A. Musan. Texas A&M University, Commerce.

Baseline lowerlimbs) A ny adverse event: N otreported ch aracteristics not F atigue: 2/42 reported cialis 20 mg lowest price erectile dysfunction doctors in st. louis. H igh loss to W eakness/h ypotonia: 2/42 follow-upormissingdata N ausea: 1/42 (17/44) buy cialis 5mg without prescription erectile dysfunction causes in early 20s. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics Brar R andomiz ed A : Baclofentitrated Patients age 24- 38 M eanage notreported 74 crossovertrial from 5 mg/day upto 54 with clinically 70% female 1991 20 mg/day definite,mild- 30 R ace notreported U nited States moderate M S B: Placebo M ultiple Sclerosis Single center 5. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events Brar M uscle tone (A sh worth Scale) F A IR. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics Denh off R andomiz ed A : Dantrolene 1 N otreported 18 A ge range 18 month s to 12 years 88 crossovertrial mg/kgqid titrated to F emale gender43% 1975 maxof3 mg/kgqid 18 U nited States Diagnoses B: Placebo Spasticquadriplegia: 15/28(54% ) Single C enter Spastich emiplegia: 7/28(25% ) 6 week intervention,2 Spasticdiplegia: 4/28(14% ) weeks wash out,6 M ixed spasticity/ath etosis: 1/28(4% ) weeks crossover M ixed spasticity/rigidity: 1/28(4% ) Degrees ofseverity M ild: 14/28(50% ) M oderate: 5/28(18% ) Severe: 9/28(32% ) Duncan R andomiz ed A : Baclofen5 mg/TID Durationof 25 A verage age: M ultiple sclerosis group=36. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events Denh off *M easurementscales notspecified F A IR. R andomiz ation, R esistance to passive movement: A =11/20(55% ) W ith drawals (due to adverse 89 scale atth e pretreatmentvisit(A =normal; allocationconcealment, vs. B=2(11% ), F requentadverse events severe ateach visit Blindingmeth od p<0. Impressionofcurrenttreatment: Improvement Vomiting: A =1,B=0 interventionph ase reported as A =14/22(64% )vs. B=2/22(9% ),p- Diz z iness: A =1,B=1 Investigatorth erapy preference: rated before value notreported butdescribed as "significant" L egedema:A =1,B=0 code broken Investigatorth erapy preference: Improvement Posturalh ypotension: A =1,B=0 reported as A =14/22(64% )vs. B=0/22(0% ),p- value notreported butdescribed as "significant" Skeletal Muscle Relaxants Page 132 of 237 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 4. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics F eldman R andomiz ed A :Baclofen15-80 A dult 33 M eanage 43 76 crossovertrial mg/day Establish ed G endernotreported 1978 diagnosis ofM S 23 R ace notreported U nited States B:Placebo Spontaneous flexor Establish ed diagnosis ofM ultiple Sclerosis Single center 1 week wash out,4 contractions/spast M eanspasticity severity notreported. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events F eldman Daily spasm frequency:meth od unspecified F A IR. W ith drawals: N one reported on 1978 R esistance to passive movement: a (normal concealmenttech niques 2/18 (11% ) treatment resistance)to f(immobile) notreported. F requentadverse events (n=23) A mbulation/transferactivity:M eth od 0/12 (0% ) Drowsiness: 4 vs. M uscularstrength :no significantdifferences steady) C lonus: no significantdifferences H eadach e:2/24 vs. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics G elenberg C rossover(notclearif A :Dantrolene 50-800 Patients with 20 M eanage=49 90 randomiz ed) mg(meandose not moderate-severe 55% M ale 1973 reported) spasticity 20 R ace unreported U. M ultiple Sclerosis Single center M oderate-Severe Spasticity (M eanunreported) 5 weeks intervention, 1 to 3 weeks wash out, Previous muscle relaxantuse notreported 5 weeks crossover H aslam R andomiz ed A : Dantrolene C h ildrenwith 26 M eanage (years):6. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events G elenberg Spasticity,strength ,clonus and tendonreflexes PO O R. F requentadverse events: minimal Tone:0=normalto 4=marked increase Passive range ofmotion,spontaneous range of leth argy th atresolved with firsttwo R eflexes:0=normalto 4=very brisk motion,muscle spasticity: N o differences days Scissoring:0=absentto 4=paraplegia-in-flexion betweentreatments M otorfunctions: stepclimbing,sittingposition time,h and-knee position,roll-overtime as measured by ph ysicalth erapists;meth ods unspecified Self-h elpskills: reach for/transferobjects, pegboard test,wh eelch airoperationas measured by ph ysicalth erapists;meth ods unspecified Daily activities: bath ing,bracing,dressing, wh eelch airtransferas measured by nursing staff;meth ods unspecified A ssessed ondays 4,8,11 and 15 ofeach treatmentperiod Skeletal Muscle Relaxants Page 136 of 237 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 4. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics H inderer R andomiz ed A : Baclofen,40-80 Patients with 5 A ge range of20-42 77 mg/day spasticity 100% male 1990 U nited States 5 R ace notreported B: Placebo Single C enter Spinalcord lesions ofunspecified traumaticetiologies 2. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events H inderer Spasticity:unspecified meth od PO O R. R andomiz ation, Spasticity: 0 subjects demonstrated th erapeutic N otreported 91 A nxiety: Beck Inventory Scale blindingtech niques not reductionofspasticity measurements wh ile taking 1990 described,intention-to- baclofen A ssessed twice perweek treatanalysis not A nxiety: 1/5 h ad significantly reduced Beck performed. H udgson Spasticity: 5 pointA sh worth scale F A IR. W ith drawals (adverse events):1/25 1971 and 53 tech niques not 0. A llocation Study stopped due to excess with drawals,no data W ith drawals (adverse events):5/9 92 Spasticity concealment,eligibility to assess efficacy. A ssessments completed initially and atweekly intervals th ereafter Skeletal Muscle Relaxants Page 138 of 237 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 4. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity Interventions A uth or Type ofStudy, Dose Enrolled Y ear Setting Duration Eligibility C riteria A nalyz ed PopulationC h aracteristics Jones R andomiz ed A : Baclofen15 H ospitaliz ed 6 A ge range (years): 17-41 170 crossovertrial mg/day titrated to 60 patients with F emale gender:2/6 1970 mg/day quadripareticor 6 R ace: notreported A ustralia quadriplegic B: Placebo spinalcord injury Durationofillness: 5/6 less th an12 month s Single center Priormuscle relaxantuse: A llpreviously ondiaz epam 15-30 14 days intervention mg/day followed by 14 days crossover Joynt R andomiz ed A : Dantrolene 4 C h ildrenwith 21 C h ildren,meanages notreported 92 mg/kg/day titrated to cerebralpalsy and G ender: notreported 1980 U nited States maximum of12 spasticity 20 R ace: notreported mg/kg/day interferingwith Single center function Diagnosticetiologies B: Placebo Diplegia: 7/20(35% ) Q uadriplegia: 7/20(35% ) 6 weeks H emiplegia: 5/20(25% ) Paraplegia: 1/20(5% ) Previous muscle relaxantuse: notreported Skeletal Muscle Relaxants Page 139 of 237 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 4. Placebo-controlled trials ofskeletalm uscle relaxants inpatients with spasticity A uth or M eth od ofO utcom e A ssessm entand O verallR ating and Y ear Tim ing ofA ssessm ent com m ents O utcom es A dverse Events Jones Spasticity: 0 (normal)to 4 (rigid) F A IR. R eflexes: N o differences F atigue: N otclear R eflexes: 1 (normal)to 4 (markedly increased) Diz z iness: N one reported N umberofspasms Dry mouth : N one reported W eakness: N one reported A ssessed daily A ny adverse event: N otclear W ith drawals: N one reported Joynt F amily observations: muscle spasm,range of F A IR.

