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Sertraline

Classification: A

Drug products: Oralin, Sertralin Actavis, Sertralin Amendia, Sertralin Bluefish, Sertralin Hexal, Sertralin Krka, Sertralin Mylan, Sertralin Orion, Sertralin ratiopharm, Sertralin Sandoz, Sertralin STADA, Sertralin Teva, Sertraline Accord, Sertraline SUN, Sertrone, Setaloft, Zoloft, Zoloft®

ATC code: N06AB06

Substances: sertraline, sertraline hydrochloride

Summary

Studies regarding differences in effect of sertraline in men and women are not conclusive. There are studies that show women to have a better effect on depression and panic attacks. In type A alcohol dependence and post traumatic stress syndrome, on the other hand, men showed a better treatment effect of sertraline.

Pharmacokinetic studies have shown that men metabolize sertraline faster than women.
 
In our opinion, the described differences do not motivate differentiated dosing or treatment in men and women.

Additional information

Pharmacokinetics and dosing

In a study in healthy volunteers (22 men, 22 women), sertraline was titrated from 50 mg daily during 9 days to 200 mg daily for 21 days. For sertraline, the terminal elimination half-life was shorter in young men (18–45 years), (22.4 hours) than in young women, older men, and women (32.1–36.7 hours). The Cmax, AUC24 and mean trough concentrations of sertraline were 21%, 25% and 33% lower in young men compared to the other groups. For the metabolite N-desmethylsertraline (DSERT) the trough plasma concentrations, Cmax and AUC24 were also lower in young men compared with the other groups [1]. This is in contrast to another study (31 men, 61 women), where the dose-concentration correlation for sertraline and DSERT was approximately 30% higher for women than for men after 12 weeks of treatment (50–150 mg daily). No sex differences in the absolute concentrations for sertraline or DSERT were observed [2]. In a bioavailability study, 100 mg sertraline were given to 24 healthy volunteers (13 men, 11 women). Women had higher Cmax values than men, but the sex difference disappeared when taking the distribution volume into consideration [3]. No sex differentiation in dosing has been recommended by the manufacturer [4].

Effects

DepressionSeveral studies show better effect of sertraline in women than in men [5-9]. Treatment response after 12 weeks of sertraline treatment has been examined in patients with chronic depression (162 men, 264 women). Women responded better to sertraline treatment than men and premenopausal women responded better than postmenopausal women, suggesting that female sex hormones may enhance treatment response [5]. Also in another study, menopause was shown to be related to worse treatment response of SSRI in depression compared to non-menopausal women [6], although one study showed that acute worsening of chronic depression was more frequent in premenopausal women than in postmenopausal women and men treated with either sertraline or imipramine (229 men, 267 premenopausal women, 58 postmenopausal women) (8.6%, 4.5% and 5.9%, respectively) [7].

Women responded better to sertraline when treated for non-melancholic depressive disorders [8] and behavioral disorders associated with Alzheimer’s disease [10]. A retrospective cohort analysis of Japanese patients with major depressive disorders treated with sertraline (36 men, 46 women) showed that women were more likely to respond to sertraline treatment than men (74% vs. 44%) [9]. According to the original manufacturer of sertraline, no differences between men and women has been recorded in the treatment response of major depressive disorders [4, 11].

PanicdisorderPooled data from four studies (in total 335 men, 338 women), showed a greater improvement on panic frequency and Clinical Global Impression-Improvement scale (CGI-I) in women [12]. According to the original manufacturer of sertraline, no differences between men and women have been recorded in the treatment response of panic disorders or social anxiety disorders. For the treatment of post-traumatic stress disorders, men showed lower response than women. The clinical significance of this is uncertain [4, 11].

Alcohol dependenceIn a 14-week double-blind placebo-controlled study (52 men, 48 women) men, but not women, with type A alcohol dependence showed an improvement with sertraline treatment [13].

Adverse effects

Pooled data from four studies (in total 335 men, 338 women), showed no sex differences in adverse events [12]. In a study where treatment response after 12 weeks of sertraline treatment was examined in patients  with chronic depression (162 men, 264 women), women were more likely to report nausea and dizziness, whereas men were more likely to report dyspepsia, sexual dysfunction and urinary frequency [5].

