FDA

Nov
3
2009

Mayo journal publishes study of Nuvigil in shift work sleep disorder patients

Cephalon announced that Mayo Clinic Proceedings published data from a Phase III trial of Nuvigil (armodafinil) Tablets [C-IV] demonstrating it significantly improved wakefulness throughout the shift in patients with excessive sleepiness associated with shift work disorder.


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Apr
24
2009

Respironics SmartMonitor 2 Infant Apnea Monitor recalled (Models 4002 and 4003)

Respironics has issued a voluntary recall on two models of its SmartMonitor 2 Infant Apnea monitor after being notified by the U.S. Food and Drug Administration of potential problems.

The company issued a voluntary Class 1 recall, which are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.


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Mar
17
2009

FDA approves Edluar as short-term treatment of insomnia

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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Nov
7
2008

Doctors must first rule out other diagnoses when treating sleep disorders

The National Sleep Foundation seventy million people in the United States suffer from sleep disorders. About 40 million of these suffer from acute sleep disorders, including circadian rhythm sleep disturbance.

Consider Dan, a 23-year old male complaining of insomnia. He can’t fall asleep at night and habitually arrives at work later than his employer’s 8 a.m. starting time. Does Dan have depression, situational insomnia, obstructive sleep apnea or a circadian rhythm disturbance? Or does he just want to start work late?


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Apr
23
2007

ResMed recalls 300,000 S8 devices worldwide

ResMed, one of the leading manufacturers of equipment used to treat sleep apnea, has issued a worldwide recall for more than one-quarter of a million CPAP machines due to a potential risk with the power supply connector that may end up costing the company an estimated $210 million to correct.

In a press release, the company indicated that specific S8 devices manufactured between July 2004 and May 15, 2006, risk a potential short circuit in the power supply connector. ResMed plans to work with its distribution partners globally to provide a replacement device to patients who have an affected S8 flow generator.


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Mar
17
2007

FDA asks for warnings on sleep disorder medications

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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Aug
14
2002

FDA clears computer-connected glucose meters

Here’s information on two new diagnostic products. These two are both sold over-the-counter for people with diabetes.

The FDA recently cleared for marketing two glucose test meters for use in conjunction with hand-held computers. The computer technology allows diabetics to do a better job of tracking and managing their blood sugar levels.


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Interesting Apnea Statistics
~~ Apnea in United States ~~

As of May 2, 2009 at 9:47 p.m. (-0500) (ET), the U.S. population
was 306,340,710. Sleep researchers estimate approximately seven percent
of the population suffers from obstructive sleep apnea. Using that
estimate, there are potentially 21,443,850 apneics in the U.S.

~~ Apnea around the world ~~

As of May 2, 2009 at 9:47 p.m. (-0500) (ET), the world population
was 6,777,286,604. Sleep researchers estimate approximately seven percent
of the population suffers from obstructive sleep apnea. Using that
estimate, there are potentially 474,410,062 apneics in the world.