Drug products: Zolmitriptan 2care4, Zolmitriptan Actavis, Zolmitriptan Arrow, Zolmitriptan Ebb, Zolmitriptan Jubilant, Zolmitriptan STADA, Zolmitriptan Teva, Zomig, Zomig Nasal, Zomig Rapimelt, Zomig®, Zomig® Nasal, Zomig® Rapimelt, Zomigon, Zomigoro Rapimelt
ATC code: N02CC03
The effect of zolmitriptan in acute migraine is similar in men and women.
Adverse effects have shown to be similar in men and women.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
There are small pharmacokinetic studies of zolmitriptan that shows varying results and of which none were judged to be of clinical importance [1, 2]. Other studies found differences in pharmacokinetics only between young men and women (18-39 years) but not in the elderly (65-75 years) [3, 4]. Although some sex differences in zolmitriptan pharmacokinetics have been reported in young adults [4-7], no dosage adjustment based on sex has been recommended .
Headache relief after administration of zolmitriptan has been evaluated in open-label clinical trials [6, 7]. Two-hour headache response rates to an initial dose of 2.5 mg or 5 mg zolmitriptan were 85% and 79-81%, respectively. Responses were unaffected by sex.Results from randomized, double-blind studies of migraineurs (66 men, 280 women) show no sex differences in response to frovatriptan 2.5 mg, rizatriptan 10 mg, zolmitriptan 2.5 mg or almotriptan 12.5 mg .
Tolerability of zolmitriptan was evaluated in an international, open-label study (288 men, 1769 women). The types of adverse events observed were similar in men and women, although the incidence of adverse events was slightly higher in women (78%) than men (61%) .A placebo-controlled clinical trial (1540 men, 1210 women) reported that the nature and type of adverse events were similar in men and women, although the frequency of reported adverse events was higher in women (48%) than in men (30%). This sex difference was also observed in patients who received placebo and may reflect a difference between the sexes in adverse event reporting. The frequency of serious adverse events did not differ between men and women .
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2014-06-26
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson