Hide this

Story at-a-glance -

  • The drug Belsomra is a questionable insomnia treatment at best. In clinical trials, the drug allowed people to fall asleep six minutes sooner than those taking a placebo, and stay asleep 16 minutes longer
  • Previous research found Ambien, Lunesta, and Sonata reduced the average time it takes to fall asleep by about 13 minutes compared to placebo, while increasing total sleep time by about 11 minutes
  • In a six-month period, FDA received 1,000 consumer complaints about Belsomra. Many complained it didn’t work. Others reported sleep paralysis, next-day drowsiness, suicidal ideation, and suicide attempts
 

Do Sleeping Pills Live Up to Their Promises?

April 21, 2016 | 218,566 views
| Available in EspañolDisponible en Español

By Dr. Mercola

The United States and New Zealand are the only two countries in the world that allow direct-to-consumer drug commercials on television.

The only ones really benefiting from this scenario are the drug companies; from the consumer's vantage point, the drawbacks far supersede the benefits. Part of the risk consumers face is rooted in deception.

According to a content analysis study1 published in the Journal of General Internal Medicine, 10 percent of claims made in drug ads were flat out false, and another 57 percent were misleading. Basically, two-thirds of the claims in any given ad are unreliable at best.

When you consider that most drugs carry the risk of side effects, being 'hooked' by a false or misleading promise of a benefit could lead to worsening your health rather than improving it. Direct-to-consumer drug advertising also drives drug prices skyward.

Overall, Americans pay 50 percent more than other countries for identical drugs, and while there are other factors that allow for and contribute to these inflated prices, advertising costs are part of the equation.

It's been estimated that if Americans paid the same prices other countries pay for the same products, we'd save about $94 billion a year. The American Medical Association (AMA) recently called for a ban on drug ads, for the expressed purpose of reining in drug prices.

Belsomra—An Overhyped Sleep Drug With Questionable Benefits

A recent Huffington Post article2 delves into some of the falsehoods found in drug ads, with a focus on Belsomra, a next-gen type sleeping pill that acts on a neurotransmitter called orexin "to turn down the brain's 'wake messages.'"

You've probably seen this ad (above), featuring a young woman with two fuzzy creatures shaped like the words "sleep" and "wake." As noted in the featured article, Belsomra is a questionable insomnia treatment at best, but despite limited clinical benefit, the ad still portrays it as a superior choice.

First of all, the company's own clinical trials showed the drug allowed people to fall asleep six minutes sooner than those taking a placebo (on average), and stay asleep 16 minutes longer.

A previous analysis of studies financed by the National Institutes of Health found that sleeping pills like Ambien, Lunesta, and Sonata reduced the average time it takes to fall asleep by about 13 minutes compared to placebo, while increasing total sleep time by about 11 minutes.

Interestingly, participants believed they had slept longer, by up to one hour, when taking the pills. This is thought to be due to anterograde amnesia, which causes trouble with forming memories. When people wake up after taking sleeping pills, they may, in fact, simply forget they'd been unable to sleep.

Belsomra Side Effects

Between February and July 2015, about 1,000 consumer complaints against Belsomra were filed with the U.S. Food and Drug Administration (FDA). Many complained it didn't work. Others reported sleep paralysis and next-day drowsiness.

Suicidal thoughts and suicide attempts were also reported. Two actually succeeded in taking their own lives, although it would be virtually impossible to prove the drug was the cause.

That said, it's worth noting that Belsomra has never been tested on people taking antidepressants or antipsychotic drugs, so there's no telling what the drug interactions might be.

As noted in the article, most of these side effects became evident during Merck's own trials:

"For a number of people, these effects were so severe that the researchers halted their driving tests, fearing someone would get into an accident.

Because of these safety concerns, the FDA ended up approving the drug at a lower starting dosage than the company had requested—a dosage so low that a Merck scientist admitted it was "ineffective"...

You have no idea watching that ad that we're talking about falling asleep 6 minutes faster and staying that way an extra 16 minutes—and that's at higher doses...

We really don't have a great idea of how well it works at the lower dose FDA actually recommends for people starting the medication."

