Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0917801 (insomnia)
 10,606 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Lorazepam, 4 mg, was evaluated in an 18-night sleep-laboratory study involving five insomniac subjects. Hypnotic effectiveness and effects on sleep stages and related parameters were assessed. Placebo was given on baseline nights 1 to 4, lorazepam on nights 5 to 11, and placebo was given again on withdrawal nights 12 to 18. Subjective and objective data clearly demonstrated that lorazepam was effective for both inducing and maintaining sleep. Sleep latency was reduced from a baseline value of 34.6 min to 17.9 min (P less than 0.01) and total wake time was reduced from 75.9 to 38.5 min (P less than 0.01). On the third and fifth nights of drug withdrawal total wake time rose above baseline levels (termed rebound insomnia) and sleep latency increased by 77% and 60% over baseline (P less than 0.01). Subjective estimates of daytime anxiety also increased above baseline (rebound anxiety) during the withdrawal period. All subjects experienced severe hangover and varying degrees of impaired functioning during the first 3 days on drug. Three subjects also experienced anterograde amnesia during the day after the first drug night. These side effects diminished in intensity over the course of the study. Our results suggest that while 4 mg lorazepam may be effective in inducing and maintaining sleep, this dose induces clinically significant side effects that are followed by consistent rebound phenomena after withdrawal.
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PMID:Lorazepam-efficacy, side effects, and rebound phenomena. 612 58

The efficacy and safety of temazepam (30 mg) were compared with the efficacy and safety of flurazepam hydrochloride (30 mg) and placebo in a four-day, double-blind study in 75 geriatric convalescent-home patients with insomnia. The efficacy and safety profiles of the two active drugs were similar. Patients treated with temazepam, however, reported significantly less drug hangover both on awakening and during the entire day after each night of treatment than did patients receiving flurazepam or placebo. The difference between temazepam and flurazepam was probably due to the drugs' markedly different half-lives, temazepam's mean half-life being ten hours compared with 65.5 hours for the active metabolite of flurazepam. It is well recognized that the elderly may be especially sensitive to the adverse effects associated with the accumulation of the long-acting metabolite of flurazepam. Since temazepam has no active metabolites and minimal accumulation, it is a particularly appropriate hypnotic for use in geriatric patients.
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PMID:Double-blind evaluation of temazepam, flurazepam, and placebo in geriatric insomniacs. 612 25

During a double-blind clinical study, a new hypnotic benzodiazepine, lormetazepam (Wy 4082), was compared at a fixed dose of 1 mg to sodium amobarbital at a fixed dose of 100 mg for the treatment of moderate insomnia in 2 groups of 25 psychiatric outpatients. The medication was given at bedtime and the duration of the study was limited to 2 weeks. The quality of sleep was evaluated by the patient after the first night and at the end of the first and second week and by investigator at the end of the 2 weeks trial. The two products appeared effective on global assessment, but with an advantage in favour of lormetazepam: earlier onset of sleep and excellent acceptability on the final evaluation. Fifty two per cent of patients treated with amobarbital had side effects, mainly hangover and sedation during the morning, while only one patient treated with lormetazepam complained of headaches in the morning.
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PMID:[Lormetazepam and amobarbital in the treatment of insomnia in psychiatric outpatients. A controlled study]. 612 88

Temazepam is a benzodiazepine derivative indicated for the treatment of insomnia. Pharmacokinetic studies of the hard capsule formulation indicate that the mean time to peak is 2.99 hours and the mean elimination half-life is 14.7 hours. Sleep laboratory studies have demonstrated improvements in all sleep parameters except sleep onset latency. Clinically, patients report improvements in all sleep parameters including sleep onset latency. The efficacy of temazepam compares favorably with barbiturates, glutethimide, nitrazepam, lorazepam, oxazepam, and flurazepam. It has not been compared with diazepam in the clinical setting. Side effects include drowsiness, dizziness, and lethargy. The incidence of hangover effects from 15- and 30-mg doses is relatively low. Temazepam has no proven advantages over other benzodiazepine hypnotics. The major issues that need further clarification include temazepam's sleep induction properties and the relative incidence of hangover and rebound insomnia when compared with longer-acting benzodiazepines.
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PMID:Temazepam (Restoril, Sandoz Pharmaceuticals). 612 97

In a double-blind clinical trial, 50 psychiatric outpatients with moderate insomnia (requiring daily treatment with a hypnotic drug) were treated for two weeks with lormetazepam (1 mg) or amobarbital sodium (100 mg). In interviews before and after treatment, data were collected on the patients' demographic characteristics, sleep disturbances, concomitant organic or psychiatric disorders, and opinions of the drug taken during the two-week period. During the trial the patients took notes on their use of the drug, the quality and duration of their sleep, and any adverse effects of the drug they were using. Lormetazepam and amobarbital were equivalent in the amount of time it took patients receiving each drug to fall asleep and in the duration of the patients' sleep, but insomnia disappeared (or the condition improved) in a larger proportion of patients receiving lormetazepam, and there were fewer adverse effects (eg, hangover in the morning, sedation in the morning and during the day, and dry mouth) in patients receiving lormetazepam than in patients receiving amobarbital.
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PMID:Lormetazepam and amobarbital sodium in the outpatient treatment of insomnia: a controlled trial. 613 7

