Wake-Up Call: FDA Pushes Drugmakers To Weaken Sleeping Pills

Sleeping Pills

Story at-a-glance -

  • Studies recently submitted to the U.S. Food and Drug Administration (FDA) revealed that blood levels of zolpidem (found in Ambien and other sleeping pills) above 50 ng/mL may impair driving to a degree that increases the risk of an accident
  • As currently prescribed, anywhere from 15-33 percent of women may have residual levels of sleeping pills in their system that could significantly increase their risk of an accident even 8 hours after use
  • According to the FDA, the recommended dosage of zolpidem for women, who appear more susceptible to its effects than men, should be essentially cut in half
  • Any insomnia drug has the potential to make you feel drowsy or impair your driving the next day – even if you feel fully alert

By Dr. Mercola

Ambien, Edluar, Zolpimist and other drugs that contain the active ingredient zolpidem are the most widely used sleeping pills in the United States. In 2011 alone, an estimated 40 million prescriptions for such drugs were dispensed.1

These drugs have long been linked to “next-morning impairment,” as some of the drugs effects still linger in the morning, making driving or operating heavy equipment dangerous.

Now new research submitted to the U.S. Food and Drug Administration (FDA) has made it clear how significant this risk actually is, and the FDA is requiring drug makers to cut the current recommended doses nearly in half as a result.

FDA Requires Lower Doses for Sleeping Pills

According to a press release from the FDA, the recommended dosage of zolpidem for women, who appear more susceptible to its effects than men, 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).2

For men, the FDA has “informed the manufacturers that the labeling should recommend that health care professionals consider prescribing these lower doses (5 mg for immediate-release products and 6.25 mg for extended-release products).”

Ellis Unger, M.D., director, Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research, said:3

“To decrease the potential risk of impairment with all insomnia drugs, health care professionals should prescribe, and patients should take, the lowest dose capable of treating the patient’s insomnia. Patients who must drive in the morning or perform some other activity requiring full alertness should talk to their health care professional about whether their sleep medicine is appropriate.”

New Data Shows Sleeping Pills May Increase Your Risk of a Car Accident the Next Day

The new requirements came after studies recently submitted to the FDA revealed that blood levels of zolpidem above 50 ng/mL may impair driving to a degree that increases the risk of an accident. The studies showed:4

  • After taking 10 mg of Ambien (or other zolpidem-containing drugs), about 15 percent of women and 3 percent of men had zolpidem concentrations in excess of 50 ng/mL eight hours later
  • Three cases in women and one in a man showed levels in over 90 ng/mL 8 hours after use
  • For extended-release drugs taken at doses of 12.5 mg, about 33 percent of women and 25 percent of men had zolpidem concentrations in excess of 50 ng/mL eight hours later; 5 percent of patients had levels over 100 ng/mL
  • For extended-release drugs taken at doses of 6.25 mg, 15 percent of women and 5 percent of men had zolpidem levels over 50 ng/mL; among elderly men and women, 10 percent had such levels

It’s noted, too, that any insomnia drug has the potential to make you feel drowsy or impair your driving the next day – even if you feel fully alert. The FDA reported:5

“FDA is also reminding the public that all drugs taken for insomnia can impair driving and activities that require alertness the morning after use. Drowsiness is already listed as a common side effect in the drug labels of all insomnia drugs, along with warnings that patients may still feel drowsy the day after taking these products. Patients who take insomnia drugs can experience impairment of mental alertness the morning after use, even if they feel fully awake.”

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Sleeping Pills Increase Your Risk of Death, Cancer

Driving while you’re still under the effects of a sleeping pill (and don’t know it) can quickly be deadly, but these drugs appear to increase your risk of death even independent of this.

Research involving data from more than 10,500 people who received sleeping pills (hypnotics) showed that "as predicted, patients prescribed any hypnotic had substantially elevated hazards of dying compared to those prescribed no hypnotics" and the association held true even when patients with poor health were taken into account – and even if the patients took fewer than 18 pills in a year.6 The study suggested that those who take such medications are not only at higher risk for certain cancers, but are nearly four times more likely to die than people who don't take them.

Sleeping pills linked to these risks included benzodiazepines (such as temazepam), non-benzodiazepines (such as Ambien, Lunesta, and Sonata), barbiturates, and sedative antihistamines.

Treating sleeping troubles with drugs is a risky bet, too, because they are notorious for being addictive, which means that once you want to stop taking them, you'll likely suffer withdrawal symptoms that could be worse than the initial insomnia. Some, including Ambien, may also become less effective when taken for longer than two weeks. Ambien may also make you want to eat while you're asleep – and the sleep eating can include bizarre foods such as buttered cigarettes, salt sandwiches and raw bacon. Other bizarre side effects reported from various sleeping pills include:

  • Sleep walking and even sleep driving
  • Hallucinations
  • Confusion and disorientation
  • Complete amnesia from events, even those that took place during the day
  • Depression

Bizarre occurrences related to sleeping pills have become so common, the American Academy of Forensic Sciences has held a presentation on the odd effects of Ambien impairment on the body. Ambien-related accidents tend to stand out from other traffic accidents in that patients typically slam into parked cars or light poles or drive in the wrong direction.

Is it Worth the Risk to Sleep for 11 More Minutes?

