Rizatriptan benzoate is used for the acute treatment of attacks of migraine with or without aura in adults and pediatric patients 6-17 years of age. The manufacturer states that rizatriptan should not be used for the management of hemiplegic or basilar migraine or for the prophylaxis of migraine. Safety and efficacy have not been established for the management of cluster headaches.
The current indication for rizatriptan in adults is based principally on the results of 4 randomized, placebo-controlled studies of rizatriptan conventional tablets and 2 similarly designed studies of rizatriptan orally disintegrating tablets in adults with moderate to severe headaches. In these studies, substantially more patients receiving single doses of rizatriptan 5 or 10 mg achieved a response (mild or no headache pain) 2 hours after treatment compared with patients receiving placebo. Rizatriptan also relieved manifestations of migraine other than headache (including nausea, photophobia, and phonophobia), reduced the need for supplemental migraine therapy, and improved functional ability. Limited data from studies of up to one year's duration suggest that intermittent rizatriptan has remained effective throughout subsequent migraine attacks. Data from several comparative studies indicate that rizatriptan is at least as effective as oral sumatriptan in alleviating the pain associated with migraine 2 hours after treatment.
Efficacy of rizatriptan in pediatric patients has been established in a randomized double-blind, placebo-controlled study of the orally disintegrating tablets in pediatric patients 6-17 years of age (mean age: 13 years) with moderate to severe migraine headaches. Patients enrolled in the study had at least a 6-month history of migraine attacks with or without aura and an inadequate response to nonsteroidal anti-inflammatory agents (NSAIAs) and acetaminophen. In this study, substantially more patients receiving rizatriptan (5 mg in those weighing at least 20 kg but less than 40 kg and 10 mg in those weighing 40 kg or more) achieved a response (no headache pain) 2 hours after treatment compared with patients receiving placebo; however, the frequency of migraine-associated symptoms (i.e., nausea, photophobia, phonophobia) at 2 hours after treatment was similar in those receiving rizatriptan and those receiving placebo.
The US Headache Consortium considers 5-HT1B/1D receptor agonists (e.g., rizatriptan) an appropriate treatment choice for the acute management of moderate to severe migraine headaches in patients without contraindications to these drugs and recommends use of 5-HT1B/1D receptor agonists, dihydroergotamine, or ergotamine in patients with more severe migraine attacks as well as in patients in whom previous therapy with nonsteroidal anti-inflammatory agents or fixed-combination preparations such as acetaminophen, aspirin, and caffeine has been ineffective.