Drug Agency Calls for Strong Warning Labels on Popular Sleep Aids

The labels must mention that side effects include risky behaviors, such as sleepwalking and sleep driving, that can lead to injury and even death.
Source: NYT Health - Category: Consumer Health News Authors: Tags: Sleep Drugs (Pharmaceuticals) Sleepwalking Ambien (Drug) Falls Parasomnias (Sleep Disorders) your-feed-science Labeling and Labels (Product) Insomnia Food and Drug Administration Source Type: news

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Ten years after diagnosis, could I finally dispense with chemical sleeping aids?
Source: NYT Health - Category: Consumer Health News Authors: Tags: Sleep Insomnia Ambien (Drug) Marijuana Cancer Melatonin (Hormone) Source Type: news
According to the latest numbers, roughly 9 million Americans — 4% of U.S. adults — use prescription sleep aids, or medications that can help with insomnia and other sleep issues. And now, some of the most popular prescription sleep drugs must carry stronger safety warnings. In April, the Food and Drug Administration (FDA) mandated black-box warnings — which the agency uses to “call attention to serious or life-threatening risks” — on three sedative-hypnotic sleep aids: eszopiclone (often sold under the brand name Lunesta), zaleplon (Sonata) and zolpidem (Ambien). Hypnotic drugs, which ar...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized Drugs Source Type: news
On Tuesday, the Food and Drug Administration (FDA) announced that several prescription sleep aids must now include aboxed warning—the FDA’s strongest safety warning—following reports of sleepwalking and other rare sleep behaviors that have led to serious injuries and deaths.Sleep aids containing eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist) must carry the boxed warning as well as another warning against the use of the medications by patients with a history of sleepwalking or other rare sleep behaviors like sleep driving.This is not the first ...
Source: Psychiatr News - Category: Psychiatry Tags: Ambien Ambien CR and Zolpimist boxed warning Edluar eszopiclone FDA insomnia Intermezzo lunesta sleepwalking Sonata zaleplon zolpidem Source Type: research
Ryan R. Kelly1,2†, Lindsay T. McDonald1,2†, Nathaniel R. Jensen1,2, Sara J. Sidles1,2 and Amanda C. LaRue1,2* 1Research Services, Ralph H. Johnson VA Medical Center, Charleston, SC, United States 2Department of Pathology and Laboratory Medicine, Medical University of South Carolina, Charleston, SC, United States The significant biochemical and physiological effects of psychological stress are beginning to be recognized as exacerbating common diseases, including osteoporosis. This review discusses the current evidence for psychological stress-associated mental health disorders as risk factors for os...
Source: Frontiers in Psychiatry - Category: Psychiatry Source Type: research
Abstract Neuropsychiatric adverse events (NPAEs) observed with the integrase strand transfer inhibitor (INSTI) dolutegravir (DTG) are usually mild to moderate. The most prevalent symptoms are insomnia and sleep disorders, but the spectrum also includes dizziness, anxiety, depression, headache, paraesthesia, muscle-skeletal pain, poor concentration, and slow thinking. In recent cohort studies involving>6400 patients in different countries, discontinuation rates due to NPAEs were observed in around 3.5% (range, 1.4-7.2%) of subjects treated with DTG. These rates have been higher than those seen in randomized clin...
Source: AIDS Reviews - Category: Infectious Diseases Authors: Tags: AIDS Rev Source Type: research
In this study, we examined the benefits of early-onset, lifelong AET on predictors of health, inflammation, and cancer incidence in a naturally aging mouse model. Lifelong, voluntary wheel-running (O-AET; 26-month-old) prevented age-related declines in aerobic fitness and motor coordination vs. age-matched, sedentary controls (O-SED). AET also provided partial protection against sarcopenia, dynapenia, testicular atrophy, and overall organ pathology, hence augmenting the 'physiologic reserve' of lifelong runners. Systemic inflammation, as evidenced by a chronic elevation in 17 of 18 pro- and anti-inflammatory cytokin...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
In this study, we examined the relationships between fatigue and demographic and psychosocial variables to further the understanding of the symptom experience and associated factors. We recruited consecutive attenders at ART clinics in the Western Cape, South Africa (N  = 134, age 11–18 years). Participants completed a battery of questionnaires including measures of fatigue, insomnia and mood disturbance. Just under a quarter (24.6%) of adolescents reported elevated levels of fatigue that affected their functioning. The linear combination of age, depression , and insomnia explained 40.6% of the var...
Source: AIDS and Behavior - Category: Infectious Diseases Source Type: research
CONCLUSIONS: There is no evidence to support the superiority of sound therapy for tinnitus over waiting list control, placebo or education/information with no device. There is insufficient evidence to support the superiority or inferiority of any of the sound therapy options (hearing aid, sound generator or combination hearing aid) over each other. The quality of evidence for the reported outcomes, assessed using GRADE, was low. Using a combination device, hearing aid or sound generator might result in little or no difference in tinnitus symptom severity.Future research into the effectiveness of sound therapy in patients w...
Source: Cochrane Database of Systematic Reviews - Category: General Medicine Authors: Tags: Cochrane Database Syst Rev Source Type: research
Title: Insomnia Treatment (Sleep Aids and Stimulants)Category: Diseases and ConditionsCreated: 9/24/1999 12:00:00 AMLast Editorial Review: 11/9/2018 12:00:00 AM
Source: MedicineNet Sleep General - Category: Sleep Medicine Source Type: news
Tens of millions of Americans struggle to sleep at night, and many of them turn to sleeping pills for relief. Prescription and over-the-counter sleep aids are especially popular among older adults. A recent study published in the American Journal of Geriatric Psychiatry found that roughly one in three adults ages 65 to 80 use these drugs at least occasionally to fall asleep, and OTC meds like Benadryl and Tylenol PM are the pills of choice for sleepless seniors. Experts say this is concerning for a number of reasons. Studies have linked the regular, long-term use of OTC sleep medicines to some potentially serious side effe...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized Baby Boomer Health sleep Source Type: news
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