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)

Cephradine (CED) was administered intravenously to the patients with respiratory infection or urinary tract infection with the dosage of 1.0 approximately 4.0 g daily and their clinical effects were investigated. Good clinical effects of CED were obtained in 5 of 8 cases with respiratory infections and in 2 of 5 cases with urinary tract infections. Side effects were noted in 2 cases, but they improved rapidly by the cessation of the drug administration. One case developed skin eruption and the other case complained general burning, palpitation after intravenous injection and slight insomnia. CED is seemed to be effective antibiotic for the respiratory as well as urinary tract infections clinically. However it was advisable that careful attention should be paid when CED is administered to the patient having drug allergy or nephropathy.
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PMID:[Clinical studies on cephradine (CED) (author's transl)]. 100 84

Patients were entered in a double-blind, placebo-controlled, multicenter study to compare low- and high-dose fleroxacin with norfloxacin for the treatment of complicated urinary tract infection (UTI). A total of 296 patients were enrolled; 102, 97, and 97 patients were randomized to receive 200 mg of fleroxacin (low-dose), 400 mg of fleroxacin (high-dose), both once daily, or 400 mg of norfloxacin twice daily, respectively, for 10 days. Of these patients, 101, 94, and 95 were included in the safety analysis, and 71, 61, and 58 in the efficacy analysis. The main reason for exclusion from the efficacy analysis was failure to isolate a pathogen at baseline. The groups were comparable with respect to demographics. In the low-dose fleroxacin group, 68 (96%) of 71 patients had bacteriologic cures (eight with superinfection), compared with 56 (92%) of 61 in the high-dose fleroxacin group (two with superinfection) and 52 (90%) of 58 in the norfloxacin group (four with superinfection). Escherichia coli was the most frequent isolate in all groups. In the low-dose fleroxacin group, clinical cure was recorded in 61 (86%) of 71, improvement in six, and failure in four. In the high-dose group, clinical cure was noted in 58 (95%) of 61 patients, improvement in two, and failure in one. In the norfloxacin group, 50 (86%) of 58 patients were clinically cured, four were improved, and four failed. Clinical adverse events were reported by 22 (22%) of 101, 36 (38%) of 94, and 19 (20%) of 95 patients in the low-dose fleroxacin, high-dose fleroxacin, and norfloxacin groups, respectively. Insomnia and nausea were reported most frequently in the fleroxacin groups, and nausea and headache were most common in the norfloxacin group. The efficacy and safety of low-dose fleroxacin are comparable to those of norfloxacin for treatment of complicated UTI.
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PMID:Randomized double-blind trial of high- and low-dose fleroxacin versus norfloxacin for complicated urinary tract infection. 845 63

Fleroxacin, 400 mg once daily, and norfloxacin, 400 mg twice daily, both administered orally, were compared for the treatment of serious urinary tract infections (UTIs). In total, 301 patients from multiple centers who had serious UTIs were randomized to receive fleroxacin or norfloxacin in a double-blind study. The demographic parameters of the two groups were similar. A total of 190 patients were evaluable for efficacy, 94 in the fleroxacin group and 96 in the norfloxacin group. The reasons for exclusion from the efficacy analysis were not significantly different in the two groups, but more patients receiving fleroxacin were prematurely withdrawn from the study. The majority (134) of the diagnoses were complicated UTI, and the pathogens were primarily Enterobacteriaceae. The clinical responses were cure or improvement in 98% of the fleroxacin group and 92% of the norfloxacin group and failure in 2% of the fleroxacin group and 7% of the norfloxacin group. The bacteriologic results by infection were cure in 98% of the fleroxacin group and 89% of the norfloxacin group (including cure with superinfection in 4% of the fleroxacin group and 5% of the norfloxacin group) and failure in 2% of the fleroxacin group and 11% of the norfloxacin group. Adverse events were more common in the fleroxacin group and were mostly nausea, insomnia, and headache. Fleroxacin, 400 mg once daily, was as effective as norfloxacin, 400 mg twice daily, in eradicating UTIs but was associated with more adverse events.
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PMID:Fleroxacin versus norfloxacin for oral treatment of serious urinary tract infections. 845 64

