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Insomnia in Medical Technology

Intra-Cellular Therapies Announces Successful Outcome of a Phase II Clinical Trial with ITI-007 in Patients with Sleep Maintenance Insomnia

... results for ITI-007 from a Phase II trial in insomnia characterized by difficulty in maintaining sleep, also known as sleep maintenance insomnia (SMI). These data demonstrate that ITI-007 is ... ABOUT SLEEP MAINTENANCE DISORDERS From insomnia to sleep apnea, sleep disorders disrupt the sleep ...

Clinical Trial Results on the Sleep-Promoting Effects of Vanda Pharmaceuticals' Circadian Regulator Tasimelteon (VEC-162) Published in The Lancet

... agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled ... Circadian rhythm sleep disorders include insomnia associated with shift work (overnight, rotating ... agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomized controlled ...

Transcept Pharmaceuticals Submits New Drug Application for Intermezzo(R) for Treatment of Middle-of-the-Night Awakenings

... indicated for use as-needed for the treatment of insomnia when a middle of the night awakening is followed ... awakening is the most frequently reported insomnia symptom. This study estimates that 35% of ... developed for use as-needed for the treatment of insomnia when a middle of the night awakening is followed ...

Phase III Data Show Vanda Pharmaceuticals' Tasimelteon (VEC-162) Significantly Improves Sleep in Patients with Chronic Insomnia

... were eligible for the study if symptoms of insomnia were chronic and LPS was greater than 30 ... of tasimelteon to treat the symptoms of insomnia acutely and chronically both in a model of transient insomnia and in patients with chronic primary insomnia. ...

HealthMedia and Aetna to Study Online Insomnia and Depression Interventions

... which will provide HealthMedia's Overcoming(TM) insomnia and Overcoming(TM) Depression online ... conditions. "We recognize that depression and insomnia are both problems that are major drivers of ... hrs/week vs. 1.5 hrs/week) -- Those with severe insomnia miss work twice as often as good sleepers -- ...

Arena Pharmaceuticals Presented Positive Phase 2a Clinical Trial Results of APD125 for the Treatment of Insomnia at 22nd Annual Meeting of the Associated Professional Sleep Societies

... 2a clinical trial of APD125 for the treatment of insomnia in an oral presentation at the SLEEP 2008 22nd ... that is being evaluated for the treatment of insomnia in patients who have difficulty maintaining sleep ... receptor. The vast majority of approved drugs for insomnia work by activating the GABA-A receptor complex in ...

Intermezzo(R) 3.5 mg Achieves Greater Early Bioavailability Than Ambien(R) 10 mg Despite 65% Lower Dose

... is developing Intermezzo(R) for the treatment of insomnia characterized by middle-of-the-night ... "One significant challenge in trying to help insomnia patients return to sleep after a ... awakenings are the most frequently reported insomnia symptom in the general population, with 35 ...

Ambien CR(R) (zolpidem tartrate extended-release) CIV Tablets Improved Insomnia and Daily Functioning in Patients with Co-Morbid Major Depressive Disorder

... time over 8 weeks in patients with co-morbid insomnia and major depressive disorder (MDD) who were ... be considered a viable treatment option for the insomnia MDD patients experience and help them get the ... in an earlier study of Ambien CR in patients with insomnia and co-morbid general anxiety disorder (GAD). It ...

Transcept Pharmaceuticals Announces Intent to Submit New Drug Application for Intermezzo(R) in Third Quarter 2008

... buffered sublingual formulation designed to treat insomnia in patients who awaken in the middle-of-the-night ... sleep-lab study of Intermezzo(R) involving 82 insomnia patients. As announced in June 2007, the ... awakenings are the most frequently reported insomnia symptom in the general population, with 35 ...

Arena Pharmaceuticals Initiates Phase 2b Clinical Trial of APD125 for the Treatment of Insomnia

... discovered by Arena with the potential to reduce insomnia symptoms and improve sleep maintenance ... tolerability of APD125 in patients with primary insomnia characterized by difficulty maintaining sleep. ... sleep maintenance and quality for patients with insomnia without the potential for dependence or impairing ...

