Use OTC Sleep Aids With Caution

The sleeping pill of choice for many Americans with insomnia can be purchased over the counter at drug and grocery stores. But a new study shows that many older adults who use OTC sleep aids know little about them and may be using them in ways that do more harm than good.

Sleeping pill users should read the label of OTC sleep medicationsIt annoys me when people dismiss sleeping pills as categorically harmful. Yes, they can be used inappropriately and it’s important to be informed about their downsides. But the existence of downsides doesn’t necessarily mean the risks associated with using them outweigh the benefits.

The sleeping pill of choice for many Americans with insomnia can be purchased over the counter at drug and grocery stores. But a new study shows that many older adults who use OTC sleep aids know little about them and may be using them in ways that do more harm than good.

Older Americans Use Them and Like Them

Participants in the new study were adults in the United States aged 60 and older who were managing their sleep problems with nonprescription sleep aids. University of Pittsburgh investigators interviewed 116 by telephone and found that well over half were satisfied with their medication and felt it improved their sleep.

Asked about her satisfaction with one such drug, an interviewee replied that she was “pretty satisfied. It does help me fall asleep and stay asleep, and go back to sleep when I invariably get up once or twice a night.”

“There is a dramatic difference when I use it versus when I don’t,” another explained.

This jibes with the results of other, quantitative research. The prevalence of insomnia and other sleep problems among older adults is high and OTC sleep aids are widely available. About 17% of older adults in the United States turn for relief to antihistamine-containing sleep aids like Unisom and Simply Sleep.

How OTC Sleep Aids Work

Diphenhydramine and doxylamine are the active ingredients in antihistamine sleep aids. They block the action of histamine neurons, which are generally active when we’re awake and inactive when we’re asleep.

“Marked drowsiness may occur,” is the type of warning that usually appears on the label. This propensity to cause sedation is likely why, despite few controlled trials supporting their efficacy for insomnia, these drugs are seen as effective by many older adults. The trials that have been conducted suggest these antihistamine sleep aids may have more to offer sleep maintenance insomniacs than people who need help falling asleep at the beginning of the night.

Side Effects of OTC Sleep Aids

But like most prescription medications, OTC sleep aids are not intended for nightly or long-term use. Continuous use has been found to lead to the development of tolerance, tempting users to take more of the drug to get the same sedative effect. Yet in the Pittsburgh study, nearly half of the participants reported using OTC sleep meds daily or very often. Over half reported using them for more than a year.

Fewer than a quarter of the study participants had studied the label on their medication to find out about the recommended dosage or about warnings and possible side effects.

“I never really paid any attention to the directions,” an interviewee said. “I take a couple before I go to bed, about twenty minutes before I go to sleep, I go upstairs and go to bed. That’s it.”

Common side effects to be aware of are morning grogginess (our bodies process drugs more slowly as we age) and blurred vision, constipation, and trouble urinating (for more on this, see my post on OTC sleep aids and anticholinergic effects).

Drug-Drug Interactions

Possible drug-drug interactions is another factor to take into account, given that almost 40% of older Americans are taking five or more prescription medications. Studies have shown that diphenhydramine (the main ingredient in many OTC sleep aids, including Benadryl, Sominex, Nytol, ZzzQuil, and Simply Sleep) interferes with the body’s metabolizing of at least three commonly prescribed drugs:

  1. tamoxifen, an anti-estrogen drug used to treat breast cancer and lower breast cancer risk
  2. metoprolol (Lopressor), a beta blocker used to treat high blood pressure and heart problems
  3. venlafaxine (Effexor), a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) used to treat depression

Reducing the effectiveness of a drug taken to manage a serious health condition isn’t something most of us would want to do. But information about all possible drug-drug interactions isn’t necessarily listed on the label of OTC sleep aids.

Americans seem to have the attitude that OTC meds are harmless—but that isn’t necessarily true. If you’re going to use an OTC sleeping pill, read the label for information about the proper dosage and potential side effects. Take concerns about possible drug-drug interactions to your doctor or pharmacist.

Over-the-Counter Sleep Aids Aren’t Harmless

Americans love over-the-counter (OTC) sleep aids. In 2015 we spent $427 million on products like ZzzQuil, Unisom, and Sominex.

These drugs are advertised “for relief of occasional sleeplessness.” Yet many Americans—particularly older adults—use OTC sleep aids several nights a week and may want to consider scaling back because of the side effects.

Older insomniacs may want to scale back on use of over-the-counter sleeping pillsAmericans love over-the-counter (OTC) sleep aids. In 2015 we spent $427 million on products like ZzzQuil, Unisom, and Sominex.

These drugs are advertised “for relief of occasional sleeplessness.” Yet many Americans—particularly older adults—use OTC sleep aids several nights a week and may want to consider scaling back because of the side effects.

Why So Popular?

Some long-time insomnia sufferers are quick to dismiss OTC sleeping pills as worthless.

“They’re like nothing burgers to me,” said Melissa, a lifelong insomniac I interviewed for my book.

Others say these drugs help them sleep. Research does indicate that the active ingredient in these medications—diphenhydramine or doxylamine—has a sedative effect. All of these first generation antihistamine drugs block secretion of histamine, a neurotransmitter associated with wakefulness.

Other factors accounting for the popularity of OTC sleep aids include their ready availability and relatively low cost; the widespread belief in the safety of OTC medications in general; and the fact that insomnia is such a common problem.

Why Such Mixed Appeal?

There’s no clear explanation for their mixed appeal among people with insomnia.    

“The problem is that there is not a whole lot of research on these medications,” said Dr. David Neubauer, associate professor of psychiatry at Johns Hopkins University School of Medicine and associate director at the Johns Hopkins Sleep Disorder Center, in a Medscape program on insomnia aired a few years ago. “Not much efficacy support exists.”

