1.2. Pediatrics

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Rizatriptan is the only SRA FDA approved in children 6 to 17 years of age to treat acute migraine attacks in patients with a history of migraine with or without aura [1,2,7]. Almotriptan, zolmitriptan nasal spray, and sumatriptan/ naproxen are FDA approved for patients 12 years of age and older [1-3,16,17]. Children/ adolescents 6 to 17 years of age prescribed propranolol weighing less than 40 kg should not receive rizatriptan concurrently.7 Maximum recommended pediatric doses for SRAs are summarized in Tables 3 and 4. Dosages exceeding these recommendations will be reviewed.

Table 3. Maximum Recommended Daily Pediatric Dosages for FDA-Approved SRAs to Manage Acute Migraine With or Without Aura – Monotherapy^1-3,7,16
Drug	Patient Characteristics	Maximum Daily Dosage
almotriptan	12 to 17 years of age	25 mg
rizatriptan	6 to 17 years of age: Less than 40 kg Greater than or equal to 40 kg	5 mg 10 mg
rizatriptan propranolol patients	6 to 17 years of age: Greater than equal to 40 kg	5 mg
zolmitriptan nasal spray	12 to 17 years of age	10 mg

Table 4. Maximum Recommended Daily Pediatric Dosages for FDA-Approved SRAs to Manage Acute Migraine With or Without Aura – Combination Therapy^1,2,17
Drug	Patient Characteristics	Maximum Daily Dosage
sumatriptan/naproxen	12 to 17 years of age	85 mg/500 mg

The remaining SRAs are not FDA-approved for use in patients less than 18 years of age as safety and efficacy have not been established in this patient population. Additionally, patients less than 18 years of age have demonstrated a significant placebo response following SRA use as well as an adverse event profile, including serious adverse events, comparable to that seen in adults^4,9,10,18.

No significant data are available evaluating SRA use in pediatric patients younger than 6 years of age. In limited randomized, controlled trials, sumatriptan nasal spray has demonstrated some efficacy in mitigating migraine attacks in adolescents; children as young as 6 years of age have achieved favorable responses with intranasal sumatriptan in a few small randomized and open-label studies.19-21 However, oral sumatriptan tablets used in children 8 to 16 years of age to treat acute migraine attacks were not significantly better than placebo.22 A few small studies with oral zolmitriptan have shown mixed outcomes.23,24 Although not FDA-approved, Table 5 summarizes SRA doses that have been utilized in the pediatric population. Due to lack of definitive efficacy, prescriptions for SRAs not FDA-approved for pediatric patients will be reviewed in patients 6 to 18 years of age.

Table 5. Non FDA-Approved Pediatric Dosages for Select SRAs^19-21,23-27
Drug	Patient Characteristics	Dose Utilized Per Headache
sumatriptan intranasal spray	6 to 17 years of age	20 mg
sumatriptan subcutaneous	6 to 18 years of age	0.06 mg/kg
sumatriptan subcutaneous	sumatriptan subcutaneous 6 to 16 years of ageLess than 30 kg Greater than or equal to 30 kg	3 mg 6 mg
zolmitriptan tablets	6 to 18 years of age	2.5 mg