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)

Despite the importance of symptom control in the cancer population, few studies have systematically assessed the prevalence and characteristics of symptoms or the interactions between various symptom characteristics and other factors related to quality of life (QOL). As part of a validation study of a new symptom assessment instrument, inpatients and outpatients with prostate, colon, breast or ovarian cancer were evaluated using the Memorial Symptom Assessment Scale and other measures of psychological condition, performance status, symptom distress and overall quality of life. The mean age of the 243 evaluable patients was 55.5 years (range 23-86 years); over 60% were women and almost two-thirds had metastatic disease. The Karnofsky Performance Status (KPS) score was < or = 80 in 49.8% and 123 were inpatients at the time of assessment. Across tumour types, 40-80% experienced lack of energy, pain, feeling drowsy, dry mouth, insomnia, or symptoms indicative of psychological distress. Although symptom characteristics were variable, the proportion of patients who described a symptom as relatively intense or frequent always exceeded the proportion who reported it as highly distressing. The mean (+/- SD range) number of symptoms per patient was 11.5 +/- 6.0 (0-25); inpatients had more symptoms than outpatients (13.5 +/- 5.4 vs. 9.7 +/- 6.0, p < 0.002) and those with KPS < or = 80 had more symptoms than those with KPS > 80 (14.8 +/- 5.5 vs. 9.2 +/- 4.9, p < 0.0001).(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Symptom prevalence, characteristics and distress in a cancer population. 792 Apr 92

A group of 19 middle aged patients suffering from primary insomnia according to the DSM-III-R were treated in a single-blind study with trimipramine, a sedating antidepressant. A total of 15 patients completed the study protocol and were evaluated. The present pilot study aimed at investigating the sleep-inducing properties of trimipramine, and at clarifying the question of whether short- or long-term rebound insomnia occurs after discontinuation of this drug. At four measurement points, i.e. under baseline conditions, under treatment and 4 and 14 days after drug discontinuation, sleep was recorded with an ambulatory-electroencephalogram (EEG) monitoring device in the patient's home environment. Simultaneously, psychometric tests were applied to measure withdrawal symptoms, subjective sleep quality and well-being during daytime. Trimipramine at a mean dose of 166 +/- 48 mg led to a significant increase in sleep efficiency, total sleep time, and stage 2% sleep-period time (SPT), whereas a significant decrease in wake time and stage 1% SPT was noted. Insomniac patients reported an improvement in subjectively perceived sleep quality following trimipramine. Additionally, an improvement in well-being during the daytime occurred. Negative side effects were limited to dry mouth due to the anticholinergic properties of the drug. Discontinuation of trimipramine did not provoke either short- or long-term rebound insomnia in objective and subjective sleep measurements considering mean values of the whole sample, although a subgroup of patients did display total sleep times below baseline values during short- and long-term withdrawal, but generally without a concomitant worsening of sleep quality according to the sleep questionnaire.
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PMID:Treatment of primary insomnia with trimipramine: an alternative to benzodiazepine hypnotics? 794 56

Twenty-one healthy, caucasian, male volunteers completed this randomized single blind, multiple-dose, crossover bioavailability study during which either phentermine HCl capsules (Minobese Forte, reference product) or phentermine base capsules (Duromine, test product) were ingested once daily for 14 days. A washout period of 14 days was allowed between the two treatment phases. On profile days (day 14 of each treatment phase) subjects remained recumbent for 24 hours after drug administration. Serial venous blood samples were drawn over the 24 hour dosing interval for plasma phentermine assay by gas chromatography. The 90% confidence intervals for the "test/reference" mean ratios of the pharmacokinetic variables Cmax,norm, Cmin,norm, AUCnorm (normalized for difference in the dose of phentermine base), %PTF and T75% Cmax, all fell within the bioequivalence range of 80% to 125%. With the aid of trough plasma phentermine concentrations, it was established that steady-state was reached after 14 days of once daily administration of either product. Adverse events experienced on both treatments included prolonged or recurrent episodes of insomnia, nausea, headache, dry mouth and dizziness. No clinically relevant changes in clinical chemistry or hematology variables occurred during the study.
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PMID:Steady-state pharmacokinetics of phentermine extended-release capsules. 822 80