The clinical efficacy and safety of single-dose and multiple-dose fleroxacin were assessed and compared with those of ciprofloxacin in women with uncomplicated urinary tract infection (UTI) in this clinical study. This multicenter, randomized, double-blind, prospective study compared single-dose therapy with fleroxacin, 400 mg, with 7-day courses of fleroxacin, 200 mg once a day, and ciprofloxacin, 250 mg twice a day, in the treatment of uncomplicated symptomatic UTI in women at 18 centers in the United States. Of 961 patients enrolled, 316 were in the fleroxacin single-dose group, 321 in the fleroxacin 7-day group, and 324 in the ciprofloxacin group. Of these patients, 943 met the criteria for inclusion in the safety analysis and 556 met those for inclusion in the efficacy analysis. Bacteriologic cure rates at 5-9 days after therapy in patients evaluable for efficacy were 88%, 96%, and 96% in the single-dose fleroxacin group, 7-day fleroxacin group, and 7-day ciprofloxacin group, respectively (p < 0.05). Clinical cures occurred in 93.6%, 97.2%, and 98% of the groups, respectively (difference not significant). At 4-6 weeks after therapy, the rates of bacteriologic cure in the single-dose fleroxacin group, 7-day fleroxacin group, and 7-day ciprofloxacin group were 91%, 89%, and 93%, respectively (difference not significant). Adverse events were similar to those with other new quinolones and comparable among the treatment groups. Insomnia was more frequent in patients who received fleroxacin. Fleroxacin and ciprofloxacin as multidose regimens are similarly safe and effective in the treatment of uncomplicated UTI in women. Single-dose fleroxacin achieved a clinical response rate comparable to that achieved by the multiple-dose regimens, whereas its bacteriologic eradication rate was inferior.
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PMID:Multicenter study of single-dose and multiple-dose fleroxacin versus ciprofloxacin in the treatment of uncomplicated urinary tract infections. 845 89

Up to 10% of premenopausal women experience recurrent symptomatic urinary tract infection (UTI), mainly due to reinfection from the faecal flora. The recently introduced fluoroquinolones possess a wide spectrum of activity against most uropathogens and achieve high urinary concentrations for extended time periods. Our initial study, conducted between 1993 and 1995, was designed to compare the efficacy and safety of oral pefloxacin 800mg once weekly with oral ciprofloxacin 125mg once daily, over a 12-month prophylactic course in women with recurrent UTI. A 12-month reinfection-free period was achieved in 83.3% of pefloxacin patients and in 78.9% of ciprofloxacin patients. The present study, which commenced in 1996, was designed to compare pefloxacin 400mg with oral fleroxacin 400mg once weekly. Prophylaxis was maintained for 12 months. There are no statistically significant differences between the 2 regimens in terms of efficacy and safety. The most frequently isolated pathogens causing breakthrough reinfections were Escherichia coli and Enterococcus spp. Adverse effects observed were mostly neuropsychic (insomnia) and gastrointestinal. In both studies, there was no evidence of emergence of quinolone-resistant organisms in the urine or rectal flora, even after 12 months of chemoprophylaxis.
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PMID:Newer quinolones in the long term prophylaxis of recurrent urinary tract infections (UTI). 1055 16

