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PubMed2003

Zopiclone-induced acute interstitial nephritis.

Zopiclone, a relatively new nonbenzodiazepine short-acting hypnotic medication is prescribed frequently for insomnia. The authors report a case of zopiclone-induced acute interstitial nephritis in a young, otherwise healthy man. The patient presented with anuric acute renal failure requiring hemodialysis. Kidney biopsy results showed acute interstitial nephritis with a prominent eosinophilic infiltrate in the interstitium. He recovered his renal function after stopping the medication and receiving corticosteroids.

Acute Disease↗
PubMedDate not supplied

[Diagnostics and treatment of sleep disorders in elderly people].

A meta-analysis was done of the published literature concerning the modern status of the issue of sleep disturbances and of findings from the author's investigations. Data are submitted obtained in a clinical examination of 61 elderly patient in a therapeutical hospital. In the above patients, high prevalence has been revealed of different sleep disturbances. Insomnia is often a sequela of psychophysiological derangements, which fact necessitates an exhaustive differential diagnosis and choice of remedies to be used in therapy of the above disorders. An experience is described of employment of zopiclon (Somnol Grindex) to deal with sleep problems in those patients in the involutional period. It is suggested that psychiatrist services be more actively used to give the necessary advice to those patients of the cardiological profile presenting with sleep disturbances.

Aged↗
PubMed1992

A comparison of efficacy and tolerance of the short acting sedatives midazolam and zopiclone.

AIMS: To compare the efficacy and tolerance of midazolam, 15 mg and zopiclone 7.5 mg once daily for seven days in a prospective, double blind trial of 88 patients, aged 18 or over, with sleep disorders in general practice. METHODS: Efficacy was evaluated using the Leeds sleep evaluation questionnaire (LSEQ). Adverse reactions were recorded as volunteered. RESULTS: fifty-one patients completed all aspects of the trial without violation of the protocol. Patients taking zopiclone improved in all aspects of the Leeds questionnaire (p < 0.01). Patients taking midazolam improved in six out of 10 items (p < 0.01). Rebound insomnia was evident in the zopiclone group in five out of 10 items of the LSEQ. Rebound was not evident in the midazolam group. There were no significant differences between midazolam 15 mg, and zopiclone 7.5 mg, in comparison between groups. Thirty-eight patients suffered 49 adverse drug reactions and there were no differences between the groups. CONCLUSIONS: Zopiclone 7.5 mg daily improved more items on the LSEQ than midazolam 15 mg daily but was associated with significant rebound insomnia. Adverse reactions were frequent with both drugs.

Adolescent↗
PubMed1992

Comparative clinical profiles of triazolam versus other shorter-acting hypnotics.

The efficacy, safety, and performance of triazolam was compared with those of other shorter-acting hypnotics acting on the gamma-aminobutyric acid (GABA) receptor--zopiclone, zolpidem, midazolam, brotizolam, temazepam, lormetazepam, and loprazolam. In all, 5506 patients participated in 38 clinical and epidemiologic studies, of whom 2462 were treated with triazolam in parallel-design and crossover studies. To provide clinically relevant comparisons, only studies using comparator agents in doses equipotent to the triazolam doses were included. Two general findings emerged. First, "serious" central nervous system side effects, such as excitement and violence, were not demonstrated for any of the hypnotic agents, including triazolam. Other central nervous system side effects, such as depression and irritability, were reported with equal frequencies for all the hypnotics reviewed. Rebound insomnia, reported intermittently with most of these agents, was short-lived and not clinically significant. So-called early morning insomnia was noted only once and does not appear to be a valid clinical entity. Daytime anxiety was not observed in large numbers of triazolam-treated subjects studied, which is contrary to claims that the drug is anxiogenic. Second, a remarkable similarity was found among all of these shorter-acting agents in terms of efficacy, side effects, and performance-related effects. This was particularly of note for zopiclone and zolpidem. Although claims have been made suggesting differences, evaluation of the studies herein showed that these nonbenzodiazepine hypnotics were indistinguishable from triazolam and other benzodiazepine hypnotics in their clinical and pharmacologic activity. Thus, different chemical structures did not a priori predict different clinical profiles when drugs share a similar mechanism of action.

Azabicyclo Compounds↗
PubMed2003

Impact of melatonin, zaleplon, zopiclone, and temazepam on psychomotor performance.

