Mg In Elderly Patients Research Articles

Şizofreni ve şizoafektif bozukluğu olan yaşlı ve genç hastalarda psikotrop ilaç tercihleri ve yan etkilerinin karşılaştırılması

Purpose: The current study investigates the preferred psychotropic drug treatments and their tolerability in elderly patients (EP) with a diagnosis of schizophrenia or schizoaffective disorder compared to younger patients (YP).
 Materials and Methods: The study included 154 EP and 195 YP with schizophrenia/schizoaffective disorder admitted to the outpatient unit at a university hospital in the last decade. The medical records of the patients were reviewed. The types and doses of antipsychotic drugs used by each patient, use of other psychotropic drugs, ongoing complaints, drug-related side effects and compliance with treatment were also examined.
 Results: Second generation antipsychotic use was higher in YP (88% in YP, 80% in EP). Antipsychotic equivalent doses were found 266.63 mg in EP, 522.21 mg in YP, that also higher in the YP group. The use of clozapine (7% in EP, 37% in YP) and mood stabilizers (4.5% in EP, 18% in YP) were higher in YP. There was a higher rate of dose reduction of antipsychotic drugs in EP (21.5% in YP, 52% in EP). When the groups were compared in terms of the reasons of antipsychotic dose reduction, it was more frequent in EP due to side effects (21.4% in YP, 40% in EP), while the dose reduction due to remission was more common in YP (78.6% in YP, 60% in EP) .
 Conclusion: Lower doses of antipsychotics in EP suggests milder symptoms or lower tolerability. The higher clozapine and mood stabilizer use in YP can be explained by avoiding side effects like extrapyramidal, cardiovascular and metabolic side effects that are more frequent in EP.

Effect of Montelukast 10 mg in Elderly Patients with Mild and Moderate Asthma Compared with Young Adults. Results of a Cohort Study

Background:The clinical characteristics and physio-pathogenic mechanisms of asthma in patients older than 60 years appear to differ from the behavior described for other age groups. Therefore, the effectiveness of medications for elderly patients with asthma should not be extrapolated from studies conducted on teenagers or young adults.Objective: The study aimed to establish the clinical effect of montelukast 10 mg in elderly patients with mild and moderate asthma compared to its effect on young adults.Method:A prospective cohort study was conducted during 12 weeks of follow-up, which consecutively included the total population of adult patients attended by a group of 21 general practitioners, between July and December 2016. Young adults (18-59 years) and older adults were included (60 years or older) with mild or moderate asthma, which, according to the criteria of his treating physician, had been prescribed montelukast 10 mg/day. The variables of interest were: use of inhaled corticosteroids during the last month, use of inhaled beta-2 adrenergic agonists as a rescue in the last month, having attended the emergency service during the last month due to an asthma attack, presence of wheezing in the physical examination, the number of attacks in the last month and the number of days without symptoms in the last month.Results:A total of 126 patients entered the cohort and 104 completed the follow-up, of which 29% were older adults. On admission, 65.4% of patients (68/104) had used rescue inhaled beta2 in the last month and had been using schemes with corticosteroids. After 12 weeks of follow-up, 58.1% (43/74) of the young adults required treatment schedules with corticosteroids, while in the elderly, only 36.7% of the patients (11/30) required this treatment scheme (p-value: 0.047). Regarding the use of rescue inhaled beta-2 at 12 weeks, 55% of young adults reported using them, compared to 33.3% of older adults (p-value: 0.041).Conclusion:In this cohort of patients, treated with montelukast 10 mg/day for 12 weeks, there was a reduction of broncho-obstructive symptoms and exacerbations of the disease. In older adults compared to young adults, a greater reduction in the use of beta2 agonists rescue medications and in the concomitant use of inhaled corticosteroid schemes was documented.

Safety of Edoxaban 30mg in Elderly Patients with Severe Renal Impairment.

