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This is most likely due to the greater prevalence among women of diseases requiring long-term nonsteroidal anti-inflammatory drug treatment buy cheapest nitrofurantoin. Genotype The proton pump inhibitors are all metabolized buy nitrofurantoin 50mg with mastercard, largely by the CYP2C19 and CYP3A4 liver enzymes purchase nitrofurantoin 50 mg free shipping. Theses enzymes are estimated to be deficient in 3% of white and African Americans and 17% to 25% of Asians. The deficiency results in a significantly longer half-life of proton pump inhibitors, although clinically significant accumulation of these drugs has not been shown. While dose adjustments are not required, and adverse effect profiles of the drugs do not differ, 184, 271 there is some evidence that lower doses may be effective in these populations and that 176, 177, 187 rapid metabolizers may have a higher rate of failure to eradicate Helicobacter pylori 272 and to heal esophagitis. Subgroup analysis found no effect by race in 1 study of esomeprazole 4 and lansoprazole in healing of erosive esophagitis. A small study (N=80) found no statistically significant difference at 8 weeks in rate of ulcer healing between rabeprazole 10 mg daily and 108 omeprazole 20 mg daily among patients with differing CYP2C19 genotype. The few adverse events were not analyzed by genotype. A trial of omeprazole in Japanese patients with recurrent 273 esophagitis found no difference in efficacy or safety by genotype. Older patients also metabolize proton pump inhibitors more slowly, resulting in significantly higher drug levels and half-lifes. However, accumulation has not been shown, and dose adjustments are not recommended. One reanalysis of data from 2 trials comparing omeprazole with either ranitidine or cimetidine for reflux esophagitis compared effect in patients 274 age 65 or older with those under age 65. In this analysis there was no difference in healing rate or symptom resolution at 4 or 8 weeks, with a slightly higher proportion of older patients both healed and symptom-free. Withdrawals due to adverse event were higher in the older group, 7. Similar data are not available for other proton pump inhibitors. Comorbidity In an uncontrolled, non-randomized open-label study, patients with peptic ulcer and comorbid 275 liver disease were given 6 to 8 weeks of rabeprazole 10 mg to 20 mg. Eleven of 108 patients (10%) reported 21 adverse drug events, resulting in 5 withdrawals (5%) and an additional 5 patients with an adverse event were lost to follow up. Two patients (2%) had adverse events that were rated as serious, 1 had an elevated bilirubin level, and the other had hepatic encephalopathy. Concomitant medications Two good quality observational studies assessed the impact of a potential drug interaction between proton pump inhibitors and clopidogrel following an acute coronary syndrome (ACS). A cohort study of 8205 patients who were discharged after an ACS and were prescribed clopidogrel between October 2003 and January 2006 were examined to Proton pump inhibitors Page 66 of 121 Final Report Update 5 Drug Effectiveness Review Project determine if the rate of death or rehospitalization for ACS was affected by concomitant use of a 276 proton pump inhibitor. Of these patients, 64% were prescribed a proton pump inhibitor. Multivariable analysis found that there was an increased risk of death or rehospitalization for ACS in those patients taking both clopidogrel and a proton pump inhibitor; adjusted odds ratio 1. The analysis controlled for multiple variables, included demographic characteristics, comorbidities, previous cardiac history, and other medications. In patients who had period with and without a proton pump inhibitor, but continued clopidogrel use, the risk of the primary outcome was also increased during the proton pump inhibitor periods; adjusted odds ratio 1. In addition to the primary outcome, secondary outcomes were evaluated. The risk of rehospitalization for ACS was increased (adjusted odds ratio 1. The authors also conducted a nested case-control analysis with these data in an attempt to confirm their findings, resulting in an adjusted odds ratio of 1. Multiple sensitivity analyses were conducted, with no meaningful change to the results. This study was conducted using data from the Veteran’s Affairs hospitals, and no patients were taking esomeprazole. Too few patients were taking pantoprazole or