INTRODUCTION: Modern military operations may require pharmaceutical methods to sustain alertness and facilitate sleep in order to maintain operational readiness. In operations with very limited sleep windows, hypnotics with very short half-lives (e.g., zaleplon, t(1/2) 1 h) are of interest, while with longer sleep opportunities, longer acting agents (e.g., zopiclone, temazepam (t(1/2) 4-6 hours) may be used. This study was designed to compare the effect of a single dose of zaleplon, zopiclone, temazepam, and melatonin on psychomotor performance and to quantify the post-ingestion time required for return to normal performance. METHOD: There were 23 subjects (9 men, 14 women), 21-53 yr of age, assessed for psychomotor performance on 2 test batteries (4 tasks) that included a sleepiness questionnaire. Psychomotor testing was conducted prior to, and for 7 h after, ingestion of a single dose of each of placebo, zaleplon 10 mg, zopiclone 7.5 mg, temazepam 15 mg, and time-released melatonin 6 mg. The experimental design was a double-blind cross-over with counter-balanced treatment order. RESULTS: Zaleplon, zopiclone, and temazepam impaired performance on all four tasks: serial reaction time (SRT), logical reasoning (LRT), serial subtraction (SST), and multitask (MT). Melatonin did not impair performance on any task. The time to recovery of normal performance for SRT during the zaleplon, zopiclone and temazepam conditions were 3.25, 6.25, and 5.25 h respectively; for LRT were 3.25, >6.25, and 4.25 h; for SST were 2.25, >6.25, and 4.25 h, and for MT were 2.25, 4.25, and 3.25 h. The recovery time to baseline subjective sleepiness levels for zaleplon, zopiclone, temazepam, and melatonin were 4.25, >6.25, 5.25, and >4.25 h, respectively. CONCLUSIONS: In spite of a prolonged period of perceived sleepiness, melatonin was superior to zaleplon in causing no impact on performance. The remaining drugs listed in increasing order of performance impact duration are zaleplon, temazepam, and zopiclone.

Acetamides↗
PubMed2003

[Effects of short-action hypnotics triazolam and zopiclone on simulated flight performance].

OBJECTIVE: To evaluate the effects of short-action hypnotics triazolam and zopiclone on simulated flight performance so as to provide experimental evidences for the use of these drugs in aircrew. METHOD: Six healthy young male volunteers served as the subjects. They were asked to take triazolam (0.25 mg), zopiclone (7.5 mg) or placebo at noon time (13:00) and sleep for 1 h. Simulated flight performances were tested in a simulator 1 h, 2 h, 3 h, 4 h, 6 b, 8 h, 10 h and 20 h (next morning 9:00) after taking the drugs. The experiments were done once a week for 3 weeks. RESULT: No significant difference was found between simulated flight performances before or after triazolam while simulated flight performances at 2 h and 3 h after taking zopiclone showed significant decrease (P<0.05), but restored to normal 4 h after taking the drug. CONCLUSION: Short-action hypnotics triazolam had no significant effect on simulated flight performance, while zopiclone had significant adverse effects on simulated flight performance at 2 h and 3 h after taking the drug.

Adolescent↗
PubMed1992

[Periodic discharges of sleep spindles with placebo and zopiclone].

According to our experiences (parietal) sleep spindles often show a periodical appearance. Successive sleep spindles in series have a distance of about four seconds. In 95% the duration of such series of sleep spindles is not longer than 40 s, so that there appears no more than ten successive periodical sleep spindles. In the present study ten subjects aged between 57 and 77 years were given Placebo and 7.5 mg Zopiclone. Under the effect of verum we found a doubling of sleep spindle series. However, the distance between the periodical spindles and the length of the spindle series remained unchanged. The variance in the ability to generate sleep spindle series was very high across subjects. One subject for example produced only one sleep spindle series in the Placebo-night (three under verum) and another subject on the other hand 95 (under verum 130). The results of the present study well corresponding to the results of a former investigation comparing Placebo, Pentobarbital, Methaqualon, Carbromal, Flunitrazepam, Triazolam and Lormetazepam.

Aged↗
PubMed2004

Melatonin and zopiclone as facilitators of early circadian sleep in operational air transport crews.

