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Zolmitriptan

Classification: A

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

Substances: zolmitriptan

Summary

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.

Additional information

Pharmacokinetics and dosing

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 [5].

Effects

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 [8].

Adverse effects

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%) [7].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 [9].

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Updated: 2019-02-26

Date of litterature search: 2014-06-26

References

  1. Seaber EJ, Peck RW, Smith DA, Allanson J, Hefting NR, van Lier JJ et al. The absolute bioavailability and effect of food on the pharmacokinetics of zolmitriptan in healthy volunteers. Br J Clin Pharmacol. 1998;46:433-9. PubMed
  2. Lionetto L, Casolla B, Mastropietri F, D'Alonzo L, Negro A, Simmaco M et al. Pharmacokinetic evaluation of zolmitriptan for the treatment of migraines. Expert Opin Drug Metab Toxicol. 2012;8:1043-50. PubMed
  3. Peck RW, Seaber EJ, Dixon RM, Layton GR, Weatherley BC, Jackson SH et al. The pharmacodynamics and pharmacokinetics of the 5HT1B/1D-agonist zolmitriptan in healthy young and elderly men and women. Clin Pharmacol Ther. 1998;63:342-53. PubMed
  4. Yates RA, Tateno M, Nairn K, Ikegami A, Dane A, Kemp J. The pharmacokinetics of the antimigraine compound zolmitriptan in Japanese and Caucasian subjects. Eur J Clin Pharmacol. 2002;58:247-52. PubMed
  5. Zomig (zolmitriptan). Summary of Product Characteristics. Medical Products Agency Sweden; 2015.
  6. Tuchman M, Edvinsson L, Geraud G, Korczyn A, Mauskop A, Pfaffenrath V. Zolmitriptan provides consistent migraine relief when used in the long-term. Curr Med Res Opin. 1999;15:272-81. PubMed
  7. The International 311C90 Long-term Study Group. The long-term tolerability and efficacy of oral zolmitriptan (Zomig, 311C90) in the acute treatment of migraine An international study The International 311C90 Long-term Study Group. Headache. 1998;38:173-83.
  8. Franconi F, Finocchi C, Allais G, Omboni S, Tullo V, Campesi I et al. Gender and triptan efficacy: a pooled analysis of three double-blind, randomized, crossover, multicenter, Italian studies comparing frovatriptan vs other triptans. Neurol Sci. 2014;35 Suppl 1:99-105. PubMed
  9. Edmeads JG, Millson DS. Tolerability profile of zolmitriptan (Zomig; 311C90), a novel dual central and peripherally acting 5HT1B/1D agonist International clinical experience based on > 3000 subjects treated with zolmitriptan. Cephalalgia. 1997;17 Suppl 18:41-52. PubMed
  10. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-29] länk
  11. von Euler, M, Keshani, S, Baatz, K, Wettermark, B. PP261 - Utilization of triptanes in Sweden; analyses of over the counter and prescriptions sales. Clinical Therapeutics. 2013;8, Suppl(35):e99.
  12. Dahlöf C, Linde M. One-year prevalence of migraine in Sweden: a population-based study in adults. Cephalalgia. 2001;21:664-71. PubMed

Authors: Linnéa Karlsson Lind, Desirée Loikas

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson