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Zolmitriptan

Classification: A

Drug products: Zolmitriptan 2care4, Zolmitriptan Arrow, Zolmitriptan Ebb, Zolmitriptan Jubilant, Zolmitriptan Orifarm, Zolmitriptan Rivopharm, 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.

Additional information

Zolmitriptan is used to treat acute migraine attacks [1].Migraine is almost twice as common in women as in men [2, 3]. In a Swedish population- based study the one-year prevalence was 16.7 % in women and 9.5 % in men [4] which is slightly lower than three months prevalence reported from the US [2]. Another indication for (parenteral) triptans is cluster headache [5]. This is a trigeminal autonomic cephalgia with very painful, unilateral and short-lasting headache attacks. Cluster headache is rare with an estimated prevalence of 0.1%. In contrast to migraine, cluster headache is more common in men than in women [5]. The men-women ratio has recently been estimated to 2.5, older studies show a more pronounced male risk [6]. Smoking is a risk factor for cluster headache and the increased risk in women has been associated with more smoking in women [5, 6].

Pharmacokinetics and dosing

There are small pharmacokinetic studies of zolmitriptan showing varying results, none which were adjudicated to be of clinical importance [7, 8]. Other studies found differences in pharmacokinetics only between young men and women (18-39 years) but not in the elderly (65-75 years) [9, 10]. Although some sex differences in zolmitriptan pharmacokinetics have been reported in young adults [7-10], no dosage adjustment based on patient’s sex is recommended. [11].

Effects

Headache relief after administration of zolmitriptan has been evaluated in open-label clinical trials. 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 patient’s sex [12, 13]. Also, the pharmaceutical company reports that the efficacy of zolmitriptan was similar in men and women, for both drug formulations [1].

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 [14].

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%) [13].

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 men (30%). This sex difference was also observed in patients who received placebo and may reflect a difference between men and women in adverse event reporting. The frequency of serious adverse events did not differ between men and women [15]. Contrary to this, the pharmaceutical company reports that there were no sex differences in incidence of adverse events in controlled clinical trials [1].

Reproductive health issues

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

Other information

Swedish population studies on dispensed triptans found a marked gender difference with a 3.6 times higher prevalence of triptan use in women [16, 17]. In contrast, over the counter use did not show any difference between men and women [17].

Updated: 2020-09-07

Date of litterature search: 2019-09-25

References

  1. Zomig (zolmitriptan). DailyMed [www]. US National Library of Medicine. [updated 2019-05-31, cited 2019-09-25]. länk
  2. Smitherman TA, Burch R, Sheikh H, Loder E. The prevalence, impact, and treatment of migraine and severe headaches in the United States: a review of statistics from national surveillance studies. Headache. 2013;53(3):427-36. PubMed
  3. Stovner LJ, Andree C. Prevalence of headache in Europe: a review for the Eurolight project. J Headache Pain. 2010;11(4):289-99. PubMed
  4. Dahlöf C, Linde M. One-year prevalence of migraine in Sweden: a population-based study in adults. Cephalalgia. 2001;21:664-71. PubMed
  5. Hoffmann J, May A. Diagnosis, pathophysiology, and management of cluster headache. Lancet Neurol. 2018;17(1):75-83. PubMed
  6. Russell MB. Epidemiology and genetics of cluster headache. Lancet Neurol. 2004;3(5):279-83. PubMed
  7. 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
  8. 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
  9. 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
  10. 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
  11. Zomig (zolmitriptan). Summary of Product Characteristics. Swedish Medical Products Agency [updated 2018-11-30, cited 2019-09-25].
  12. 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
  13. 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.
  14. 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
  15. 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
  16. 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.
  17. Frisk P, Sporrong SK, Ljunggren G, Wettermark B, von Euler M. Utilisation of prescription and over-the-counter triptans: a cross-sectional study in Stockholm, Sweden. Eur J Clin Pharmacol. 2016;72(6):747-54. PubMed
  18. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2019 [cited 2020-03-10.] länk

Authors: Linnéa Karlsson Lind

Reviewed by: Mia von Euler, Diana Rydberg

Approved by: Karin Schenck-Gustafsson