1. Dosage
1.1. Adults
Serotonin 5-HT1B/1D receptor agonists (SRAs) are FDA-approved to manage acute migraine headache attacks with or without aura. Injectable sumatriptan is also FDA-approved to manage cluster headache episodes. The maximum recommended adult doses for available SRAs are summarized in Tables 1 and 2. Dosages exceeding these recommendations will be reviewed.
| Drug Name | Dosage Form/Strength | Treatment Indication | Maximum Recommended Dosage |
|---|---|---|---|
| almotriptan (generic) | tablets (6.25 mg, 12.5 mg) | migraine with or without aura | 25 mg/day |
| eletriptan (Relpax®, generic) | tablets (20 mg, 40 mg) | migraine with or without aura | 80 mg/day |
| frovatriptan (Frova®, generic) | tablets (2.5 mg) | migraine with or without aura | 7.5 mg/day |
| naratriptan (Amerge®, generic) | tablets (1 mg, 2.5 mg) | migraine with or without aura | 5 mg/day |
| rizatriptan (Maxalt®, generic) | tablets (5 mg, 10 mg) | migraine with or without aura | 30 mg/day |
| rizatriptan (Maxalt -MLT®, generic) | orally disintegrating tablets (5 mg, 10 mg) | migraine with or without aura | 30 mg/day |
| rizatriptan propranolol patients | migraine with or without aura | 15 mg/day | |
| sumatriptan (Imitrex®, generic) | intranasal spray (5mg/spray, 20 mg/spray - 6 per package) | migraine with or without aura | 40 mg/day |
| sumatriptan (Onzetra Xsail®) | intranasal powder (11 mg/actuation) | migraine with or without aura | 44 mg/day* |
| sumatriptan (Imitrex®, generic) | oral tablets (25 mg, 50 mg, 100 mg) | migraine with or without aura | 200 mg/day |
| sumatriptan (Imitrex®, generic) | subcutaneous injection (4 mg and 6 mg STATdose system, 6 mg/0.5 mL single dose vial) | migraine with or without aura | 12 mg/day |
| cluster headache | 12 mg/day | ||
| sumatriptan (Tosymra®) | Intranasal spray (10 mg/ spray - 6 per package) | migraine with or without aura | 30 mg/day |
| sumatriptan (Zembrace® SymTouch®) | 3 mg/0.5 mL auto injector | migraine with or without aura | 12 mg/day |
| zolmitriptan (Zomig®, generic) | tablets (2.5 mg, 5 mg) | migraine with or without aura | 10 mg/day |
| zolmitriptan (Zomig-ZMT®, generic) | orally disintegrating tablets (2.5 mg, 5 mg) | migraine with or without aura | 10 mg/day |
| zolmitriptan (Zomig®) | intranasal (2.5 mg/ actuation, 5 mg/ actuation) | migraine with or without aura | 10 mg/day |
Legend:
- * Alternatively, patients may receive a maximum Onzetra Xsail® dose of 22 mg plus one dose of another sumatriptan product at least 2 hours later
| Drug Name | Treatment Indication | Dosage Form/Strength | Maximum Recommended Dosage |
|---|---|---|---|
| sumatriptan/naproxen (Treximet®, generics) | migraine with or without aura | tablets (85 mg/500 mg) | 170 mg/1000 mg per day |
1.2. Pediatrics
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 aura1,2,7. Almotriptan, zolmitriptan nasal spray, and sumatriptan/naproxen are FDA approved for patients 12 years of age and older1-3,16,17. 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.
| 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 |
| 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 adults4,9,10,18.
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.
| 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 |