lansoprazole to be able to conduct individual analyses, but omeprazole and rabeprazole resulted in increased adjusted odds ratios for the primary outcome (adjusted odds ratios: 1. Analysis by dose of proton pump inhibitor indicated did not indicate a dose-response relationship. A population-based nested case-control study examined data from all patients in Ontario, Canada who were prescribed clopidogrel after hospital discharge following a myocardial 277 infarction between April 2002 and December 2007. Among this group, cases were identified as patients who were rehospitalized for myocardial infarction within 90 days of discharge (N=734), while controls were those who were not. Controls were identified in a 3:1 ratio to cases and matched on age, percutaneous coronary intervention, and a validated risk score (N=2057). Proton pump inhibitor exposure was defined as current (within 30 days of rehospitalization), previous (31 to 90 days) or remote (91 to 180 days). The logistic regression analysis controlled for demographic variables, socioeconomic status, Charlson comorbidity index, length of stay during initial admission for myocardial infarction, and 9 comorbid conditions (for example diabetes). A similar adjusted odds ratio was found in this study as the cohort study; 1. Previous or remote use was not associated with an increased risk of recurrent myocardial infarction. All-cause mortality was again not affected statistically significantly (adjusted odds ratio 0. Analysis of recurrent myocardial infarction within 1 year of initial discharge also indicated an increased risk with current proton pump inhibitor use; odds ratio 1. Because pantoprazole does not inhibit the P450 2C19 enzyme system responsible for activation of clopidogrel, it has been suggested that it may not result in a clinically-relevant drug interaction. An analysis of pantoprazole alone (N=cases 46, controls 125) found no statistically significant increase in risk (adjusted odds ratio 1. Analysis of all other proton pump inhibitors (which inhibit the P450 2C19 enzyme system to varying degrees) together resulted in increased risk; adjusted odds ratio 1. Analysis stratified further by individual proton pump inhibitor was not undertaken; insufficient data may have prevented such analysis. Proton pump inhibitors Page 67 of 121 Final Report Update 5 Drug Effectiveness Review Project Because these are post-hoc sub-group analyses of small groups, further research is needed to confirm these findings. Pregnancy A multicenter, prospective cohort study enrolled 410 pregnant women who had sought counseling after exposure to omeprazole (N=295), lansoprazole (N=62), or pantoprazole (N=53) 278 between 1992 and 2001. Details of exposure were collected during pregnancy before pregnancy outcome was known, and follow-up was performed in the neonatal period. A control group of 868 women who had been counseled during pregnancy about exposures known to be nonteratogenic served as a control group. There were some differences between control and treatment groups at baseline (for example, number of children was larger in then treatment than the control group), and confounders were not controlled for in the analysis.

Antiphospholipid syndrome: pin antibodies in the antiphospholipid syndrome: a systematic clinical and immunologic manifestations and patterns of dis- review of the literature 50mg nitrofurantoin with amex. Urbanus RT nitrofurantoin 50 mg amex, Siegerink B discount nitrofurantoin 50 mg overnight delivery, Roest M, Rosendaal FR, de Groot 2002;46(4):1019-1027. International dial infarction and ischaemic stroke in young women in the consensus statement on an update of the classification criteria RATIO study: a case-control study. Anti- tein I (beta2GPI) autoantibodies recognize an epitope on the phospholipid antibodies are directed against a complex antigen first domain of beta2GPI. Anticardiolipin recognize domain I of beta2-glycoprotein I only after a antibodies (ACA) directed not to cardiolipin but to a plasma conformational change. Ioannou Y, Pericleous C, Giles I, Latchman DS, Isenberg DA, 5. Matsuura E, Igarashi Y, Fujimoto M, Ichikawa K, Koike T. Binding of antiphospholipid antibodies to discon- Anticardiolipin cofactor(s) and differential diagnosis of autoim- tinuous epitopes on domain I of human beta(2)-glycoprotein I: mune disease. Pengo V, Biasiolo A, Pegoraro C, Cucchini U, Noventa F, agulant/Antiphospholipid Antibody of the Scientific and