Patients with atrial fibrillation (AF) and advanced chronic kidney disease (CKD) are at high risk of adverse events and are complicated to manage. There is little evidence on the effects of non-vitaminK oral anticoagulants in patients with severe CKD. Preliminary data in patients taking edoxaban whose creatinine clearance fell below 30mL/min showed a low risk of stroke and major bleeding. The aim of our study is to test the safety of edoxaban 30mg/day in patients with severe renal impairment with an estimated glomerular filtration rate (eGFR) of 15-29mL/min. We analyzed retrospective data from 46 patients who had documented AF with severe renal impairment (eGFR between 15 and 29mL/min). The follow-up, characterized by clinical examination and blood analysis, was performed at 3, 6, and 12months. The main endpoint was the incidence of major bleedings or clinically relevant non-major (CRNM) bleedings or thromboembolic events. At the time of the data collection, the average follow-up was 9.13 ± 3.0months. There were no major bleedings, strokes, systemic embolisms, or cardiovascular deaths reported: one non-cardiac death and five minor hemorrhages occurred. No differences related to the severity of CKD were observed in the left ventricular ejection fraction at echocardiography and in the thrombotic and hemorrhagic risk profile. In this explorative study analyzing patients with severe CKD treated with edoxaban 30mg once daily, no major bleeding or thrombotic events were observed. Some minor bleedings were observed. While additional studies are necessary to confirm the results of this exploratory study, edoxaban 30mg once daily appears to be safe in patients with severe CKD.

Ability of suvorexant to prevent delirium in patients in the intensive care unit: a randomized controlled trial.

AimThere are no effective, tolerable, and established medications for preventing delirium in critically ill patients admitted to the intensive care unit (ICU). We investigated whether suvorexant was effective in preventing ICU delirium.MethodsThis randomized controlled study evaluated 70 adult patients (age ≥20 years) admitted to the mixed medical ICU of the Tokyo Medical University Hospital (Tokyo, Japan) between May 2015 and February 2017. Patients were randomized using a sealed envelope method to receive either suvorexant (n = 34; 15 mg for elderly patients and 20 mg for younger adults) or conventional treatment (n = 36) for a 7‐day period. The primary outcome was delirium incidence based on the definition in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders.ResultsNo significant between‐group differences were observed in the demographic or clinical characteristics. Kaplan−Meier estimates revealed that time to delirium onset was significantly longer in the suvorexant group than in the conventional group (P < 0.05).ConclusionSuvorexant might be effective in preventing delirium in ICU patients.

Efficacy of Tianeptine 25-50 mg in Elderly Patients With Recurrent Major Depressive Disorder: An 8-Week Placebo- and Escitalopram-Controlled Study.

The present placebo-controlled study evaluated the efficacy and safety of 8 weeks of treatment with tianeptine 25-50 mg/d in elderly patients suffering from major depressive disorder (MDD) according to DSM-IV-TR. Escitalopram 5-10 mg/d was used as an active comparator. Elderly outpatients aged at least 65 years with a primary diagnosis of moderate to severe episode of recurrent MDD were recruited by psychiatrists in 44 clinical centers in 10 countries from October 2013 to January 2016. Patients were randomly assigned to receive tianeptine (n = 105), placebo (n = 107), or escitalopram (n = 99) for 8 weeks. The primary outcome measure was the 17-item Hamilton Depression Rating Scale (HDRS₁₇) total score. Tianeptine improved depressive symptoms, as evaluated by the HDRS₁₇ total score in terms of absolute change from baseline (week 0) to week 8 (placebo-tianeptine difference [SE] of 3.84 [0.85] points, P < .001, using a last-observation-carried-forward approach) and response to treatment (tianeptine: 46.7%; placebo: 34.0%, estimate [SE] = 12.70% [6.70], P = .06). A sensitivity analysis using a mixed model for repeated measures confirmed the main results on HDRS total s​core. The placebo-tianeptine difference (SE) was 0.66 (0.15) for Clinical Global Impressions-Severity of Illness (95% CI, 0.37 to 0.96; P < .001) and 0.57 (0.14) for Clinical Global Impressions- Improvement (95% CI, 0.30 to 0.83; P < .001). Positive results were also obtained with the active control escitalopram (HDRS₁₇ total score placebo-escitalopram difference of 4.09 ± 0.86 points, P < .001), therefore validating the sensitivity of the studied population. Tianeptine was well tolerated, with only minimal differences in tolerability from placebo. The present study provides robust evidence that an 8-week treatment period with tianeptine 25-50 mg is efficacious and well tolerated in depressed patients aged 65 years or older. EudraCT identifier: 2012-005612-26​.

