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)

The efficacy and tolerability of reboxetine, a unique selective noradrenaline reuptake inhibitor, were compared with those of placebo in a 6-week, randomized, double-blind study of hospitalized patients with a DSM-III-R diagnosis of major depressive disorder. Fifty-two patients (25 in the placebo group, 27 in the reboxetine group) were included in the efficacy analysis. Sixteen (64%) of those in the placebo group and four (15%) in the reboxetine group were withdrawn during the study because of lack of efficacy. Improvement in the mean Hamilton Rating Scale for Depression (HAM-D) total score at last assessment was significantly greater in the reboxetine group than in the placebo group (p < 0.001). Similarly, the response rate to treatment, defined as > or =50% reduction in HAM-D total score, was 74% for patients who received reboxetine compared with 20% for those who received placebo (p < 0.001). A significantly greater response with reboxetine than with placebo was seen as early as day 10 of treatment (p = 0.006). The therapeutic efficacy of reboxetine was substantiated by improvement in mean scores on the Zung Self-Rating Scale and on the Clinical Global Impression Severity of Illness and Global Improvement scales. Reboxetine was well tolerated, and only one patient in each group withdrew because of adverse events. Dry mouth, insomnia, blurred vision, sweating, and constipation were recorded more frequently in the reboxetine group than in the placebo group. There was a tendency toward orthostatic changes in the systolic blood pressure, but this was not clinically significant. This study demonstrated that reboxetine is significantly more effective than placebo in the treatment of hospitalized patients with severe major depressive disorder and is well tolerated.
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PMID:Double-blind, placebo-controlled study with reboxetine in inpatients with severe major depressive disorder. 1065 5

Depression in the elderly is often not recognised and is frequently under-treated. Reboxetine is a selective noradrenaline reuptake inhibitor (selective NRI) which is effective and well tolerated in the treatment of depressed adult patients. This prospective, uncontrolled, multicentre study was designed to assess the efficacy and tolerability of reboxetine as maintenance therapy for major depressive disorder or dysthymia in 160 elderly patients (aged 65-94 years). One hundred and thirty-nine patients completed the 6-week run-in period and entered the long-term phase; 104 patients completed the 52-week treatment period. The proportion of patients with CGI-global improvement ratings assessed as 'much' and 'very much' improved increased from 15.1% at week 2 to 88.7% at week 6 and to 95.2% at week 52. The mean HAM-D total score showed a reduction from 24.0 at baseline to 10.4 at week 6 and 7.5 at week 52. Twenty-five patients discontinued treatment due to adverse events. The most frequently reported adverse events were nausea (11.9%), insomnia (11.9%), headache (10.0%) and dry mouth (9.1%), and these were of mild or moderate severity. In summary, results from this study show reboxetine to be effective, and well tolerated in both the short- and long-term treatment of elderly depressed or dysthymic patients.
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PMID:Reboxetine in the maintenance therapy of depressive disorder in the elderly: a long-term open study. 1098 24

Geriatric patients with major depression present clinical challenges not encountered in younger individuals, including a greater incidence of medical comorbidity, higher rates of multiple medication use, changes in drug metabolism due to age or physical illness, and increased sensitivity to antidepressant side effects. Nevertheless, successful treatment of depressive disorders in the elderly improves mental and physical functioning, decreases morbidity and perhaps mortality, and enhances quality of life. Recent research indicates that newer antidepressants are effective for late life depression and safer for older individuals. Among newer antidepressants, venlafaxine has a pharmacological profile that makes it an attractive choice for geriatric patients. It has limited potential to interact with other medications because it only weakly inhibits the cytochrome P450 system and binds to plasma proteins at a low level. Dosing may have to be adjusted for patients with renal failure, but typically not for those with liver disease or other medical conditions. Data from three double-blind and four open clinical trials support the safety and efficacy of venlafaxine for geriatric depression. Patients may experience transient, generally tolerable side effects such as insomnia, nausea, agitation, or dry mouth early in treatment, but more serious problems such as falls or cardiac rhythm disturbances seem to be rare. Treatment emergent hypertension occurs in a small percentage of older patients, generally at doses above 150 mg/day. Finally, emerging data suggest that venlafaxine may be effective for conditions such as stroke, anxiety, and neuropathic pain that frequently accompany depressive disorders in the elderly.
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PMID:Efficacy of venlafaxine in geriatric depression. 1109 16