Despite all of that, Belsomra is expected to generate more than $300 million in sales this year, and part of its success can be ascribed to Merck spending $96 million to promote it.

Drug Ads Are Very Effective in Altering Consumer Behavior

Personally, I find it hard to believe anyone in their right mind would be interested in a drug that comes with a long laundry list of side effects, including ones that are worse than the initial complaint. But statistics show drug advertising really drives sales numbers.

One study cited by The Huffington Post that looked into this found American consumers were more than twice as likely to ask their doctor for a particular drug they'd seen on TV, compared to their Canadian counterparts who were not exposed to drug advertising.

Yet another study revealed just how easy it is to get a prescription for a drug you absolutely do not need, simply by asking your doctor for it:

"[R]esearchers trained actors to seek medical help for symptoms that resembled depression at different levels of severity. The good news was that most people with symptoms warranting medication received drugs.

The bad news was that most people without symptoms warranting medication also received drugs. Just over half of that latter group came away from their physician's office with a prescription for a drug they'd asked about after seeing an ad on TV...

[D]rug companies have been spending much of their time pushing drugs of questionable clinical advantage, or persuading viewers to seek medication for "a disease that may be hard to distinguish from normal behavior in most cases," according to Aaron Kesselheim, an associate professor at Harvard Medical School who focuses on the drug industry.

In his field, the tactic is known as "disease mongering." And to critics of consumer drug advertising, Belsomra is a perfect example of these practices at work...

All of the sleep medicine experts I interviewed emphasized that therapy and behavioral changes remain the best treatments for insomnia. Like most other sleep drugs, Belsomra provides only mild relief. 'Clinically meaningless' is the way one sleep expert, Gregg Jacobs from the University of Massachusetts Medical School, described Belsomra's effects."

Tiny Pills, Big Risks

While sleeping pills like Belsomra may provide "clinically meaningless" benefits, their risks can be quite significant. A startling study3,4 published in 2012 revealed that people who take sleeping pills not only have a 35 percent higher risk for certain cancers, they're also nearly four times as likely to die as people who don't take them.

Remarkably, this association held true even if the patients took fewer than 18 sleeping pills in a year (equating to reaching for a sleeping pill just once every three weeks). Other health risks associated with sleeping pills include:

  • Increased risk for insulin resistance, food cravings, weight gain and diabetes
  • Amnesia, even of events that occurred during the day
  • Depression, confusion, disorientation, and hallucinations
  • Increased risk of accidents. Studies submitted to the FDA reveal blood levels of zolpidem (found in Ambien and other sleeping pills) above 50 ng/mL may impair your driving to a degree that increases the risk of an accident, especially among women.5 Sleep aids that contain Benadryl can have a half life of about 18 hours, so if you take them every night, you're basically sedated for a large portion of the day as well, resulting in cognitive deficits and accident proneness
  • Increased risk for dementia in seniors (anti-cholinergics)

Sleeping pills can cause a variety of bizarre behavioral reactions6 that could be both risky and embarrassing. These behaviors, called "parasomnias," are more common when you are stressed or sleep-deprived, but can also be triggered by medications such as sleeping pills:

  • Sleepwalking
  • Sleep-driving
  • Sleep eating (including bizarre things like buttered cigarettes, salt sandwiches, or raw bacon)
  • Sleep-sex or "sexsomnia" (sexual acts carried out in your sleep)
  • Sleep-texting or sleep-tweeting7,8

Tips to Improve Your Sleep

Considering the virtually insignificant benefit sleeping pills provide—say an extra 15 minutes at best—are they really worth the potential risks? Small adjustments to your daily routine and sleeping area can go a long way toward ensuring you uninterrupted, restful sleep, without the added hazards. To get you started, check out the suggestions listed in the table below. For even more helpful guidance on how to improve your sleep, please review my 33 Secrets to a Good Night's Sleep.

If you're even slightly sleep deprived I encourage you to implement some of these tips tonight, as high-quality sleep is one of the most important factors in your health and quality of life. As for how much sleep you need for optimal health, a panel of experts reviewed more than 300 studies to determine the ideal amount of sleep, and found that, as a general rule, most adults need right around eight hours per night.

