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PubMed2002

Melatonin and zopiclone: the relationship between sleep propensity and body temperature.

STUDY OBJECTIVES: The sleep promoting effects of the sedative-hypnotics, melatonin and temazepam, have been associated with a decline in core body temperature (Tc). To determine whether changes in body temperature are a general feature of sedative-hypnotics, the present study compared the sleep inducing, core and peripheral temperature effects of melatonin, with those of zopiclone. DESIGN: Subjects were supine from 08:00-21:30 h and received melatonin, zopiclone or placebo at 14:00 h. SETTING: Individual, light and temperature controlled bedrooms. PARTICIPANTS: 12 healthy, young, adults (7m, 5f; 20.3 +/- 0.6 years). INTERVENTIONS: Melatonin (5mg), zopiclone (Imovane; 7.5 mg) and placebo were administered in a double-blind, crossover design. MEASUREMENTS AND RESULTS: From 11:00-20:00 h, modified hourly multiple sleep onset latency tests (MSLT) of a 20-min duration were conducted and heart rate (HR) was recorded. Tc and foot temperature (T(Ft)) were recorded continuously using thermistors. Compared with placebo, melatonin and zopiclone significantly reduced sleep onset latency (SOL) to stage 1 (by 3.50 +/- 0.73 min and 6.80 +/- 0.61 min, respectively) and reduced Tc (by 0.22 +/- 0.02C and 0.14 +/- 0.02C, respectively). For melatonin, Tc declined as the result of an increase in peripheral heat loss (increase in T(Ft) of 1.65 +/- 0.43 degrees C), and possibly a reduction in heat production as indicated by a decrease in HR (4.56 +/- 0.94 bpm). Zopiclone increased heat loss (increase in T(Ft) of 1.43 +/- 0.68C) and had no cardiac effects. For melatonin, a negative association was found between Tc (mean r=-0.43), however, this association was only weak for zopiclone (mean r=-0.23). CONCLUSIONS: These results suggest that body temperature changes may be a general feature of sedative-hypnotics. The potential role of this effect in the promotion of sleep appears to vary between agents.

Adult↗
PubMed2003

Sustained efficacy of eszopiclone over 6 months of nightly treatment: results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia.

STUDY OBJECTIVES: To determine the long-term efficacy of eszopiclone in patients with chronic insomnia. DESIGN: Randomized, double-blind, multicenter, placebo-controlled. SETTING: Out-patient, with monthly visits. PATIENTS: Aged 21 to 69 years meeting DSM IV criteria for primary insomnia and reporting less than 6.5 hours of sleep per night, and/or a sleep latency of more than 30 minutes each night for at least 1 month before screening. INTERVENTIONS: Eszopiclone 3 mg (n = 593) or placebo (n = 195), nightly for 6 months MEASUREMENTS AND RESULTS: Efficacy was evaluated weekly using an interactive voice-response system. Endpoints included sleep latency; total sleep time; number of awakenings; wake time after sleep onset; quality of sleep; and next-day ratings of ability to function, daytime alertness, and sense of physical well-being. At the first week and each month for the study duration, eszopiclone produced significant and sustained improvements in sleep latency, wake time after sleep onset, number of awakenings, number of nights awakened per week, total sleep time, and quality of sleep compared with placebo (P < or = 0.003). Monthly ratings of next-day function, alertness, and sense of physical well-being were also significantly better with the use of eszopiclone than with placebo (P < or = 0.002). There was no evidence of tolerance, and the most common adverse events were unpleasant taste and headache. CONCLUSIONS: Throughout 6 months, eszopiclone improved all of the components of insomnia as defined by DSM-IV, including patient ratings of daytime function. This placebo-controlled study of eszopiclone provides compelling evidence that long-term pharmacologic treatment of insomnia is efficacious.

Adult↗
PubMed2005

A 2-week efficacy and safety study of eszopiclone in elderly patients with primary insomnia.