It should be realized that the summary effects from such analyses do not have the same scientific Heparin cheap 10 mg cialis free shipping impotence in men over 60, with or without aspirin buy generic cialis 10mg on-line erectile dysfunction vacuum pump, to prevent pregnancy loss strength as a randomized controlled trial of sufficient size. The efficacy of antithrombotic agents in women with unexplained (eg, in the absence of abnormal parental karyotype, uterine anoma- lies, or APS) recurrent pregnancy loss was compared with no Summary of randomized controlled trials and 26,27 treatment or placebo in 2 relatively large randomized trials. In meta-analyses the SPIN study, 294 women with 2 or more unexplained pregnancy Aspirin to prevent pregnancy loss losses were randomized to enoxaparin 40 mg combined with aspirin In women with APS, almost no data are available to support the use 75 mg plus standard surveillance or standard surveillance only. The pooled results effect of the medical intervention was observed (odds ratio for of 3 very small trials (total number of 71 participants) showed no successful pregnancy 0. In the ALIFE effect of aspirin only compared with no treatment [risk ratio (RR) of study, we randomized 364 women with 2 or more unexplained pregnancy loss 1. Of these starting aspirin before conception may be associated with a better women, 299 became pregnant. The chance of live birth did not pregnancy outcome than starting it once pregnancy is established. Based on the available evidence that also included trials comparing 2 active treatments,28 Aspirin to prevent preeclampsia various guidelines recommend against the use of antithrombotic A meta-analysis of individual patient data from 31 randomized agents in women with unexplained recurrent pregnancy loss. How I treat women with aspirin or LMWH to prevent pregnancy complications My approach in most patients My alternatives (not exhaustive) Recurrent pregnancy loss (2 or more), No LMWH, no aspirin unexplained Recurrent pregnancy loss (3 or more) and Aspirin 80 mg preconceptionally Start aspirin as soon as a pregnancy test is APS positive (Low-dose) LMWH as soon as a pregnancy In case of a history of venous or arterial test is positive thromboembolism and long term use of anticoagulant therapy; therapeutic dose LMWH and no aspirin In case of a history of a single episode of venous thromboembolism, antepartum and postpartum LMWH according to current guidelines and no aspirin24 Recurrent pregnancy loss (2 or more) and Enroll in ALIFE2 trial after informed In case of a history of venous or arterial inherited thrombophilia consent, and randomize to either LMWH thromboembolism and long term use of or no LMWH anticoagulant therapy; therapeutic dose LMWH and no aspirin If no informed consent for trial participation, In case of a history of a single episode of venous no LMWH thromboembolism, antepartum and No aspirin postpartum LMWH according to current guidelines24 History of severe preeclampsia, unexplained Counsel about the modest risk reduction of aspirin and prescribe on an individual basis No LMWH History of severe preeclampsia, a single late Aspirin 80 mg as soon as a pregnancy test Start aspirin in the second trimester pregnancy loss, placental abruption, or is positive severe intra-uterine growth restriction and (Low dose) LMWH as soon as a pregnancy In case of a history of venous or arterial APS test is positive thromboembolism and long term use of anticoagulant therapy; therapeutic dose LMWH added to aspirin In case of a history of a single episode of venous thromboembolism, antepartum and postpartum LMWH according to current guidelines added to aspirin24 History of severe preeclampsia and Counsel about the modest risk reduction of In case of a history of venous or arterial inherited thrombophilia aspirin and prescribe on an individual thromboembolism and long term use of basis anticoagulant therapy; therapeutic dose LMWH and no aspirin No LMWH In case of a history of a single episode of venous thromboembolism, antepartum and postpartum LMWH according to current guidelines24 History of a single late pregnancy loss, No LMWH In case of a history of venous or arterial placental abruption or severe intra-uterine thromboembolism and long term use of growth restriction and