Postmarketing Surveillance of Zopiclone in Insomnia: Analysis of 20,513 Cases

Abstract

The subjective response to the prescription drug zopiclone, an hypnotic agent belonging to the cyclopyrrolone family, was assessed under the usual conditions of prescription of an hypnotic in general practice. The study included 20,513 insomniac outpatients with at least two of the following symptoms: sleep onset latency longer than 1 hour, more than two nocturnal awakenings, early morning awakening 1 hour or more before scheduled time, total sleep time of less than 6 hours, complaint of tiredness on awakening. Insomniac patients were treated with zopiclone and followed for 21 consecutive days within the context of a follow-up surveillance study. The population was predominantly female (62.6%), and the mean age was 52.3 years. The dosage of zopiclone prescribed at the inclusion visit was 7.5 mg per day in 87.5% of the cases and 3.75 mg per day in 10.5%. A total of 93.8% of the patients completed the survey. Spiegel questionnaire improved during the 21-day survey, and 9.2% of the patients reported at least one adverse event that led to treatment discontinuation in only 2.8% of the population. No serious or unexpected adverse events were reported.

A Double-Blind Comparative Study of Zolpidem versus Zopiclone in the Treatment of Chronic Primary Insomnia

“…The incidence of adverse events recorded with zolpidem was nevertheless higher than those reported in previous studies comparing zolpidem with triazolam (9.7%) 12 and nitrazepam (16.5%), 54 possibly because it was based on review of the detailed information recorded in the patient diaries as well as on patients' oral reports. The bitter taste frequently reported by zopiclone-treated patients in this study was also noted in an analysis of post-marketing surveillance reports on zopiclone, 55 although not in a placebocontrolled study on zopiclone in Japan. 56 In conclusion, the results of this study indicate that zolpidem provides a benefit to insomniac patients at least equal to that of S Tsutsui, Zolpidem Study Group Zolpidem versus zopiclone in chronic primary insomnia zopiclone in terms of improving sleep parameters and daytime performance, while being better tolerated and inducing less rebound insomnia as defined by aggravated sleep onset latency.…”

Paradoxical insomnia in a patient taking zopiclone

“…Zopiclone is recommended for the short-term treatment of primary insomnia and insomnia due to psychiatric disturbances 2. The product monograph reported rebound insomnia with sudden discontinuation of zopiclone but not intractable insomnia while on the medication 3. Other commonly reported side effect of zopiclone is the so-called ‘hangover effect’ due to delayed elimination, so there may be a prolonged drug effect resulting in residual sedation or the hangover effect 4.…”

Zopiclone: Is there cause for concern in addiction services and general practice?

“…It is evident that if prescribing guidelines relating to doses and time-frames are followed, problems with zopiclone are minimal and confined almost entirely to common side-effects such as bitter taste, dry mouth, itching, headaches and the like [7,[8][9][10][11]. In our clinical practice we have noted, however that prescribing guidelines are exceeded with frequency and it is common to find patients on higher doses, for extended periods of time.…”

“…One large study involving 20,513 subjects [7], considered patients who had complained of poor sleep, with symptoms of sleep onset latency of longer than one hour, more than two nocturnal awakenings, early morning awakening, sleep time of less than six hours and complaints of tiredness on awakening. After 21 consecutive days of treatment with zopiclone, improvements were rated by participants as excellent or good in more than 80%, fair in 11.6% and poor or bad in 4%.…”