Sumatriptan

DRUG INFORMATION

  ADULT
    - • Single dose of 25 mg, 50 mg, or 100 mg tablet.( 2.1 ) • A second dose should
      only be considered if some response to the first dose was observed.
      Source: US FDA label for sumatriptan (Sumatriptan), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.1 ) • Maximum dose in a 24-hour period: 200 mg.
      Source: US FDA label for sumatriptan (Sumatriptan), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.2 ) 2.1 Dosing Information The recommended dose of sumatriptan tablets is 25
      mg, 50 mg, or 100 mg.
      Source: US FDA label for sumatriptan (Sumatriptan), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness in pediatric patients have not been established.
      Sumatriptan tablets are not recommended for use in patients younger than 18 years
      of age. Two controlled clinical trials evaluated sumatriptan nasal spray (5 to 20
      mg) in 1,248 adolescent migraineurs aged 12 to 17 years who treated a single
      attack. The trials did not establish the efficacy of sumatriptan nasal spray
      compared with placebo in the treatment of migraine in adolescents.
      Source: US FDA label for sumatriptan (Sumatriptan), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No kidney-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for sumatriptan (Sumatriptan),
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - ( 2.1 ) • Maximum single dose should not exceed 50 mg in patients with mild to
      moderate hepatic impairment.
      Source: US FDA label for sumatriptan (Sumatriptan), section 'dosage and
      administration', retrieved 2026-08-29
    - The safety of treating an average of more than 4 headaches in a 30-day period has
      not been established. 2.2 Dosing in Patients With Hepatic Impairment If treatment
      is deemed advisable in the presence of mild to moderate hepatic impairment, the
      maximum single dose should not exceed 50 mg [see Use in Specific Populations (8.6)
      and Clinical Pharmacology (12.3) ] .
      Source: US FDA label for sumatriptan (Sumatriptan), section 'dosage and
      administration', retrieved 2026-08-29
    - A cardiovascular evaluation is recommended for geriatric patients who have other
      cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity,
      strong family history of CAD) prior to receiving sumatriptan tablets [see Warnings
      and Precautions (5.1) ] . 8.6 Hepatic Impairment The maximum single dose in
      patients with mild to moderate hepatic impairment should not exceed 50 mg.
      Source: US FDA label for sumatriptan (Sumatriptan), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Teratogenic Effects Pregnancy Category C: There are no adequate and well-
      controlled trials in pregnant women.
      Source: US FDA label for sumatriptan (Sumatriptan), section 'pregnancy', retrieved
      2026-08-29
    - In developmental toxicity studies in rats and rabbits, oral administration of
      sumatriptan to pregnant animals was associated with embryolethality, fetal
      abnormalities, and pup mortality.
      Source: US FDA label for sumatriptan (Sumatriptan), section 'pregnancy', retrieved
      2026-08-29
    - When administered by the intravenous route to pregnant rabbits, sumatriptan was
      embryolethal.
      Source: US FDA label for sumatriptan (Sumatriptan), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Sumatriptan is excreted in human milk following subcutaneous administration.
      Source: US FDA label for sumatriptan (Sumatriptan), section 'nursing mothers',
      retrieved 2026-08-29
    - Infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12
      hours after treatment with sumatriptan tablets.
      Source: US FDA label for sumatriptan (Sumatriptan), section 'nursing mothers',
      retrieved 2026-08-29
    - Oral treatment of pregnant rats with sumatriptan during the latter part of
      gestation and throughout lactation resulted in a decrease in pup survival.
      Source: US FDA label for sumatriptan (Sumatriptan), section 'use in specific
      populations', retrieved 2026-08-29