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Insomnia is too little or poor-quality sleep caused by one or more of the following:

Trouble falling asleep
Waking up a lot during the night with trouble returning to sleep
Waking up too early in the morning
Having un-refreshing sleep (not feeling well rested), even after sleeping 7 to 8 hours at night

Insomnia can cause problems during the day, such as excessive sleepiness, fatigue, trouble thinking clearly or staying focused, or feeling depressed or irritable. It is not defined by the number of hours you sleep every night. Although the amount of sleep a person needs varies, most people need between 7 and 8 hours of sleep a night.

FDA approves sNDA for pediatric autism drug ABILIFY

20. November 2009 23:40
Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ABILIFY® (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. [More]

Millennium commences Phase I clinical trial for its second-generation proteasome inhibitor

18. November 2009 10:31
Millennium: The Takeda Oncology Company today announced it has further expanded its protein homeostasis program with the initiation of a Phase I clinical trial for an oral formulation of MLN9708, the Company’s second-generation proteasome inhibitor. An intravenous formulation of MLN9708 entered clinical trials in March. [More]

Shire publishes new study results on INTUNIV Extended-Release Tablets

17. November 2009 04:21
Shire plc, the global specialty biopharmaceutical company, announced new study results on INTUNIV- (guanfacine) Extended-Release Tablets published in the October Journal of Child and Adolescent Psychopharmacology. In this open-label safety study, there was no evidence of unique adverse effects with the combination of INTUNIV and amphetamine or methylphenidate relative to what was observed with either medication alone. [More]

Assessing the neurology market and its major players

17. November 2009 04:13
Research and Markets (http://www.researchandmarkets.com/research/63cb3f/dealmaking_and_ind) has announced the addition of Decision Resources, Inc.'s new report "Dealmaking and Industry Outlook: Neurological Disease" to their offering. [More]

Results of Phase III clinical trials of flibanserin for treatment of HSDD in pre-menopausal women released

16. November 2009 23:15
Data from pivotal Phase III clinical trials demonstrate that flibanserin 100mg increased the number of satisfying sexual events (SSE) and sexual desire (the co-primary endpoints) while decreasing the distress associated with Hypoactive Sexual Desire Disorder (HSDD). [More]

Posted in: Drug Trial News | Women's Health News

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ECR Pharmaceuticals to commercialize and manufacture ZolpiMist in the U.S. and Canada

16. November 2009 11:25
NovaDel Pharma Inc. today announced its entry into an exclusive license and distribution agreement with ECR Pharmaceuticals Company, Inc., a wholly owned subsidiary of Hi-Tech Pharmacal Co., Inc. to commercialize and manufacture ZolpiMist™ in the United States and Canada. ZolpiMist™ is our oral spray formulation of zolpidem tartrate approved by the FDA in December of 2008. [More]

Posted in: Pharmaceutical News

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Alkermes' phase 3 trial of naltrexone XR-NTX meets primary endpoint

16. November 2009 08:49
Alkermes, Inc. today announced positive preliminary results from a phase 3 clinical trial of naltrexone for extended-release injectable suspension (XR-NTX) for the treatment of opioid dependence. The six-month phase 3 study met its primary efficacy endpoint and data showed that patients treated once-monthly with XR-NTX demonstrated statistically significant higher rates of clean (opioid-free) urine screens, compared to patients treated with placebo, as measured by the cumulative distribution of clean urine screens (p<0.0002). [More]

Findings from post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse announced

16. November 2009 05:57
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse-. In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS IV) and Connors' Parent Rating Scale-Revised Short (CPRS-RS) in children with ADHD aged 6 to 12 years. [More]

Shire announces findings from Phase 3 study data with Vyvanse

13. November 2009 04:41
Shire plc, the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse®. In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS IV) and Connors' Parent Rating Scale-Revised Short (CPRS-RS) in children with ADHD aged 6 to 12 years. [More]

Transcept Pharmaceuticals reports financial results for the third quarter of 2009

13. November 2009 00:48
Transcept Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in neuroscience, today announced financial results for the three and nine months ended September 30, 2009. [More]

Posted in: Business / Finance

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Mental Health America and Prescription Audio team up to provide free sound therapy

12. November 2009 03:50
Mental Health America today announced it is partnering with Prescription Audio, a Philadelphia-area based firm (Voorhees, N.J.), to make the company's scientifically based sound therapy available without charge as a download to veterans, active duty servicemen and women, their family members and health care providers. [More]

Posted in: Healthcare News

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Potential benefits of Labopharm's novel trazodone formulation published

11. November 2009 04:19
Labopharm Inc. today announced an article has been published in the international journal of neuropsychiatric medicine, CNS Spectrums October, 2009 issue, citing the potential benefit of its novel trazodone formulation, which contains Contramid(R). Labopharm's Contramid is the clinically validated proprietary technology that controls the release of active substances from oral medications to optimize drug delivery. [More]

New market research report on insomnia drugs

11. November 2009 03:03
Reportlinker.com announces that a new market research report is available in its catalogue: Central Nervous System Insomnia or Sleep Disorders [More]

Posted in: Medical Condition News | Pharmaceutical News

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Computerized alerts induce clinicians to prescribe comparable generic equivalents

10. November 2009 02:48
Simple computerized alerts can help curb the impulse to prescribe unnecessarily expensive, heavily marketed drugs. A study in the August issue of Journal of General Internal Medicine found that when clinicians received computerized alerts, which compared medication brands, they changed 23.3 percent of prescriptions for four heavily marketed sleep medications to comparable generic equivalents. [More]

Posted in: Device / Technology News | Healthcare News

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USPTO issues Notice of Allowance to NovaDel Pharma

6. November 2009 01:01
NovaDel Pharma Inc., today announced that it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for claims under U.S. Patent Application No. 10/671,715, entitled “Buccal, Polar and Non-polar Spray Containing Zolpidem,” which covers a method of treating insomnia by administering zolpidem to humans utilizing NovaMist™ Oral Spray spray technology. [More]
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