Navigation Links
FDA Approves First Insomnia Drug for Middle-of-the-Night Waking Followed By Difficulty Returning to Sleep

SILVER SPRING, Md., Nov. 23, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.  


This is the first time the FDA has approved a drug for this condition. Intermezzo should only be used when a person has at least four hours of bedtime remaining. It should not be taken if alcohol has been consumed or with any other sleep aid.

Insomnia is a common condition in which a person has trouble falling or staying asleep. It can range from mild to severe, depending on how often it occurs and for how long. Insomnia can cause excessive daytime sleepiness and lack of energy. It also can make a person feel anxious, depressed, or irritable. People with insomnia may have trouble focusing on tasks, paying attention, learning, and remembering.

Zolpidem tartrate was first approved in the United States in 1992 as the drug Ambien.  Intermezzo is a lower dose formulation of zolpidem. The recommended and maximum dose of Intermezzo is 1.75 milligrams for women and 3.5 mg for men, taken once per night. The recommended dose for women is lower because women clear zolpidem from the body at a lower rate than men.

"For people whose insomnia causes them to wake in middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking," said Robert Temple, M.D., deputy center director for clinical science in the FDA's Center for Drug Evaluation and Research. "With this lower dose there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving."

Intermezzo was studied in two 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:

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,
Consumer Inquiries: 888-INFO-FDA

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

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:
(Date:11/25/2015)... -- Allergan plc (NYSE: AGN ), a ... start-up  biotechnology company focused on the development of ... by the F-Prime Biomedical Research Initiative (FBRI), today ... collaboration to support the discovery and development of ... Obsessive Compulsive disorders (OCD). ...
(Date:11/25/2015)... Ohio , Nov. 25, 2015 ... handle hazardous drug preparations (e.g. pharmacists, pharmacy technicians, ... and veterinary technicians). The chapter also covers all ... drugs (e.g., pharmacies, hospitals, other healthcare institutions, patient ... --> --> ...
(Date:11/25/2015)... Asia -based venture ... and the New Investors will make a direct equity ... private placement. The financing will help IOPtima to continue ... in the treatment of glaucoma, as well as to ... system with the U.S. Food and Drug Administration, commencing ...
Breaking Medicine Technology:
(Date:11/26/2015)... ... , ... Inevitably when people think Thanksgiving, they also think Holiday sales and ... Friday and Cyber Monday massage chair sales to receive the best pricing ... to find the best massage chair deals, they can see all of the coupons ...
(Date:11/26/2015)... ... November 26, 2015 , ... Jobs in hospital medical ... professionals and offered by healthcare staffing agency Aureus Medical Group . ... of October 2015 among those searching for healthcare jobs through the company’s website, ...
(Date:11/26/2015)... ... November 26, 2015 , ... ... wellness consultation, has collaborated with Women’s Web – an online resource for ... topics on mental and emotional well-being relationship, life balance, stress, professional development, ...
(Date:11/25/2015)... ... November 25, 2015 , ... The holiday ... dish and pleasing the palates of attendees is of the utmost importance. Whether ... a seasonal get-together, give these recipes a try this holiday season. , Turkey ...
(Date:11/25/2015)... ... 2015 , ... Dr. John Pierce, Medical Director at the Ageless Forever clinic ... the Capillus272™ Pro laser therapy cap. FDA cleared for safety and efficacy, the Capillus272 ... need for surgery, prescription pills, or topical foams. , “Capillus272™ Pro is a ...
Breaking Medicine News(10 mins):