Stan- Iliceto S. Antibody profiles for the diagnosis of antiphospho- dardisation Committee of the International Society on Thrombo- lipid syndrome. Influence of different thrombotic therapy for the prevention of recurrent thrombosis IgG anticardiolipin antibody cut-off values on antiphospholipid in patients with the antiphospholipid syndrome (WAPS). Ruiz-Irastorza G, Cuadrado MJ, Ruiz-Arruza I, et al. Lupus anticoagulants and the risk of a first based recommendations for the prevention and long-term episode of deep venous thrombosis. Tincani A, Filippini M, Scarsi M, Galli M, Meroni PL. Clinical significance of antibodies and subsequent thrombo-occlusive events in patients different antiphospholipid antibodies in the WAPS (warfarin in with ischemic stroke. Comparison between single antiplatelet therapy and combina- 28. Antibody profile and tion of antiplatelet and anticoagulation therapy for secondary clinical course in primary antiphospholipid syndrome with prevention in ischemic stroke patients with antiphospholipid pregnancy morbidity. Ruiz-Irastorza G, Ramos-Casals M, Brito-Zeron P, Khamashta study of antibodies to beta2-glycoprotein I and prothrombin, MA. Clinical efficacy and side effects of antimalarials in and risk of thrombosis. Tektonidou MG, Laskari K, Panagiotakos DB, Moutsopoulos 41. Risk factors for thrombosis and primary thrombosis protects the annexin A5 anticoagulant shield from disruption by prevention in patients with systemic lupus erythematosus with antiphospholipid antibodies: evidence for a novel effect for an or without antiphospholipid antibodies. Morbidity and mortality in the antiphospholipid syndrome during a 5-year option for antiphospholipid syndrome patients? Expert Rev period: a multicentre prospective study of 1000 patients. A systematic open-label phase II trial of rituximab for non-criteria manifesta- review of secondary thromboprophylaxis in patients with tions of antiphospholipid syndrome. Ruiz-Irastorza G, Khamashta MA, Hunt BJ, Escudero A, catastrophic antiphospholipid syndrome: causes of death and Cuadrado MJ, Hughes GR. Bleeding and recurrent thrombosis prognostic factors in a series of 250 patients. Catastrophic antiphos- tional normalized ratio of 3. Update on the catastrophic antiphospho- intensities of warfarin for the prevention of recurrent thrombo- lipid syndrome and the “CAPS Registry”. Semin Thromb sis in patients with the antiphospholipid antibody syndrome. A randomized perspectives for refractory catastrophic antiphospholipid syn- clinical trial of high-intensity warfarin vs. Wilmot Cancer Center and Department of Medicine, University of Rochester, Rochester, NY Cancer-associated thrombosis accounts for almost one-fifth of all cases of venous thromboembolism (VTE) and is a leading cause of death, morbidity, delays in care, and increased costs. Our understanding of risk factors for cancer-associated thrombosis has expanded in recent years, and investigators have begun to use biomarkers and clinical prediction models to identify those cancer patients at greatest risk for VTE. The Khorana Risk Model, which is based on easily obtained biomarkers and clinical factors, has now been validated in several studies. Recent clinical trials of prophylaxis and treatment of VTE in cancer patients are reviewed here. In addition, consensus guidelines and expert opinion regarding management of VTE in specific challenging situations are presented. Epidemiology and impact of cancer-associated Several cancer-specific factors, such as site, stage, and histologic thrombosis subtype, are also risk factors for thrombosis. In pooled analyses of Approximately 20% of all cases of venous thromboembolism patients with many types of cancer, those with tumors originating in (VTE) occur in the setting of cancer,1 and cancer patients are 4- to the pancreas, stomach, brain, kidney, uterus, lung, and ovary had the highest incidence of VTE. In ated thrombosis also results in increased morbidity, mortality, and patients with non-small-cell lung cancer, 9. Thrombosis is a leading direct cause of death in cancer adenocarcinoma developed VTE in the first 6 months after diagno- patients with fatal pulmonary embolism, being 3 times more sis compared with 7. A prospective analysis of more than 800 patients with VTE revealed that the 12-month Various treatments also increase the risk of VTE. Surgery is a major cumulative incidence of recurrent VTE was significantly higher in provoking factor for