Intra-Cellular Therapies Initiates Phase 2 Clinical Trial for Sleep Maintenance Insomnia

... announced it has initiated a sleep maintenance insomnia (SMI) Phase 2 clinical study using its drug ... women, and in other disorders where insomnia is a problem, including ... Sleep Maintenance Disorders From nightmares to insomnia to sleep apnea, sleep disorders disrupt the sleep ...

New Data Show Improvements in Work Performance in Patients with Chronic Insomnia Treated with AMBIEN CR(R) (zolpidem tartrate extended-release) Tablets CIV

... Role of AMBIEN CR in Effectively Managing insomnia to Improve Quantity and Quality of ... patients taking placebo. Patients with chronic insomnia can have a higher frequency of work-related ... study included 728 patients with chronic primary insomnia (478 treated with AMBIEN CR and 250 treated with ...

Arena Pharmaceuticals Announces Positive Phase 2 Clinical Trial Results of APD125 for the Treatment of Insomnia

... discovered by Arena that is being evaluated in insomnia patients who have difficulty maintaining sleep ... of APD125 for the treatment of insomnia patients who have difficulty maintaining sleep. ... receptor. The vast majority of approved drugs for insomnia activate the GABA-A receptor in the brain, ...

New Study Presented at WorldSleep 2007 Demonstrates Ramelteon Has Sustained Efficacy Over Six Months in Adults With Chronic Insomnia

... of 451 patients age 18 or older with chronic insomnia were randomized in this clinical study. Patients ... effects, pharmacological tolerance, rebound insomnia or withdrawal symptoms. Poster 525 will be ... all other prescription medications indicated for insomnia are classified as Schedule IV controlled ...

New Studies on Once-Daily Extended Release Pramipexole Presented at American Academy of Neurology Annual Meeting

... nausea (28% vs. 18%), dizziness (25% vs. 24%), somnolence (22% vs. 9%), insomnia (17% vs. 12%), asthenia (14% vs. 12%), and constipation (14% vs. 6%). In ... vs. 48%), dyskinesia (47% vs. 31%), extrapyramidal syndrome (28% vs. 26%), insomnia (27% vs. 22%), dizziness (26% vs. 25%), accidental injury (17% vs. 15%), ...

Continued Overall Survival Advantage Reported From Pivotal Trial of VELCADE(R) (Bortezomib) for Injection Based Therapy in Patients With Previously Untreated Multiple Myeloma

... and dysesthesia and headache (each 22%), dyspnea (21%), cough and insomnia (each 20%), rash (18%), arthralgia (17%), neutropenia and dizziness ... vs 17%), anorexia (23% vs 10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edema peripheral (20% vs 10%), rash (19% vs 7%), back pain ...

New England Journal of Medicine Publishes Phase III Results of VELCADE(R) (Bortezomib) for Injection in Previously Untreated Multiple Myeloma Patients

... vs 17%), anorexia (23% vs 10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edema peripheral (20% vs 10%), rash (19% vs 7%), back pain ... and dysesthesia and headache (each 22%), dyspnea (21%), cough and insomnia (each 20%), rash (18%), arthralgia (17%), neutropenia and dizziness ...

Alexza Announces Positive Phase 1 Results With AZ-007 (Staccato(R) Zaleplon)

... tolerated in this population of healthy volunteers. About Insomnia insomnia is a prevalent disorder that drives a multi-billion dollar market of ... showed that 54% of the respondents experienced a minimum of one symptom of insomnia at least a few nights a week. Of those, respondents complained primarily ...

Intra-Cellular Therapies Announces the Discovery of Potent Antidepressant Activity in ITI-007

... activity in addition to its potential in treating sleep maintenance insomnia and psychosis in patients," stated Sharon Mates, Ph.D., Chairman and ... is being developed simultaneously for the treatment of sleep maintenance insomnia in the general population. Due to the unique separation of D2 and 5HT2A ...

Intra-Cellular Therapies Announces the Discovery of Potent Antidepressant Activity in ITI-007/ITI-722

... activity in addition to its potential in treating sleep maintenance insomnia and psychosis in patients," stated Sharon Mates, Ph.D., Chairman and ... is being developed simultaneously for the treatment of sleep maintenance insomnia in the general population. Due to the unique separation of D2 and 5HT2A ...

