Minimum Age for Sumatriptan Use

Sumatriptan is not recommended for use in patients younger than 18 years of age. 1

FDA Labeling and Safety Information

The FDA label explicitly states that safety and effectiveness of sumatriptan tablets have not been established in pediatric patients 1
Clinical trials evaluating oral sumatriptan (25 to 100 mg) in 701 adolescent migraineurs aged 12-17 years did not establish efficacy compared with placebo 1
Similarly, two controlled clinical trials of sumatriptan nasal spray in 1,248 adolescent migraineurs aged 12-17 years failed to demonstrate efficacy compared with placebo 1
Serious adverse reactions have been reported in pediatric populations after use of subcutaneous, oral, and intranasal sumatriptan, including stroke, visual loss, and death 1
A myocardial infarction was reported in a 14-year-old male following oral sumatriptan use 1

Despite the FDA labeling, some clinical research has investigated sumatriptan use in pediatric populations:
- Nasal sumatriptan has shown more positive results than oral formulations in pediatric patients 2
- In Europe, nasal sumatriptan is approved for children older than 12 years of age 2
- A systematic review found that triptans as a class were superior to placebo for pain freedom in children and adolescents, though with increased risk of minor adverse events 3

For adolescents (12-17 years):
- While some studies suggest potential benefit, particularly with nasal formulations, the FDA has not approved sumatriptan for this age group 1, 2
- Adverse reactions in clinical trials were similar to those in adults but appeared to be both dose and age-dependent, with younger patients reporting reactions more commonly 1
For children under 12 years:
- Even less evidence exists for efficacy and safety in this younger population 2
- One small open-label study of nasal sumatriptan in children aged 5-12 years showed potential effectiveness but requires confirmation with controlled trials 4

For pediatric migraine treatment, ibuprofen has shown effectiveness for pain freedom in children and is supported by low-quality evidence 3
Almotriptan is the first triptan to obtain FDA indication specifically for adolescents with migraines lasting 4 or more hours 2

The risk-benefit profile for sumatriptan in patients under 18 years remains unfavorable according to FDA assessment 1
Clinicians should be aware that adverse effects may be more common in younger patients, and serious adverse events have been documented 1
If considering off-label use in exceptional circumstances, nasal formulations have shown more promising results than oral formulations in pediatric studies 2, 4