Similar efficacy and safety of once‐weekly dulaglutide in patients with type 2 diabetes aged ≥65 and &lt;65 years

AimsTo evaluate the efficacy and safety of dulaglutide 1.5 and 0.75 mg in elderly patients (aged ≥65 years) with type 2 diabetes (T2D) in six phase III clinical trials.MethodsPatients were grouped into two age groups: ≥65 and <65 years. Pooled analysis for glycated haemoglobin (HbA1c) change from baseline, percentage of patients achieving HbA1c targets, and gastrointestinal tolerability were evaluated at 26 weeks for each dulaglutide dose. Change in weight from baseline and rates of hypoglycaemia were evaluated for each individual study.ResultsA total of 958 of 5171 (18.5%) patients were aged ≥65 years. The reductions in HbA1c were similar between age groups for dulaglutide 1.5 mg‐treated patients {least squares [LS] mean for patients aged ≥65 years: −1.24 [95% confidence interval (CI) −1.36, −1.12] and for patients aged <65 years: −1.29 [95% CI −1.38, −1.20]} and for dulaglutide 0.75 mg‐treated patients [LS mean for patients aged ≥65 years: −1.16 (95% CI −1.29, −1.03) and for patients aged <65 years: −1.10 (95% CI −1.19, −1.01)] at 26 weeks. The percentages of patients who achieved HbA1c targets of <7, <8 or <9% were also similar in the two groups with both dulaglutide doses. Patients aged ≥65 years had similar weight change to patients aged <65 years. Severe hypoglycaemic events were infrequent. A similar incidence of gastrointestinal adverse events was observed in each age group with both dulaglutide doses.ConclusionBoth dulaglutide doses were well tolerated, with similar efficacy in patients with T2D aged ≥65 years to those aged <65 years. Dulaglutide can be considered a safe and effective treatment option for use in older adults.

Suvorexant for insomnia: a systematic review of the efficacy and safety profile for this newly approved hypnotic - what is the number needed to treat, number needed to harm and likelihood to be helped or harmed?

To describe the efficacy and safety of suvorexant for the treatment of insomnia. The pivotal registration trials were accessed by querying http://www.ncbi.nlm.nih.gov/pubmed/ and http://www.clinicaltrials.gov for the search terms 'suvorexant' and 'MK4305'. Briefing documents from the US Food and Drug Administration Peripheral & Central Nervous System Drugs Advisory Committee and product labelling, provided additional information. All available clinical reports of studies were identified. Descriptions of the principal results and calculation of number needed to treat (NNT) and number needed to harm (NNH) for relevant dichotomous outcomes were extracted from the available study reports and other sources of information. Suvorexant (MK4305) is the first orexin receptor antagonist approved for the treatment of insomnia. This approval was based in part on a Phase 3 clinical development programme that included two similarly designed, 3-month, randomised, double-blind, placebo-controlled, parallel-group studies examining suvorexant 40 and 20 mg in non-elderly adults (age < 65 years) and 30 and 15 mg in elderly patients (age ≥ 65 years). Suvorexant was superior to placebo for sleep latency as assessed both objectively by polysomnography and subjectively by patient-estimated sleep latency; suvorexant was also superior to placebo for sleep maintenance, as assessed both objectively by polysomnography and subjectively by patient-estimated total sleep time. NNT vs. placebo for response as measured by a ≥ 6 point improvement on the Insomnia Severity Index at month 3 was 8 (95% CI 6-14) for both the higher and lower dose regimens. The most commonly encountered adverse event (incidence ≥ 5% and at least twice the rate of placebo) as identified in product labelling is somnolence, with NNH values vs. placebo of 13 (95% CI 11-18) for suvorexant 40 and 30 mg, and 28 (95% CI 17-82) for suvorexant 20 and 15 mg. The efficacy and tolerability profile of suvorexant is similar for those < 65 and ≥ 65 years of age. Rebound insomnia and withdrawal effects were not observed when suvorexant was discontinued after 3 months or after 12 months of nightly use. Because of concerns about dose-related, next-day effects, including sedation, the recommended dose range is 10-20 mg. Suvorexant appears efficacious and relatively tolerable. Its different mechanism of action and potentially different safety and tolerability profile compared with currently available hypnotics represents a new option for the pharmacological treatment of insomnia.