Experience from a UK national telephone helpline SANELINE (run by the mental health charity SANE), showed that availability and access to better medications and services are among the most important issues for patients with mental illness. SANELINE, therefore, conducted a survey of patients' satisfaction with antipsychotic medication between July 1998 and February 1999. A total of 202 completed questionnaires were available for analysis. A majority of patients (56%) were treated with conventional neuroleptics, 20% with new 'atypical' antipsychotics and 11% were on a combination of conventional and novel antipsychotics. Virtually all respondents (99%) reported suffering from at least one side-effect, of which 31% were perceived as 'severe' or 'very severe'. The most common side-effects reported were depression/low mood (90%), sedation (88%), difficulty in thinking/concentrating (78%), insomnia (68%), dry mouth (65%), muscle/joint stiffness (45%), sexual dysfunction (43%) and weight gain (39%). Notably, 73% of those who had experienced weight gain reported it to be 'quite or extremely distressing'. Depression was rated as 'quite or extremely distressing' by 67% of sufferers and insomnia was similarly rated by 66% of patients. Despite the methodological limitations of the survey, the results suggest there is a high level of patient dissatisfaction and distress related to the currently available medications, which may have unfavourable effects on compliance and treatment outcome.
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PMID:Real progress--the patient's perspective. 1125 24

The aim of this study was to evaluate the response to venlafaxine in patients with treatment-resistant depression during an extension phase of an open-label study of venlafaxine. After completing the initial 8 weeks of the study, patients could continue venlafaxine treatment for an additional period of up to 10 months. Efficacy results are given for 149 patients with treatment-resistant depression. Response was defined as a 50% reduction in scores on the Montgomery-Asberg Depression Rating Scale (MADRS); 69% were responders after 8 weeks of treatment in the initial study phase, and 73% were responders at their final extension-phase visit. The mean MADRS score was 32.8 before treatment, 12.9 by 8 weeks, and 10.8 at the final extension visit. There was a statistically significant reduction of 2.1 MADRS units from entry into the extension phase to the final extension visit. At extension entry, 36.7% patients were in remission, as defined by a MADRS score of less than 12, whereas at the final extension visit, this had increased to 49%. Improvement in Clinical Global Impressions Scale scores (both patient and physician ratings) was maintained throughout the extension period, with 88% of patients reporting some improvement (75% with "very much" or "much") and 92% of doctors noting some improvement in patients (79% with "very much" or "much") at the last extension visit. The safety profile during the extension phase of the study was similar to that found in the initial phase and in other studies. The most common study events were somnolence (21%), headache (18%), insomnia (16%), sweating (16%), constipation (14%), dry mouth (11%), nausea (10%), and dizziness (10%). Patients with resistant depression that was treated with venlafaxine maintained their response for up to 10 months after an 8-week phase of treatment and showed some evidence of further improvement.
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PMID:Sustained response to open-label venlafaxine in drug-resistant major depression. 1127 Sep 15

The aims of this cross-sectional survey were to assess psychotic sufferers' perception of the effectiveness of their medication, the distress caused by adverse effects and the impact these might have on overall patient satisfaction with treatment. Three hundred and forty-one people diagnosed with psychosis who called a national mental health helpline (SANELINE) in the UK, between July 1998 and February 1999, were asked to take part in the survey. They were given a choice of either a postal questionnaire or a telephone interview in which the same questionnaire was used. One hundred and nineteen were interviewed on the telephone and 83 (out of 222) returned completed questionnaires. In total, information was available from 202 callers. Almost one-half of the respondents were dissatisfied with their medication, and almost all of them reported experiencing at least one adverse effect. Depression (or low mood), sedation and difficulty thinking and concentrating were the most prevalent adverse effects. Weight gain was the most distressing, particularly to women. Those taking atypical antipsychotics were significantly more likely than those on typical antipsychotics to experience insomnia and dry mouth, but were less likely to perceive depression and difficulty thinking/concentrating as quite or extremely distressing. Low satisfaction, as opposed to high satisfaction, was significantly associated with reporting weight gain, difficulty thinking/concentrating, insomnia and sexual dysfunction. It was also significantly associated with reporting weight gain, difficulty thinking/concentrating, muscle/joint stiffness and depression as quite or extremely distressing. Attention should be given to the management of cognitive impairment and weight gain as adverse effects of antipsychotics. Doctors should be more open to discussing the risks and nature of adverse effects with patients who should also be encouraged to do so.
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PMID:Prevalence and extent of distress of adverse effects of antipsychotics among callers to a United Kingdom National Mental Health Helpline. 1135 37

