationale will not be accepted
  • Approval is for 9 months

Quantity limits

  • Diclegis: 4 tablets per day
  • Bonjesta: 2 tablets per day
  • Subsequent request may be approved for a future pregnancy


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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