In clinical trials, short-term galantamine treatment produces consistent positive effects on global ratings, cognitive tests, and assessments of activities of daily living and behavior in patients with mild-to-moderate Alzheimer's disease (AD), providing the rationale for longer-term, open-label treatment. In this continuation trial following enrollment in previous 12-month trials, patients received galantamine 24 mg/day for a total of 24 months (total exposure up to 36 months). Primary efficacy measures were the ADAS-cog/11 and DAD. Adverse events (AEs) were coded to WHO preferred terms, including AEs begun in previous trials. Initial improvement in cognitive function was followed by a gradual decline, as measured by increased ADAS-cog/11 scores. At 36 months, ADAS-cog/11 scores increased by a mean (SEM) of 12.4 (0.80) points (P < 0.001) versus a projected 22-point increase for untreated patients. Functional abilities, as measured by the DAD, had decreased significantly at each time point versus baseline (P < 0.001). The most common treatment-emergent AEs were agitation (16.1%), insomnia (12.4%), fall (11.2%), and urinary tract infection (10.2%). AEs were mainly mild to moderate, appropriate for an elderly population, with few judged treatment related. Galantamine 24 mg/day is safe and effective for long-term treatment of mild-to-moderate AD. Potential exists for prolonged benefit with galantamine therapy versus lack of treatment for the long-term.
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PMID:Long-term efficacy and safety of galantamine in patients with mild-to-moderate Alzheimer's disease: multicenter trial. 1552 94

Ramelteon is a selective MT(1)/MT(2)-receptor agonist indicated for insomnia treatment. Because it has no depressant effects on the nervous system, it is not expected to affect the control of breathing. The potential effects of ramelteon on apneic and hypopneic events and arterial oxygen saturation (SaO(2)) in individuals with obstructive sleep apnea were assessed. In this double-blind, randomized, crossover study, 26 adults with mild to moderate obstructive sleep apnea received ramelteon 16 mg and placebo for one night each, with a 5- to 12-day washout period between treatments. Treatments were administered 30 min before habitual bedtime. Respiratory effort was monitored using respiratory inductance plethysmography, SaO(2) was measured by pulse oximetry, and sleep onset and duration were measured by polysomnography and post-sleep questionnaire. Post-sleep questionnaire also measured next-day residual effects. The primary measure was apnea-hypopnea index. Apnea-hypopnea index was similar in ramelteon and placebo groups (11.4 vs 11.1, respectively; CI = -2.1, 2.6, P = 0.812). Ramelteon had no effect on the number of central, obstructive, or mixed apnea episodes. No significant differences were observed in SaO(2) for the entire night between ramelteon and placebo (95.1 vs 94.7%; P = 0.070). Ramelteon did not meaningfully affect sleep when evaluated by polysomnography and post-sleep questionnaire. Compared with placebo, ramelteon had no significant effect on next-day residual effects. Adverse events were reported by three subjects in the ramelteon group: headache (n = 2) and urinary tract infection (n = 1). No adverse events were reported with placebo. Ramelteon was well-tolerated and, as expected, did not worsen sleep apnea when administered to subjects with mild to moderate obstructive sleep apnea.
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PMID:Safety of ramelteon in individuals with mild to moderate obstructive sleep apnea. 1729 32