In a double-blind parallel study in which a placebo phase preceded and followed the double-blind verum phase, midazolam 15 mg and Vesparax (150 mg secobarbital, 50 mg brallobarbital, 50 mg hydroxyzine) were administered to 30 female patients aged 20-76 years, suffering from insomnia secondary to neuromuscular disease. Both products were shown to be efficient hypnotics maintaining a constant level of effect. Midazolam proved to be better tolerated and, in contrast to Vesparax, did not cause hangover, nor did rebound phenomena ensue after its withdrawal.
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PMID:Efficacy and safety of midazolam and vesparax in treatment of sleep disorders. 613 72

A multicentre, parallel group hospital study was carried out in 190 subjects with insomnia to compare the efficacy, incidence of hangover and the side-effects of loprazolam and nitrazepam. Following 2 nights single-blind phase on placebo, loprazolam (1.0 mg), nitrazepam (5.0 mg) or placebo was administered double-blind for 7 consecutive nights. Visual analogue scales and questions were used to rate efficacy. There was no statistically significant difference between loprazolam and nitrazepam for 'ease of getting to sleep', 'restfulness of sleep' and 'depth of sleep'. Like nitrazepam, loprazolam diminished the number of periods of wakefulness and made it 'easier to get to sleep again'. Subjective evaluation showed that hangover was not a feature of loprazolam. It did not affect morning alertness and patients thought they had improved balance and co-ordination while on this drug. These findings are in keeping with the evidence of other workers who have shown only minimal psychomotor impairment, if any, with loprazolam (1.0 mg). There was no statistically significant difference between treatments with respect to frequency or incidence of side-effects.
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PMID:A multicentre hospital study to compare the hypnotic efficacy of loprazolam and nitrazepam. 614 85

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.
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PMID:The clinical and psychometric evaluation of a new hypnotic drug, loprazolam, in general practice. 634 Sep 77

In 60 insomnia patients placebo-controlled clinical examinations were performed with Dormicum hypnotic containing 15 mg midazolam active substance and made available by EGIS Pharmaceuticals. The patients involved in the study lived a normal life and belonged to both sexes. In the introduction the author summarizes the different forms of pathological sleep and discusses the pharmacology of some hypnotics on the basis of which a detailed, multifactorial, up-to-date clinical examination of a hypnotic should be planned. He uses up-to-date methods and means for the examination of the drug which meet the requirements of an adequate clinical testing of a hypnotic. The sleep disturbances of the patients have been classified and characterized by the author from the somnological aspects and with somnological methods. Patients with sleep onset, sleep maintenance, early morning, as well as mixed insomnias were differentiated. The effectivity of the drug was evaluated on the basis of data of sleep questionnaires referring to the target symptoms and the results of 24-hour polygraphic monitorings performed in 18 patients. In addition, the eventual hangover effect of the drug was assessed in these patients on the basis of the changes in reaction time, pulse rate, and skin resistance measured by polygraphy, besides placebo control on the day following the intake of the drug. The neurological and other organic side-effects were also examined and registered by means of the self-evaluating questionnaires, target specific interviewing of the patients, as well as by laboratory examinations. The drug proved to be most valuable as a hypnotic in patients with sleep onset and mixed insomnias. The hypnotic action was not so definite in sleep maintenance insomnias, the poorest responses were obtained in early morning insomnia cases. According to the results of polygraphic sleep examinations the two first sleep cycles become normal following the intake of the hypnotic. Parameters characteristic of REM sleep do not show changes. In the examined patients the number of side- and hangover effects attributable to the drug was very low. The author calls the attention to the importance of the observance of the dosage and administration of the drug which may prevent the development of a great number of side-effects. By giving a detailed description of a case history of an insomniac patient the author illustrates how the application field of midazolam may be further extended--within the frames of a sleep therapeutic process.
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PMID:Placebo-controlled clinical trial of Dormicum 15-mg tablet. 820 70

Regarding the treatment of insomnia, it is said that a considerable degree of advancement has been made to date in terms of controlling toxicity, preventing the development of tolerance and avoiding addiction, which were often observed when administering barbiturates. Nevertheless, the majority of hypnotics used today, which are benzodiazepines, still retain certain side effects such as hangover effects, development of dependence, rebound insomnia as a withdrawal symptom, muscular atonia resulting in falling down and causing bone fracture, inhibition of respiratory system, negative interaction with alcohol, etc. The current trend of selecting hypnotics is to use short-half-life agents. However, there are yet other problems such as cognitive disorders including amnesia, rebound insomnia and increased anxiety during the daytime. In order to cope with these problems, three new hypnotics have recently been developed. They are non-benzodiazepine derivatives and considered to be safer than the others, because they are supposed to cause less side effects than conventional hypnotics. The pharmacokinetic characteristics of these new hypnotics can be summarized as follows: 1) these hypnotics have selective affinity to benzodiazepine receptor omega-1 subtype although the agent itself does not belong to the benzodiazepine derivative family; 2) the half-life-time in the serum is extremely short, namely 1-2 hours; 3) they increase the level of slow waves (delta-wave) during sleep; 4) they have a lesser effect toward atonic muscle and amnestic thought and behavioral disturbance as compared to conventional hypnotics; and 5) the risks of developing drug tolerance and reciprocal negative effects with alcohol are smaller. Consequently, we can expect that these new hypnotics will bring a certain advantage, especially regarding the avoidance of hypnotics-induced side effects in the course of clinical treatment of insomnia in the future.
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PMID:[Recent progress in development of psychotropic drugs (5)--Hypnotics]. 896 34


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