Efficacy and Safety of Doxepin 1 mg, 3 mg, and 6 mg in Elderly Patients With Primary Insomnia

Evaluate efficacy and safety of the histamine-H1 antagonist doxepin at doses of 1 mg, 3 mg, and 6 mg in elderly adults with primary insomnia. A randomized, double-blind, placebo-controlled, crossover design was used in this population of elderly adults with primary insomnia (DSM-IV). Each treatment period consisted of 2 polysomnographic (PSG) assessment nights with a 5- or 12-day drug-free interval between periods. The study was conducted from September 2004 to January 2005. Sleep laboratories in 11 sleep centers in the United States. Elderly adults with primary insomnia. Doxepin 1 mg, 3 mg, and 6 mg. Efficacy was assessed using PSG and patient-reported measures. Seventy-six patients were randomly assigned. All 3 doxepin doses produced dose-related significant improvements in PSG-determined wake time during sleep (p < .0001), wake time after sleep onset (p < .0001), total sleep time (p < .0001), and overall sleep efficiency (p < .0001) versus placebo. At the 3-mg and 6-mg doses, sleep efficiency was significantly improved during all thirds of the night (p < .05). There was a dose-related decrease in patient-reported sleep latency, with the 6-mg dose achieving statistical significance in latency to sleep onset (p = .0181). The pattern of the remaining subjective efficacy results was consistent with PSG. All 3 doxepin doses had side effect profiles comparable to placebo, with no spontaneously reported anticholinergic effects, no memory impairment, and no significant next-day residual effects. In this 2-night study of elderly adults with primary insomnia, doxepin doses of 1 mg, 3 mg, and 6 mg were well tolerated and produced significant improvement in objective and subjective sleep maintenance and duration endpoints that persisted into the final hour of the night. Positive effects on patient-reported sleep onset were observed at the highest dose. All 3 doxepin doses had a safety profile comparable to placebo. These data demonstrate that doxepin was efficacious in improving sleep in elderly adults.

Age-adapted morphine titration produces equivalent analgesia and adverse effects in younger and older patients

To determine the efficacy and safety of intravenous postoperative morphine titration in the elderly compared with younger patients. In the post-anaesthesia care unit, patients complaining of pain received morphine until adequate pain relief. Intravenous morphine was titrated as 3 mg boluses in young (age 65 yr) and 2 mg in elderly patients (>65 yr) every 5 min. We studied 350 young and 68 elderly patients. There were no significant differences between the two age groups for pain intensity at the onset of titration (numerical rating scale, 7.4 +/- 1.7 in young vs. 7.5 +/- 1.7 in elderly patients), area under the curve of numerical rating scale vs. morphine boluses (97.7 +/- 59.6 vs. 98.2 +/- 62), number of boluses required to obtain pain relief (3 +/- 1.3 vs. 3 +/- 1.3), percentage of titration failures (10% vs. 9%) and incidence of excessive sedation (18% vs. 21%). Renal clearance was significantly reduced in elderly compared with young patients (55 +/- 21 vs. 85 +/- 15 mL min(-1); P < 0.0001). Using lower bolus doses, pain relief in the immediate postoperative period with morphine was as efficacious and safe in elderly patients as in younger patients. The decrease in renal clearance of morphine in the elderly justifies the reduction of intravenous morphine boluses for the treatment of postoperative pain.

Treatment of Vulvodynia with Tricyclic Antidepressants: Efficacy and Associated Factors

Vulvodynia, or chronic vulvar pain, which often is accompanied by dyspareunia, is quite prevalent and difficult to treat effectively. Neuropathic pain typically is described, and findings that sensitization to pain is increased at sites removed from the vulva suggest that systemic treatment for nerve hypersensitivity might prove helpful. Today antidepressants, especially tricyclic antidepressants (TCAs) such as amitriptyline, are commonly used in low dosage to treat vulvodynia. This retrospective study included 271 affected women, 209 of whom were initially treated with a TCA. Amitriptyline was administered to 183 women, while smaller numbers received desipramine or other TCAs. A total of 162 women, including 122 started on a TCA, were followed up for a median time of 3.2 months. The typical starting TCA dose was 25 mg each night (or 10 mg for elderly patients), and the maximum nightly dose was 225 mg. Patients rated their pain on a 0-to-10 scale. Localized pain was somewhat more frequent than generalized vulvar pain in these women, whose average age was 37 years and who had experienced pain for nearly 5 years on average. During a median follow-up of 3.2 months, 59% of women who had taken a TCA improved by more than 50%, compared with 38% of those not taking a TCA at follow-up; the odds ratio (OR) was 2.35, with a 95% confidence interval (CI) of 1.23–4.42. Multivariate analysis showed that taking a TCA at the first follow-up assessment correlated strongly with improvement (OR, 4.23; 95% CI, 1.98–9.01). Among the factors not associated with the outcome were age, severity of pain, localized versus generalized vulvar pain, duration of untreated pain, age at menarche, oral contraceptive use, and the number of previous pregnancies. A repeat analysis limited to women taking amitriptyline yielded similar results. Of 51 women not taking any antidepressant or anticonvulsant drug when followed up, one-third reported improvement. Most women with vulvodynia who take TCAs in general, or amitriptyline in particular, tolerate the medication and are likelier than other affected women to report at least 50% improvement at follow-up. Randomized controlled trials comparing TCAs with other treatments are needed.

