Posts Tagged ‘fda warning sleep drugs’
The U.S. Food and Drug Administration has announced it is requiring users of the insomnia drug Ambien and its generic counterparts (all drugs containing the active ingredient zolpidem), to take a lower recommended dose of these medications. They are particularly aiming this toward women, as the drug stays in their system much longer than with men. Women at the time of menopause frequently have sleep problems and insomnia, and some may turn to sleep medications.
Ellis Unger, M.D., director of the Office of Drug Evaluation in the FDA’s Center for Drug Evaluation and Research said: “Over the years FDA has received spontaneous adverse event reports of driving impairment and motor vehicle accidents associated with zolpidem, but these reports lacked the information necessary to fully understand whether and how zolpidem affected people’s mental alertness and ability to drive. Recently, data from clinical trials and other types of studies have become available, which allowed FDA to better characterize the risk of next-morning impairment.”
According to the FDA press release: “The FDA has informed the manufacturers that the recommended dosage of zolpidem for women should be lowered from 10 milligrams (mg) to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). For men, the FDA has informed the manufacturers that the labeling should recommend that health care professionals consider prescribing these lower doses.”
Along the lines of natural insomnia remedies, nature has provided us with some natural sleep aids and relaxants that have stood the test of time. Regarding mineral deficiency as we age and at the time of menopause, the pioneering nutritionist Adelle Davis says, “The amount of calcium in a woman’s blood parallels the activity of the ovaries. During the menopause, the lack of ovarian hormones (estrogen and progesterone) can cause severe calcium deficiency symptoms to occur, including irritability, hot flashes, night sweats, leg cramps, and insomnia. These problems can be easily overcome if the intakes of calcium, magnesium, and vitamin D are all generously increased and are well absorbed.”
Chronic insomnia is one of the main symptoms of magnesium deficiency. Sleeping with a magnesium deficiency is usually agitated, with frequent nighttime awakenings. On the other hand, a high magnesium diet has been found to be associated with deeper, less interrupted sleep. This was shown in a study done by James Penland at the Human Nutrition Research Center in North Dakota.
One natural sleep aid that is gaining in popularity is Sleep Minerals II from Nutrition Breakthroughs. It contains highly absorbable forms of calcium and magnesium, the best minerals for sleeplessness and insomnia, as well as for restless leg syndrome, bone strength, aches and pains, and menopause insomnia. The formula also includes vitamin D and zinc and is delivered in a softgel form with healthy carrier oils, making the minerals more quickly assimilated than tablets or capsules. The softgel formulation provides a deeper, longer-lasting sleep and is an effective alternative to medications.
L.R.C. of Massachusetts says: “Due to some very stressful issues in my life, I hadn’t slept much in two and a half months before being prescribed sleeping drugs. I had become dependent on them and couldn’t sleep without them. I did my research on the Internet and came across Sleep Minerals II. I take this before bed and now I can sleep through the night without drugs. If I do have to get up, I can fall right back asleep. Another benefit is it also helps alleviate my chronic fatigue and aches and pains.”
Natural sleep aids can be effective against insomnia, without risking the side effects of drugs.
For more information on Sleep Minerals II visit this page: http://www.nutritionbreakthroughs.com/sleep minerals ii
The U.S. Food and Drug Administration has announced it is requiring users of the insomnia drug Ambien and its generic counterparts (all drugs containing the active ingredient zolpidem), to take a lower recommended dose of these medications. They are particularly aiming this toward women, as the drug stays in their system much longer than with men. Women at the time of menopause frequently have sleep problems and insomnia, and some may turn to sleep medications.
Ellis Unger, M.D., director of the Office of Drug Evaluation in the FDA’s Center for Drug Evaluation and Research said: “Over the years FDA has received spontaneous adverse event reports of driving impairment and motor vehicle accidents associated with zolpidem, but these reports lacked the information necessary to fully understand whether and how zolpidem affected people’s mental alertness and ability to drive. Recently, data from clinical trials and other types of studies have become available, which allowed FDA to better characterize the risk of next-morning impairment.”
According to the FDA press release: “The FDA has informed the manufacturers that the recommended dosage of zolpidem for women should be lowered from 10 milligrams (mg) to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). For men, the FDA has informed the manufacturers that the labeling should recommend that health care professionals consider prescribing these lower doses.”
