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PubMed1983

Evaluation of zopiclone physical dependence liability in normal volunteers.

The potential of zopiclone, a non-benzodiazepine sedative hypnotic, to induce physical dependence in normal human volunteers was investigated. 9 male subjects (age range 21-39 years) participated in a 56-day double-blind study with random assignment to initial treatment A or B: (A) zopiclone 7.5 mg p.o. nightly for 21 days followed by placebo for 7 days, and (B) placebo nightly for 21 days followed by placebo for 7 days. Heart rate, blood pressure, hand tremor and auditory-evoked EEG were repeatedly measured during the withdrawal periods. No differences in any of these variables between phases were found (beta = 0.90 for mean differences of 16% between phases). Subjects slept longer (mean 28 min, p less than 0.013) on zopiclone than on placebo. Symptoms of state anxiety were greater on days 2 and 4 after discontinuing zopiclone compared to all other withdrawal days (p less than 0.0021). The mean relative increase on days 2 and 4 was 30%. Sleep depth (self-rating scale) was no deeper on drug than on placebo, but during the withdrawal phases, sleep was less deep on days 2 and 4 of withdrawal from zopiclone compared to all other withdrawal days (p less than 0.0001). Subjects were unable to identify the pattern of drug administration on withdrawal, and none reported important symptoms. Discontinuation of zopiclone (7.5 mg for 21 days) is associated with detectable increase in state anxiety and lighter sleep on days 2 and 4 of withdrawal. Quantitatively, similar changes occur with other hypnotic drugs of relatively low dependence liability.

Adult↗
PubMed1983

Comparison of the reinforcing properties of zopiclone and triazolam in former alcoholics.

The reinforcing properties of zopiclone (3.75 mg) and triazolam (0.25 mg) and their side effects were studied in a double-blind crossover design, followed by forced choice in 40 volunteers taken from a population of chronic alcoholic inpatients who had just completed withdrawal from alcohol. After initial interview when the physician checked if the inclusion and exclusion criteria were met, patients were submitted to the following assessments: profile of mood states (POMS), ARCI subscales (items of scales No. 452, 129, 125, and 52), drug record form and vital signs, SESI (side effect checklist), preference form, subjective effect scale (subscale 220 of the ARCI), and withdrawal assessment. No difference between the drugs could be found on the POMS, ARCI or in the drug intake. There was a difference in patients' drug preference for triazolam in comparison to zopiclone. Zopiclone, like triazolam, may induce some feelings similar to those obtained with alcohol. Side effects noticed by patients were of mild to moderate degree and harmless.

Adolescent↗
PubMed1994

Changes in mouse hippocampal EEG characteristics after oral administration of Ro 41-3696, nitrazepam, or zopiclone alone and in combination with ethanol.

Ro 41-3696, a benzoquinolizinone derivative, is a partial agonist to the benzodiazepine (BDZ) receptor and is expected to be a nonsedative hypnotic. The present comparative study was performed to examine the effects of the oral administration of Ro 41-3696, nitrazepam or zopiclone alone and in combination with a 'social' dose of ethanol on mouse hippocampal EEG. Ro 41-3696 (1-10 mg/kg), nitrazepam (0.1 and 1 mg/kg), and zopiclone (1 and 10 mg/kg) each alone caused an increase in the drowsy EEG pattern associated with a decrease in the duration of hippocampal rhythmic slow-wave activity (RSA). On the other hand, nitrazepam markedly lowered, while Ro 41-3696 and zopiclone slightly lowered the RSA frequency during waking mobility. In combination with a noneffective oral dose (1 g/kg) of ethanol, the reductions in both total duration and peak frequency of RSA caused by nitrazepam, unlike those by Ro 41-3696 and zopiclone, were significantly potentiated. In addition, only nitrazepam produced motor impairment. These results suggest that Ro 41-3696 acts more selectively than nitrazepam to promote the drowsy EEG pattern, and the partial agonistic properties may minimize the residual effects during waking mobility similar to the short-acting agent zopiclone.

Animals↗
PubMed1988

Respiratory center output following zopiclone or diazepam administration in patients with pulmonary disease.

Mouth occlusion pressure at 0.1 s (P0.1) and minute ventilation (VE) were measured at rest and during progressive hypercapnia in 32 patients. Under double-blind conditions and according to a 2 x 2 Latin-square design, half the patients received one oral dose of diazepam and its placebo. Using the same design, the other half received zopiclone and its placebo. Normocapnic and moderately hypoxemic patients between the ages of 21 and 69 with moderate to severe chronic obstructive pulmonary disease were included in the study. Diazepam produced a statistically significant decrease (p less than 0.05) over its placebo in delta P0.1/delta PETCO2 values following CO2 rebreathing. Zopiclone did not influence either delta P0.1/delta PETCO2 or delta VE/delta PETCO2, but produced a significant increase in respiratory frequency. However, no statistically significant differences were observed between the two active treatments.

