• Regulatory NewsRegulatory News

    FDA Releases New Recommendations to Ensure Drugs Don't Cause Car Accidents

    US regulators have released new recommendations for manufacturers of psychoactive drugs—including sleep aids—following several warnings by the US Food and Drug Administration (FDA) that some drugs were causing patients to get into car accidents hours after the effects of the drug should have worn off. Background Sleep drugs have long been on FDA's radar, primarily due to their association with impaired driving. The concern has been that some patients respond atypically,...
  • Regulatory NewsRegulatory News

    Second Major Sleep Drug Associated With Impaired Driving as FDA Dials Back Recommended Dosing

    The US Food and Drug Administration (FDA) has again issued a warning about a sleep drug, this time requiring a labeling change for the popular sleep drug Lunesta after data indicated that some patients experienced long-lasting effects that could impair their ability to function, even after a full night's sleep. Background Sleep drugs have long been on FDA's radar, primarily due to their association with impaired driving. The concern has been that some patients respond a...
  • Feature ArticlesFeature Articles

    Sleep—Still a Mystery!

    • 07 May 2014
    Most people spend a full third of their lives asleep, yet most of us do not have the faintest idea what sleep does to our bodies and our brains. Sleep remains one of the secrets of science. 1 However, there is ample evidence indicating that difficulty in falling asleep and non-restorative sleep are associated with the risk of cardiovascular disease in adults and young children. Statistically, after adjusting for lifestyle factors, age and chronic conditions, researchers ...
  • Can a YouTube Video be a Medical Device? The Curious Case of Videos to Treat Insomnia

    Can a YouTube video be a medical device, and should the US Food and Drug Administration (FDA) be cracking down on certain videos on the Google-owned network? Background As reported by ABC , The Huffington Post and other news outlets, practitioners of "Autonomous Sensory Meridian Response" (ASMR) have been taking to YouTube in recent years. The practice focuses on relaxing noises, which practitioners claim cause a "relaxing" and "tingling" sensation in the body...