ObjectiveTo determine the speed of onset of headache response and duration of response with zolmitriptan 5mg orally disintegrating tablet (ODT) in the acute treatment of migraine.BackgroundRapid pain relief is important for migraine sufferers. The early efficacy (30 minutes) of the 5mg dose of the zolmitriptan ODT formulation was evaluated.MethodsIn this double-blind, parallel-group trial, 670 patients were randomised to receive either zolmitriptan 5mg ODT (n = 329) or matching placebo (n = 341) to treat two migraine headaches of moderate or severe intensity.ResultsZolmitriptan 5mg ODT was significantly more effective than placebo in achieving a headache response (reduction in migraine headache intensity from moderate or severe to mild or no pain) at 30 minutes (16.5% vs 12.5%; p = 0.048; primary endpoint), 1 hour (p < 0.0001), and 2 hours (p < 0.0001). Significantly more patients achieved a sustained headache response for 24 hours with zolmitriptan 5mg ODT than with placebo (42.5% vs 16.4%; p < 0.0001). Zolmitriptan 5mg ODT also produced a higher pain-free rate than placebo at all timepoints (0.5, 1 and 2 hours post-dose), with the differences becoming significant at 1 hour. Adverse events were reported by 37.7% of the patients treated with zolmitriptan 5mg ODT and 18.1% of the patients treated with placebo. Those that occurred most often for the patients treated with zolmitriptan 5mg ODT were tightness (7.0%), dizziness (6.7%), somnolence (6.7%) and paraesthesias (6.1%).ConclusionsA significant headache response as early as 30 minutes post-dose and good maintenance of this headache response at 24 hours makes zolmitriptan 5mg ODT an excellent acute treatment for migraine. Together with the relatively low adverse event rate, these data demonstrate that zolmitriptan 5mg ODT is a valuable therapy for migraine sufferers.