New Survey Suggests Cultural Ambivalence to Allergies Leaves Many Suffering Needlessly

... and outdoor allergies. Twenty-nine percent of consumers said they view insomnia as more serious than indoor and outdoor allergies. In addition, while the ... do not overstate allergy symptoms. In addition, most physicians view insomnia (83 percent) and osteoarthritis (69 percent) as being less serious or ...

Alexza Initiates AZ-007 (Staccato(R) Zaleplon) Phase 1 Clinical Trial and Updates Clinical Pipeline Development Status

... from 0.5 to 4.0 mg) will be compared to placebo. About Insomnia insomnia is a prevalent disorder that drives almost $5 billion in worldwide sales ... showed that 54% of the respondents experienced a minimum of one symptom of insomnia at least a few nights a week. Of those, respondents complained primarily ...

European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection

... reported central nervous system symptoms (including dizziness [28.1%], insomnia [16.3%], impaired concentration [8.3%], somnolence [7.0%], abnormal dreams ... fatigue (7%), headache (5%), rash (5%), sinusitis (4%), depression (4%), insomnia (4%), and abnormal dreams (4%). The dose of ATRIPLA is one tablet ...

Bristol-Myers Squibb and Gilead Sciences Expand Their Alliance to Include Commercialization of ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in Europe

... reported central nervous system symptoms (including dizziness [28.1%], insomnia [16.3%], impaired concentration [8.3%], somnolence [7.0%], abnormal dreams ... fatigue (7%), headache (5%), rash (5%), sinusitis (4%), depression (4%), insomnia (4%), and abnormal dreams (4%). The dose of ATRIPLA is one tablet ...

Biological Psychiatry Publishes Study Showing VYVANSE Demonstrated Significant Efficacy for Treatment of ADHD for up to 12 Hours After Administration

... in severity. The most frequently reported adverse events for VYVANSE were insomnia (8 percent), decreased appetite (6 percent), anorexia (4 percent) and ... were decreased appetite (4 percent), upper abdominal pain (4 percent), insomnia (2 percent), upper respiratory tract infection (2 percent) and vomiting (2 ...

European CHMP Issues Positive Opinion for ATRIPLA(R) (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)

... reported central nervous system symptoms (including dizziness [28.1%], insomnia [16.3%], impaired concentration [8.3%], somnolence [7.0%], abnormal dreams ... fatigue (7%), headache (5%), rash (5%), sinusitis (4%), depression (4%), insomnia (4%), and abnormal dreams (4%). The dose of ATRIPLA is one tablet ...

Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV

... reported central nervous system symptoms (including dizziness [28.1%], insomnia [16.3%], impaired concentration [8.3%], somnolence [7.0%], abnormal dreams ... fatigue (7%), headache (5%), rash (5%), sinusitis (4%), depression (4%), insomnia (4%), and abnormal dreams (4%). The dose of ATRIPLA is one tablet ...

Study Demonstrating Lurasidone Is Effective in Patients With Schizophrenia Published in The Journal of Clinical Psychiatry

... vs. 3%), headache (11.1% vs. 10%), constipation (11.1% vs. 5.6%), vomiting (11.1% vs. 5.6%), dyspepsia (11.1% vs. 3.3%), somnolence (11.1% vs. 3.3%), insomnia (10.0% vs. 3.3%) and sedation (10.0% vs. 4.4%). Lurasidone had a lower overall discontinuation rate (42.2%) compared to placebo (48.8%) with few ...

Addrenex Pharmaceuticals Expands Product Pipeline by Licensing New Drug to Treat Narcolepsy

... (ADHD) and Sympres(R) for the treatment of hypertension. The company also plans to develop drugs to treat menopausal flushing and potentially pain, insomnia and migraines, all of which are impacted by the adrenergic system. "ADX-N05 represents a significant advance toward expanding our product ...

