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PubMed1983

Effectiveness of zopiclone as a preoperative hypnotic.

A controlled, double-blind study was made of the efficacy and safety of a new hypnotic, zopiclone, on the preoperative night's sleep by a Joint Study Unit Group of the anesthesiology departments in 6 national hospitals. The following results were found: (1) zopiclone 7.5 and 10 mg and nitrazepam 10 mg were significantly superior to placebo both on the quality of sleep and the mental state of the patient, while no significant differences were observed among these three active drugs; (2) a significantly higher incidence of side-effects was observed for nitrazepam 10 mg than for zopiclone 7.5 and 10 mg and placebo; (3) zopiclone 7.5 and 10 mg and also nitrazepam 10 mg were significantly more useful than placebo, and (4) the above results show that 7.5 and 10 mg of zopiclone are of great benefit to the preoperative night's sleep and have less side-effects than 10 mg of nitrazepam.

Adult↗
PubMed1984

The effects of brotizolam, a new hypnotic, on cardiac and respiratory function in volunteers.

In a double-blind, cross-over study we measured the effect of a 0.5-mg oral dose of brotizolam, a new thienodiazepine hypnotic, on cardiac and respiratory functions in 12 healthy volunteers. No deleterious effects on pulse, blood pressure, forced vital capacity, forced expiratory volume in 1 s, respiratory rate, mouth occlusion pressure (P0.1) and ventilatory responses to carbon dioxide occurred over a 6-hour period. In the usual therapeutic dose, brotizolam does not suppress cardiac and respiratory functions in healthy volunteers.

Adult↗
PubMed1979

Sleep and hypnotics.

Sleep is an enigma and the clinical importance of disturbed sleep is not clear. Much has been learnt in the past 25 years of the physiology of normal and abnormal sleep. Complaints of insomnia can be related to several causes--normal extreme patterns, psychiatric, physical, specific and drug-related. The treatment of insomnia is essentially that of the primary condition. Hypnotics have a limited role and their use should always be carefully considered.

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↗
PubMed1976

Hypnotic efficacy of triazolam and methyprylon ininsomniac in-patients.

The hypnotic effects of a new triazolobenzodiazepine, triazolam (Halcion) 0-5 mg and methyprylon 300 mg was compared in twenty oncologic in-patient volunteers with insomnia using the preference technique. On the first night of the two-night trial, or methyprylon was given on a double-blind basis and on the second night the patients received the alternate medication. Following each trial night the patients were interviewed in regard to their sleep. Of the seventeen patients who completed the study, eleven patients preferred triazolam, three preferred methyprylon and three had no preference (p=0-057). Analysis of the various sleep parameters showed that triazolam helped the patients sleep more than methyprylon (p=0-13), induced more rapid sleep onset (p=0-003), gave a longer duration of sleep (p=0-013). The treatment was considered a success if the patient went to sleep in thirty minutes or less and slept for at least six hours. Triazolam was more successful than methyprylon in this respect (p=0-012). There were no side-effects reported on either of the drugs.

Adult↗
PubMed1976

Nitrazepam and temazepam: a comparative trial of two hypnotics.

A specially designed sleep questionnaire was used to assess the performance of the two hypnotic drugs. Psychiatric patients were given 5 mg nitrazepam or 10 mg temazepam in identical capsules, and were allowed more if necessary. A double-blind cross-over design was used. We found that 5-2 mg nitrazepam showed few differences from 13-2 mg temezepam. The two regimes produced fairly similar reports on patient satisfaction, quality of sleep, number of awakenings, depth of sleep and other variables. Patients on nitrazepam were a little more clear-headed in the morning, though they tended to wake later, sleep longer, and take more sleep over the 24-hour period. No toxicity was found with either drug over the 434 patient days of administration. In view of the advantages of the benzodiazepine drugs over their predecessors, we feel that it is worth exploring further the use of temazepam as a sleep inducing drug.

Adult↗
PubMed1979

Comparative trial of a new hypnotic (Finorgal) with nitrazepam and triclofos sodium.

Thirty patients complaining of insomnia were studied in a double-blind trial with crossover of Finorgal, nitrazepam and triclofos sodium. Finorgal given as a hypnotic produced similar results to nitrazepam and triclofos sodium in terms of induction of sleep, duration and quality of sleep, dream recall and morning 'hangover'. Reported side-effects were not serious and occurred less frequently in association with Finorgal treatment than with nitrazepam or triclofos sodium. Laboratory investigations gave no indication of the development of any drug toxicity during the three-week period of the trial.