Adult↗
PubMed2000

Residual effects of hypnotics on disengagement of spatial attention.

In an earlier study, we postulated that the residual effects of hypnotics could induce a spatial attention disengagement deficit independent of any decrease in alertness. To test this hypothesis, we compared the residual effects of zolpidem, zopiclone and flunitrazepam in two ocular saccade tests, gap and overlap. In the gap paradigm, the lateral target is illuminated 200 ms after the extinguishing of the central target. In the overlap paradigm, the central target stayed on when the lateral target was illuminated. Zopiclone increases latency in the overlap, but not in the gap test, which appears to be specific to a deficit of disengagement of spatial attention. Zopiclone impairs the saccadic precision in gap, but not in overlap, which may be interpreted as an impairment of visuospatial memory. The effects of zolpidem are limited to visuospatial impairment. The effects of flunitrazepam are massive and probably the results of a decrease in alertness.

Adult↗
PubMed2003

Do zopiclone, zolpidem and flunitrazepam have residual effects on simulated task of collision anticipation?

Few studies have addressed the modifications in visual information processing brought about by taking hypnotic substances. The present experiment with healthy subjects investigated the residual effects of taking a single night-time dose of hypnotics on collision anticipation capacities the next morning. Visual sequences simulated the movement of a driver approaching an intersection where another vehicle was arriving. Ten participants had to estimate, as quickly as possible, whether the other vehicle would arrive before or after them at the intersection. They were tested after having taken a capsule of zolpidem (10 mg), zopiclone (7.5 mg), flunitrazepam (1 mg) or a placebo. The results show no residual effects of the molecules. Only flunitrazepam, a benzodiazepine with a long half-life, appears to cause subjects to focus their attention on an element which, while relevant for the task (a road sign playing the role of a spatial reference), is not used correctly.

Accidents, Traffic↗
PubMed1983

The acceptability of a non-benzodiazepine hypnotic (Zopiclone) in general practice.

The hypnotic effects of Zopiclone, a novel cyclopyrrolone derivative, were compared with placebo in a double-blind randomized crossover study in insomniac patients. Subjective morning assessments by the patients showed that Zopiclone 7.5 mg improved the quality of sleep, with a reduction in the sleep onset latency and the number of nocturnal awakenings. Zopiclone was judged by the physicians to be superior to placebo and was preferred by the patients. Subjective residual effects and adverse reactions were minimal.

Adult↗
PubMed2006

Sedative hypnotic use in Alberta.

OBJECTIVE: Benzodiazepines and similar sedative-hypnotics (BDZ-SSHs) are associated with both beneficial and adverse effects. Pharmacoepidemiologic data describing the use of these medications in contemporary Canadian populations has not been readily available. Our objective was to examine the hypothesis that increasing use of antidepressant medications for anxiety and mood disorders during the past decade led to less frequent use of BDZ-SSH medications. METHOD: We used data from an Alberta Mental Health Survey to describe the pattern of BDZ-SSH use and to estimate provincial and health region frequencies of use. We supplemented the data with pharmacy dispensing data from IMS Health. RESULTS: The frequency of use was comparable to that reported in previous studies. Unexpectedly, in the survey data, we observed trends suggesting regional variation both in the frequency and pattern of use. Examination of prescription dispensing data confirmed this pattern. Clinical factors, including the use of other psychotropic medications and psychiatric diagnoses, were strongly associated with BDZ-SSH use. Among the drugs examined, zopiclone had the highest frequency of use. Prescription dispensing data confirmed that the frequency of zopiclone use in Alberta is higher than that in most other provinces. CONCLUSIONS: This descriptive study generates several new research questions and provides benchmarks for future pharmacoepidemiologic monitoring.

Acetamides↗
PubMed1988

A sleep laboratory evaluation of the long-term efficacy of zopiclone.

Six patients between the ages of 25 and 59, with chronic, primary insomnia received the new, non-benzodiazepine, hypnotic zopiclone continuously for 17 weeks after a drug free interval of 12 nights. To qualify for the study, sleep efficiency, determined by a sleep study on two, consecutive, placebo-controlled nights, had to be less than 75%. Patients evaluated their sleep by questionnaire and had sleep studies completed throughout active treatment. Zopiclone (7.5 mg) increased sleep efficiency by decreasing sleep latency, wakefulness after sleep onset and increasing total sleep time. Sleep architecture was minimally affected by zopiclone treatment; no significant changes in delta or REM sleep were observed. The commonest side effect was a bitter or metallic taste. No significant changes in biological functioning were noted throughout the study period. These findings indicate that zopiclone is a safe and effective hypnotic medication which maintains its effectiveness with protracted use.