Ground-Breaking Combination of All-Oral Agents Demonstrates Potential as Hepatitis C Treatment Regimen

... were fatigue/asthenia (65 percent), headache (43 percent), pyrexia (41 percent), myalgia (40 percent), irritability/anxiety/nervousness (33 percent), insomnia (30 percent), alopecia (28 percent), neutropenia (27 percent), nausea/vomiting (25 percent), rigors (25 percent), anorexia (24 percent), injection ...

Roche and Pharmasset Initiate Phase IIb Clinical Trial of R7128, Most Advanced Nucleoside Polymerase Inhibitor in Development for Chronic Hepatitis C

... were fatigue/asthenia (65 percent), headache (43 percent), pyrexia (41 percent), myalgia (40 percent), irritability/anxiety/nervousness (33 percent), insomnia (30 percent), alopecia (28 percent), neutropenia (27 percent), nausea/vomiting (25 percent), rigors (25 percent), anorexia (24 percent), injection ...

Video: Zometa(R) Reduces Risk of Breast Cancer Recurrence in Premenopausal Women, Study in The New England Journal of Medicine Reports

... cough (22%), arthralgia (21%), lower-limb edema (21%), malignant neoplasm aggravated (20%), headache (19%), dizziness (excluding vertigo) (18%), insomnia (16%), decreased weight (16%), back pain (15%) and paresthesia (15%). Caution is advised when bisphosphonates are administered with ...

Nplate(R) Approved in the European Union for the Treatment of Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

... injection site pain, peripheral oedema, dizziness, muscle spasms, nausea, contusion, diarrhoea, bone marrow disorder, influenza like illness, insomnia and pruritus. Reoccurrence of thrombocytopenia and bleeding after cessation of treatment and increased bone marrow reticulin have been ...

Three Studies Presented at the American Society of Hematology Annual Meeting Showed Response to Treatment with Campath(R) in Patients with High-Risk CLL

... of infusion reactions was highest in the first week of treatment. Other commonly reported adverse reactions include vomiting, abdominal pain, insomnia and anxiety. The most commonly reported serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections. See "Warnings ...

Prolonged Progression-Free Survival Demonstrated by VELCADE(R) (Bortezomib) for Injection Based Induction Regimens in Transplant-Eligible Previously Untreated Multiple Myeloma Patients

... (33% vs 16%), pyrexia (29% vs 19%), fatigue (29% vs 26%), lymphopenia (24% vs 17%), anorexia (23% vs 10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edema peripheral (20% vs 10%), rash (19% vs 7%), back pain (17% vs 18%), pneumonia (16% vs 11%), dizziness (16% vs 11%), dyspnea (15% ...

Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients

... or equal to 5 percent higher patient incidence in Nplate versus placebo) were Arthralgia (26 percent, 20 percent), Dizziness (17 percent, 0 percent), insomnia (16 percent, 7 percent), Myalgia (14 percent, 2 percent), Pain in Extremity (13 percent, 5 percent) , Abdominal Pain (11 percent, 0 percent), ...

Novel VELCADE(R) (Bortezomib) for Injection Based Four-Drug Combination Was Well Tolerated In Previously Untreated Multiple Myeloma Patients

... (33% vs 16%), pyrexia (29% vs 19%), fatigue (29% vs 26%), lymphopenia (24% vs 17%), anorexia (23% vs 10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edema peripheral (20% vs 10%), rash (19% vs 7%), back pain (17% vs 18%), pneumonia (16% vs 11%), dizziness (16% vs 11%), dyspnea (15% ...

Bayer Announces Upcoming Presentations of Campath(R) and Leukine(R) Data at the 50th Annual Meeting of the American Society of Hematology

... of infusion reactions was highest in the first week of treatment. Other commonly reported adverse reactions include vomiting, abdominal pain, insomnia and anxiety. The most commonly reported serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections. See "Warnings ...

More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies

... cough (22%), arthralgia (21%), lower-limb edema (21%), malignant neoplasm aggravated (20%), headache (19%), dizziness (excluding vertigo) (18%), insomnia (16%), decreased weight (16%), back pain (15%) and paresthesia (15%). Caution is advised when bisphosphonates are administered with ...

Arthritis Advisory Committee Recommends FDA Approval of Febuxostat for the Treatment of Hyperuricemia in Patients With Gout

... of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for ...
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