Sleep Drugs Get Stronger Warnings of Side Effects, Problems

March 2007

Medicines used to treat insomnia and sleep disorders must now carry strengthened warnings about potential side effects and problems. The insomnia report on this Web site (click here) already discusses some of these problems.

The Food and Drug Administration (FDA) has ordered changes to the labeling for 13 drugs. If you are taking one of the following medicines, or any drug for insomnia or other sleeping problems, you should read up on the new warning. You may want to check in with your doctor, too. Don’t stop taking the medicine, however, before you check with your doctor. The drugs are:

• Ambien, Ambien CR (zolpidem)
• Butisol sodium (butabarbital)
• Carbrital (pentobarbital and carbromal)
• Dalmane (flurazepam)
• Doral (quazepam)
• Halcion (triazolam)
• Lunesta (eszopiclone)
• Placidyl (ethchlorvynol)
• Prosom (estazolam)
• Restoril (temazepam)
• Rozerem (ramelteon)
• Seconal (secobarbital)
• Sonata (zaleplon)

Many of these medicines, including Ambien, are available as generics, so check the names in parentheses, too.

The strengthened warnings pertain to two things:

• Allergic reactions – These are rare, but some of the medicines listed above have been found to cause a severe reaction in which airway passages swell. This can close off your wind pipe, making it difficult to breathe. Such reactions can be life-threatening and require immediate medical attention.

• Strange behaviors – These also appear to be rare, but all these medicines, the FDA now believes, have the potential to permit people to rise from sleeping and do things without being fully awake or remembering what they did. Put another way, they can produce a condition in which the brain is essentially asleep (unconscious) but the body and motor functions are “awake.” Reported behaviors included walking, cooking, eating, and driving while asleep, and even making phone calls. In one reported case, a person painted her front door. Again, the next day, you may not remember any of what happened.

The strengthened warnings will also underscore that sleeping pills and alcohol don’t mix. Alcohol consumption – even just a few drinks – may enhance the “strange behavior” effect. In addition, sleeping pills and alcohol have an adverse additive effect that increases the risk of what is called “next-day drowsiness.”

Next-day drowsiness is already a potential side effect of sleep drugs. If you have a few drinks along with a sleeping pill, before going to bed, you are substantially more likely to have trouble getting up the next day, and less likely to be able to go to work and function normally.

In addition, the companies will now have to warn both doctors and patients more clearly that sleeping pills should not be combined – or combined only when necessary – with other medicines that “depress” the central nervous system. This includes a wide array of medicines – antidepressants, antipsychotics, and seizure drugs, for example.

Both you and your doctor need to be vigilant about this, the FDA advises. Antidepressants, in particular, are among the most widely prescribed drugs in the U.S. But many people may not tell all their doctors they are taking one. And they may have filled a prescription for a sleep drug and an antidepressant at different pharmacies.

The best policy if you are getting a prescription for a sleep drug is to tell the doctor about all the other drugs you are taking.

Remember also: if you are struggling with sleep problems, first consider non-drug measures, such as improving sleep routines and habits, relaxation techniques, and addressing underlying health problems. If you suffer from chronic insomnia – lasting months, talk to your doctor about behavioral therapy.

If you need help sleeping for a night or two because of stress, illness, or jet lag, try nonprescription (over-the-counter) sleep aids containing antihistamines (such as Nytol, Sominex, Tylenol PM, and Unisom). These are often just as effective as prescription sleeping pills for short-term use.

The FDA has asked companies to produce “patient medication guides” to go along with the prescription drugs listed above. As with other such guides, these will be given to you when you fill or refill your prescription.

The new rules also mean that both doctor-directed and consumer-directed ads for sleep drugs will have to more prominently mention the potential side effects. The FDA has asked the companies to conduct more research on frequency of the strange behavior effect, too.