Navigation Links
FDA Approves First Insomnia Drug for Middle-of-the-Night Waking Followed By Difficulty Returning to Sleep
Date:11/23/2011

clinical trials involving more than 370 patients. In the studies, patients taking the drug had a shorter time to fall back asleep after waking compared to people taking an inactive pill (placebo). The most commonly reported adverse reactions in the clinical trials were headache, nausea and fatigue.

Like other sleep medicines, Intermezzo may cause serious side effects, including getting out of bed while not fully awake and doing an activity that you do not know you are doing or do not remember having done. Reported activities while under the influence of sleep medicines include driving a car, making and eating food, having sex, talking on the phone, and sleep walking—without knowing at the time or remembering later. Chances of such activity increase if a person has consumed alcohol or taken other medicines that make them sleepy.  

Intermezzo is a federally controlled substance because it can be abused or lead to dependence.

Intermezzo is made by Transcept Pharmaceuticals Inc. of Port Richmond, Calif.

For information:

FDA: Approved Drugs: Questions and Answers:
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. 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
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. 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
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/30/2014)... LONDON , Sept. 30, 2014 ... conducting this study is to provide an overview ... global market for protein drugs/therapeutics. The key objective ... direction of protein drugs as an important tool ... report explores present and future strategies within the ...
(Date:9/30/2014)... Mass. , Sept. 30, 2014  Decision Resources Group finds ... Australia , China , ... Korea—will expand at a strong rate through 2023. Dental implant procedure ... and as patient awareness rises. Other key findings from ... dental implant market: , Dental implant penetration: ...
(Date:9/30/2014)... , Sept. 30, 2014   Easy Breathe ... destination , today announced that it now offers the ... AirSense CPAPs are the first sleep apnea therapy devices ... simple and easy to track and share real-time data ... effectiveness of their CPAP therapy.  In addition, the internal ...
Breaking Medicine Technology:Global Markets and Manufacturing Technologies for Protein Drugs -- Focus on Cytokines and Monoclonal Antibodies 2Global Markets and Manufacturing Technologies for Protein Drugs -- Focus on Cytokines and Monoclonal Antibodies 3Global Markets and Manufacturing Technologies for Protein Drugs -- Focus on Cytokines and Monoclonal Antibodies 4Asia Pacific Dental Implant Market Will Grow at a Strong Rate Through 2023 2Asia Pacific Dental Implant Market Will Grow at a Strong Rate Through 2023 3Easy Breathe Now Offers World's First "Smart" CPAP Device to Treat Sleep Apnea 2Easy Breathe Now Offers World's First "Smart" CPAP Device to Treat Sleep Apnea 3Easy Breathe Now Offers World's First "Smart" CPAP Device to Treat Sleep Apnea 4
... BOSTON, Dec. 29, 2011  Solos Endoscopy, Inc. (OTCPK: SNDY) ... continued growth in 2012 through the development and sales ... treatment and management of medical conditions. In 2011, Solos ... approximately $300,000 in debt for the Company. The signed ...
... Dec. 29, 2011 Janssen Research & Development, LLC (JRD) ... Application (sNDA) to the U.S. Food and Drug Administration (FDA) ... an oral anticoagulant, to reduce the risk of (thrombotic) cardiovascular ... The filing is supported by data from the pivotal Phase ...
Cached Medicine Technology:Solos Endoscopy, Inc. is Primed for Growth in 2012 2Solos Endoscopy, Inc. is Primed for Growth in 2012 3Janssen Research & Development Submits Application to U.S. FDA for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome 2Janssen Research & Development Submits Application to U.S. FDA for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome 3Janssen Research & Development Submits Application to U.S. FDA for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome 4Janssen Research & Development Submits Application to U.S. FDA for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome 5Janssen Research & Development Submits Application to U.S. FDA for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome 6Janssen Research & Development Submits Application to U.S. FDA for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome 7Janssen Research & Development Submits Application to U.S. FDA for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome 8Janssen Research & Development Submits Application to U.S. FDA for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome 9Janssen Research & Development Submits Application to U.S. FDA for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome 10Janssen Research & Development Submits Application to U.S. FDA for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome 11
(Date:10/1/2014)... October 01, 2014 October is national ... and early detection plans while raising money for breast ... Breast Cancer Awareness Month in the effort to ... to promote the importance of having access to clean, ... may be linked to certain forms of cancer. ...
