FDA States Risks for Sleep Drugs, Demand Grows for Natural Sleep Aids

natural sleep aidsThe FDA has recently heightened its warnings and restrictions for several sleep medications, citing side effects and addiction risks.

These include dependency, cognitive and memory impairments, daytime fatigue, nausea, dizziness, sleepwalking, driving while asleep, and increased risk of falls and accidents.

In an FDA article of March 6, 2024, the agency says that these complex sleep-related behaviors have also been linked to fatalities. Incidents of these behaviors are more prevalent with Lunesta, Sonata and Ambien, when compared to other sleeping medications.

This news has sparked higher interest and a greater demand for safer, more natural sleep aids such as calcium, magnesium, vitamin D, zinc, B vitamins, and others that have been proven effective.

According to HealthDirect, one significant risk associated with sleep drugs is the potential for developing a dependency. This can lead to reduced effectiveness over time and the necessity to take larger amounts. This increases the risk of side effects, and a person may feel unwell or face increased insomnia when attempting to discontinue their use. Note that any reduction in dose or discontinuation should be done in coordination with one’s prescribing doctor.

In hopeful contrast to this, recent studies point to the sleep-enhancing benefits of essential minerals and vitamins. These nutrients work naturally with the body, providing calming and restorative effects without the risks associated with pharmaceutical options. Several of them have additional benefits such as strengthening bones and teeth, boosting immunity, calming restless legs, relieving muscle cramps, and calming menopause symptoms.

Natural Sleep Aids for Better Sleep

  1. Calcium Calm: Known as a relaxation mineral, calcium aids the brain in converting the amino acid tryptophan into melatonin, the hormone responsible for sleep regulation. Research in the journal “Nutrients” has found that individuals with calcium deficiencies experience sleep disruptions more often than those with adequate levels.
  2. Magnesium for Sleep: This mineral supports muscle relaxation and reduces stress by regulating GABA, a natural chemical in the brain critical for restful sleep. The Journal of Research in Medical Sciences found that supplementing with magnesium remedies insomnia in older adults.  The researchers commented that these results and benefits can also be expanded to the general population.
  3. Vitamin D: Adequate vitamin D levels are linked to improved sleep duration and quality. The results of a clinical trial of vitamin D supplementation was published in a recent issue of the journal “Medical Hypothesis.” Over a 2 year period, a consistent level of vitamin D was maintained in the blood of 1,500 people. This produced normal sleep in most of the participants.
  4. Zinc: Research published in the International Journal of Molecular Sciences demonstrated that zinc can help individuals fall asleep faster, stay asleep longer, and wake up feeling refreshed.  Zinc is a vital mineral for sleep regulation and it is also the most important mineral for immune function.

Minerals and Vitamins: A Safer Path to Restful Sleep

Unlike sleep medications, minerals and vitamins offer sustainable, natural support without harmful side effects. Combinations of these nutrients in supplements work synergistically to relax muscles, calm the mind, and regulate the body’s sleep-wake cycle. For people seeking alternatives to sleep medications, supplements are an excellent choice, with proven effectiveness.

The popular natural sleep aid Sleep Minerals II from Nutrition Breakthroughs combines zinc, calcium, vitamin D and magnesium for sleep, to create an effective natural remedy for sleeplessness and insomnia. The blend of these essential minerals in a unique softgel form, work together to promote relaxation and improve sleep quality and quantity. The softgel is absorbed more rapidly and completely than tablets, capsules or gummies.

***** L.R.C. of Massachusetts says: “I had become dependent on sleeping drugs and couldn’t sleep without them. Now I take the Sleep Minerals II before bed and I can sleep through the night without drugs. I’m also able to easily fall back to sleep if I do have to get up. Another benefit is this helps alleviate my chronic fatigue and aches and pains.”

***** Doctor P. P. of Houston, Texas says: “I had developed sleeping problems and took two different sleeping medications over the course of several weeks. When I discontinued them the insomnia came back even worse. I literally got about 20 hours of sleep in 6 weeks time. Sleep Minerals II was just what I needed. I’ve been taking it for a couple weeks and getting many hours of sleep a night. As a doctor I would definitely avoid prescribing sleeping drugs — I would recommend Sleep Minerals II.”

For more information, visit the Sleep Minerals II page. sleep minerals ii

Antidepressants Can Lead to Hot Flashes, Night Sweats and Insomnia

hot flashes night sweatsHot flashes and night sweats create a sudden feeling of warmth and often a breakout of sweating in the upper half of the body.

These flashes are experienced by up to 80% of women around the time of menopause, and also by men due to a lessening of testosterone in middle age.

Hot flashes are normally brought on by a reduced function in the brain’s temperature regulation, caused by changing hormone levels.  Night sweats that occur while sleeping can cause overheating and frequent awakenings.

Another source of hot flashes are medications. According to WebMD, “Taking certain medications can lead to night sweats. Antidepressant medications are a common type of drug that can lead to night sweats. From 8% to 22% of people taking antidepressant drugs have night sweats. Other psychiatric drugs have also been associated with night sweats.”

The “Sleep in America” poll results from the National Sleep Foundation found that more than half of all Americans (60%) experience a sleep problem every night or almost every night.  Interestingly, a ten-year study to discover which drugs are used to treat insomnia was published in the journal “Sleep”.  The study found that prescriptions for sleeping medications have decreased by 53.7%, but that antidepressant drugs prescribed for insomnia have increased by a surprising 146%. Examples of antidepressants prescribed for insomnia are trazodone, doxepin, trimipramine, and amitriptyline.

Medications may not always have the desired effects.  For example, Drugs.com says the following about an antidepressant drug called Welbutrin — “Nervous system side effects have frequently included headache (27%), insomnia (16% to 33%)….and sleep abnormalities.”  Health.com lists some other possible side effects of antidepressants as sexual dysfunction, weight gain, dry mouth and throat, racing pulse, confusion, disturbed dreams, and an increased risk of suicide.

On the other hand, Nature has provided us with some natural sleep remedies 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.”

One sleep remedy that’s increasing in popularity is Sleep Minerals II from Nutrition Breakthroughs. This natural sleep aid contains highly absorbable forms of calcium and magnesium, the best minerals for sleeplessness and insomnia, as well as for restless legs 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.

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.”

Alex R. of Ramseur of 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.”

In summary, while antidepressant medications and other drugs are being prescribed widely for insomnia, natural remedies for sleep and relaxation should be tried first.  Those with absorbable calcium and magnesium have been proven effective.  And they come without side effects such as hot flashes and night sweats and can even be a good remedy for these.  For more information, visit the Sleep Minerals II page.

Insomnia Remedies Needed, 25% of U.S. takes Sleep Drugs

natural insomnia remediesSleeplessness 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 sleep.

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 natural insomnia remedies 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 www.NutritionBreakthroughs.com in Clearwater, FL., 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.

FDA Requires Lower Doses of Certain Sleep Drugs

sleep drugsFDA Requires Lower Doses of Certain 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 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.”

Nature has provided us with some natural remedies 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.”

One natural sleep aid 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.

A. 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.”

For more information, visit the Sleep Minerals II page.

Sleep Drugs: FDA Warns of Side Effects: Minerals Offer a Remedy

sleep drugsThe U.S. FDA (Food and Drug Administration) recently updated their web page that describes the many potential side effects of sleep 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 sleep 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 in Clearwater, Florida, 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.

This natural sleep aid 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 sleep 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 two 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 on Sleep Minerals II, visit this page.