Reproductive health issues

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

Other information

In a German drug utilization observational study (1594 men, 3858 women), the mean prescribed dose of sertraline was lower for women than for men (45.5 vs. 46.5 mg/day) [14].

Updated: 2019-02-26

Date of litterature search: 2013-05-06

References

  1. Ronfeld RA, Tremaine LM, Wilner KD. Pharmacokinetics of sertraline and its N-demethyl metabolite in elderly and young male and female volunteers. Clin Pharmacokinet. 1997;32 Suppl 1:22-30. PubMed
  2. Reis M, Aberg-Wistedt A, Agren H, Höglund P, Akerblad AC, Bengtsson F. Serum disposition of sertraline, N-desmethylsertraline and paroxetine: a pharmacokinetic evaluation of repeated drug concentration measurements during 6 months of treatment for major depression. Hum Psychopharmacol. 2004;19:283-91. PubMed
  3. Almeida S, Portolés A, Terleira A, Filipe A, Cea E, Caturla MC. Comparative bioavailability/ bioequivalence of two different sertraline formulations: a randomised, 2-period x 2-sequence, crossover clinical trial in healthy volunteers. Drug Res. 2005;55:191-7. PubMed
  4. Zoloft (sertralin). Summary of Product Characteristics. Medical Products Agency - Sweden. [updated 2016-03-30, cited 2016-04-04]. länk
  5. Kornstein SG, Schatzberg AF, Thase ME, Yonkers KA, McCullough JP, Keitner GI et al. Gender differences in treatment response to sertraline versus imipramine in chronic depression. Am J Psychiatry. 2000;157:1445-52. PubMed
  6. Pinto-Meza A, Usall J, Serrano-Blanco A, Suárez D, Haro JM. Gender differences in response to antidepressant treatment prescribed in primary care Does menopause make a difference?. J Affect Disord. 2006;93:53-60. PubMed
  7. Harvey AT, Silkey BS, Kornstein SG, Clary CM. Acute worsening of chronic depression during a double-blind, randomized clinical trial of antidepressant efficacy: differences by sex and menopausal status. J Clin Psychiatry. 2007;68:951-8. PubMed
  8. Baca E, Garcia-Garcia M, Porras-Chavarino A. Gender differences in treatment response to sertraline versus imipramine in patients with nonmelancholic depressive disorders. Prog Neuropsychopharmacol Biol Psychiatry. 2004;28:57-65. PubMed
  9. Morishita S, Kinoshita T. Predictors of response to sertraline in patients with major depression. Hum Psychopharmacol. 2008;23:647-51. PubMed
  10. Lanctôt KL, Herrmann N, van Reekum R, Eryavec G, Naranjo CA. Gender, aggression and serotonergic function are associated with response to sertraline for behavioral disturbances in Alzheimer's disease. Int J Geriatr Psychiatry. 2002;17:531-41. PubMed
  11. Zoloft (sertraline). DailyMed [www]. US National Library of Medicine. [updated 2013-04-01, cited 2013-05-06]. länk
  12. Clayton AH, Stewart RS, Fayyad R, Clary CM. Sex differences in clinical presentation and response in panic disorder: pooled data from sertraline treatment studies. Arch Womens Ment Health. 2006;9:151-7. PubMed
  13. Pettinati HM, Dundon W, Lipkin C. Gender differences in response to sertraline pharmacotherapy in Type A alcohol dependence. Am J Addict. 2004;13:236-47. PubMed
  14. Thiels C, Linden M, Grieger F, Leonard J. Gender differences in routine treatment of depressed outpatients with the selective serotonin reuptake inhibitor sertraline. Int Clin Psychopharmacol. 2005;20:1-7. PubMed
  15. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-29] länk

Authors: Fadiea Al-Aieshy, Desirée Loikas

Reviewed by: Expertrådet för psykiatriska sjukdomar, Expertrådet för geriatriska sjukdomar, Mia von Euler

Approved by: Karin Schenck-Gustafsson