(Date:10/1/2014)... Two bicyclists began a journey on September 8, ... an effort to raise funds and awareness to the ... father-daughter team, plan to bike more than 4,000 miles ... in Key West Florida. Funds raised along their ... nonprofit organization that assists post-9/11 service members, their families, ...
(Date:10/1/2014)... (PRWEB) October 01, 2014 This October, ... to consumer lab testing, is offering 10% off all ... DIBN10 when placing their order to save. The Center ... the United States are affected by Diabetes. Because many ... to go undiagnosed until it causes serious health problems. ...
(Date:10/1/2014)... The Oliver Law Group P.C. ... Other-Sonic Ultrasound Gel lawsuit web page to ... surrounding the 2011 Pseudomonas aeruginosa / bacterial infection ... Michigan, which was ultimately traced to the recalled ... Beaumont patients who allegedly became ill following exposure ...
(Date:10/1/2014)... The annual Social Security cost-of-living adjustment (COLA) ... a new forecast by The Senior Citizens League (TSCL) ... (CPI) data through August, TSCL forecasts that COLAs will be ... consecutive year of record low COLAs,” states TSCL Chairman, Ed ... in 1975,” he notes. , Over the past five years ...
Breaking Medicine News(10 mins):Health News:Pelican Water Supports Breast Cancer Awareness Month with Order Donations 2Health News:Father-Daughter Cycling Duo to Ride Cross-Country to Benefit Hope For The Warriors 2Health News:Request A Test Offers 10% off Diabetes Testing in October 2014 2Health News:Request A Test Offers 10% off Diabetes Testing in October 2014 3Health News:Other-Sonic Ultrasound Gel Lawsuit Page Launched by The Oliver Law Group P.C. To Provide Information On Pseudomonas Outbreak Linked to Recalled Ultrasound Gel 2Health News:Other-Sonic Ultrasound Gel Lawsuit Page Launched by The Oliver Law Group P.C. To Provide Information On Pseudomonas Outbreak Linked to Recalled Ultrasound Gel 3Health News:Other-Sonic Ultrasound Gel Lawsuit Page Launched by The Oliver Law Group P.C. To Provide Information On Pseudomonas Outbreak Linked to Recalled Ultrasound Gel 4Health News:The Senior Citizens League (TSCL) Says Sixth Consecutive Year Of Record Low COLAs “Unprecedented” 2Health News:The Senior Citizens League (TSCL) Says Sixth Consecutive Year Of Record Low COLAs “Unprecedented” 3
... 19 GlaxoSmithKline (NYSE: GSK ),today reported ... million, equivalent to almost 4% of pre-tax profits ... 1%). Donations of albendazole treatments,for the company,s flagship ... were valued at $29 million, bringing the,total number ...
... in heparin samples , , WEDNESDAY, March 19 (HealthDay News) ... found in the blood-thinner heparin, which has been linked ... in the United States. , The contaminant is a ... and Drug Administration officials could not say Wednesday how ...
... before ... Patients, ST. LOUIS ... side, International Union of Operating,Engineers Local 49 leaders today at a news ... medical coverage to,several thousand Minnesota seniors., "This is a death sentence ...
... drug-resistant bacteria, CDC study finds , , WEDNESDAY, March 19 ... aureas bacterium and caught outside of the hospital ... than previously believed, preliminary research suggests. , "Over the ... a severe CAP [community-acquired pneumonia] caused by S. ...
... at the University of Pennsylvania School of Medicine have ... the molecular pathways underlying sleep apnea, which affects more ... of Health. Sleep apnea is a condition characterized by ... occur dozens or even hundreds of times a night. ...
... (PRI),and Medicos, Inc. are pleased to announce that over ... mobile version of,the MPR drug databases. For over 23 ... print editions of MPR for up-to-date, concise drug,information at ... drug,information on computers and mobile devices in all 50 ...
Cached Medicine News:Health News:GSK Charitable Support Valued at $564 Million in 2007 2Health News:GSK Charitable Support Valued at $564 Million in 2007 3Health News:FDA Identifies Contaminant in Blood-Thinning Drug 2Health News:FDA Identifies Contaminant in Blood-Thinning Drug 3Health News:Park Nicollet to Cut Off Care to Thousands of Minnesota Seniors 2Health News:Community-Based Staph Pneumonia More Common Than Thought 2Health News:Molecular biology of sleep apnea could lead to new treatments 2Health News:eMPR Digital Drug Reference Reaches 50,000 Downloads and the Publisher Launches a Raffle for Healthcare Providers 2Health News:eMPR Digital Drug Reference Reaches 50,000 Downloads and the Publisher Launches a Raffle for Healthcare Providers 3
... IntraLase FS laser introduces new high precision ... now have the opportunity to offer their ... a microkeratome for creating the corneal flap. ... laser and proprietary IntraLASIK software, surgeons may ...
... Teco Diagnostics manufactures fine urine chemistry ... urine chemistry reagent strips from start ... offer more economical prices compared to ... quality. Teco Diagnostics urine reagent strips ...
... with diabetes continue to have a tremendous ... life of patients, in addition to the ... to be associated with elevated levels of ... of haemoglobin A1c (HbA1c) in a diabetic ...
The Lifestream Plus Cholesterol Monitor provides you with a comprehensive tool to help you monitor your cholesterol as part of your wellness program....
Medicine Products: