Helping others sleep better every night!
From the category archives:
Head and neck cancer patients who report poor sleep quality one year after diagnosis had more symptoms of chronic pain and complaints of dry mouth related to radiation treatments, according to a recent study from the University of Michigan Comprehensive Cancer Center.
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Orexo has announced the U.S. Food and Drug Administration (FDA) has approved Edluar (formerly Sublinox) 5 mg and 10 mg sublingual tablets for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
Meda, Orexo’s partner, acquired exclusive worldwide commercial licensing for Edluar in 2008 with expectations to launch the product in the U.S. market during the second half of 2009. Orexo will receive royalties based on Meda’s sales of Edluar.
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The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks.
These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.
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The U.S. FDA is requesting all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.
“There are a number of prescription sleep aids available that are well-tolerated and effective for many people,” said Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research. “After reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks.”
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Prescription sleep aids may do little to improve the use of continuous positive airway pressure devices (CPAP) among patients with obstructive sleep apnea (OSA).
A new study published in the November issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians (ACCP), finds that patients with OSA who were given prescription sleep aids were no more likely to use their CPAP machines than patients with obstructive sleep apnea taking a placebo.
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