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.
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PMID:Zopiclone. A review of its pharmacological properties and therapeutic efficacy as an hypnotic. 824 8

A double-blind, randomized, placebo-controlled, parallel trial was conducted to compare the efficacy and safety of terfenadine, 60 mg (immediate-release)/pseudoephedrine hydrochloride, 120 mg (controlled-release) (T/Ps) and clemastine fumarate, 1.34 mg (immediate-release)/phenylpropanolamine, 75 mg (sustained-release) (C/Ph) in a combination tablet b.i.d. in 178 patients (12-59 years of age) with symptoms of seasonal allergic rhinitis. After seven days of treatment, the total symptom scores recorded in the diaries of 175 patients showed that both therapies had a highly significant overall treatment effect when compared with placebo (P < or = .02). The overall level of improvement, as well as improvement of individual symptoms, was similar with the two therapies. Total symptom scores assigned by physicians to 170 patients showed significant and similar levels of improvement with both therapies when compared with placebo (P < .01). The two therapies were also similar on physicians' evaluations of overall effectiveness. Both therapies relieved most histamine-mediated symptoms as well as nasal congestion, although only T/Ps showed improvement of the latter symptom in both the patients' diaries and physicians' evaluations. Among 178 patients, drowsiness and fatigue occurred more often in the C/Ph group (25% and 11.7% for the two adverse events, respectively) than in the T/Ps group (10.2% and 1.7%, respectively). The incidence of insomnia and dry mouth/nose/throat was higher with T/Ps (23.7% and 11.9%, respectively) than with C/Ph (6.7% and 3.3%, respectively). No serious or unexpected adverse events were reported. These results indicate that T/Ps and C/Ph are both superior to placebo and equally effective in the treatment of symptoms of seasonal allergic rhinitis.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Safety and efficacy of terfenadine/pseudoephedrine versus clemastine/phenylpropanolamine in the treatment of seasonal allergic rhinitis. 849 30

The efficacy and tolerability of moclobemide and sertraline were compared in a 13 week trial on 55 depressive patients. Patients were diagnosed according to DSM-III-R criteria using SCID (Structured Clinical Interview for DSM-III-R). The study group was composed of 48 patients with major depression and 7 with minor depression. Patients were randomized in two drug groups and raters were blind to the drugs patients used. HDRS and CGI were used to assess the change in depressive symptoms. Twenty seven patients received moclobemide and 28 patients received sertraline. The dose of moclobemide used was 300-600 mg/day and that of sertraline was 50-200 mg/day. At the end of 13 weeks mean drop in HDRS for the overall group was 14.78 and the response rate calculated as percentage of patients showing a 50% drop in HDRS score was 77.8. The response rate was 76.5% for moclobemide and 78.5% for sertraline. The difference was not significant. The side effects were assessed by using UKU Side Effects Rating Scale. The most three observed side effects were dry mouth, headache and insomnia.
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PMID:Moclobemide and sertraline in the treatment of depressive disorders: a comparative study. 852 56

