Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Zopiklon

Klassificering: A

Preparat: Imovane®, Zopiclon Stada, Zopiclone Actavis, Zopiclone Jubilant, Zopiclone Orion, Zopiklon Mylan, Zopiklon Pilum

ATC kod: N05CF01

Substanser: zopiklon

Sammanfattning

Inga könsrelaterade skillnader har observerats för zopiklon. I en studie sågs påverkad bilkörningsförmåga i en grupp kvinnor och män 3 timmar efter intag av zopiklon men inte av zolpidem. Till skillnad från zolpidem, har man dock inte visat på någon skillnad i trötthet/körförmåga mellan kvinnor och män. Zopiklon har längre halveringstid och därmed längre effekt än zolpidem.

Additional information

Pharmacokinetics and dosing

Zopiclone has a half-life of 3.5-6 h. No differences in zopiclone pharmacokinetics have been seen between men and women [3].The absorption of zopiclone is similar in men and women and no sex differentiation in dosing has been recommended by the pharmaceutical company [4].

Effects

No studies with a clinically relevant sex analysis regarding the effects of zopiclone have been found.

Adverse effects

In a study of driving capacity after medication with sleeping pills (9 men, 14 women) zopiclone 7.5 mg, but not zolpidem 10 mg, was found to increase the number of collisions in a driving simulator compared to placebo. No analysis based on patient’s sex was performed probably due to the low number of study participants [1]. Also another study showed that zopiclone 7.5 mg, but not zolpidem 3.5 mg (administered 3 hours before driving), impaired next-day driving, but with no differences between men and women [2].However, pooled data from four placebo-controlled studies (in all 50 men, 51 women) on the effects of zopiclone 7.5 mg on driving performance showed no differences between men and women [5]. A review article concludes that no difference in driving performance the day after intake of zopiclone 7.5 mg could be observed between healthy men and women [6].

Reproductive health issues

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

Other information

Two large register-based studies analyzing utilization of zopiclone in men and women (aged ≥75 years) in Sweden showed that men were more likely than women to dispense zopiclone [7, 8]. However, aggregated data from the Swedish Board of Health and Welfare shows that utilization of zopiclone has been higher among women than men (aged ≥ 75 years) in Sweden every year since 2006. A possible explanation to the different findings could be that the two studies focused on shorter time periods (3 and 4 months), while the aggregated data is based on one year data and the two Swedish studies were conducted only during the year 2005 [9]. In large register-studies from Denmark and Norway, women dispensed more prescriptions of zopiclone and zolpidem in the years 2004 and 2006, respectively [10, 11]. In a Canadian questionnaire study from 2003 (518 men, 941 women), no sex differences in prescribing patterns of zopiclone were observed [12].

Försäljning på recept

Fler kvinnor än män hämtade ut tabletter innehållande zopiklon (ATC-kod N05CF01) på recept i Sverige år 2020, totalt 254 134 kvinnor och 143 721 män. Det motsvarar 50 respektive 28 personer per tusen invånare. Andelen som hämtat ut läkemedel ökade med stigande ålder hos båda könen. I genomsnitt var tabletter innehållande zopiklon 1,6 gånger vanligare hos kvinnor [9].

Uppdaterat: 2021-04-19

Litteratursökningsdatum: 2021-02-16

Referenser

  1. Staner L, Ertlé S, Boeijinga P, Rinaudo G, Arnal MA, Muzet A et al. Next-day residual effects of hypnotics in DSM-IV primary insomnia: a driving simulator study with simultaneous electroencephalogram monitoring. Psychopharmacology (Berl). 2005;181:790-8. PubMed
  2. Vermeeren A, Vuurman EF, Leufkens TR, Van Leeuwen CJ, Van Oers AC, Laska E et al. Residual effects of low-dose sublingual zolpidem on highway driving performance the morning after middle-of-the-night use. Sleep. 2014;37:489-96. PubMed
  3. Dollery C Sir, editor. Therapeutic drugs. 2nd ed. Edinburgh: Churchill Livingstone; 1999
  4. Imovane (zopiklon). Summary of Product Characteristics. Swedish Medical Products Agency [updated 2020-10-23, cited 2021-02-16]. länk
  5. Leufkens TR, Vermeeren A. Zopiclone's residual effects on actual driving performance in a standardized test: a pooled analysis of age and sex effects in 4 placebo-controlled studies. Clin Ther. 2014;36:141-50. PubMed
  6. Verster JC, Roth T. Gender differences in highway driving performance after administration of sleep medication: a review of the literature. Traffic Inj Prev. 2012;13:286-92. PubMed
  7. Johnell K, Fastbom J. The use of benzodiazpines and related drugs amongst older people in Sweden: associated factors and concomitant use of other psychotropics. Int J Geriatr Psychiatry. 2009;24:731-8. PubMed
  8. Johnell K, Fastbom J. Gender and use of hypnotics or sedatives in old age: a nationwide register-based study. Int J Clin Pharm. 2011;33:788-93. PubMed
  9. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2020 [cited 2021-03-10.] länk
  10. Andersen AB, Frydenberg M. Long-term use of zopiclone, zolpidem and zaleplon among Danish elderly and the association with sociodemographic factors and use of other drugs. Pharmacoepidemiol Drug Saf. 2011;20:378-85. PubMed
  11. Hausken AM, Furu K, Skurtveit S, Engeland A, Bramness JG. Starting insomnia treatment: the use of benzodiazepines versus z-hypnotics A prescription database study of predictors. Eur J Clin Pharmacol. 2009;65:295-301. PubMed
  12. Brownlee K, Devins GM, Flanigan M, Fleming JA, Morehouse R, Moscovitch A et al. Are there gender differences in the prescribing of hypnotic medications for insomnia?. Hum Psychopharmacol. 2003;18:69-73. PubMed

Författare: Linnéa Karlsson Lind

Faktagranskat av: Diana Rydberg

Godkänt av: Karin Schenck-Gustafsson