VTE in patients without cancer, and underlying cancer patients compared with patients without cancer (20. That study estimated the total VTE-related health care VTE occurs in 8% to 27% of myeloma patients treated with costs to be $9247 per patient with VTE. Many risk factors for cancer-associated thrombosis have been Several large clinical trials and meta-analyses have demonstrated identified, including patient-related, cancer-related and treatment- that bevacizumab is associated with an 2-fold increased risk of arterial thromboembolic events19 and this agent may also increase related factors (Table 1). The evidence to support patient-related risk factors, including age, sex, and race, has been reviewed VTE risk (although this is controversial). A systematic review encompassing 37 trials and 6743 patients 684 American Society of Hematology Table 1. Risk factors and biomarkers for cancer-associated thrombosis Cancer-related factors Patient-related factors Primary site of cancer Older age Pancreas, stomach, brain, kidney, lung, and ovary Female sex Advanced stage of cancer Race (lower in Asians, higher in blacks) Initial period after diagnosis of cancer Comorbidities (Renal disease, obesity, infection) Histology Prior history of VTE Lower performance status Treatment-related factors Major surgery Candidate biomarkers Hospitalization Platelet count 350 000/mm3 Chemotherapy (particularly cisplatin) Leukocyte count 11 000/mm3 Hormonal therapy Hemoglobin 10 g/dL Anti-angiogenic agents (bevacizumab, sunitunib, sorafenib) Elevated tissue factor Immunomodulatory drugs (thalidomide, lenalidomide) Elevated D-dimer Erythropoiesis-stimulating agents Elevated soluble P-selectin Transfusions (platelets and red blood cells) Elevated C-reactive protein Central venous catheters Thrombin generation potential showed that erythropoietin-stimulating agents significantly in- patients from a prospective registry. Observed rates of VTE in the creased the risk of thrombotic complications in cancer patients development and validation cohorts were 0. This factors suggested there is also an increased risk of thrombosis with model has now been validated in several other studies (Table 2), the use of GM-CSF. Several consensus guidelines have outlined specific recom- Efforts to identify cancer patients at greatest risk of VTE have 32-35 mendations for prophylaxis in these situations. Many older focused on clinical factors, biomarkers, and risk prediction tools.

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Pneumocystis pneumonia (PCP) discount nitrofurantoin 50 mg mastercard, CT scans Ground-glass pattern predominantly involving perihilar and mid zones order 50 mg nitrofurantoin with mastercard. Figure 3 shows also several KS lesions (in the setting of an IRIS) Clinical Images 721 1 2 3 4 3 nitrofurantoin 50 mg fast delivery. MRI scan of the same patient, multiple, small TE lesions. Solitary TE lesion with typical ring enhancement (CT scan). Cerebral CT scan with a large, solitary lesion and extensive edema. Typical ring enhancement Clinical Images 723 1 2 3 4 5 6 5. Large CMV ulcer on the tongue, severe immune deficiency 3. Refractory HSV-infection in a patient with massive immune deficiency (1), lesions completely resolved after weeks of foscarnet treatment (2). Zoster lesions at the upper back, dermatomes C7 and C8, prior and three weeks after therapy 726 Clinical Images 1a 1b 2 3 8. Esophageal candidiasis, endoscopic pictures Clinical Images 727 1 2 3 9. Left sided “Tree-in-bud” phenomenon as seen in bronchial spread of tuberculosis. Lymph node tuberculosis Cervical and supraclavicular abscesses due to M. In all patients, TB became manifest in the setting of an immune reconstitution syndrome (IRIS), shortly after initiation of ART. General living conditions, nutritional status, physi- Primary amenorrhea is the absence of menarche in cal activity and genetic factors all influence sexual a girl aged 16 years or older. Secondary amenorrhea 4 maturation and age at menarche. Menarche is the first menstrual period and starts In primary amenorrhea after the development of secondary sexual charac- • Presence of secondary sexual characteristics. Are teristics: pubic and axillary hair and breast develop- axillary and pubic hair present and is there breast ment (Tanner stages, Figure 1). The mean age of development (see Tanner stages, Figure 1)? Generally, is usually a delay in puberty due to malnutrition (stunting), chronic childhood