A polysomnography study of eszopiclone in elderly patients with insomnia

ABSTRACTObjective: 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] ≥ 20 min and latency to persistent sleep ≥ 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.

Zolpidem Extended-Release

Zolpidem extended-release, or controlled-release (CR), is a new formulation of zolpidem, a nonbenzodiazepine hypnotic. It is indicated in the US for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance. Zolpidem CR is a dual-layered tablet; one layer releases zolpidem immediately and a second layer provides a slower release of additional zolpidem for maintenance of plasma zolpidem concentrations. Efficacy of zolpidem CR was assessed in two 3-week, randomised, double-blind, placebo-controlled, phase III polysomnography trials in younger adult (aged 18-64 years) or elderly (aged > or =65 years) patients with primary insomnia. Patients received nightly zolpidem CR (12.5mg in younger adult and 6.25mg in elderly patients). Efficacy was assessed objectively on nights 1, 2, 15 and 16. Patients who received zolpidem CR had significantly improved objective latency to persistent sleep, wake time after sleep onset and sleep efficiency on assessment nights compared with placebo recipients. In subjective assessments of sleep quality on day 2 and nights 15 and 22, significantly more zolpidem CR than placebo recipients gave favourable responses on a Patient Global Impression scale in the study in younger adult patients. In the other study, significantly more elderly patients in the zolpidem CR group rated their sleep as improved compared with the placebo group. Zolpidem CR was generally well tolerated and appears to have a tolerability profile similar to that of the original formulation of zolpidem.

Efficacy, Tolerability and Influence on "Quality of Life" of Nifedipine GITS versus Amlodipine in Elderly Patients with Mild-moderate Hypertension

Objective: The main purpose of this study was to compare efficacy, tolerability and influence on quality of life (QOL) of nifedipine gastrointestinal therapeutic system (NI) 30-60 mg once a day vs amlodipine (AM) 5-10 mg once a day in elderly patients with mild-moderate hypertension. Design: This was a randomized, double-blind, parallel-group, multicenter study. After a 2-week single-blind placebo run-in, patients were randomized to either NI 30 mg or AM 5 mg. Responders continued on the same dosage for 16 additional weeks, while non-responders were titrated to 60 mg NI or 10 mg AM. Methods: Blood pressure was measured by mercury sphygmomanometer and efficacy equivalence of NI and AM tested by covariance analysis. Diastolic blood pressure (DBP) was the primary efficacy parameter, its baseline value being taken as covariate while centers effect and treatment interaction were included as fixed effects in the analysis model. The secondary efficacy variables systolic blood pressure (SBP) and scores for QOL were analyzed according to the same model. Results: At the end of the study, overall mean DBPs, calculated as least-square means (LSMEANS), in the "by protocol" population were 87.5 mmHg for NI and 86.7 for AM (difference 0.8 mmHg with 90% CI-1.2 to 2.8 mmHg). In the "by intention to treat" (ITT) population LSMEANS were 87.6 mmHg for NI and 86.4 mmHg for AM (difference 1.2 mmHg with 90% CI-0.6 to 3.1 mmHg). SBP LSMEANS in the "by protocol" population were 147.7 mmHg for NI and 147.3 mmHg for AM (difference 0.3 mmHg, with 90% CI-3.7 to 4.3); corresponding values in the "by ITT" population were 148.0 mmHg for NI and 147.2 for AM (difference 0.8 mmHg, with 90% CI-2.8 to 4.6). Mean values for QOL parameters were not significantly different. A total of 173 episodes of adverse events were documented in 54 patients (26 NI and 28 AM), dropouts were 15 (20% of group) on NI and 21 (28%) on AM. Conclusions: NI 30-60 mg was shown to be as efficacious and safe as AM 5-10 mg in elderly patients with mild-moderate hypertension. QOL improved compared to baseline with no significant difference between the two drugs, thus confirming a positive class effect for calcium antagonists.