STUDY OBJECTIVES: Evaluate the efficacy of eszopiclone in primary insomnia. DESIGN/SETTING: Randomized, double-blind, placebo-controlled multicenter in outpatient setting with weekly visits. PARTICIPANTS: Two-hundred thirty one men and women aged 65 to 85 years (mean age 72.3 years) with primary insomnia, as defined by the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition. INTERVENTIONS: Eszopiclone 1 mg (n = 72), eszopiclone 2 mg (n = 79), or placebo (n = 80) nightly for 2 weeks. MEASUREMENTS/RESULTS: Efficacy was assessed using an interactive voice response system. Following the predefined hierarchical testing strategy, the eszopiclone 2-mg group had a significantly shorter sleep latency compared with placebo over the double-blind period (P = .0034). The eszopiclone 2-mg group had significantly longer total sleep time (P = .0003) and eszopiclone 1-mg group had significantly shorter sleep latency (P < or = .012) compared with placebo. The eszopiclone 1-mg group was not significantly different from placebo on total sleep time or any other secondary efficacy endpoint. Secondary analyses indicated that the eszopiclone 2-mg group had significantly less wake after sleep onset; significantly fewer and shorter in duration daytime naps; and significantly higher ratings of sleep quality and depth, daytime alertness, and sense of physical well-being compared with placebo (P < .05). Eszopiclone was well tolerated. The most frequent treatment-related adverse event was unpleasant taste. CONCLUSION: Nightly treatment with eszopiclone 1 mg effectively induced sleep, while the 2-mg dose was effective in inducing and maintaining sleep. Eszopiclone was well tolerated in elderly patients with primary insomnia, and the sleep efficacy was accompanied by significantly less napping and significantly higher ratings of daytime alertness, sense of physical well-being, and several quality-of-life parameters at the higher dose.

Aged↗
PubMed2006

A comparison of actigraphy and polysomnography in older adults treated for chronic primary insomnia.

STUDY OBJECTIVES: The present study explores the accuracy and clinical utility of actigraphy compared with polysomnography in older adults treated for chronic primary insomnia. DESIGN: Polysomnographic and actigraphic data were collected before and after treatment. SETTING: A university-based outpatient clinic for adults and elderly. PARTICIPANTS: Thirty-four participants with chronic primary insomnia. Mean age was 60.5 years. INTERVENTIONS: Participants received either a manualized treatment package based on cognitive-behavior therapy and sleep management or hypnotic-drug treatment (7.5 mg zopiclone) for 6 weeks (these findings are reported elsewhere). MEASUREMENTS AND RESULTS: Although the sensitivity of actigraphy to detect sleep was very high (95.2%), actigraphy performed poorly in detecting wakefulness (specificity: 36.3%), yielding on an overall level of accuracy of 83.1%. However, the level of actigraphy accuracy was dependent upon polysomnography-registered sleep efficiency. Actigraphy underestimated total wake time and sleep-onset latency and consequently overestimated total sleep time and sleep efficiency. Compared with polysomnography, actigraphy captured only part of the treatment effects on total wake time and sleep-onset latency and failed to detect significant changes in sleep efficiency. CONCLUSIONS: The present findings suggest that the clinical utility of actigraphy is still suboptimal in older adults treated for chronic primary insomnia and should, hence, be used in this clinical setting with the concurrent use of supplementary assessment methods.

Aged↗
PubMed1986

Modulation of delta activity by hypnotics in middle-aged subjects: studies with a benzodiazepine (flurazepam) and a cyclopyrrolone (zopiclone).

Period crossing analysis was used to study the effects of flurazepam (30 mg) and zopiclone (5, 7.5, and 10 mg) on delta wave activity (0.5-2.0 Hz) during the first 4 h of sleep in middle-aged subjects. The drugs do not affect the visual scoring of slow wave sleep in middle age, but modification of delta activity does occur. Mean amplitude of delta wave activity over the 4-h period was reduced by both drugs, while the total number of delta waves and their mean period increased. The number of high-amplitude delta waves (greater than 60 microV) was decreased by the drugs, and those of low amplitude (10-60 microV) increased. Power in the frequency band 1.2-2.0 Hz was reduced.

Aging↗
PubMed2004

Comparison of lorazepam and zopiclone for insomnia in patients with stroke and brain injury: a randomized, crossover, double-blinded trial.

OBJECTIVES: To determine if lorazepam or zopiclone is more effective in providing a restful night of sleep and to assess the effects of these medications on cognition. DESIGN: A randomized, double-blinded, crossover trial was performed at a tertiary care rehabilitation inpatient unit in a teaching hospital. A total of 18 brain-injured and stroke patients, aged 20-78 yrs, were administered lorazepam, 0.5-1.0 mg, orally at bedtime as needed for 7 days and zopiclone, 3.75-7.5 mg, orally at bedtime as needed for 7 days. Total sleep time and characteristics of sleep were measured. Effects on cognition were also measured using the Folstein Mini Mental Status Exam. RESULTS: There was no difference in average sleep duration or in subjective measures of sleep. Cognition as assessed by the Mini Mental Status Exam revealed no difference in the zopiclone arm compared with the lorazepam arm. CONCLUSION: Zopiclone is equally effective as lorazepam in the treatment of insomnia in stroke and brain-injured patients.

