FDA fast tracks dangerous sleep drug

Insomnia is a huge money-making business. And the market exploded over the last couple years, [Click here](1770d7/ct0_0/1/ms?sid=TV2%3AiEishvMgg) to view this message in your browser | [Click here](1770d7/l-002e/zout?sid=TV2%3AiEishvMgg) to stop receiving our messages [] [] Al Sears, MD 11905 Southern Blvd. Royal Palm Beach, FL 33411 [] May 10, 2022 [] Reader, Insomnia is a huge money-making business. And the market exploded over the last couple years, thanks to the government’s scare tactics about Covid. Since the start of the media’s never-ending news coverage, nearly 60% of Americans reported an increase in trouble sleeping.1 That number is predicted to soar even higher in the next few years, leading to a sleep aid market that’s projected to surpass $162.5 billion by 2030 – more than double what it is today.2,3 And Big Pharma can’t wait to cash in. In fact, the FDA just fast-tracked another new prescription sleeping pill. This one belongs to a class of drugs known as dual orexin receptor antagonists (DORA).4 These pills are marketed as better than other kinds of insomnia medications because they didn’t cause sleepiness, confusion, or cognitive impairment the next day. But the exact opposite is true. In a recent study, researchers found that volunteers who took a DORA felt so drowsy the next day, they had to stop driving immediately. Others reported getting into an accident. Additional participants reported hallucinations or sleep paralysis, a feeling that you can’t move or talk while either falling asleep or waking up. And here’s the real kicker... Not one person got a substantially better night’s sleep after taking the drug. In fact, volunteers who took the pill every night for three months fell asleep just six minutes faster than those who got a placebo.5 And they only slept 16 minutes more. I talk to my patients about the danger of not sleeping all the time. Unfortunately, it’s a common problem that affects 75 million Americans. People who don’t sleep or who sleep badly have up to 400% more accidents than people who do.6 Not getting enough sleep also increases your risk of developing chronic diseases. Studies found that those who slept less than six hours developed a:7,8,9,10,11 - 48% increase in the incidence of coronary heart disease - 30% increased risk of dementia - 15% increase in the incidence of stroke - 17% higher risk of diabetes - 95% increase in depression - 750% higher risk of obesity For a long time, we didn’t understand how lack of sleep could age us so much. Now we know it’s connected to our telomeres. Those are the little caps on the ends of your chromosomes. Each time your cells divide, these telomeres get a little shorter and your cells get closer to the end of their life. Short telomeres are also associated with most of the chronic diseases we associate with aging... from cancer to heart disease. But a good night’s sleep keeps your telomeres long. Harvard researchers measured telomere length in 4,117 women. Compared with women who got the most sleep, those who slept six hours or less per night had a 12% decrease in their telomere length. That change is equivalent to 9 years of biological aging!12 Get to sleep soundly and safely You can’t count on the FDA and their cohorts in Big Pharma to take care of you. I recommend natural sleep aids for my patients. Here are three I suggest you try tonight: - First take some CBD. The Center for Applied Health Sciences recently reported the results of a placebo-controlled study of CBD oil. They found that otherwise healthy adults who took the oil experienced a 22% improvement in sleep quality and a 21% improvement in sleep quantity.13 In another study of 72 patients with sleep and anxiety-related disorders 79% of those participating reported less anxiety after using CBD, while 67% reported improved sleep.14 - Then add this CBD cousin. Cannabinol, or CBN, is proving to be a powerful sleep agent because it interacts with special receptors in your body that cause sedation. A recent study found that just 5 mg of CBN can relax your body into falling asleep as effectively as 10 mg of diazepam, the ingredient in Valium — but without the groggy side effects.15 CBN is not a cannabinoid in and of itself. It’s a byproduct of THCA. But CBN does not produce intoxicating effects. It works by binding to CB1 receptors, but at only one-tenth the strength of THC. A friend of mine who tried it said it worked so quickly he couldn’t even get upstairs to bed and ended up sleeping peacefully on the living room couch all night. I tried it and I agree it works faster than anything I’ve taken before. But unlike my friend, I was able to get into bed before it kicked in. - Before bed, take melatonin. When it comes to melatonin, too much is NOT a good thing. Many supplements have as much as 10 mg. That dosage raises your blood melatonin level much higher than it should be. At high levels, melatonin stops working or even causes insomnia. Too much can also affect your blood pressure if you’re already taking hypertension medication. You don’t need more than 0.3 mg. And use an oral spray that hits your bloodstream faster. To Your Good Health, [Al Sears, MD] Al Sears, MD, CNS --------------------------------------------------------------- References: 1. Brown L, et al. “Worry about Covid as a predictor of future insomnia.” J Sleep Res. 2022 Feb 14;e13564. 2. Sleeping Aids Market to Surpass $162.5 Billion Revenue by 2030. PR Newswire. Published August 12, 2020. 3. Stranges S, et al. “Sleep problems: an emerging global epidemic? findings from the INDEPTH WHO-SAGE study among more than 40,000 older adults from 8 countries across Africa and Asia.” Sleep. 2012;35(8):1173-1181. doi:10.5665/sleep.2012 4. Dunleavy K. “Idorsia scores FDA go-ahead for insomnia drug Quviviq to rival Merck's Belsomra, Eisai's Dayvigo.” 5. Rhyne D, Anderson S. "Suvorexant in insomnia: efficacy, safety and place in therapy." Therapeutic Advances in Drug Safety. 2015 Oct; 6(5): 189–195. 6. Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem. Institute of Medicine. Washington, DC: The National Academies Press; 2006. 7. Cappuccio F, et al. “Sleep duration predicts cardiovascular outcomes: a systematic review and meta-analysis of prospective studies.” Eur Heart J. 2011. 32;1484–1492. 8. Hasler G, et al. “The association between short sleep duration and obesity in young adults: A 13-year prospective study.” Sleep. 2004;27(4):661–666. 9. Franzen P. “Sleep disturbances and depression: risk relationships for subsequent depression and therapeutic implications.” Dialogues in Clinical Neuroscience. 2008 Dec; 10(4): 473–481. 10. Sabia S, et al. “Association of sleep duration in middle and old age with incidence of dementia.” Nat Commun. 2021 Apr 20;12(1):2289. 11. Yuan S, Larrson S. “An atlas on risk factors for type 2 diabetes: a wide-angled Mendelian randomisation study.” Diabetologia. 2020. 63: 2359–2371. 12. Liang G, et al. “Associations between rotating night shifts, sleep duration, and telomere length in women.” PLoS One. 2011;6(8):e23462. 13. CV Sciences, Inc. (2019, June 17). Effects of a CBD-containing supercritical fluid extract of hemp on markers of optimal wellness, stress resilience, and recovery in healthy subjects [Press release]. 14. Shannon S, et al. “Cannabidiol in anxiety and sleep: A large case series.” Perm J. 2019;23:18-041. 15. Cannabinol (CBN): A Sleeping Synergy. Steep Hill. Published October 31, 2017. alsearsmd@send.alsearsmd.com [Preferences | Unsubscribe](1770d7/l-002e/zout?sid=TV2%3AiEishvMgg) 11905 Southern Blvd., Royal Palm Beach, Florida 33411, United States