Along the lines of natural insomnia remedies, nature has provided us with some natural sleep aids and relaxants that have stood the test of time. Regarding mineral deficiency as we age and at the time of menopause, the pioneering nutritionist Adelle Davis says, “The amount of calcium in a woman’s blood parallels the activity of the ovaries. During the menopause, the lack of ovarian hormones (estrogen and progesterone) can cause severe calcium deficiency symptoms to occur, including irritability, hot flashes, night sweats, leg cramps, and insomnia. These problems can be easily overcome if the intakes of calcium, magnesium, and vitamin D are all generously increased and are well absorbed.”
Chronic insomnia is one of the main symptoms of magnesium deficiency. Sleeping with a magnesium deficiency is usually agitated, with frequent nighttime awakenings. On the other hand, a high magnesium diet has been found to be associated with deeper, less interrupted sleep. This was shown in a study done by James Penland at the Human Nutrition Research Center in North Dakota.
One natural sleep aid that is gaining in popularity is Sleep Minerals II from www.NutritionBreakthroughs. It contains highly absorbable forms of calcium and magnesium, the best minerals for sleeplessness and insomnia, as well as for restless leg syndrome, bone strength, aches and pains, and menopause insomnia. The formula also includes vitamin D and zinc and is delivered in a softgel form with healthy carrier oils, making the minerals more quickly assimilated than tablets or capsules. The softgel formulation provides a deeper, longer-lasting sleep and is an effective alternative to medications.
L.R.C. of Massachusetts says: “Due to some very stressful issues in my life, I hadn’t slept much in two and a half months before being prescribed sleeping drugs. I had become dependent on them and couldn’t sleep without them. I did my research on the Internet and came across Sleep Minerals II. I take this before bed and now I can sleep through the night without drugs. If I do have to get up, I can fall right back asleep. Another benefit is it also helps alleviate my chronic fatigue and aches and pains.”
Natural sleep aids can be effective against insomnia, without risking the side effects of drugs.
For more information on Sleep Minerals II visit this web site:
With 25% of the U.S. Suffering Side Effects from Sleep Drugs, Natural Insomnia Remedies are Needed
Posted on: September 2, 2013
Sleeplessness is a big problem in America. According to the National Sleep Foundation (NSF), almost six out of ten Americans report having insomnia at least a few nights weekly. Additionally, in a recent NSF poll they found that as many as 25 percent of the people in the U.S. use medications in an effort to combat insomnia and get some rest.
The use of prescription sleeping drugs, such as Ambien, Lunesta and Sonata, has been steadily increasing. Global sales for all sleeping pills, called hypnotics, will top $5 billion in the next several years. Most sleeping pills, especially when taken over long periods of time, stay in the bloodstream and give a hangover effect the next day and beyond. They impair memory, reduce performance on the job and at home, and contribute to machine and car accidents.
From a nutritional perspective, several research studies have shown certain minerals to be effective alternatives to help people fall asleep and stay asleep through the night. James F. Balch, M.D., author of Prescription for Nutritional Healing, writes: “A lack of the nutrients calcium and magnesium will cause you to wake up after a few hours and not be able to return to sleep.”
The pioneering nutritionist Adelle Davis discusses minerals as an insomnia remedy in her book Let’s Get Well. She says: “A calcium deficiency often shows itself by insomnia, another form of an inability to relax. The harm done by sleeping tablets, to say nothing of the billions of dollars spent on them, could largely be avoided if the calcium intake were adequate.”
Regarding magnesium, Davis says: “Hundreds of recent studies indicate that almost everyone, especially ill persons, is deficient in magnesium. Probably no other single deficiency is so responsible for the widespread use of tranquilizers.”
Calcium is directly related to our cycles of sleep. In one study, published in the European Neurology Journal, researchers found that calcium levels in the body are higher during some of the deepest levels of sleep, such as the rapid eye movement (REM) phase. The study concluded that disturbances in sleep, especially the absence of REM deep sleep or disturbed REM sleep, are related to a calcium deficiency. Restoration to the normal course of sleep was achieved following the normalization of the blood calcium level.
In magnesium deficiency, chronic insomnia is one of the main, central symptoms. Sleep is usually agitated with frequent nighttime awakenings. On the other hand, a high magnesium diet has been found to be associated with deeper, less interrupted sleep. This was proven in a study done by James Penland at the Human Nutrition Research Center in North Dakota. The study was titled “Effects of trace element nutrition on sleep patterns in adult women.”
It’s important to note that a balanced ratio of calcium and magnesium is beneficial to overall health, and that these two minerals should be taken together in a 2 to 1 ratio for best results (twice as much calcium as magnesium).