Optimize your light exposure during the day, and minimize light exposure after sunset

Your pineal gland produces melatonin roughly in approximation to the contrast of bright sun exposure in the day and complete darkness at night.

If you're in darkness all day long, your body can't appreciate the difference and will not optimize melatonin production. 

Make sure you get at least 30 to 60 minutes of outdoor light exposure during the daytime in order to "anchor" your master clock rhythm, in the morning if possible. More sunlight exposure is required as you age.

Once the sun sets, minimize artificial light exposure to assist your body in secreting melatonin, which helps you feel sleepy.

It can be helpful to sleep in complete darkness, or as close to it as possible. If you need navigation light, install a low-wattage yellow, orange, or red light bulb.

Light in these bandwidths does not shut down melatonin production in the way that white and blue light does. Salt lamps are great for this purpose.

Address mental states that prevent peaceful slumber

A sleep disturbance is always caused by something, be it physical, emotional, or both. Anxiety and anger are two mental states that are incompatible with sleep.

Feeling overwhelmed with responsibilities is another common sleep blocker. To identify the cause of your wakefulness, analyze the thoughts that circle in your mind during the time you lie awake, and look for themes.

Many who have learned the Emotional Freedom Techniques (EFT) find it is incredibly useful in helping them to sleep.

One strategy is to compile a list of your current concerns, and then "tap" on each issue. To learn how to tap, please refer to our free EFT guide.

Keep the temperature in your bedroom below 70 degrees Fahrenheit

Many people keep their homes too warm at night.  Studies show that the optimal room temperature for sleep is between 60 and 68 degrees Fahrenheit.

Take a hot bath 90 to 120 minutes before bedtime

This raises your core body temperature, and when you get out of the bath it abruptly drops, signaling your body that you're ready for sleep.

Avoid watching TV or using electronics in the evening, at least an hour or so before going to bed

Electronic devices emit blue light, which tricks your brain into thinking it's still daytime. Normally, your brain starts secreting melatonin between 9 pm and 10 p.m., and these devices may stifle that process.

If you have to use your cellphone or computer at night, downloading a free application called F.lux will automatically dim your computer device screens as the evening wears on.9

Be mindful of electromagnetic fields (EMFs) in your bedroom

EMFs can disrupt your pineal gland and its melatonin production, and may have other detrimental biological effects. A gauss meter is required if you want to measure EMF levels in various areas of your home. Ideally, you should turn off any wireless router while you are sleeping—after all, you don't need the Internet when you sleep.

Develop a relaxing pre-sleep routine

Going to bed and getting up at the same time each day helps keep your sleep on track, but having a consistent pre-sleep routine or "sleep ritual" is also important.

For instance, if you read before heading to bed, your body knows that reading at night signals it's time for sleep.

Sleep specialist Stephanie Silberman, PhD suggests listening to calming music, stretching or doing relaxation exercises.10 Mindfulness therapies have also been found helpful for insomnia.11

Avoid alcohol, caffeine and other drugs, including nicotine

Two of the biggest sleep saboteurs are caffeine and alcohol, both of which also increase anxiety. Caffeine's effects can last four to seven hours.

Tea and chocolate also contain caffeine. Alcohol can help you fall asleep faster, but it makes sleep more fragmented and less restorative.

Nicotine in all its forms (cigarettes, e-cigs, chewing tobacco, pipe tobacco, and smoking cessation patches) is also a stimulant, so lighting up too close to bedtime can worsen insomnia. Many other drugs can also interfere with sleep.

Use a fitness tracker to help you get to bed on time, and track which activities boost or hinder deep sleep

To optimize sleep you need to go to bed early enough. If you have to get up at 6:30 a.m., you're just not going to get enough sleep if you go to bed after midnight.

Many fitness trackers can now track both daytime body movement and sleep, allowing you to get a better picture of how much sleep you're actually getting.

Newer fitness trackers like Jawbone's UP3 can even tell you which activities led to your best sleep and what factors resulted in poor sleep.

Thank you! Your purchases help us support these charities and organizations.