illness, excessive physical activity combined with reduced energy intake or the delay is constitutional. Encephalitis and meningitis might have dam- aged the hypothalamus or pituitary. Removal of the ovaries because of tumors, cysts or tubo- ovarian abscesses. Chronic debilitating disease can lead to anovulation through hypo- thalamic dysfunction. Together with an abdominal mass, this symptom could indicate a vaginal septum or imperforate hymen. Severe weight loss due to for example a chronic disease influences hypo- thalamic function. A masculine distribution of body hair Komorniczak (breast, abdomen, face, thighs) and/or severe 84 Amenorrhea acne indicate androgen excess and is a symptom prolactinemia causing amenorrhea. Question the girl ance may indicate a pituitary macroadenoma. Sexually transmitted infections operations can lead to intrauterine adhesions or (STIs), including HIV and pregnancy should be cervical stenosis/adhesions. Severe endo/myometritis or PID can des- troy the endometrium, cause intrauterine or In secondary amenorrhea cervical adhesions. HIV, tuberculosis, woman have a regular menstrual cycle (21–35 cancer, end-stage renal disease etc. A masculine distribution of body hair nal contraception? What type has (breast, abdomen, face, thighs) and/or severe she used? After stopping the combined oral acne indicate androgen excess and is a symptom contraceptive pill, a woman should regain her of polycystic ovary syndrome. The use of long-acting • Age of menopause in mother, older sisters. Age depot medroxyprogesterone can delay the re- at menopause is usually hereditary. Subfertility and amenor- INVESTIGATIONS rhea are closely linked: around 20% of women with subfertility have amenorrhea. Women Physical examination with subfertility are more likely to seek medical Always explain to the girl or woman what you are help (both in the formal and informal sector) going to do and ask a girl if she wants someone she and are prone to undergo curettage as ‘treat- trusts present at the examination. They are also more likely to have weight (kg)/length × length (m). BMI <18 is had more sexual partners and therefore are at underweight and BMI >30 is obese. Infection of the uterus can cause intra- abdomen and/or thighs. Pituitary necrosis due to severe postpartum • Breasts: leaking of milk spontaneously or after hemorrhage (syndrome of Sheehan) causes lack careful expression (see how to do that in of pituitary hormones like follicle-stimulating Chapter 1). Failure to breastfeed is usually the first • External genitalia: clitoris, hymen, hair growth. In a girl with primary amenorrhea look for a • Abdominal pain. In non-pregnant women leakage charge, cervical abnormalities, cervical excita- of milk from the breast can point to hyper- tion, uterine size, pelvic mass. Then follows a progestational challenge test with norethis- No Yes terone 10mg daily for 10 days. If the patient bleeds, the presence of a uterus with sufficiently prepared ConsƟtuƟonal delay endometrium by estrogens and a competent outflow puberty Pregnancy test negĂƟve tract is confirmed. If the patient does not bleed, the Chronic illness or malnutriƟon next step is to give the combined oral contraceptive pill for one cycle which will cause a withdrawal Norethisterone 10 mg OD 10 days bleeding when a uterus and a functional outflow tract are present. No withdrawal bleeding usually means there is a defect in the endometrium, uterus No withdrawal bleeding Withdrawal bleeding or outflow tract and further investigations should be directed towards assessing these. Combined oral contracepƟve pill CAUSES OF AMENORRHEA See Table 1. No bleeding Bleeding Disorders of the ovary Absence of uterus Ovarian failure Gonadal dysgenesis imperforate hymen PCOS Gonadal dysgenesis can occur with normal XX and XY karyotypes, but the best known condition is Figure 2 Diagnostic work-up of primary amenorrhea Turner syndrome (45,X), whereby oocyte loss is accelerated. A typical girl with Turner syndrome • Ultrasound examination (see Chapter 1) (abdo- has short stature, webbed neck, shield chest, cubi- minal with full bladder or vaginal): uterus present, tus valgus and prepubertal external genitals. Because size of uterus, endometrium, ovarian size and the ovaries contain no primordial follicles, she will presence of follicles, tubo-ovarian mass, cysts, free not ovulate and menstruate and is infertile. In a girl with primary amenorrhea specifi- primary amenorrhea.