Jobee Knight, a nutritional researcher and founder of Nutrition Breakthroughs in Glendale, CA., is someone who fought her own battle against sleeplessness and insomnia. She decided to put her background to use by searching out effective natural ingredients for relaxation and deeper sleep.
The result was Sleep Minerals II, a natural sleep aid that contains highly absorbable forms of calcium and magnesium, the best minerals for insomnia, as well as for heart health, restless legs syndrome, bone strength and menopause insomnia. The formula also includes vitamin D and zinc and is delivered in a softgel form with healthy carrier oils, making it more quickly assimilated than tablets or capsules and providing a better, longer-lasting sleep.
Alex R. of Ramseur, North Carolina says: “Sleep Minerals II has been a blessing for me. It has given me the opportunity to withdraw from a highly addictive sleep medication over time, and has allowed me to sleep while going through this most difficult ordeal. What’s great about it is it doesn’t lose its effectiveness, which is something that happens with sleep medications. I am most thankful for this product.”
Sleeping drugs can wreak havoc on one’s health and well-being. The right blend of natural minerals can be an effective natural insomnia remedy that helps the sleepless get some good rest.
For more information, visit the Sleep Minerals II page.
Pioneering Nutritionist Adelle Davis Recommends Calcium for Insomnia, Menopause and PMS
Posted on: June 7, 2013
The use of prescription sleeping drugs, such as Ambien, Lunesta and Sonata, has been steadily increasing. Global sales for all sleeping pills, called hypnotics, will top $5 billion in the next several years. Most sleeping pills, especially when taken over long periods of time, have considerable side effects, stay in the bloodstream, and give a hangover effect the next day and beyond. They can become addictive, impair memory, reduce performance on the job and at home, and contribute to machine and car accidents.
Adelle Davis is one of the earliest nutritionists to base her dietary recommendations on scientific research studies. Davis writes about the roles of calcium in her book “Let’s Eat Right to Keep Fit”. She suggests a natural sleep remedy for insomnia and says: “A calcium deficiency often shows itself by insomnia, another form of an inability to relax. The harm done by sleeping tablets, to say nothing of the thousands of dollars spent on them, could largely be avoided if the calcium intake were adequate.”
Regarding the many roles of calcium in women’s health, Davis says: “The amount of calcium in a woman’s blood parallels the activity of the ovaries. The blood calcium falls to such an extent during the week prior to menstruation that PMS with nervous tension, irritability, and perhaps mental depression results. At the onset of menstruation, the blood calcium takes a further drop, often causing cramps of the muscular walls of the uterus.”
Davis also describes the role of calcium in menopause: “During the menopause, the lack of the ovarian hormones (estrogen and progesterone) causes severe calcium deficiency symptoms to occur. At these times, high amounts of calcium should be obtained and every step be taken to insure its absorption into the blood. When these precautions are taken and the diet is adequate in other respects, the woman at menopause usually loses her irritability, hot flashes, night sweats, leg cramps, insomnia, and mental depression.”
One natural insomnia remedy gaining popularity with women and people of all ages is Sleep Minerals II from http://www.NutritionBreakthroughs.com. Sleep Minerals II contains powerful forms of the best known minerals for relaxation and sleep — calcium and magnesium, combined with vitamin D. The ingredients are formulated in a softgel with healthy oils, making them more quickly absorbable than tablets or capsules, and providing a deeper, longer-lasting sleep. The minerals are also helpful for restless legs syndrome, bone strength, aches and pains, and menopause insomnia.
Anita L. of New Caney, Texas says: “I was having hot flashes every 30 minutes to an hour through the night and was so miserable. After about two weeks of taking the Sleep Minerals, I noticed an incredible difference with my sleep. I have much less interruption from flashes, I’m sleeping much better, and I’m a lot more comfortable.”
Valerie H. in Santa Clarita, CA says: “I had such severe menopause insomnia, it took me hours to fall asleep even though I was extremely tired. I also had crawling and tingling feelings in my legs at night. I got the Sleep Minerals II and after a few days of taking it, it started to work really well. I fall asleep now within 20 minutes and no more restless legs.”
More and more, doctors and nutritionists are recommending natural remedies to help people avoid the harmful side effects of medications. The “Father of Medicine” Hippocrates spoke to his students in 400 B.C. and said: “Let thy food be thy medicine and thy medicine be thy food.”
