Almotriptan malate is used for the acute management of attacks of migraine with or without aura in adults. Almotriptan malate also is used for the acute management of migraine headache pain in adolescents 12-17 years of age who have migraine attacks with or without aura that usually last 4 hours or longer without treatment. The manufacturer states that the drug is not to be used for the management of hemiplegic or basilar migraine nor for the prophylaxis of migraine.
Efficacy in adults has been established in 3 randomized, double-blind, placebo-controlled studies principally in women (86%) and white patients (98% or more) with moderate to severe migraine headaches. In these studies, substantially more patients receiving almotriptan achieved a response (mild to no pain) 2 hours after treatment than those receiving placebo. The drug also relieved manifestations of migraine other than headache (including nausea, vomiting, photophobia, and phonophobia), decreased the need for supplemental analgesic therapy, and improved functional ability. In long-term (e.g., 6-12 months) studies, intermittent almotriptan remained effective during subsequent migraine attacks.
Efficacy in adolescents has been established in a randomized, double-blind, placebo-controlled study in adolescents 12-17 years of age, mainly girls (60%) and white patients (75%), with moderate to severe migraine headaches. Patients enrolled in the study had at least a one-year history of migraine attacks with or without aura that usually lasted 4 hours or longer without treatment. In this study, substantially more patients receiving almotriptan achieved a response (mild or no pain) 2 hours after treatment compared with those receiving placebo; however, the frequency of migraine-associated symptoms (i.e., nausea, photophobia, phonophobia) at 2 hours after treatment was similar in those receiving almotriptan and those receiving placebo.
Limited data suggest that 12.5 mg of almotriptan is at least as effective as 50 or 100 mg of oral sumatriptan in alleviating the pain associated with migraine 2 hours after treatment.
The US Headache Consortium considers 5-HT1B/1D receptor agonists (e.g., almotriptan) 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.
Safety and efficacy of almotriptan have not been established for the management of cluster headaches, which are more likely to occur in older, predominantly male patients.