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R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or cheapest nitrofurantoin,year O utcom e M easure R esults Z opiclone:31 cheap nitrofurantoin 50mg overnight delivery. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or nitrofurantoin 50mg low cost,year O utcom e M easure R esults sleeplatency time (min),day 14 Z olpidem:89. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults Dockh orn,1996 ability to concentrate (1=excellent;4=poor), Z olpidem:2. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults morningsleepiness (0=very sleepy;100=not Z olpidem:53. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults totalsleeptime (min),day 3-10 Z olpidem:422. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults quality oflife Z olpidem:N R ; Placebo:N R ; :; :; :; P-value=N S sleeplatency (min),4 weeks average Z olpidem:31. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults dreams (score),week 12 Z opiclone:3. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults patternofawakening(score),week 12 Z opiclone:2. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults Drewes,1998 N o. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults frequency ofawakenings (score),week 2 Z opiclone:3. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults sense ofbalance and coordination Z olpidem:49. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults PSG wake aftersleeponset(W A SO ),min R amelteon4mg:48. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults F ava,2006 Bech subscale meanch anged from clinician Esz opiclone:-4. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults H A M -D-17 meanch anged excluding Esz opiclone:-8. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults Sleeplatency (min),week 1 Esz opiclone:54. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults W A SO (min),week 1 Esz opiclone:30. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults Profession Z opiclone:23. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults quality ofwakingup Z opiclone:1. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults rebound insomnia:subjective sleeplatency Z aleplon5mg:11; Z aleplon10mg:12; Placebo:7; :; :; P-value= rebound insomnia:subjective totalsleeptime Z aleplon5mg:14; Z aleplon10mg:17; Placebo:6; :; :; P-value= rebound:subjective numberofawakenings, Z aleplon5mg:2; with drawalday 1 Z aleplon10mg:2; Placebo:2; :; :; P-value= rebound:subjective sleeplatency (min), Z aleplon5mg:45; with drawalday 1 Z aleplon10mg:50; Placebo:60; :; :; P-value= rebound:subjective totalsleeptime (min), Z aleplon5mg:330; with drawalday 1 Z aleplon10mg:300; Placebo:330; :; :; P-value= subjective numberofawakenings,week 1 Z aleplon5mg:2; Z aleplon10mg:2; Placebo:2; :; :; P-value= Insomnia 87 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 4. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults subjective numberofawakenings,week 2 Z aleplon5mg:2; Z aleplon10mg:1; Placebo:2; :; :; P-value= subjective sleeplatency (min),week 1 Z aleplon5mg:43; Z aleplon10mg:40; Placebo:60; :; :; P-value= subjective sleeplatency (min),week 2 Z aleplon5mg:40; Z aleplon10mg:37; Placebo:50; :; :; P-value= subjective sleepquality,improvementin Z aleplon5mg:48; sleepquality-week 1 Z aleplon10mg:55; Placebo:36; :; :; P-value= subjective sleepquality,improvementin Z aleplon5mg:53; sleepquality-week 2 Z aleplon10mg:63; Placebo:36; :; :; P-value= subjective sleepquality,week 1 (score). R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults subjective sleepquality,week 2 (score). R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults sleepefficiency (% ),day 21 treatment Z olpidem:86. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults time awake (min),day 21 treatment Z olpidem:34. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults H indmarch ,1995 activity,ch ange from baseline,day 14 Z olpidem:20; Placebo:9. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults profession,ch ange from baseline,endpoint Z olpidem:24. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults social,ch ange from baseline,endpoint Z olpidem:14. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults N umberofawakenings R amelteon:3. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults W A SO (mins) R amelteon:8. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults R ebound effectonnigh t-2--Increase inTST Z olpidem:44. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults daytime fatigue Esz opiclone:1. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults sleepdifficulties (nigh ts/wk) Esz opiclone:3. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults wake time aftersleeponset,estimate from Esz opiclone:18; figures (data notreported)atmonth 1,min Placebo:33; :; :; :; P-value<0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults sense ofph ysicalwell-being,month 6 Esz opiclone:6. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults numberofawakenings -post-treatment Z olpidem 10mg:1. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults sleepquality (1=excellent;4=poor)-post- Z olpidem 10mg:2. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults sleeponsetlatency (min) Z olpidem:11; Placebo:34; :; :; :; P-value=N S sleeponsetlatency/totalinbed (% ) Z olpidem:91; Placebo:84; :; :; :; P-value=<0. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults M eanch ange from baseline inL PS,mins Esz opiclone:-33. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults TSTmins,meanch ange from baseline Esz opiclone:48. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults totalsleeptime (score) Z olpidem 5mg:2. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults numberofawakenings,treatmentday 7 Z olpidem:1. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults sleepiness duringth e day,treatmentday 7 Z olpidem:2. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults sleeplatency (score),day 12 Z opiclone:8; Placebo:6. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults movementtime,nigh ts 29-30 Z olpidem:6. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults sleepefficiency (% ),nigh ts 29-30 Z olpidem:87. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults totalnumberofawakenings,nigh ts 29-30 Z olpidem:24. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults wake time aftersleeponset(min),nigh ts 29- Z olpidem:26. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults disturbed sleep-nigh t19-21 (1=agree; Z olpidem:62. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults sleepefficiency (% )-nigh t19-21, Z olpidem:69.

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