The Food and Drug Administration has issued an announcement that could affect millions of Americans who take some of the most common medications for sleep. The FDA said it will require drug makers who produce sleep medications containing zolpidem to reduce some of their recommended dosages, cutting them by half.
Zolpidem is the active component in some of the most frequently prescribed sleep medications on the market, including Ambien, Ambien CR, Edluar, and Zolpimist, as well as generic versions of these drugs.
The new requirements put specific focus on lowering the recommended dosage for women. This comes as a result of research showing that morning blood levels of the medication may be high enough to reduce alertness and interfere with activities such as driving. The research indicates that women are at higher risk for this morning-after impairment from sleep medications containing zolpidem because it takes significantly longer for women’s bodies to process and eliminate the drug from their systems, compared to men’s. The goal in lowering dosage of zolpidem medications is to lower the levels of the medication in the blood by morning, thereby reducing the risk of early-in-the-day drowsiness and impairment.
The FDA’s research also indicates that the problem of next-day impairment from zolpidem is greatest with the extended release version of this type of medication, including Ambien CR and generic types.
Intermezzo, a zolpidem medication released in 2011, is not affected by these changes. Intermezzo, a prescription sleep aid that is targeted for people who wake in the night after initially falling asleep, already carries a lower dose of zolpidem than other medications that are designed to address difficulties falling asleep.
The FDA also announced that it would continue to research the impairment risks of other prescription medications and over-the-counter sleep aids.
The required changes to the recommendations dosages for sleep medications containing zolpidem are as follows:
- For women, the recommended dose should be lowered from 10 milligrams to 5 milligrams. For the extended-release versions, the recommended dose should be lowered from 12.5 milligrams to 6.25 milligrams
- The FDA will not require that the recommended dose for men be lowered. However, it suggests that medical professionals warn all patients, men and women, about the risks of morning drowsiness and impairment, particularly for activities such as driving.
I understand the FDA’s concerns. But I see a couple of additional issues that may contribute to the early-in-the-day drowsiness and impairment that people experience while taking these sleep medications.
- Not enough time in bed. Patients who are prescribed sleep medication with zolpidem are not giving themselves enough time in bed for sleep after taking their dose in the evening. In a clinical setting, it is a standard recommendation that people taking this type of sleep medication have a full 8 hours to spend in bed. It would not surprise me if some people who are taking zolpidem are not giving themselves sufficient time for a full night’s sleep, during which time the drug’s effects would subside.
- Patient Compliance. Another possible issue has to do with patient compliance. People who take something other than their prescribed dose, or fail to follow directions on the timing of their dose, may encounter next-day drowsiness as a problem.
In either case, patient education is critical. Doctors who prescribe these sleep medications must be thorough in educating their patients on the proper use of these powerful drugs. And patients must listen to—and follow through with—their doctors’ instructions.
I do have concerns about the response that may follow these new lower-dosage recommendations. In my experience in clinical practice, the 10-milligram dose of zolpidem is usually the most effective dose for treating insomnia. I worry that patients who are moved to a lower dosage will simply take twice as much of their medication, in an attempt to reach the desired effect of their previously higher dose. Again, compliance is a critical issue: if you are a patient taking this type of sleep medication, it’s important that you follow your prescribing physician’s instructions, including sticking to the right dose.
It’s also important to keep in mind that there are low-cost, effective, non-chemical alternatives to prescription sleep medication. Drug therapy for sleep is just one option for treatment, and in some cases it will be the best option. But don’t overlook these alternatives:
Cognitive-Behavioral Therapy (CBT): I’ve written before about the power of CBT in improving sleep. Studies show that CBT can be as effective or even more effective than drug therapy. And this type of therapy doesn’t always have to be an extended, long-term endeavor: research shows that targeted, short-term behavioral therapy can improve sleep for people with insomnia.
Meditation and Relaxation: Mind-body therapies such as meditation and relaxation can also help to improve sleep, and diminish symptoms of insomnia and other sleep disorders. Relaxation techniques such as deep breathing exercises, muscle relaxation, and visualization techniques are recommended treatments for sleep by the American Academy of Sleep Medicine. This is a growing area of sleep research, which shows promise in treating sleep disorders such as insomnia and restless leg syndrome.
Sleep Restriction: This is a behavioral therapy that limits time spent in bed as a way to improve sleep. Rather than tossing and turning in bed, feeling frustrated and anxious at not falling asleep, get out of bed. Find a quiet place to relax (not in front of the television), until you feel ready to go back to bed and sleep. Sleep restriction also involves keeping regular morning wake times, and not staying in bed longer in the morning in order to make up for sleep lost at night.
Hearing reports such as these can be unsettling. But making abrupt changes to your prescription sleep medication is not a good idea. If you’re taking a zolpidem sleep medication, you should continue to take your regular dose until your prescribing physician makes a change. Do not make a change to your dose on your own. Talk with your doctor and follow his or her recommendation.
Michael J. Breus, PhD
The Sleep Doctor™