inherited anticoagulant therapy; therapeutic dose thrombophilia LMWH and no aspirin In case of a history of a single episode of venous thromboembolism, antepartum and postpartum LMWH according to current guidelines24 Forjustification,pleaseseefulltext. In a few small studies, the use of LMWH and with aspirin only (n 109; RR 0. Comparing any heparin (unfractionated observed a profound effect of unfractionated heparin added to heparin or LMWH) combined with aspirin (n 199) with aspirin aspirin; this is markedly lower than in the comparator arms of only (n 199), the beneficial effect of heparin of reducing the risk studies comparing LMWH and aspirin with aspirin only or aspirin 396 American Society of Hematology with placebo, in which the chances of a live birth varied between study, a nonsignificant increase in live birth was observed in the 2 68% and 80%. This indicates clinical heterogeneity between the active treatment arms for women with inherited thrombophilia (RR trials. We are currently performing the observed (RR for live birth for women treated with bemiparin ALIFE2 study (NTR 3361; www. The ACCP guidelines recommend unfractionated hepa- pregnancy surveillance only. The Royal College of without aspirin compared with no treatment in women with a history Obstetricians and Gynaecologists guidelines state that pregnant of various pregnancy complications, including preeclampsia, small- women with APS should be considered for treatment with aspirin for-gestational age babies, and placental abruption, to reduce the combined with heparin to prevent further miscarriage, without 29 risk of recurrence in subsequent pregnancies. These 6 studies were specifying clinical criteria of APS in the recommendation. The primary outcome was a composite of preeclampsia, birth of a small-for-gestational- Therefore, although evidence for a beneficial effect of heparin th age newborn ( 10 percentile), placental abruption, or pregnancy combined with aspirin in women with APS and 3 or more loss later than 20 weeks. The effect of antithrombotic agents in mediated pregnancy complications, compared with 127 of 296 different subgroups of women with APS based on laboratory or (42. Nevertheless, based on the currently available evidence thrombophilia. Although the pooled risk reduction is statistically of studies with small numbers of participants, clinicians worldwide significant, the results are strikingly positive in some studies, with have adopted the practice of prescribing aspirin with or without 36-39 relative risk reductions up to 85%, whereas in the 2 most heparin to all women with APS. This is reflected by the statistical heterogeneity that no sufficiently sized trials have been performed that show an effect 2 17 was also observed in the meta-analysis (I 69%). In all studies of heparin on the prognosis of a subsequent pregnancy. The combined, 25% of women had thrombophilia and only the FRUIT Habenox trial randomized women with at least 3 consecutive first 40 study was dedicated to thrombophilic women only. In this trial, trimester miscarriages to enoxaparin 40 mg and placebo once daily women with inherited thrombophilia and a history of preeclampsia (n 68), enoxaparin 40 mg and aspirin 100 mg (n 63), or aspirin th 33 or intrauterine growth restriction, 10 percentile requiring deliv- 100 mg (n 76); there was no control group without intervention. The primary outcomes were recurrence of a hyperten- 0. Almost a quarter of the included women gestation or recurrence at any gestational age. The overall primary had either hereditary thrombophilia or anticardiolipin antibodies outcome did not differ between the 2 groups; hypertensive disorders 40 GPL or beta 2 glycoprotein I antibodies, and no differential occurred in 18. None of the women in after 10 weeks gestation and heterozygous factor V Leiden muta- the LMWH aspirin group developed recurrent hypertensive disor- tion, prothrombin G20210A mutation, or protein S deficiency; they ders before 34 weeks gestational age, whereas 6 (8. Women treated with enoxaparin had a much development of recurrent hypertensive disorders, with 3 women higher chance of a live birth than those allocated to aspirin (86% and delivering at 19-22 weeks (risk difference 8. The recently finished TIPPS study, which included 95% CI 7–34).

