Drug products: Imovane®, Zopiclon Stada, Zopiclone Actavis, Zopiclone Jubilant, Zopiclone Orion, Zopiklon Mylan, Zopiklon Pilum
ATC code: N05CF01
No sex-related differences have been observed for zopiclone. One study showed impaired driving capacity in both men and women using zopiclone but not zolpidem (3 hours after dose intake). In contrast to zolpidem, no difference in fatigue/driving performance between men and women has been shown. Zopiclone have a longer half-life and thus longer effect duration than zolpidem.
Zopiclone has a half-life of 3.5-6 h. No differences in zopiclone pharmacokinetics have been seen between men and women .The absorption of zopiclone is similar in men and women and no sex differentiation in dosing has been recommended by the pharmaceutical company .
No studies with a clinically relevant sex analysis regarding the effects of zopiclone have been found.
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 . 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 .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 . 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 .
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
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 . 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 .
Date of litterature search: 2021-02-16
Reviewed by: Diana Rydberg
Approved by: Karin Schenck-Gustafsson