Administration, Oral↗
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↗
PubMed1978

The effectiveness of temazepam as a hypnotic: an open, multi-centre assessment in 804 patients with sleep disorders.

An open, multi-centre study was carried out in 804 patients complaining of sleep disorders to assess the effectiveness and acceptance of temazepam as a hypnotic. Patients received between 10 mg and 30 mg (mean 16.4 mg) temazepam each night for a week. Subjective assessments using a self-administered questionnaire were made daily of the quality and quantity of sleep. The results showed that sleep induction was rapid and most patients enjoyed a relatively uninterrupted night's sleep, and awakened feeling refreshed. Patient acceptance was good and there was a low incidence of residual or other adverse effects of treatment.

Aged↗
PubMed1983

The clinical and psychometric evaluation of a new hypnotic drug, loprazolam, in general practice.

A double-blind crossover study was carried out in 16 patients with insomnia to assess the effectiveness and tolerance of a new hypnotic, loprazolam, with that of nitrazepam and placebo. Patients received 1 capsule each night for 7 days of either 1 mg loprazolam, 5 mg nitrazepam or placebo and then 7 days' treatment with each of the other medications in random order. The results of analogue rating scale assessment by the patients showed that 'ease of getting to sleep' and 'quality of sleep' were significantly better with loprazolam than with placebo. Loprazolam appeared to be at least as effective, if not more so, than nitrazepam. There were no significant differences between treatments on the morning muzziness assessment, which was low in each group, or in the psychometric tests carried out indicating that loprazolam is unlikely to produce hangover effects. There were no obvious differences between treatments in the incidence or frequency of side-effects spontaneously volunteered by the patients.

Adult↗
PubMed1985

Sleep and wake after benzodiazepine hypnotics: a 20-hour EEG comparison of lormetazepam and flunitrazepam.

In an electropharmacokinetic study, the effects of lormetazepam and flunitrazepam were compared by the means of a sleep EEG and waking EEG during the following daytime. At a 1-week interval, 6 normal subjects received at random either 2 mg lormetazepam or 2 mg flunitrazepam in a double-blind, crossover fashion. Sleep EEG was recorded throughout the night; 6-min EEG samples were recorded every hour during 10 hours on the following daytime for spectral analysis. Night sleep after flunitrazepam showed lower Stage IV sleep than after lormetazepam. During daytime, only flunitrazepam induced an increased percentage of beta 2 frequencies, which remained above baseline up to 10 hours after awakening, indicating a prolonged impregnation time. This study permitted comparison of the relative intensity and duration of these two benzodiazepines: lormetazepam appeared to be a short-acting hypnotic while flunitrazepam displayed longer modification of the brain electrical activity.

Adult↗
PubMed1985

Zopiclone: a non-benzodiazepine hypnotic. Controlled comparison to temazepam in insomnia.

Zopiclone, a non-benzodiazepine hypnotic, was compared with temazepam in the treatment of 36 patients suffering from insomnia; the trial period was two weeks, with cross-over of medications at one week and a randomised order of administration. There were highly significant improvements with both drugs, as compared to the control period in respect of: sleep latency, number of times waking during the night, and quality and duration of sleep. The incidence of side-effects was very low. No significant between-drug differences were found in respect to any of the assessment measures or of the incidence of side-effects.

Adult↗
PubMed2006

Impact of cognitive behavior therapy on health-related quality of life among adult hypnotic users with chronic insomnia.

Results were combined from representative surveys of health related quality of life (HRQoL; n=11,877; age range=16-104) with data from a randomized controlled trial of cognitive behavior therapy for chronic insomnia (n=209; age range=31-92). Secondary analyses of scores from the SF-36 measure of HRQoL were conducted in order: (a) to compare the health related quality of life profiles of adult hypnotic users with chronic insomnia with those of population norms, and (b) to assess the impact of cognitive behavior therapy (CBT) for insomnia on HRQoL outcomes over 6 months. Compared with the primary care reference values, HRQoL among the trial participants at baseline was generally poorer. The magnitude of these decrements reduced markedly with advancing age. In the evaluation of the CBT intervention, statistically significant differences in SF-36 scores in favor of the intervention were present for physical functioning, emotional role limitation, and mental health over 6 months. Overall, this study shows that the SF-36 can play an important role in describing HRQoL in this patient group, and in the evaluation of interventions within this group.