Erratum to Zopiclone review

Synopsis Zopiclone is a cyclopyrrolone which is chemically unrelated to the benzodiazepines and is thought to act on the GABAA receptor complex at a site distinct from, but closely related to, the benzodiazepine binding site. The hypnotic efficacy of zopiclone administered as single oral doses has been demonstrated in patients undergoing next-day surgery and in patients with insomnia, and these studies have established an optimal dose of 7.5mg for elderly patients. Using this dose, clinical studies have shown that zopiclone improved sleep in elderly patients to a similar extent as triazolam 0.125 to 0.5mg, flurazepam 15mg, and nitrazepam 5mg. Studies that also included younger patients have shown that zopiclone 7.5mg is at least as effective as triazolam 0.25 or 0.5mg, and on most sleep parameters is comparable to temazepam 20mg, nitrazepam 5mg, flunitrazepam 2mg, and flurazepam 20mg. Zopiclone causes minimal impairment to psychomotor performance and mental alertness the morning after night-time administration. The drug is generally well tolerated by patients of all ages; the most frequently reported adverse effects being bitter taste and dry mouth. Treatment withdrawal due to adverse effects is seldom required and reports of rebound insomnia after zopiclone withdrawal are rare. While symptoms of physical dependence have not been observed in clinical studies, there have been isolated reports of physical dependence in patients with a history of substance abuse. Although the latter finding should be kept in mind, it appears that zopiclone has a low dependence liability. Thus, with its short duration of action and good tolerability profile, zopiclone is a well established alternative to the benzodiazepine hypnotics and may be particularly beneficial in those patients unable or unwilling to tolerate the residual effects associated with many other hypnotic agents.

Zopiclone. A review of its pharmacological properties and therapeutic efficacy as an hypnotic.

Zopiclone is a cyclopyrrolone which is chemically unrelated to the benzodiazepines and is thought to act on the GABAA receptor complex at a site distinct from, but closely related to, the benzodiazepine binding site. The hypnotic efficacy of zopiclone administered as single oral doses has been demonstrated in patients undergoing next-day surgery and in patients with insomnia, and these studies have established an optimal dose of 7.5mg for elderly patients. Using this dose, clinical studies have shown that zopiclone improved sleep in elderly patients to a similar extent as triazolam 0.125 to 0.5mg, flurazepam 15mg, and nitrazepam 5mg. Studies that also included younger patients have shown that zopiclone 7.5mg is at least as effective as triazolam 0.25 or 0.5mg, and on most sleep parameters is comparable to temazepam 20mg, nitrazepam 5mg, flunitrazepam 2mg, and flurazepam 20mg. Zopiclone causes minimal impairment to psychomotor performance and mental alertness the morning after night-time administration. The drug is generally well tolerated by patients of all ages; the most frequently reported adverse effects being bitter taste and dry mouth. Treatment withdrawal due to adverse effects is seldom required and reports of rebound insomnia after zopiclone withdrawal are rare. While symptoms of physical dependence have not been observed in clinical studies, there have been isolated reports of physical dependence in patients with a history of substance abuse. Although the latter finding should be kept in mind, it appears that zopiclone has a low dependence liability. Thus, with its short duration of action and good tolerability profile, zopiclone is a well established alternative to the benzodiazepine hypnotics and may be particularly beneficial in those patients unable or unwilling to tolerate the residual effects associated with many other hypnotic agents.

Lormetazepam (Loramet) in the elderly: an acceptability study.

In an open, single centre, general practice study, the short acting benzodiazepine lormetazepam (Loramet) was administered nightly for a period of 7 nights to fifty-eight geriatric insomniacs. All patients took 0.5 mg on the first night but were allowed to increase their dosage to 1.0 mg and 1.5 mg as required. The patients assessed the efficacy and acceptability of lormetazepam with the aid of a diary card completed on each morning of the study. The results showed that 65.5% of the patients reported an improvement in their sleep pattern and 76.9% were taking the 0.5 mg dosage by the last night of the study. Throughout the study there was a progressive increase in the mean duration of sleep and a similar increase in the number of patients awaking refreshed. The effects were significant after the second and third nights, respectively. Three patients withdrew from the study, two due to lack of efficacy and one dropped out following the occurrence of side-effects. It was concluded that the results confirm the efficacy and acceptability of lormetazepam and may suggest 0.5 mg to be a more suitable dosage than 1.0 and 1.5 mg in elderly patients.