2. Duration of Therapy

Migraine headache is a chronic, recurrent condition usually requiring long-term, intermittent therapy for pain relief. Serotonin 5-HT1B/1D receptor agonists are approved for acute treatment of migraine attacks and may be utilized indefinitely to manage migraine headaches provided that the maximum dosage recommendation is not exceeded in a 24-hour period. Additionally, the safety of treating more than 3 or 4 headaches during a 30-day period has not been established with the exception of sumatriptan/naproxen which has been FDA approved for 5 migraine headaches during a 30-day period1-17. Children/ adolescents 6 to 17 years of age are allowed only one rizatriptan dose per 24 hours, as safety and efficacy have not been determined for multiple rizatriptan doses in pediatric patients7. Maximum quantities of serotonin 5-HT1B/1D receptor agonists to be dispensed in a 30-day time period, based on number of headaches to be treated, are summarized in Tables 6 and 7 for adults and Tables 8 and 9 for adolescents. Patient profiles documenting quantities of serotonin 5-HT1B/1D receptor agonists that exceed these recommendations will be reviewed.

Table 6. Maximum Recommended SRA Adult Dosage Frequency – Monotherapy1-17
Drug Maximum Number of Headaches Treated per 30 Days Recommended Prescribed Tablet Number/Sprays or Dose per 30 Days
almotriptan tablets 4 headaches 8 x 12.5 mg tablets or 100 mg
eletriptan tablets 3 headaches 6 x 40 mg tablets or 240 mg
frovatriptan tablets 4 headaches 12 x 2.5 mg tablets or 30 mg
naratriptan tablets 4 headaches 8 x 2.5 mg tablets or 20 mg
rizatriptan tablets 4 headaches 12 x 10 mg tablets or 120 mg
rizatriptan orally disintegrating tablets (ODTs) 4 headaches 12 x 10 mg ODT or 120 mg
rizatriptan propranolol patients (regular or ODT) 4 headaches 12 x 5 mg tablets/ODT or 60 mg
sumatriptan intranasal spray (Imitrex®, generic) 4 headaches 8 x 20 mg spray or 160 mg
sumatriptan intranasal spray (Tosymra®) 4 headaches 12 x 10 mg spray or 120 mg
sumatriptan intranasal powder 4 headaches 8 x 22 mg powder or 176 mg
sumatriptan oral tablets 4 headaches 8 x 100 mg tablets or 800 mg
sumatriptan subcutaneous injection ----+ ----
zolmitriptan intranasal 4 headaches 8 x 5 mg spray or 40 mg
zolmitriptan tablets 3 headaches 6 x 5 mg tablets or 30 mg
zolmitriptan orally disintegrating tablets 3 headaches 6 x 5 mg tablets or 30 mg

Legend:

  • + Patients taking Imitrex® should not receive more than 2 subcutaneous injections in a 24-hour time period; patients taking Zembrace® should not receive more than 4 subcutaneous injections per day
Table 7. Maximum Recommended SRA Adult Dosage Frequency – Combination Therapy1,2,17
Drug Maximum Number of Headaches Treated per 30 Days Recommended Prescribed Tablet Number/Sprays or Dose per 30 Days
sumatriptan/naproxen tablets 5 headaches 10 x 85/500 mg tablets or 850 mg/5000 mg
Table 8. Maximum Recommended SRA Pediatric Dosage Frequency – Monotherapy1-3,7,16
Drug Maximum Number of Headaches Treated per 30 Days Recommended Prescribed Tablet Number/Sprays or Dose per 30 Days
almotriptan tablets 4 headaches 8 x 12.5 mg tablets or 100 mg
rizatriptan tablets Less than 40 kg: 4 headaches
Greater than or equal to 40 kg: 4 headaches		 4 x 5 mg tablets or 20 mg
4 x 10 mg tablets or 40 mg
rizatriptan orally disintegrating tablets (ODTs) Less than 40 kg: 4 headaches
Greater than or equal to 40 kg: 4 headaches		 4 x 5 mg tablets or 20 mg
4 x 10 mg tablets or 40 mg
rizatriptan propranolol patients (regular or ODT) 4 headaches 4 x 5 mg tablets or 20 mg
zolmitriptan nasal spray 4 headaches 8 x 5 mg/actuation or 40 mg
Table 9. Maximum Recommended SRA Pediatric Dosage Frequency – Combination Therapy1,2,17
Drug Maximum Number of Headaches Treated per 30 Days Recommended Prescribed Tablet Number/Sprays or Dose per 30 Days
sumatriptan/naproxen tablets 2 headaches 2 x 85 mg /500 mg tablets or 170 mg/1000 mg