Others just die generic cialis 10mg with visa impotence from prostate removal, isolated by severe pain with terrible Note: palliative care teams in some richer coun- smells from their fungating lesions buy cialis 20 mg free shipping impotence natural food. The breast is a tries prefer to give medications through subcutane- life-giving organ, and a debilitating breast disease is ous routes (SC) via the syringe driver when oral often considered the worst fate for a woman. In some countries this is not fear of mastectomy and of losing her attraction to a acceptable in the home where most wish to be at man is a factor delaying reporting to a health facil- the end of life. Many attend a traditional healer for a long time, the cultural aspects of caring. Remember once SC suffering with applied poultices and incisions of the is in place the patient needs to be visited more fre- tumor before seeking care from biomedicine. When ascites is one of the leading symptoms you can aspirate ascites under ultrasound guidance, if available: look with a transabdominal ultrasound probe for a place in the abdomen where no bowels are near the abdominal wall. Disinfect the abdomen, insert an IV cannula in the abdominal cavity and remove the needle once you aspirate the ascites, leaving the cannula inside. Connect the cannula via an IV giving set to a basin and allow approximately 2 liters to drain in this basin. The advantage for the patient is immediate Figure 10 Mary was found lying in her bed in the relief of the symptoms associated to distention. Dis- village; she had never attended a health worker and was in advantages are that she will lose a lot of protein via severe physical and psychological pain 413 GYNECOLOGY FOR LESS-RESOURCED LOCATIONS Table 1 Main problems associated with breast cancer Symptom Cause Management Pain: in breast Primary cancer Step 1 analgesics in wound Pain in other sites: Metastasis Paracetamol, NSAIDS and/or morphine, NSAIDS or low-dose steroids, bone, liver, brain high-dose steroids to relieve pressure plus morphine Bleeding wound Vascular invasion Radiotherapy Smelly wound Anaerobic organisms Apply crushed metronidazole tablets to site after cleansing b. Counseling Spiritual pain Beliefs and guilt Listening and supporting with family or with requested spiritual guide NSAIDS, non-steroidal anti-inflammatory drugs. HIV/AIDS Those who are feeling good and receiving ARVs are supported by ‘support organizations’. However, The scourge of sexually transmitted HIV has brought palliative care requires skills and knowledge of the much suffering to many resource-poor settings management of the opportunistic infection and where the majority of sufferers are found. Many in particular, have suffered, not only from the physi- patients will come from the ARV clinics with side- cal pain and symptoms but from misunderstandings, effects of ARVs. The palliative care team will rejection and stigmatization, as well as seeing chil- mainly be dealing with the very ill patients in clini- dren die before them infected by the same virus via cal stage IV of HIV. For the general background on mother-to-child-transmission. In this chapter have special gynecological problems and needs. See we will highlight a few palliative care issues of Chapter 18 for a more detailed description of this HIV/AIDS. HIV has doubled the incidence of cancers in Africa and women are more affected by Kaposi’s Immune reconstitution syndrome sarcoma and cancer of the cervix. However, HIV is not the same disease as it was Immune reconstitution inflammatory syndrome 20 years ago when it was visible at any gathering (IRIS) is a condition of increasing importance and with many having the dreaded ‘slim’ disease. The seen with increasing frequency as more patients advent of affordable antiretroviral therapies (ARVs), access highly active antiretroviral therapy (HAART). Many now die of something else if they can pression of the virus and recovery of the immune access treatment. In patients with underlying opportunistic 60% of those in need of ARVs access continuous infections such as tuberculosis, cryptococcal menin- treatment in African countries. The other 40% are gitis or toxoplasmosis, the immune system suddenly mainly living in rural areas with poor access to recovers enough to start fighting these underlying, modern medicine. These still die of opportunistic previously hidden infections and mounts an im- infections with severe suffering and stigmatization. This response can be Most of them will not reach care unless there are quite violent and occurs classically within 3–8 community volunteer workers in each village, spe- weeks (but may be delayed for months) of a patient cially trained to be vigilant, who report those suf- starting ART. Patients become acutely unwell, pre- fering to the palliative care team. This has worked senting with severe symptoms of infections, e.

