The U.S. Food and Drug Administration (FDA) has ordered the makers of some sleep aids to reduce recommended doses for the drugs. The decision came after the FDA reviewed recent driving simulation studies. They showed that the drugs remained in some people's bodies enough to affect driving 8 hours later. The new rule applies to sleep aids that contain the drug zolpidem. The drugs include Ambien, Edluar, Zolpimist and others. Problems with driving were seen most often in women. They process the drug more slowly than men. Therefore, the recommended dose for women will be cut in half, from 10 milligrams to 5 milligrams for regular products. Extended-release doses will drop from 12.5 to 6.25 milligrams. The FDA recommends that these doses apply to men, too. However, the changes will not be required for men. The Associated Press wrote about the announcement January 10.
By Howard LeWine, M.D.
Harvard Medical School
What Is the Doctor's Reaction?
Drugs for sleep have been around for decades. Barbiturates were popular in the '50s and '60s. They fell out of favor because of the high risk of dependency and overdose.
Next came the Valium-like drugs. The official name is benzodiazepines. They were somewhat safer than the barbs. But regular use of benzos also leads to dependency for sleep. Some of them stay in the body a long time. And nightly use causes drug effects to linger well into the next day.
In the early 1990s, the U.S. Food and Drug Administration (FDA) approved Ambien (the generic name is zolpidem). It was supposed to be an improvement over drugs like Valium. It appeared to leave the body faster and have fewer side effects. Supposedly, this allowed people to wake up feeling refreshed and have normal daytime functioning.
Other non-benzodiazepines followed the approval of zolpidem. These include eszopiclone (Lunesta) and zaleplon (Sonata).
As with all drugs for sleep, including over-the-counter sleep aids, daytime drowsiness and other side effects can occur in anyone. The same has been true for zolpidem and the other newer drugs.
Zolpidem and the others are effective, particularly if the difficulty is getting to sleep. But many people who start taking one of them don't like to give it up. The drugs are not approved for long-term use, but many people do take them that way.
Sometimes smaller doses of sleeping pills become less effective, so people go to a higher dose. And that is just the opposite of what the FDA wants. The recommended doses for zolpidem are already too high for many folks, especially women and older adults.
What Changes Can I Make Now?
Before you turn to sleeping pills, try these tips to help you get a better night's sleep:
- Get regular exercise. It boosts the effect of natural sleep hormones such as melatonin. Watch the timing of your workouts. Exercising too close to bedtime can be stimulating. Morning is best.
- Reserve bed for sleep and sex. Don't use your bed as an office for answering phone calls and responding to e-mails. Also avoid watching late-night TV there.
- Keep your bedroom cool, quiet and dark.
- Start a sleep ritual. Bedtime rituals help signal the body and mind that it's coming to be time for sleep. For example, take a bath. Or listen to calming music to unwind before bed.
- Eat, but not too much. A grumbling stomach can be distracting enough to keep you awake. But so can an overly full belly. Avoid eating a big meal within two to three hours of bedtime. If you're hungry right before bed, eat a small, healthy snack.
- Avoid alcohol and caffeine before bed. Like caffeine, alcohol actually acts as a stimulant.
- Learn to relax. Give yourself time to wind down before bed. To relax, try deep breathing exercises.
You may still need medicine to help you sleep. If you do, use it only from time to time, or at most once or twice a week.
With any new sleep drug, start with one-half the usual dose. That might be enough for you. Ideally, take your first dose on a night when you have nothing special planned the next morning and you won't need to drive.
What Can I Expect Looking to the Future?
The FDA has required dose changes for zolpidem based on driving simulation studies. You can expect these same studies to be done on other sleeping pills. Meanwhile, it's always a good idea to see if a lower dose might work just as well for you.