Administration, Oral↗
PubMed1990

A double-blind placebo-controlled trial of zopiclone 7.5 mg and temazepam 20 mg in insomnia.

Zopiclone, a cyclopyrrolone with hypnotic properties was compared with temazepam and placebo in the treatment of insomnia. After a week's washout period, suitable subjects were allocated at random to zopiclone 7.5 mg or temazepam 20 mg or placebo for 2 weeks. Measurements of psychomotor function using the Leed's psychomotor tester and letter cancellation were carried out on day 0, 7 and 14. Sleep latency, duration of sleep and number of times waking during the night were recorded on a sleep diary filled by the subjects nightly. Forty-four subjects completed the trial, 15 taking zopiclone, 16 taking temazepam and 10 taking placebo. Both zopiclone and temazepam had significant hypnotic properties when compared to placebo. Zopiclone increased total sleep time in both weeks of the trial while temazepam increased sleep time in the first week only. There was no significant deterioration in psychomotor performance at the end of both weeks for zopiclone. Critical flicker fusion was significantly increased in subjects on temazepam. There were no abnormalities for both zopiclone and temazepam subjects in the blood picture, renal profile, liver function, urine and ECG before and after the study. Zopiclone is an effective hypnotic comparable to temazepam.

Adult↗
PubMed1990

Zopiclone and triazolam in insomnia associated with generalized anxiety disorder: a placebo-controlled evaluation of efficacy and daytime anxiety.

In a double-blind placebo-controlled study, following a 1 week washout, 75 outpatients suffering from generalized anxiety disorder with severe insomnia as the target symptom were randomly assigned to 4 weeks of treatment with zopiclone 7.5 mg, triazolam 0.5 mg or placebo at bedtime. Zopiclone was significantly better than placebo on most sleep parameters. Triazolam tended to be superior to placebo, but its superiority was significant only on the sleep induction factor. Triazolam-treated patients presented significantly more day-time-interdose anxiety than zopiclone as assessed by the weekly HARS and Clinical Global Assessment of Anxiety. Although daytime-interdose anxiety was observed with both drugs, this treatment emergent symptom was more frequent and severe with triazolam. Side-effects were of a mild to moderate intensity for both zopiclone and triazolam; however, taste perversion frequently appeared with zopiclone. Although both drugs share similar pharmacological properties and bind to benzodiazepine receptors, they differ significantly with respect to side-effects and daytime anxiety.

Adult↗
PubMed1990

Zopiclone versus flurazepam in insomnia: prolonged administration and withdrawal.

Zopiclone (7.5 mg), a cyclopyrrolone derivative with a 6.5 h half-life, and flurazepam (30 mg) were compared to placebo in a randomized double-blind study involving 36 adult patients suffering from insomnia. All previous psychotropic drugs were discontinued 1 week prior to the study. During 4 weeks, 12 patients received zopiclone, 12 flurazepam and the others placebo. Thereafter, all patients received single-blind placebo for 3 nights. Rapidity of sleep onset, sleep duration, frequency of nocturnal awakenings, psychomotor coordination and side-effects were assessed daily with a questionnaire and a symptom checklist. The results of the study suggest that zopiclone 7.5 mg was at least as potent as flurazepam 30 mg in inducing and maintaining sleep. Both drugs maintained their efficacy during the 4 weeks of treatment. However, the two drugs differed in that flurazepam impaired psychomotor coordination whereas zopiclone did not demonstrate daytime protracted effects on psychomotor performance. Upon discontinuation of drug treatment, score values of the different sleep parameters under study returned to the baseline values. Side-effects were mild and consistent with earlier studies.

Adult↗
PubMed1994

Zopiclone improves sleep quality and daytime well-being in insomniac patients: comparison with triazolam, flunitrazepam and placebo.

