• Regulatory NewsRegulatory News

    FDA Adds Boxed Warnings to Insomnia Medicines Following Injuries, Deaths

    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. The agency said the behaviors appear to be “more common with eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) than other prescription medicines used for sleep.” Over ...
  • 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...