The efficacy and tolerability of fluvoxamine (100-300 mg/day) and clomipramine (100-250 mg/day) were compared in a randomized, double-blind, parallel-group study of 79 patients with obsessive-compulsive disorder (OCD) without coexisting major depression. After a 2-week placebo lead-in period, patients were randomized to fluvoxamine (37 patients) or clomipramine (42 patients) for 10 weeks. Efficacy was evaluated with the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), the National Institute of Mental Health Obsessive-Compulsive scale, and Patient and Clinical Global Improvement scales. Hamilton Rating Scale for Depression scores and somatic symptoms were also assessed. Seventy-eight percent of fluvoxamine patients and 64% of clomipramine patients completed the study. At the end of treatment, 56% of fluvoxamine patients were classified as responders (> or = 25% decrease in Y-BOCS score), compared with 54% of clomipramine patients. Both groups showed steady improvement throughout the study; no statistically significant differences were observed between the groups for any efficacy variable at any time. A similar percentage of patients in both groups withdrew because of adverse events. No serious adverse events related to drug occurred with either drug. Insomnia, nervousness, and dyspepsia were more statistically frequent with fluvoxamine; dry mouth and postural hypotension were more frequent with clomipramine. In this study, fluvoxamine and clomipramine were equally effective in reducing OCD symptoms over a 10-week treatment period but displayed different side effect profiles.
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PMID:Fluvoxamine versus clomipramine for obsessive-compulsive disorder: a double-blind comparison. 869 Aug 27

Early adverse effects of a drug may be a manifestation of individual differences in drug metabolism or of different pathologic processes. These differences may influence therapeutic responsiveness. Using data from Ciba-Geigy's multicenter 10-week clinical trial, we studied the relationship between early side effects and subsequent therapeutic response to clomipramine (CMI) in obsessive-compulsive disorder. We used tabular analyses and multiple regression to evaluate associations between early complaints and change in score on the Yale-Brown Obsessive-Compulsive Scale. We also evaluated whether early complaints were drug related (i.e., true side effects). It appeared that dry mouth, constipation, dizziness, insomnia, male impotence, nervousness, palpitation, and tremor reported during the first 4 weeks were predictive of good response to CMI. Myoclonus and tinnitus appeared weakly associated with treatment success. Most of these complaints were reported more by the CMI group than the placebo group, and more during CMI treatment than before. The more common complaints may reflect an individual's ability to metabolize CMI appropriately so that adequate therapeutic blood levels are attained. The less common complaints may reflect a sensitivity to CMI's serotonergic actions.
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PMID:Relationship between early side effects and therapeutic effects of clomipramine therapy in obsessive-compulsive disorder. 883 9

A 12-month open-label clinical trial was conducted to evaluate patient acceptance and safety of venlafaxine, a novel antidepressant, in ambulatory geriatric depressed patients. The sample consisted of 58 depressed patients aged 65 years and older who needed long-term antidepressant treatment. The setting was multiple study sites in California, Florida, New York, Utah, and Washington. All patients took venlafaxine; 52 qualified for the intent-to-treat analysis, and 24 completed 12 months of treatment. Repeated-measures analysis of variance within subjects showed significant improvements in Clinical Global Impressions severity and improvement, Modified Symptom Checklist, and Quality of Life Questionnaire scores. One patient developed a rash that was judged to be a serious drug-related side effect. The most common side effects were headache (n = 25), nausea (n = 21), insomnia (n = 18), dry mouth (n = 18), and sweating (n = 18). The results demonstrate the safety and patient acceptance of venlafaxine in depressed geriatric outpatients for acute and maintenance treatment.
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PMID:Venlafaxine in depressed geriatric outpatients: an open-label clinical study. 885 49

Fifty major depressed patients, resistant to multiple pharmacotherapies, were treated by the addition of moclobemide (up to 600 mg/day) to paroxetine or fluoxetine (20 mg/day) for 6 weeks in an open study to assess tolerability. There were 188 adverse events: insomnia, dizziness, headache, nausea, dry mouth and myoclonic jerks were the most common. Many events were rated as severe. The high rate of adverse events suggest that there are clinically significant pharmacodynamic interactions between moclobemide and SSRIs. However the uncontrolled data on effectiveness is encouraging and the combination deserves further consideration as a strategy for treating intractable depression.
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PMID:Safety and tolerability of combined treatment with moclobemide and SSRIs: a systematic study of 50 patients. 892 97


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