A population pharmacokinetic and pharmacodynamic analysis evaluated the relationships of dose, plasma concentrations of bupropion and metabolites, and patient covariates with the safety and efficacy of bupropion sustained release (SR) for smoking cessation. A total of 519 outpatient chronic cigarette smokers were randomized to one of three bupropion SR doses: 100, 150, or 300 mg/day or placebo. The bupropion plasma concentration time data were fit and subject-specific bayesian estimates of clearance were obtained. Logistic regression analyses evaluated the role of dose, concentrations, and covariates in predicting efficacy and safety endpoints. For the evaluation of efficacy, patients were classified as quitters or non-quitters on the basis of a 4-week quit variable (defined as complete abstinence for weeks 4-7 of the study). For the evaluation of safety, patients were classified into two categories for each adverse event evaluated, corresponding to whether the patient ever experienced the adverse event during the course of the study or never experienced the event, regardless of whether the event was treatment-emergent. The efficacy of bupropion SR in facilitating smoking cessation was found to be related to dose and a mean metabolite concentration, and quitting in general was found to be related to the number of cigarettes smoked per day at baseline. Smoking cessation was 1.42, 1.69, and 2.84 times more likely in patients receiving 100, 150, and 300 mg/day of bupropion SR, respectively, as compared to placebo (p = 0.0001). As the baseline number of cigarettes smoked per day increased, the likelihood of quitting decreased regardless of the treatment condition. Insomnia and dry mouth were positively associated with mean metabolite concentrations, and dry mouth was inversely related to patient weight. Anxiety was inversely related to predicted steady-state concentration (Cpss), suggesting a positive effect on this withdrawal symptom. Bupropion SR exhibits a statistically significant dose/plasma level-response relationship for smoking cessation. Dry mouth and insomnia, related to concentrations, may be managed with dose reduction, with the realization that smoking cessation may be impaired.
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PMID:Relationship between drug exposure and the efficacy and safety of bupropion sustained release for smoking cessation. 1140 27

The goal of treatment in pediatric allergic rhinitis is to provide effective prevention of or relief from allergic rhinitis symptoms as safely and effectively as possible. Removing or avoiding allergens is always advised; however, pharmacotherapy is often necessity. Pharmacologic options include systemic decongestants, which are associated with irritability and insomnia, particularly in children. Antihistamines are widely used; however, first-generation antihistamines are known to cause dry mouth and sedation. Oral corticosteroids are very effective but can have unwanted systemic effects. Over the past decade, intranasal corticosteroids have been shown to be the most effective form of pharmacologic treatment for allergic rhinitis. Data support the use of intranasal corticosteroids as first-line therapy over oral antihistamines; nonetheless, some clinicians have been reluctant to prescribe these agents, particularly for children, because of concerns for systemic effects. Overall, the newer corticosteroids, including mometasone furoate (MF), beclomethasone dipropionate, and budesonide have an improved risk-benefit ratio compared with older cortico-steroids and are now considered the drug of choice for pediatric allergic rhinitis. A good deal of evidence exists that confirms the lack of systemic effects from intranasal cortico-steroids. However, reports of decreased bone growth in children receiving intranasal budesonide short-term and beclomethasone dipropionate long-term have heightened concerns that some of these drugs may have systemic effects. A new intranasal corticosteroid, MF nasal spray, has been studied in children 3 to 12 years of age and has been shown to be effective. Intranasal MF is available with once-daily dosing, which has the potential to decrease systemic side effects.
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PMID:Corticosteroids in the treatment of pediatric allergic rhinitis. 1144 8