INTRODUCTION: This study was an extension into an operational setting of previous laboratory work investigating the use of zopiclone and melatonin to facilitate early circadian sleep in transport aircrew. The previous laboratory-based study demonstrated that both melatonin and zopiclone were effective in inducing early circadian sleep without impacting on psychomotor performance after a 7-h sleep period. METHODS: In a repeated measures, placebo-controlled protocol, 30 aircrew flew 3 transatlantic missions over which they took each of the 3 medications (placebo, sustained-release melatonin 2 mg, or zopiclone 5 mg) at an early body clock time (17:00) during their first stopover. They wore wrist actigraphs prior to and throughout the missions, took a single dose of their scheduled medication immediately prior to their early circadian bedtime, and completed a sleep questionnaire on arising from their medicated sleep. RESULTS: The results of the actigraphic data show that relative to placebo, aircrew on melatonin and zopiclone fell asleep more quickly (melatonin: p < 0.01, zopiclone: p < 0.003), slept more (melatonin: p < 0.02, zopiclone: p < 0.005), had fewer awakenings after sleep onset (melatonin: p < 0.004, zopiclone: p < 0.01), and spent less time awake after sleep onset (melatonin: p < 0.01, zopiclone: p < 0.05). The results of the questionnaire data show that relative to placebo, aircrew on melatonin and zopiclone experienced less difficulty getting to sleep (melatonin: p < 0.0001, zopiclone: p < 0.001), had fewer awakenings (melatonin: p < 0.005, zopiclone: p < 0.001), less difficulty returning to sleep after awakening (melatonin: p < 0.0001, zopiclone: p < 0.0001), and reported a better sleep quality (melatonin: p < 0.0003, zopiclone: p < 0.0004). There were no statistically significant differences between melatonin and zopiclone in any of the actigraphic or questionnaire sleep parameters. CONCLUSIONS: Melatonin and zopiclone, in the dosages we used, are equipotent facilitators of early circadian sleep during transmeridian air transport operations.

Adult↗
PubMed2004

Sleep-inducing pharmaceuticals: a comparison of melatonin, zaleplon, zopiclone, and temazepam.

INTRODUCTION: Current military operations often require pharmaceutical methods to sustain alertness and facilitate sleep in order to maintain operational readiness. This study was designed to compare the sleep-inducing power of four medications. METHOD: There were 9 men and 14 women, ages 21-53 yr, who were assessed for psychomotor performance before and for 7 h after ingestion of a single dose of placebo, zaleplon 10 mg, zopiclone 7.5 mg, temazepam 15 mg, or time-released melatonin 6 mg. The experimental design was a double-blind crossover with counterbalanced treatment order. Subjects wore polysomnographic electrodes to record total sleep and sleep latency during 4-min periods with eyes closed immediately before and after each psychomotor test sequence. Subjective drowsiness was assessed by questionnaire. RESULTS: There were drug x trials interactions for zaleplon, zopiclone, and temazepam for total sleep, sleep latency, and subjective drowsiness. More sleep, shorter sleep latency, and more drowsiness occurred immediately after psychomotor testing compared to before testing for all medications. Melatonin did not cause any sleep prior to psychomotor testing sessions, but caused sleep and reduced sleep latency after psychomotor test sessions from 1 3/4 h to 4 3/4 h post-ingestion. CONCLUSIONS: The sleep-inducing power of the medications before psychomotor testing was zopiclone > zaleplon > melatonin > temazepam. The corresponding effect after psychomotor testing was zopiclone > melatonin > zaleplon > temazepam.

Acetamides↗
PubMed2004

[Sleep disorders in elderly patients who take hypnotics on a regular basis].

BACKGROUND: Several studies have shown that the prevalence of sleep disorders such as sleep apnoea and periodic limb movements in sleep increases significantly with age. The assessment capacity is limited and there is a paucity of knowledge in this field among health professional, hence we hypothesise that these disorders are to a considerable extent under-diagnosed in the elderly, as the symptoms are often conceived of as insomnia. MATERIAL AND METHODS: Using ambulant clinical polysomnography, we investigated 19 patients aged 55 years or above who had been taking hypnotics on a daily basis (5 to 7 days a week) for at least one year. RESULTS: Among these 19 patients, the prevalence of sleep apnoea (AHI > 10) as well as periodic limb movements in sleep (PLM index > 10) was 42%; 74% had either sleep apnoea, periodic limb movements in sleep, or both. INTERPRETATION: Seen in relation to the fact that these elderly patients were given hypnotics for insomnia, the prevalence rates of sleep apnoea and periodic limb movements in sleep were high. We suggest that non-pharmacological alternatives should be considered and careful sleep assessment carried out before long-term prescription of hypnotics is instituted.

Aged↗
PubMed2004

Pharmacologic management of insomnia.

Pharmacotherapy is indicated for many types of insomnia, most notably transient insomnia associated with stress, acute illness, or jet lag. Many patients with chronic insomnia, including primary insomnia and insomnia secondary to a variety of medical and psychiatric disorders, also benefit from pharmacotherapy. Relatively few individuals receive prescription medication to help them sleep, and the majority use medication for a few nights to several weeks, as opposed to continuous use for months or years. The hypnotics available on the U.S. market today are benzodiazepine receptor agonists (BZRAs). The BZRAs are efficacious in reducing sleep latency, increasing total sleep time, reducing awakenings, and improving sleep quality without the development of tolerance in studies as long as 6 months. Side effects of the BZRAs are infrequent, dose-related, and related to the sedative properties of the drug. Sedating antidepressants are also frequently prescribed to promote sleep despite inadequate data to support their efficacy for this indication and a greater potential for clinically troublesome side effects.

Antidepressive Agents↗