What is the treatment for nausea and vomiting in pregnancy with Diclegis (doxylamine succinate and pyridoxine hydrochloride)?

Diclegis Prescription for Nausea and Vomiting in Pregnancy

Diclegis (doxylamine succinate 10mg/pyridoxine hydrochloride 10mg) is the first-line pharmacologic treatment for nausea and vomiting of pregnancy (NVP) when non-pharmacologic measures are insufficient, with proven safety and efficacy. 1

Dosing Regimen

• Starting dose: 2 tablets daily at bedtime
• Titration: Based on symptom severity as measured by PUQE score
  • If symptoms persist, add 1 tablet in the morning
  • If needed, add another tablet mid-afternoon
  • Maximum dose: 4 tablets daily (1 in morning, 1 mid-afternoon, 2 at bedtime)

Assessment of Severity

Use the Motherisk Pregnancy-Unique Quantification of Emesis (PUQE) score to determine severity:

• Score ≤6: Mild NVP
• Score 7-12: Moderate NVP
• Score ≥13: Severe NVP

Clinical Considerations

• Timing: Start treatment early to prevent progression to hyperemesis gravidarum 1
• Administration: Delayed-release formulation; take on an empty stomach
• Duration: NVP typically begins at 4-6 weeks, peaks at 8-12 weeks, and subsides by week 20 1
• Efficacy: Significant symptom improvement can be seen as early as 3-5 days after starting treatment 2

Safety Profile

• FDA Pregnancy Category A (one of few medications with this designation)
• No increased risk of adverse events compared to placebo, including:
  • No increased CNS depression
  • No increased cardiovascular effects
  • No increased gastrointestinal adverse effects 3
• Safe when used at recommended doses of up to 4 tablets daily 3

Treatment Algorithm

1. First step: Non-pharmacologic approaches

   • Dietary modifications (small, frequent meals; BRAT diet; high-protein, low-fat meals)
   • Avoid triggers (strong odors, specific foods)
   • Ginger (250mg capsule 4 times daily)

2. If symptoms persist: Start Diclegis

   • Begin with 2 tablets at bedtime
   • Titrate up as needed based on symptoms

3. If inadequate response to maximum Diclegis dose:

   • Consider adding metoclopramide or promethazine as second-line agents
   • Ondansetron only as third-line therapy due to potential first-trimester safety concerns 1
   • IV glucocorticoids only for severe, refractory cases

Important Clinical Pearls

• Diclegis is the only FDA-approved medication specifically for NVP 4
• Early intervention is key to prevent progression to hyperemesis gravidarum 1
• The combination of doxylamine and pyridoxine has substantial safety data accumulated over decades 4
• Avoid prescribing medications not specifically indicated for NVP when a safe, effective option is available 5
• Efficacy is demonstrated within 3-5 days, but continued use is recommended as symptoms typically persist until 20 weeks gestation 2