For more information on Sleep Minerals II visit http://www.nutritionbreakthroughs.com/html/sleep_remedy_for_insomnia_help.html
Insomnia Drugs – FDA Warns of Side Effects While Natural Minerals are a Remedy
Posted on: May 28, 2013
The U.S. FDA (Food and Drug Administration) recently updated their web page that describes the many potential side effects of sleeping drugs. On their site, they state that “Complex behaviors are a potential side effect of sedative-hypnotic products – a class of drugs used to help a person fall asleep and stay asleep. These include making phone calls, sleep-eating, and getting into the car and driving while not fully awake. Most people do not remember these events later.”
Russell Katz, M.D., Director of the FDA’s Division of Neurology Products says, “Complex behaviors, such as sleep-driving, could be potentially dangerous to both the patients and to others.”
Other rare but potential side effects of sedative-hypnotic drugs are a severe allergic reaction and severe facial swelling, both of which can occur as early as the first time the product is taken. Katz says, “Severe allergic reactions can affect a patient’s ability to breathe and can affect other body systems as well, and can even be fatal at times.”
To make the serious risks of these products better known, the FDA requested earlier that all manufacturers of sedative-hypnotic drug products strengthen their product labeling to include warnings about complex sleep-related behaviors. The revised labeling affects the following drug products:
* Ambien, Ambien CR (zolpidem tartrate)
* Butisol sodium
* Carbrital (pentobarbital and carbromal)
* Dalmane (flurazepam hydrochloride)
* Doral (quazepam)
* Halcion (triazolam)
* Lunesta (eszopiclone)
* Placidyl (ethchlorvynol)
* Prosom (estazolam)
* Restoril (temazepam)
* Rozerem (ramelteon)
* Seconal (secobarbital sodium)
* Sonata (zaleplon)
From a nutritional perspective, several research studies have shown certain minerals to be effective alternatives to help people fall asleep and stay asleep through the night. James F. Balch, M.D., author of Prescription for Nutritional Healing, writes: “A lack of the nutrients calcium and magnesium will cause you to wake up after a few hours and not be able to return to sleep.”
The pioneering nutritionist Adelle Davis discusses minerals as an insomnia remedy in her book Let’s Get Well. She says: “A calcium deficiency often shows itself by insomnia, another form of an inability to relax. The harm done by sleeping tablets, to say nothing of the billions of dollars spent on them, could largely be avoided if the calcium intake were adequate.”
Calcium is directly related to our cycles of sleep. In one study, published in the European Neurology Journal, researchers found that calcium levels in the body are higher during some of the deepest levels of sleep, such as the rapid eye movement (REM) phase. The study concluded that disturbances in sleep, especially the absence of REM deep sleep or disturbed REM sleep, are related to a calcium deficiency. Restoration to the normal course of sleep was achieved following the normalization of the blood calcium level.
In magnesium deficiency, chronic insomnia is one of the main, central symptoms. Sleep is usually agitated with frequent nighttime awakenings. On the other hand, a high magnesium diet has been found to be associated with deeper, less interrupted sleep. This was proven in a study done by James Penland at the Human Nutrition Research Center in North Dakota. The study was titled “Effects of trace element nutrition on sleep patterns in adult women.” It’s important to note that a balanced ratio of calcium and magnesium is beneficial to overall health, and that these two minerals should be taken together in a 2 to 1 ratio for best results.
Jobee Knight, a nutritional researcher and founder of Nutrition Breakthroughs Glendale, CA., is someone who fought her own battle against sleeplessness and insomnia. She decided to put her background to use by searching out effective natural ingredients for relaxation and deeper sleep. The result was Sleep Minerals II. Sleep Minerals II contains highly absorbable forms of calcium and magnesium, the best minerals for sleep and insomnia, as well as heart health, restless leg syndrome, bone strength, and menopause insomnia. The formula also includes vitamin D and zinc, and is delivered in a softgel form with healthy carrier oils, making it more quickly absorbable than tablets or capsules and providing a deeper, longer-lasting sleep.
L.R.C. of Massachusetts says: “Due to some very stressful issues in my life, I hadn’t slept much in two and a half months before being prescribed sleeping drugs. I had become dependent on them and couldn’t sleep without them. I did my research on the Internet and came across Sleep Minerals II. I take this before bed and now I can sleep through the whole night without drugs. If I do have to get up, I can fall right back asleep. Another benefit is it also helps alleviate my chronic fatigue and aches and pains.”