An analysis of studies financed by the National Institutes of Health found that sleeping pills like Ambien, Lunesta and Sonata reduced the average time to go to sleep by just under 13 minutes compared with fake pills, while increasing total sleep time by just over 11 minutes – but, the participants believed they had slept longer, by up to one hour, when taking the pills.7 When people wake up after taking sleeping pills, they may, in fact, simply forget that they had been unable to sleep!

But unlike getting a restful night's sleep, which will leave you alert and refreshed, getting slightly more sleep (or what you think is more sleep) by taking a sleeping pill is not the same thing. Author and sleeping pill researcher Dr. Daniel Kripke reports that sleeping pills make your brain less active, and, as the FDA recently realized, that depressed activity doesn't typically simply vanish when the sun comes up. He noted that:8

"...almost all sleeping pills produce immediate impairments in memory and performance. Further there is extensive evidence that sleeping pills on average impair performance and memory on the following day.”

What’s REALLY Keeping You Awake?

As explained by sleep expert Dr. Rubin Naiman in a previous interview, insomnia is the most commonly reported sleep disorder. To understand why insomnia occurs, you need to understand that sleep is the outcome of an interaction between two variables: sleepiness, and what Dr. Naiman refers to as "noise."

Ideally and under normal conditions, your sleepiness should gradually increase throughout the day, peaking just before you go to bed at night. In order to get a good night's sleep, you want your sleepiness level to be high, and the noise level to be low. More often than not, the reason why people can't fall asleep is not because of lack of sleepiness, but rather because of excessive noise. If "noise" is conceptually greater than your level of sleepiness, you will not fall asleep. “Noise" can be any kind of stimulation that inhibits or disrupts sleep, and is generally classified into three zones:

  1. Mind – The most common type is referred to as "cognitive popcorn" – unstoppable thoughts running through your mind at night.
  2. Body – Such as physical pain, discomfort, indigestion, side effects from prescription drugs, or residual caffeine from drinking coffee too late in the day.
  3. Environmental – Environmental noise is usually obvious, such as noises in your room or house, a snoring partner, music, lights, or a bedroom that's too warm.

To help you get to sleep, you need to find out where your “noise” is coming from. If it’s in your mind, try using the Emotional Freedom Technique (EFT), which can help you address any emotional issues that might keep you tossing and turning at night.

If it’s environmental, take steps to remedy the problem, such as making your bedroom cooler (the ideal temperature to promote sound sleep is actually quite cool – between 60 to 68 degrees F (15.5 to 20 C)) or darker. Many fail to consider, for instance, that the use of lights, such as your TV, iPad, and computer, before going to bed can significantly interfere with your sleep. These emit the type of blue light that will suppress melatonin production and hamper your ability to fall asleep. Ideally, you'll want to turn them off at least an hour prior to bedtime.

For use in the evening, you can purchase "low blue lights," which emit an amber light instead of the blue that suppresses melatonin production. Therefore, these bulbs are ideal for areas such as your bedroom, bathroom, or living room in the evening. Dr. Naiman actually takes a small amount of melatonin each night even though he does not have any sleep problems because – like most people living in developed countries – he believes he's overexposed to light at night, which contributes to melatonin deficiency.

Tips for Getting to Sleep Naturally

If you're having even slight trouble sleeping, I suggest you review my 33 Secrets to a Good Night's Sleep for helpful guidance on how to get restful sleep. For example:

  1. Cover your windows with blackout shades or drapes to ensure complete darkness. Even the tiniest bit of light in the room can disrupt your internal clock and your pineal gland's production of melatonin and serotonin. (Even the faint glow from your clock radio could be interfering with your sleep.)
  2. Also close your bedroom door, get rid of night-lights, and refrain from turning on any light during the night, even when getting up to go to the bathroom.

  3. Keep the temperature in your bedroom at or below 70 degrees F (21 degrees Celsius). Many people keep their homes and particularly their upstairs bedrooms too warm. When you sleep, your body's internal temperature drops to its lowest level, generally about four hours after you fall asleep. Scientists believe a cooler bedroom may therefore be most conducive to sleep, since it mimics your body's natural temperature drop.
  4. Check your bedroom for electro-magnetic fields (EMFs). These can disrupt your pineal gland and the production of melatonin and serotonin, and may have other negative effects as well.
  5. To do this, you need a gauss meter. You can find various models online, starting around $50 to $200. Some experts even recommend pulling your circuit breaker before bed to kill all power in your house. Move alarm clocks and other electrical devices away from your head. If these devices must be used, keep them as far away from your bed as possible, preferably at least 3 feet.

If you've made the necessary changes to your sleep routine and find you're still having trouble sleeping, a high-quality melatonin supplement may be helpful and far less damaging than sleeping pills. The amount of melatonin you create and release every night varies depending on your age. Children usually have much higher levels of melatonin than adults, and as you grow older your levels typically continue to decrease.

Researchers believe this may explain why many older adults occasionally experience disrupted sleep patterns. With less melatonin in their blood, the stimulus to fall asleep, stay asleep, and wake feeling rested can potentially be compromised, which is why some older adults may benefit from extra melatonin – likewise if you perform night shift work, travel often and experience jet lag, or otherwise suffer from occasional sleeplessness due to stress or unexplained reasons.