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Most OTC sleep-aid product labels caution patients with certain conditions to check with a doctor before taking the product. Such conditions include shortness of breath, asthma, emphysema, chronic pulmonary disease, glaucoma, and difficulty urinating due to enlarged prostate gland. The labels also warn against taking the product along with alcohol or other central nervous system depressants, such as sedatives or tranquilizers, because they heighten the depressant effect.

(Recently approved revisions in wording will appear on all labels by April 11, 1995: The words "breathing problems" will be used to describe shortness of breath and difficulty breathing related to obstructive pulmonary disease; "chronic bronchitis" will replace "chronic pulmonary disease"; and the word "asthma" will be removed. These changes will help consumers recognize respiratory distress symptoms more readily.)

Sleep-aids that contain aspirin must carry a warning to consult a doctor about Reye syndrome before giving the product to children and teenagers who have chickenpox or flu symptoms. Reye syndrome is a rare but serious disease that has been associated with use of aspirin in children with these conditions. This warning may also appear on products containing other salicylates. These drugs should not be given to children under 12, and they should not be used for more than two weeks unless under a doctor's direction. Pregnant and nursing women should check with a doctor before taking these products.

OTC nighttime sleep-aids can provide welcome relief from a night of wide-eyed wakefulness. OTC status does not, however, guarantee the product is hazard-free. Just like prescription drugs, OTC drug products must be used with care.

"The bottom line for all OTC drug products," says FDA's Benson, "is to read the label and follow the instructions."

The Doxylamine Dilemma

In 1978, FDA approved a new drug application providing for OTC marketing of doxylamine succinate for nighttime sleep-aid use.

Subsequently, the National Cancer Institute found that methapyrilene, an antihistamine similar to doxylamine, was a potent cancer-causing agent in rats. As a result, methapyrilene was removed from the market in 1979. This prompted FDA's National Center for Toxicological Research to study doxylamine for carcinogenicity and chronic toxicity.

The scientists gave mice and rats variable doses of doxylamine in their feed for two years and then examined their tissues.

"We got the study results in 1991, and they were inconclusive," says FDA microbiologist Katharine Freeman. "There were no significant differences in survival in the treated or nontreated rats or mice, and it was impossible to say if the changes seen in some animals — like tumors and liver toxicity — were species-specific, or if the findings were relevant to human use. We were left with the problem of how to deal with such nebulous findings."

At FDA's request, the Pulmonary-Allergy Drugs Advisory Committee evaluated the data and concluded doxylamine would not likely cause cancer in humans. It recommended OTC status, but suggested the rodent findings be included in the product labeling.

Concerned about how to present the information in a way that would be useful to consumers, FDA in 1993 asked its newly formed Nonprescription Drugs Advisory Committee for recommendations about doxylamine and its labeling.

This committee agreed with the pulmonary-allergy panel that doxylamine is unlikely to cause cancer in humans and is safe for OTC use. It recommended, however, that there be no statement about tumors in the labeling, but that FDA present the information in an agency talk paper and FDA Consumer article. In January 1994, FDA amended the monograph for OTC antihistamine drug products to include doxylamine succinate.

Tricks for the Tired

If you're having trouble sleeping, you may want to try modifying some behaviors that might be keeping you awake. The American Sleep Disorders Association suggests one or more of the following practices might help:

• Get up about the same time every day, regardless of when you go to bed.
• Go to bed only when sleepy.
• Establish relaxing pre-sleep rituals, such as a warm bath, light bedtime snack, reading, or watching television.
• Exercise regularly. Get vigorous exercise — such as jogging or squash — in the late afternoon, and mild exercise — such as simple stretching or walking — two or three hours before bedtime.
• Don't eat or drink caffeine-containing products within six hours of bedtime. It's better not to smoke at all, but if you do, avoid smoking at bedtime. Caffeine and nicotine are both stimulants. Even if they don't interfere with falling asleep, they may trigger awakenings later.
• Don't drink alcoholic beverages at bedtime. A nightcap may induce sleep, but it can interfere with sound sleep through the night.
• Don't nap, unless you find that naps don't interfere with sleep later on.
• If you often worry at bedtime, reserve another time of day for working on problems.
• If you can't sleep, get out of bed and go to another room to read or watch television.

You may want to try sleep restriction. This strategy is based on the finding that many insomniacs spend excessive time in bed, hoping to make up for lost sleep.

Go to bed later than usual, and get up at the same time each morning. Stay in bed only as long as you actually sleep, even if it's only a few hours. When you sleep at least 90 percent of your allotted time in bed for five days in a row, go to bed 15 minutes earlier. After a week or two you should be sleeping better and, after a few months, as long as you want.

While you can try this on a do-it-yourself basis, ASDA says, it is generally more easily done under the supervision of a sleep specialist.

Tags: Sleep

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.