Sleeping drugs can wreak havoc on one’s health and well-being and cause life-threatening side effects. The right blend of natural minerals can be an effective natural insomnia remedy that helps the sleepless get some good rest.
For more information, visit the Sleep Minerals II page.
A study from the University of Colorado at Boulder has found that people who take one of the world’s most commonly prescribed sleep medicines are significantly more at risk for nighttime falls, potential injury, and memory impairment. The study, which involved twenty-five healthy adults, showed 58 percent of the older adults and 27 percent of the young adults who took a hypnotic, sleep-inducing drug called zolpidem showed a significant loss of balance and impaired thinking-ability when awakened two hours after sleep.
Zolpidem is a generic drug that is marketed under a number of different brand names, including Ambien, Zolpimist, Edluar, Hypogen, Somidem and Ivedal. “These findings are important because falls are the leading cause of injury in older adults, and 30 percent of adults sixty-five and older who fall require hospitalization each year,” said Associate Professor Kenneth Wright, lead study author.
Professor Wright continues: “The balance impairments of older adults taking zolpidem were clinically significant and the cognitive impairments were more than twice as large compared to the same older adults taking placebos. This suggests to us that sleep medication produces significant safety risks.”
The good news is that there are natural alternatives available. The mineral magnesium has been studied as an effective sleep remedy. A recent Gallup Poll survey reported that magnesium consumption greatly declines as we age. 79 percent of adults fifty-five and over are eating below the recommended dietary allowance (RDA) of magnesium. In fact, the National Institutes of Health web site says that older adults are at increased risk of magnesium deficiency due to their decreased ability to absorb the mineral. Also, the diseases to which older adults are vulnerable, and some of the drugs used in therapy, also contribute to magnesium loss.
Richard Rivlin, M.D., Chief of the Nutrition Division at New York Hospital/Cornell Medical Center says: “The prevalence of heart disease, diabetes and even leg cramps increases dramatically among older persons, and these are all health conditions in which magnesium deficiency has been found.”
A recent National Sleep Foundation poll found that 67 percent of older Americans report having frequent insomnia and sleep problems. Particularly for older people, a possible underlying nutritional cause of insomnia may be a deficiency of certain minerals. James F. Balch, M.D., author of Prescription for Nutritional Healing, writes: “A lack of the nutrients calcium and magnesium will cause you to wake up after a few hours and not be able to return to sleep.”
Chronic insomnia is one of the main symptoms of magnesium deficiency. Sleep in magnesium deficiency is usually agitated with frequent nighttime awakenings. On the other hand, a high magnesium diet has been found to be associated with deeper, less interrupted sleep. This was shown in a study done by James Penland at the Human Nutrition Research Center in North Dakota. The study was called “Effects of trace element nutrition on sleep patterns in adult women.”
Regarding the use of a nutritional sleep remedy containing magnesium for insomnia relief, certain formulas are more effective than others. The combination of minerals included and the presence of cofactors in the product are key. Formulas should contain a two to one ratio of calcium to magnesium. The original research on this recommended ratio appeared in 1935 in the Journal of Physiological Reviews, and is made on the basis of long-term metabolic studies in men and women.
One natural insomnia remedy showing good results is Sleep Minerals II, made by Nutrition Breakthroughs in Glendale, California. Sleep Minerals II contains highly absorbable forms of calcium and magnesium, the best minerals for sleeplessness and insomnia, as well as heart health, restless legs syndrome, bone strength, and menopause insomnia. The formula also includes vitamin D and zinc and is delivered in a softgel form with healthy carrier oils, making it more quickly absorbable than tablets or capsules and providing a deeper, longer-lasting sleep.
Richard P. of Parkville, Maryland says: “The Sleep Minerals are making quite a difference. I was regularly waking up at around 3:00 a.m. and after a few days use my sleep improved quite a lot. I wake up once a night to go to the bathroom, but the great thing is, I then fall back asleep and sleep several more hours. This has been a great improvement.”
Kimberly B. of Troy, Michigan says: “I have been taking Sleep Minerals II for about a month now. I have tried everything out there and this supplement is amazing. I have suffered with insomnia for 2 1/2 years. I have also had restless leg syndrome my entire life and this is the first relief I’ve ever had…gone for a month now.”
As research continues to emerge on sleep medications, more and more adverse effects are likely to be discovered. Natural minerals can be an effective, safe alternative.
For more information on Sleep Minerals II, visit this page.
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