Adolescent↗
PubMed2003

Tolerance to the hypnotic and electroencephalographic effect of gamma-hydroxybutyrate in the rat: pharmacokinetic and pharmacodynamic aspects.

Tolerance to gamma-hydroxybutyrate (GHB) has been suggested in illicit users and has been described for the hypnotic effect in the rat. The aim of this study was to investigate whether tolerance is also observed for the EEG effect, and whether the EEG can give insight into the pharmacodynamic aspects of GHB tolerance. In three series of experiments, rats were pre-treated with either the GHB precursor gamma-butyrolactone (GBL) or saline intraperitoneally twice daily. In the first series, a reduction in sleeping time was observed in the GBL pre-treated rats compared with controls. In the second series, a fast infusion of GHB (300 mg kg(-1) over 5 min) was given after 10 days pre-treatment. The GHB plasma concentration-time curves showed a slightly faster decrease in GHB concentration in the GBL pre-treated rats, suggesting a small induction of the GHB metabolism (V(max) = 2882 +/- 457 microg min(-1) kg(-1) vs 2205 +/- 315 microg min(-1) kg(-1), P < 0.01). In contrast to controls, GBL pre-treated rats did not lose righting reflex. In the third series, a slow infusion of 480 mg kg(-1) h(-1) was given after 7 days pre-treatment, which allowed fitting a sigmoid E(max) model to the EEG amplitude versus GHB plasma concentration curve. This showed reduced end-organ sensitivity to GHB in the GBL pre-treated rats (EC50 (concentration required to obtain 50% depression of the baseline effect) = 653+/- 183 microg mL(-1) vs 323 +/- 68 microg mL(-1), P < 0.001). In conclusion, chronic pre-treatment with gamma-butyrolactone in the rat results in a reduced sleeping time and this tolerance is reflected by the EEG. This can mainly be explained by reduced end-organ sensitivity.

Animals↗
PubMed1994

Synthesis and hypnotic and anti-human immunodeficiency virus-1 activities of N3-substituted 2'-deoxy-2'-fluorouridines.

Reaction of 9-[3,5-di-O-(tetrahydropyran-2-yl)-beta-D-arabinofuranosyl]uracil (2) with diethylaminosulfur trifluoride in the presence of pyridine afforded 2'-deoxy-2'-fluororiboside 3a, from which 2'-deoxy-2'-fluorocytidine (4b) has been synthesized in good yield. Compound 3a was deprotected and subsequently treated with various benzyl halides or 2-chloro-4-fluoroacetophenone to give corresponding N3-substituted 2'-deoxy-2'-fluorouridines 5a-c and 6. Compounds 5a-c, as well as 6, showed weak hypnotic activity in mice. Compound 4b showed moderate antiviral activity against human immunodeficiency virus-1 but 3b, 5a-c, and 6 were virtually inactive.

Animals↗
PubMed2001

Synthesis and hypnotic activities of 4-thio analogues of N3-substituted uridines.

Reaction of tri-O-acetyluridine (1) with benzyl bromide or 2-chloroacetophenone in the presence of K2CO3 gave the N3-substituted analogues 2a,c. Condensation of 1 with (+/-)-1-phenylethanol or 3,5-dimethylbenzyl alcohol using the Mitsunobu reaction also gave 2b,d in good yields. These compounds were allowed to react with Lawesson's reagent and were subsequently treated with ammonia to afford the 4-thiouracil derivatives 5a-d. Compounds 5a-c showed moderate hypnotic activity in mice. However, N3-(3,5-dimethyl)benzyl derivatives 3d, 5d were found to be almost inactive in this assay.

Animals↗
PubMed2002

[Pharmacological profile and clinical effect of zolpidem (Myslee tablets), a hypnotic agent].

Zolpidem is a non-benzodiazepine hypnotic agent with a chemical structure of imidazopyridine. In vitro and in vivo binding studies, zolpidem exhibits selectivity to omega 1 receptors (GABAA-receptor subtypes containing alpha 1 subunits). Unlike benzodiazepines, zolpidem produces sedative effects in preference to anxiolytic, anticonvulsant and myorelaxant effects in behavioral experiments using mice. Double-blind comparative studies with reference drugs such as triazolam and zopiclone show that zolpidem is an effective and highly safe drug for the treatment of insomnia. In addition, zolpidem does not produce next-day residual effects, rebound insomnia and tolerance. This clinical profile of zolpidem may be related to its selectivity and high intrinsic activity for omega 1 receptors.

Animals↗