Taiwan's Food and Drug Administration (FDA) on Tuesday (April 29) banned doctors from prescribing medicine containing any of four ingredients to people who have experienced an episode of sleepwalking or other movements while in a partially conscious state.
If you have trouble sleeping, you're not alone. According to SleepHealth.org, 70% of American adults say they get insufficient sleep at least one night per month, and 11% struggle to get sufficient sleep on a nightly basis.1 As noted by this organization:
The U.S. Food and Drug Administration today announced the agency is requiring a new boxed warning – the agency's most prominent warning – on certain prescription insomnia drugs to better ensure patients and their health care professionals have the information they need when considering use of these medicines. The boxed warning follows several reports of rare, but serious injuries and deaths resulting from various complex sleep behaviors after taking these medicines. These complex sleep behaviors may include sleepwalking, sleep driving and engaging in other activities while not fully awake, such as unsafely using a stove. The new warnings will be required for eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist).
The US Food and Drug Administration (FDA) on Tuesday announced the addition of a boxed warning to certain prescription insomnia medicines because of various behaviors, including sleepwalking and sleep driving, that have led to injuries and deaths
In a letter dated August 9, 2011, FDA informed Upsher-Smith that it had concerns about the validity of bioequivalence data submitted with ANDA 078706 from studies conducted by a certain contract research organization, establishing bioequivalence of Upsher-Smith's product to the reference listed drug, SONATA (ZALEPLON) Capsules, 5 mg and 10 mg. In that letter, FDA directed Upsher-Smith to supplement its ANDA with either: (1) New bioequivalence studies or (2) re-assays of the samples from the original bioequivalence studies. Upsher-Smith did not respond to this letter.
Intec Pharma Ltd. (Nasdaq: NTEC), a clinical stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill™ platform technology, announces it has entered into an agreement with the Michael J. Fox Foundation for Parkinson's Research (MJFF) to support patient recruitment and retention support for the Intec Pharma's pivotal Phase III clinical trial of its lead product candidate, the Accordion Pill Carbidopa/Levodopa, or AP-CD/LD, for the treatment of Parkinson's disease symptoms in advanced Parkinson's disease patients, which began enrolling participants in April 2016.
8 Invented Diseases Big Pharma Is Banking On
Research and Markets: China Sleep Disorder Treatment Drugs Markets Report 2015