Past and current drug therapies for weight loss are discussed. More than 50% of Americans can be categorized as overweight or obese. Obesity is associated with increased mortality and with comorbidities such as hypertension, hyperglycemia, dyslipidemia, coronary artery disease, and certain cancers. According to guidelines for identification, evaluation, and treatment of obesity, patients with a body mass index (BMI) of > or = 30 kg/m2 should attempt to lose weight. Patients with a BMI of > or = 25 kg/m2 plus two or more risk factors or patients with an excessive waist circumference plus two or more risk factors should also attempt to lose weight. The initial goal is a 10% weight reduction in six months achieved through lifestyle changes. If lifestyle changes alone are not effective, then drug therapy may be indicated. Pharmacotherapeutic options for obesity have decreased over the past few years. Fenfluramine, dexfenfluramine, and phenylpropanolamine have been withdrawn because of severe adverse effects, leaving only sympathomimetics, sibutramine, and orlistat as anorectics with FDA-approved labeling. Phentermine has been shown to cause a 5-15% weight loss if given daily or intermittently. Compared with sibutramine and orlistat, phentermine is cheaper, and specific formulations allow once-daily administration. However, phentermine is indicated only for short-term treatment, and tolerance often develops. Common adverse effects associated with phentermine are dry mouth, insomnia, increased blood pressure, and constipation. Sibutramine increases norepinephrine and serotonin levels in the CNS and should not be taken with many antidepressants because of the risk of increased norepinephrine and serotonin levels. Its use is also contraindicated in patients with cardiovascular disease. Orlistat is not systemically absorbed; therefore, it does not cause the systemic adverse effects or drug interactions of phentermine and sibutramine. Orlistat has a cholesterol-lowering effect not seen with other diet medications. However, the three-times-daily administration and frequent gastrointestinal effects limit its use. Sibutramine, phentermine, and orlistat have both positive and negative properties. Choosing among the medications will depend on concurrent disease states and medications, ease of administration, and cost.
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PMID:Pharmacologic options for the treatment of obesity. 1147 77

Most patients with advanced cancer develop diverse symptoms that can limit the efficacy of pain treatment and undermine their quality of life. The present study surveys symptom prevalence, etiology and severity in 593 cancer patients treated by a pain service. Non-opioid analgesics, opioids and adjuvants were administered following the WHO-guidelines for cancer pain relief. Other symptoms were systematically treated by appropriate adjuvant drugs. Pain and symptom severity was measured daily by patient self-assessment; the physicians of the pain service assessed symptom etiology and the severity of confusion, coma and gastrointestinal obstruction at each visit. The patients were treated for an average period of 51 days. Efficacy of pain treatment was good in 70%, satisfactory in 16% and inadequate in 14% of patients. The initial treatment caused a significant reduction in the average number of symptoms from four to three. Prevalence and severity of anorexia, impaired activity, confusion, mood changes, insomnia, constipation, dyspepsia, dyspnoea, coughing, dysphagia and urinary symptoms were significantly reduced, those of sedation, other neuropsychiatric symptoms and dry mouth were significantly increased and those of coma, vertigo, diarrhea, nausea, vomiting, intestinal obstruction, erythema, pruritus and sweating remained unchanged. The most frequent symptoms were impaired activity (74% of days), mood changes (22%), constipation (23%), nausea (23%) and dry mouth (20%). The highest severity scores were associated with impaired activity, sedation, coma, intestinal obstruction, dysphagia and urinary symptoms. Of all 23 symptoms, only constipation, erythema and dry mouth were assessed as being most frequently caused by the analgesic regimen. In conclusion, the high prevalence and severity of many symptoms in far advanced cancer can be reduced, if pain treatment is combined with systematic symptom control. Nevertheless, general, neuropsychiatric and gastrointestinal symptoms are experienced during a major part of treatment time and pain relief was inadequate in 14% of patients. Cancer pain management has to be embedded in a frame of palliative care, taking all the possibilities of symptom management into consideration.
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PMID:Symptoms during cancer pain treatment following WHO-guidelines: a longitudinal follow-up study of symptom prevalence, severity and etiology. 1151 84


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