Adult↗
PubMedDate not supplied

A double-blind comparative study of zolpidem versus zopiclone in the treatment of chronic primary insomnia.

Zolpidem (10 mg/day) and zopiclone (7.5 mg/day), administered at night, were compared in a 14-day, double-blind, equivalence trial on 479 chronic primary insomniacs (zolpidem, 231; zopiclone, 248) throughout Japan, with a 1-week follow-up to assess rebound. The primary endpoint was the investigators' rating of global improvement of sleep disorders. A total of 32 patients in the zolpidem group (13.9%) and 45 patients in the zopiclone group (18.1%) withdrew from the study before the end of the treatment. In the zolpidem group, 67.9% (142/209) of patients were rated at least 'moderately improved' versus 61.6% (135/219) with zopiclone, zolpidem being at least as effective as zopiclone (90% confidence interval: -1.7, 14.3). With zolpidem, sleep onset latency improved in significantly more patients (85.8% versus 77.5%) and significantly fewer patients showed aggravated sleep onset latency relative to baseline at follow-up (4.5% versus 15.4%). Significantly fewer patients receiving zolpidem experienced drug-related adverse events (31.3% versus 45.3%), with bitter taste representing 5.8% (six of 104) of such complaints with zolpidem compared with 39.9% (69/173) with zopiclone. In conclusion, zolpidem was at least as effective as zopiclone, showed significantly less rebound on discontinuation and was better tolerated.

Adult↗
PubMed1997

Effect of zopiclone on sleep, night-time ventilation, and daytime vigilance in upper airway resistance syndrome.

We have assessed the effects of zopiclone (7.5 mg), a new cyclopyrrolone hypnotic drug, on ventilation, sleep parameters, and daytime vigilance in snorers with upper airway resistance syndrome (UARS). Using a randomized double-blind design, eight male patients with UARS took either oral zopiclone or a placebo each evening for seven consecutive days and then crossed over to the other drug after a 7 day placebo period. Polysomnography followed by a multiple sleep latency test (MSLT) was performed during the last night of each treatment period. Zopiclone produced significant improvements in the sleep efficiency index (total sleep time/time in bed) (placebo 84+/-15% versus zopiclone 91+/-7%) and average MSLT (placebo 10.3+/-3.7 min versus zopiclone 14.9+/-2.8 min), as well as nonsignificant improvements in sleep onset latency and total sleep time. It had no effect on sleep architecture or on the arousal index (placebo 17+/-8 arousals x h(-1) versus zopiclone 17+/-4 arousals x h[-1]). Furthermore, none of the respiratory parameters were significantly affected by zopiclone. In conclusion, zopiclone has no adverse effects on sleep architecture, respiratory parameters during sleep, and daytime sleepiness in patients with UARS.

Airway Resistance↗
PubMed2006

A polysomnography study of eszopiclone in elderly patients with insomnia.

OBJECTIVE: To evaluate the safety and efficacy of eszopiclone 2 mg in elderly patients (aged 64-86 years) with chronic insomnia. METHODS: This was a randomized, double-blind, placebo-controlled 2-week study. Patients meeting DSM-IV criteria for primary insomnia and screening polysomnography criteria (wakefulness after sleep onset [WASO] >or= 20 min and latency to persistent sleep >or= 20 min) were randomized to 2 weeks of nightly treatment with eszopiclone 2 mg (n = 136) or placebo (n = 128). Efficacy was assessed using polysomnography (Nights 1, 2, 13, and 14) and patient reports (Nights 1-14); safety was assessed using adverse events, clinical labs, physical examination, and vital signs. The mean of all efficacy results during the double-blind period was used for the efficacy analysis. RESULTS: Results indicated that eszopiclone was associated with significantly shorter sleep onset, less WASO, higher sleep efficiency, more total sleep time, and greater patient-reported quality and depth of sleep scores than placebo (p < 0.05 for all) with a trend in patient-reported morning sleepiness (p = 0.07). Other measures of daytime functioning (ability to function, daytime alertness, and sense of well-being) were not significantly different between the two treatment groups. Among patients who napped, eszopiclone patients reported fewer naps (p = 0.03) and less cumulative naptime (median: 98 min placebo, 70 min eszopiclone, p = 0.07). Unpleasant taste, dry mouth, somnolence, and dizziness were higher in the eszopiclone group (12.5%, 8.8%, 6.6%, and 6.6%, respectively) than in the placebo group (0%, 1.6%, 5.5%, and 1.6%, respectively). CONCLUSION: In this study, eszopiclone was well tolerated and produced significant improvements in both polysomnographic and patient-reported measures of sleep maintenance, sleep induction, and sleep duration in elderly patients with chronic primary insomnia.

Aged↗