There were very few significant differences between the drugs on any outcomes order 2.5mg cialis fast delivery erectile dysfunction treatment dallas texas. The exceptions were significantly shorter sleep latency and longer sleep duration with eszopiclone compared to ramelteon 5mg cialis fast delivery erectile dysfunction pills made in china. On average, sleep latency was 11 minutes shorter with eszopiclone than ramelteon (95% CI -21 to -1. Sleep duration was an average of 37 minutes longer with eszopiclone than ramelteon (95% CI 17 to 56 minutes). Patients taking eszopiclone had significantly fewer awakenings than those taking zolpidem, but the difference was less than one time per night (mean difference 0. Insomnia Page 25 of 86 Final Report Update 2 Drug Effectiveness Review Project Table 6. Adjusted indirect meta-analysis: Summary of results Mean difference (95% confidence interval) Sleep latency Sleep duration Number of WASO in minutes in minutes awakenings in minutes Eszopiclone a -11. We performed several subgroup analyses to determine if meta-analysis results varied by population or study design characteristics. When studies conducted in adult and elderly patients were analyzed separately, adjusted indirect analysis showed no significant differences between any of the drugs in subjective sleep latency or WASO (Table 7). In elderly patients, sleep duration was significantly longer with eszopiclone than with ramelteon and zolpidem in elderly patients, but there was no difference between any of the drugs in adult patients under age 65. Insomnia Page 26 of 86 Final Report Update 2 Drug Effectiveness Review Project Table 7. Subgroup analysis by elderly and non-elderly adult patients Mean difference (95% confidence interval) Sleep latency Sleep duration Number of WASO in minutes in minutes awakenings in minutes Eszopiclone compared Adults -14. We also performed a subgroup analysis excluding studies that used doses other than the manufacturers’ recommended initial dose. Recommended initial doses are eszopiclone 2 mg, ramelteon 8 mg, zaleplon 10 mg, zolpidem 10 mg, and zopiclone 7. In fair-quality studies, eszopiclone significantly increased sleep duration compared with zolpidem (mean difference 37. PSG-measured outcomes in trials of ramelteon 77, PSG-measured sleep outcomes were reported in three placebo-controlled trials of ramelteon. The primary outcome, sleep latency at week 1 was reduced for both the 8 mg (32 minutes) and 16 mg (29 minutes) groups compared to placebo (48 minutes, P<0. Total sleep time was improved with ramelteon compared with placebo at weeks 1 and 3 but not week 5. There were no differences in WASO or number of awakenings. In a crossover study of 2 nights of treatment with ramelteon 4 mg, 8 mg, 16 mg, or 32 mg, all doses of ramelteon resulted in reductions in PSG-measured sleep latency (P<0. There were no differences in WASO for any of the treated groups compared to placebo. In a 2-night crossover study conducted in patients over age 65, there were significant improvements in PSG-measured sleep latency with ramelteon 4 mg (28. PSG-measured total sleep time was also improved with ramelteon (359 minutes for 4 mg and 362 minutes for 8 mg compared with 350 minutes for placebo; P=0. There was no difference in objective WASO with either dose of ramelteon compared to placebo, and there was an increase in number of awakenings with ramelteon 4 mg (but not with the 8 mg dose). Zolpidem extended-release There are no head-to-head trials comparing zolpidem extended-release with other newer drugs for insomnia. Evidence for the efficacy of zolpidem extended-release comes from three fair- 89, 115, 121 quality placebo-controlled trials. Additional information is provided in the FDA 79 statistical review of zolpidem extended-release Table 8 summarizes the results of these trials. Because they did not report means for subjective sleep outcomes at endpoint, we were not able to include their data in our meta-analysis. Insomnia Page 28 of 86 Final Report Update 2 Drug Effectiveness Review Project Table 8.