Labels on some of these sleep aids state that the product “reduces the time it takes to fall asleep if you have difficulty falling asleep.” But results of the few studies conducted in recent years do not back this claim up. Diphenhydramine has not been shown to put people to sleep any faster than placebo.

So sleep onset insomniacs—those whose sleep problem occurs at the beginning of the night—may not have much luck with OTC sleep aids.

Sleep maintenance insomniacs—those with trouble staying asleep—may fare a little better. A small amount of evidence suggests that diphenhydramine can reduce the number of nighttime wake-ups and improve sleep efficiency.

Dependency and Tolerance

Drug companies promote these sleep aids as “non-habit forming.” The fact that they can be purchased without a prescription indicates that healthcare professionals evaluating diphenhydramine and doxylamine for the FDA felt the risk of developing a dependency was low.

But tolerance to the drugs may build up if they’re used too frequently. Research suggests that if you take them every night, you’ll wind up needing to increase the dose to get the same sedative effect.

Long-Lasting Sedative Effects

Another problem with these antihistamines is that their sedative effects are fairly long lasting. “The elimination half-life is relatively long, so patients often experience morning grogginess,” Neubauer said. (Half-life is the time it takes for a dose of a drug in the blood plasma to decrease by half.)

Diphenhydramine has a half-life of 2.4 to 9.3 hours, and its half-life tends to increase with users’ age. The half-life of doxylamine is about 10 hours and may be longer in older adults. Morning grogginess increases the risk of falls and driving incidents.

“Dirty” Drugs

The other big problem with these OTC sleeping pills is their many nasty side effects.

“Most problematic would be the potential for anticholinergic effects,” Neubauer said. Common anticholinergic effects include blurred vision, constipation, decreased sweating, dizziness, dry mouth, and difficulty urinating and/or kidney failure.

“If people are taking too much of these medications or taking them in conjunction with other medications that might have anticholinergic effects, they can have side effects like delirium, confusion, dry mouth, or constipation. I have seen people with complete urinary retention caused by adding some diphenhydramine to their medication regimen to try to sleep better,” Neubauer said.

Anticholinergic drugs also put users at increased risk of developing dementia.

How Much Is Too Much?

The warnings I see in the literature these days are mainly directed at older adults, whose bodies process drugs more slowly and who are also more likely to be taking other anticholinergic drugs.

“Older adults are more likely to take diphenhydramine or doxylamine products 15 or more days in a month, an indicator of inappropriate use,” state the authors of a paper on the use of OTC sleep aids in older adults.

These authors are speaking to fellow physicians—but older adults who use these medications should also take note. It may be time to pull back on use of OTC sleep aids and look for other ways to get a good night’s sleep.

Hands Off My Sleep Meds, Dr. Oz!

Last week Dr. Oz hosted a show about “killer” sleeping pills. Now, there are lots of reasons to be cautious about sleep meds, including the fact that some leave you feeling groggy in the morning.

But when celebrities like Dr. Oz use information like this to whip up hysteria about sleeping pills, it makes my blood boil.

boxerLast week Dr. Oz hosted a show about “killer” sleeping pills.

Now, there are lots of reasons to be cautious about sleep meds, including the fact that some leave you feeling groggy in the morning. The FDA in January lowered the recommended dose of zolpidem (a.k.a. Ambien) from 10 mg. to 5 mg. for women, based on reports that women tend to metabolize the drug more slowly than men. The resulting morning grogginess can impair driving.

But when celebrities like Dr. Oz use information like this to whip up hysteria about sleeping pills, it makes my blood boil.

Consider the opener to the show.

“This is breaking news!,” Dr. Oz shouted. “There’s an alarming link between prescription sleep aids and an increased risk of cancer and death!”

“Women taking less than 18 pills had a 3½ times greater risk of increased mortality,” Dr. Michael Breus chimed in.

Oh really, doctors? Reports of the study you’re referring to first came out a full year ago. That study had serious limitations, including that the data did not show whether the increased mortality was in fact linked to the use of sleeping pills or rather to insomnia itself. Minor point.

There is nothing “breaking” about this news. But it’s a hell of an opener if your aim is to demonize sleeping pills.

Zolpidem’s Effect on Morning Driving

“Sleeping pills alter your state of consciousness,” said Dr. Breus, preparing us to understand the harm they do.

Well, duh. If I wanted to remain in a waking state all night, I’d play Monopoly and sip Kool-Aid.

“Alcohol moves out of your system faster than sleeping pills,” he added.

The statement is misleading, at best. Some sleeping pills have very short half-lives. (Take Sonata [zaleplon] with its half-life of one hour.) Others stick around in your body for many hours.

Like alcohol, sleeping pills can produce a “hangover” and cause traffic accidents, Breus said.

A Closer Look

Let’s look more closely at the comparison. The FDA has received about 700 reports of zolpidem-related driving incidents in all, according to The New York Times. Contrast this with the nearly 9,900 traffic fatalities attributable to alcohol in the year 2011 alone.

One sleeping pill-related driving incident is one too many, I think we’d all agree. But in withholding information about the scale of the problem, the doctors imply that the danger sleeping pills pose to driving is greater than it actually is.

Many sleep experts think sleeping pills are over-prescribed, and I do not doubt this claim. Prescriptions shouldn’t be tossed out like candy in cases where there are safer ways to get sound sleep.

But sleeping pills can be a godsend for people constitutionally predisposed to poor sleep. Dr. Oz’s show was not so much alarming as alarmist. It did nothing to promote thoughtful dialog on the safety and appropriate use of sleeping pills.