Zomig Tablets Response Rates

Zomig is indicated for the acute treatment of migraine with or without aura in adults, where a clear diagnosis of migraine has been established. Zomig is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Zomig is not indicated for cluster headache.

See below for Complete Indication and Important Safety Information.

Zomig Tablets deliver fast migraine pain relief. Zomig Tablets start working at 60 minutes for some and at 2 hours for many.1,8-12

Zomig Tablets—Migraine Headache Response* Rate

Rapoport et al1,8

For First Attack

zomig tablets pain free response rates

Solomon et al1,9

For First Attack

zomig tablets migraine response rates
  • In 5 separate studies,1,8-12 headache response* in patients treated with Zomig 2.5 or 5 mg Tablets was compared with the response in those treated with placebo.† Primary end point was headache response at 2 hours. Results from the 2 studies of Zomig 2.5 mg are shown in the graphs above. In Rapoport et al, both the 2.5 mg and 5 mg doses were compared to placebo
  • As shown in the graph above, in the Rapoport et al study the 1-hour response rate was significantly better than with placebo: 44% with Zomig 2.5 mg vs. 26% with placebo, increasing to 65% at 2 hours vs. 34% with placebo (P<.05 vs. placebo for both time points). In the Solomon et al study, the 2-hour response rate was significantly better than with placebo: 62% with Zomig 2.5 mg vs. 36% with placebo (P<.05 vs. placebo for both time points)1,8,9
  • Studies that reported the headache response to Zomig 5 mg included
    • Rapoport et al: headache response rates with Zomig 5 mg (n=245) were 44%, 67%, and 77% at 1 hour, 2 hours, and 4 hours, respectively, vs. 26%, 34%, and 32% with placebo (n=121) (P<.05 vs. placebo for all time points)1,8
    • Visser et al: headache response rates with Zomig 5 mg (n=21) were 24% and 62% at 1 hour and 2 hours, respectively, vs. 15% and 15% with placebo (n=20) (P=NS vs. placebo at 1 hour, P<.05 at 2 hours vs. placebo)1,10
    • Geraud et al: headache response rates with Zomig 5 mg (n=491) were 34%, 59%, and 80% at 1 hour, 2 hours, and 4 hours, respectively, vs. 21%, 44%, and 60% with placebo (n=55) (P<.05 vs. placebo for all time points)1,11
    • Dahloff et al: headache response rates with Zomig 5 mg (n=179) were 44% and 66% at 1 hour and 2 hours, respectively, vs. 16% and 19% with placebo (n=88) (P<.05 vs. placebo for both time points)1,12
  • In the only direct comparison of Zomig Tablets 2.5 mg and 5 mg, there was little added benefit from the larger dose, but side effects were generally increased at 5 mg. Patients should, therefore, be started on 2.5 mg or lower. A dose lower than 2.5 mg can be achieved using the conventional tablet formulation by manually breaking the scored 2.5mg tablet in half1
  • *Defined as a reduction in headache severity from moderate or severe pain to mild or no pain.
  • †From single-center and multicenter, randomized, double-blind, placebo-controlled studies that included Zomig 2.5 mg and/or 5 mg vs. placebo for the acute treatment of moderate or severe migraines in adults.1,8-12

Zomig Tablets—Pain-Free Response‡ Rate

Rapoport et al1,8

For First Attack

zomig tablets pain free response rates

Solomon et al1,9

For First Attack

zomig tablets migraine response rates
  • In 5 separate studies,1,8-12 pain-free response‡ in patients treated with Zomig 2.5 mg and 5 mg Tablets were compared with the response in those treated with placebo.§ Primary end point was headache response at 2 hours. Results from the 2 studies of Zomig 2.5 mg are shown in the graphs above. In Rapoport et al, both the 2.5 mg and 5 mg doses were compared to placebo
  • Studies that reported the pain-free response to Zomig 5 mg included
    • Rapoport et al: pain-free response rates with Zomig 5 mg (n=245) were 14%, 33%, and 52% at 1 hour, 2 hours, and 4 hours, respectively, vs. 3%, 7%, and 11% with placebo (n=121) (P<.001 vs. placebo for all time points)1,8
    • Visser et al: pain-free response rate with Zomig 5 mg (n=21) was 0% and 14% at 1 hour and 2 hours, respectively, vs. 0% and 5% with placebo (n=20) (P=NS vs. placebo for both time points)1,10
    • Geraud et al: pain-free response rates with Zomig 5 mg (n=491) were 8%, 29% and 55% at 1 hour, 2 hours and 4 hours, respectively, vs. 2%, 13% and 22% with placebo (n=55) (P=NS for 1 hour vs. placebo, P<.05 vs. placebo for 2 hours and 4 hours)1,11
    • Dahloff et al: pain-free response rates with Zomig 5 mg (n=179) were 10% and 39% at 1 hour and 2 hours, respectively, vs. 0% and 1% with placebo (n=88) (at 1 hour 95% CI 6, 16 for Zomig, 95% CI 0, 4 for placebo; at 2 hours 95% CI 32, 47 for Zomig, 95% CI 0, 6 for placebo)1,12
  • In the only direct comparison of Zomig Tablets 2.5 mg and 5 mg, there was little added benefit from the larger dose, but side effects were generally increased at 5 mg. Patients should, therefore, be started on 2.5 mg or lower. A dose lower than 2.5 mg can be achieved using the conventional tablet formulation by manually breaking the scored 2.5 mg tablet in half1
  • ‡Pain-free response was defined as a reduction in headache pain from severe or moderate pain to no pain.
  • §From single-center and multicenter, randomized, double-blind, placebo-controlled studies that included Zomig 2.5 mg and/or 5 mg vs. placebo for the acute treatment of moderate or severe migraines in adults.1,8-12