Drug products: Mirtazapin 2care4, Mirtazapin Actavis, Mirtazapin Alternova, Mirtazapin Arrow, Mirtazapin Aurobindo, Mirtazapin Bluefish, Mirtazapin Ebb, Mirtazapin Ethypharm, Mirtazapin Hexal, Mirtazapin Imi Pharma®, Mirtazapin Krka, Mirtazapin Mylan, Mirtazapin Orion, Mirtazapin ratiopharm, Mirtazapin Sandoz, Mirtazapin STADA, Mirtazapin STADA®, Mirtazapin Teva, Mirtazapine, Mirtin, Remeron SolTab, Remeron®, Remeron®-S
ATC code: N06AX11
Published controlled studies on differences between men and women regarding the effect of mirtazapine are lacking.
Mirtazapine is metabolized more slowly in women who thus achieve higher serum concentrations than men.
One study showed that men were more likely than women to discontinue antidepressive medication.
In our opinion, the described differences do not motivate differentiated dosing or treatment in men and women.
Several studies have shown the pharmacokinetics properties of mirtazapine to be different in men and women [1,2,3]. The mean elimination half-life of mirtazapine is longer in women than in men (37 h vs. 26 h) . In a study of 30 mg mirtazapine daily to 32 women and 13 men for 14 days, women had higher plasma concentrations of the enantiomers of mirtazapine and its demethyl metabolite . In another pharmacokinetic study (36 men, 36 women), the concentration of mirtazapine was analyzed after intake of a single 30 mg dose of mirtazapine. Dose-weight adjusted AUC was about 15% lower in women and the dose/weight adjusted Cmax was slightly higher in women .
Pharmacokinetic variations of mirtazapine and its demethyl metabolite were examined in a therapeutic drug monitoring (TDM) study (110 men, 253 women). Median dose-corrected concentrations of mirtazapine, demethylmirtazapine and demethylmirtazapine/mirtazapine ratio were significantly higher in women than in men . In another TDM study (303 men, 357 women), women had higher mirtazapine (30 mg/day) concentrations than men (107 vs. 92 nmol/L) .
No studies with a clinically relevant sex analysis regarding effects of mirtazapine have been found.
No studies with a clinically relevant sex analysis regarding adverse effects of mirtazapine have been found.
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
In a Spanish study based on a prescription database, 7525 patients who had received one or more antidepressant drug were included. Male sex was associated with a greater risk of treatment drop-out compared to women . The prescription history during the first year after the introduction of mirtazapine, sertraline and venlafaxine were collected from 20 pharmacies in the Netherlands. No differences between men or women were observed . In an Australian national survey, the prevalence and treatment of affective and anxiety disorder were estimated. Both prevalence and treatment were higher in women (5.25 vs. 4.53 DDD/1000 population/day) .
Date of litterature search: 2013-04-05
Reviewed by: Expertrådet för psykiatriska sjukdomar, Expertrådet för geriatriska sjukdomar
Approved by: Mia von Euler