Eszopiclone is the S-isomer of racemic zopiclone, a cyclopyrrolone with sedative-hypnotic activity that has been available in Europe, Canada, and Latin America since 1987. Eszopiclone acts by binding to the GABA(A) receptor. In contrast to the benzodiazepine (BZD) hypnotics, eszopiclone has more selectivity for certain subunits of the GABA(A) receptor. Oral eszopiclone is rapidly absorbed and extensively distributed to body tissues including the brain. Peak plasma concentrations are attained 1.0-1.6 hours after a 3 mg dose, while the mean elimination half-life is 6 hours. The half-life increases with age to about 9.0 hours in patients 65 years or older. Eszopiclone's pharmacokinetic (PK) profile is not substantially modified in patients suffering from renal failure or mild-to-moderate hepatic impairment, although patients with severe hepatic insufficiency should have a reduced dose. The subjective perception of improved sleep following eszopiclone 2 or 3 mg treatment has been demonstrated in randomized, double-blind, placebo-controlled studies of up to 6 months' duration. In these studies the drug significantly reduced sleep onset latency (SOL), the number of awakenings, and wake time after sleep onset (WASO) whereas total sleep time (TST) and quality of sleep were increased in non-elderly and elderly subjects. Sleep laboratory studies of the effects of eszopiclone have confirmed the drug's clinical efficacy in subjects with chronic primary insomnia. Eszopiclone, unlike BZD hypnotics, does not significantly alter values corresponding to slow wave sleep (SWS or stages 3 and 4) and rapid eye movement (REM) sleep. Rebound insomnia following withdrawal of eszopiclone has been examined in only one study. Discontinuation of the active treatment with 2 mg was followed by rebound insomnia in non-elderly subjects. Three-mg doses of eszopiclone administered for a period of up to 12 months was associated with a sustained beneficial effect on sleep induction and maintenance, with no occurrence of tolerance. The most common side-effects were unpleasant or bitter taste, headache, dyspepsia, pain, diarrhea, dry mouth, upper respiratory infection, urinary tract infection, dizziness, and accidental injury. New adverse events (withdrawal symptoms) including anxiety, abnormal dreams, hyperesthesia, nausea, and upset stomach were recorded in one study on the days following eszopiclone 2 or 3 mg discontinuation. Although dependence and abuse potential have not been formally assessed, unpublished data show that eszopiclone at doses of 6 and 12 mg produces euphoria effects similar to those of diazepam 20 mg in BZD drug addicts. In conclusion, available evidence tends to indicate that eszopiclone is effective and safe for the treatment of chronic primary insomnia in non-elderly and elderly subjects. Tolerance did not occur during active drug administration for a 12-month period. Thus eszopiclone can be efficacious not only during short- and intermediate-term administration but also in patients requiring prolonged regular drug usage.
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PMID:Eszopiclone: its use in the treatment of insomnia. 1930 May 73

The adverse effects profile of levetiracetam in epilepsy is still being fully described. We recently published a Cochrane Review evaluating the effectiveness of levetiracetam, added on to usual care, in treating drug-resistant focal epilepsy. The five most common adverse effects were reported and analysed with no scope for reporting any less common adverse effects than those. Here, we report and analyse the remaining adverse effects (including the five most common). These were (in decreasing order of frequency) somnolence; headache; asthenia; accidental injury; dizziness; infection; pharyngitis; pain; rhinitis; abdominal pain; flu syndrome; vomiting; diarrhoea; convulsion; nausea; increased cough; anorexia; upper respiratory tract infection; hostility; personality disorder; urinary tract infection; nervousness; depression; aggression; back pain; agitation; emotional liability; psychomotor hyperactivity; pyrexia; rash; ECG abnormalities; decreased appetite; nasal congestion; irritability; abnormal behaviour; epistaxis; insomnia; altered mood; anxiety; bloody urine; diplopia; dissociation; memory impairment; pruritis; increased appetite; acne; and stomach discomfort. Only somnolence and infection were significantly associated with levetiracetam. When adverse effects pertaining to infection were combined, these affected 19.7% and 15.1% of participants on levetiracetam and placebo (relative risk 1.16, CI 0.89-1.50, Chi(2) heterogeneity p = 0.13). Somnolence and infection further retained significance in adults while no single adverse effect was significant in children. This review updates the adverse effects profile data on levetiracetam use by empirically reporting its common and uncommon adverse effects and analysing their relative importance statistically using data from a group of trials that possess low Risk of Bias and high Quality of Evidence GRADE scores.
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PMID:The adverse effects profile of levetiracetam in epilepsy: a more detailed look. 2425 46

Enterobius vermicularis may cause infections of the gastrointestinal tract and occurs approximately in 4% to 28% of children worldwide. It is most common in children aged 5 to 14 years.The most commonly reported symptoms are pruritus in the perianal region, abdominal pain, urinary tract infection, insomnia, irritability, salpingitis, and appendicitis, whereas intestinal obstruction is a very rare but would be considered to perform the right instrumental examination avoiding unnecessary surgical exploration.We report a case of an 8-year-old boy with an intestinal occlusion due to a colonic intussusception by Enterobius vermicularis managed conservatively.
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PMID:Enterobius Vermicularis as a Cause of Intestinal Occlusion: How To Avoid Unnecessary Surgery. 2619 60


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