In a randomized, double-blind, parallel group study in private practice, zopiclone given for 28 days was compared with flunitrazepam, triazolam and placebo in its effect on quality of sleep and daytime well-being in 1507 patients suffering from insomnia. For quantitative assessment, patients were defined as responders according to either a shortening of sleep latency by at least 15 min, or prolongation of total sleep time by at least 20%, or reduction of the number of nocturnal awakenings to three or less and a fresh feeling in the morning, as well as lack of impairment in daytime well-being as a result of tiredness or anxiety. The responder rate tended to be higher with zopiclone (37.4%) than with flunitrazepam (30%) and triazolam (32.2%) and was significantly greater (p = 0.0017) than with placebo (26.8%). Daytime well-being was particularly responsive to zopiclone and most responsive in severe insomniacs. With the exception of those to triazolam, rates of response were most pronounced in patients with insomnia of a short duration (< or = 1 year) than in those with insomnia of a longer duration (> or = 1 year). Following discontinuation of treatment, all groups showed a moderate reduction in therapeutic effect, but no rebound insomnia occurred.

Azabicyclo Compounds↗
PubMed2002

Chromatographic screening for zopiclone and metabolites in urine using liquid chromatography and liquid chromatography-mass spectrometry techniques.

Zopiclone is a benzodiazepine-like hypnotic that was believed not to have any abuse potential. Nevertheless, during the past few years there have been an increasing number of reports on the abuse and misuse of zopiclone. Despite this, methods for screening analysis in urine are lacking. To investigate whether UV detection would be possible to use for this purpose, a liquid chromatography method with ultraviolet detection for analyzing zopiclone and its urinary metabolites was developed, with liquid chromatography-mass spectrometry for confirmation. The method was used for analyzing samples from subjects receiving methadone. The limits of detection were approximately 100 ng/mL in control urine samples and 500 ng/mL in urine samples from subjects receiving methadone. However, due to the high background in these patients' urine, a single therapeutic dose was impossible to detect.

Adult↗
PubMed2004

Drug-facilitated robbery or sexual assault: problems associated with amnesia.

Amnesia following sedative-hypnotic drug exposure is discussed. Anterograde amnesia clearly occurs with many benzodiazepines. Several drugs are assessed: benzodiazepines and two hypnotics in particular that are structurally unrelated to the benzodiazepines but share some of their properties: zolpidem and zopiclone. The amnesic effects of these drugs are described, memory process, biology of memory, and memory process impairment documented. With these drugs anterograde amnesia has been demonstrated to be dose dependent. This effect is associated with hypnotic drugs, however, the receptors are different. As regards forensic medicine, a significant and specific type of amnesia should be considered: amnesia automatism or amnesic complex automatism. Also, several cases observed in our laboratory are presented to demonstrate the impact of amnesia.

Amnesia↗
PubMed2000

Comparative effects of zopiclone and loprazolam on psychomotor and physical performance in active individuals.

OBJECTIVE: Sedative hypnotics are used by athletes to alleviate precompetition anxiety and insomnia. The effects of these agents on exercise tolerance have not been extensively researched. DESIGN: To determine the effects of sedative hypnotics on psychomotor and physical performance, a double-blind, placebo- (P) controlled, cross-over designed trial investigated the effects of zopiclone (Z) and loprazolam (L) on performance in 12 athletes. INTERVENTION: Subjects ingested either P, Z (7.5 mg), or L (2 mg) on three different occasions separated by a 1-week washout period. Eye-hand coordination tests, a 30-m sprint test, an agility test, and a graded treadmill run to exhaustion for determination of VO2max were performed 10 hours after drug administration. RESULTS: Subjects reported a significantly greater hangover effect following ingestion of L (8/11 subjects) compared with ingestion of Z (3/11 subjects; p < 0.01). A greater number of subjects felt alert after ingestion of P (9/11 subjects) and Z (9/11 subjects) compared with L (4/11 subjects; p < 0.01). The results of the eye-hand coordination tests, the 30-m sprint, the T-test, the VO2max, and the time to exhaustion during the treadmill run were not significantly altered following the ingestion of P, Z, and L. There was a significant difference between the delta values for Z and L for the number of missed responses in the eye-hand coordination tests (p < 0.02). Therefore, following the ingestion of L, subjects experienced a significant hangover effect and altered reaction time, whereas the ingestion of Z did not significantly impair either psychomotor or physical performance in the administered tests. CLINICAL RELEVANCE: Investigate the extent of the effects of sedative hypnotics on exercise performances, enabling team physicians to prescribe such drugs to the athlete more effectively.

Adult↗