NewYork-Presbyterian. The University Hospital of Columbia and Cornell.

-- Although many pediatricians recommend an antihistamine most commonly sold as Benadryl® for babies who have trouble sleeping, a new study finds the antihistamine does not work as a pediatric sleep aid.

In a report published this week in the Archives of Pediatrics and Adolescent Medicine, researchers found that diphenhydramine (the generic name for Benadryl) was more likely to keep children awake.

Among the children studied, just one out of 22 showed improvement in sleeping after being given diphenhydramine, compared with three of the 22 children who received a placebo.

Because of the medication's lack of effectiveness, a data safety monitoring board shut down the study early.

Babies Studied

In their study, called TIRED (Trial of Infant Response to Diphenhydramine), Dr. Dan Merenstein and colleagues tracked 44 babies, ages 6 months to 15 months, for six weeks.

Dr. Merenstein currently is a pediatrics specialist at Georgetown University Medical Center in Washington, D.C. He was at Johns Hopkins School of Medicine in Baltimore during the time of the study.

During the study, parents kept diaries to record the sleep habits of the babies throughout the night. All were given Benadryl or a placebo for one week, 30 minutes before anticipated bedtime. The days before and after treatment were monitored to record the outcome.

"The kids got more hyperactive on Benadryl," Dr. Merenstein says. "Studies show that about 7 to 10 percent of kids do become hyperactive on Benadryl."

Works for Adults, Not Children

Benadryl often makes adults sleepy, so many people think it would have the same effect on children, Dr. Merenstein says.

"The problem is that certain medicines work differently in an adult than in a kid, and Benadryl might be one of those," he says.

"We really don't have many medicines to get kids to sleep," Dr. Merenstein adds. "None of the sleep medicines are approved for kids. There is no quick fix for sleep problems for kids."

"Important aspects of a young child's health care, such as proper food intake and sleep routine, often are based on assumptions," they write. "Our study results illustrate that such assumptions may be wrong and should be subjected to study in life laboratories."

A spokeswoman for Pfizer, the maker of Benadryl, says the company does not recommend using the medication as a sleep aid for children.

"Benadryl is a very safe and effective medicine to relieve allergy symptoms," says Erica Johnson of Pfizer. "It is not intended as a sleep medication. That's not the intended use of the product. That's not how we recommend it be used."

Dr. Daniel Rosenbaum, an associate professor of pediatrics at Dartmouth Medical Center, thinks giving Benadryl to babies who have trouble sleeping is another example of something that doctors think should work, without any real evidence to back it up.

"There are a lot of things we do in medicine that are conventional wisdoms," Dr. Rosenbaum says. "But we really have no idea if it's a good or effective thing to do. This is just one of them."

"Based on this study, offering Benadryl to kids is probably not the right thing to do," he adds.

Dealing with a Child's Sleep Issues

As far as helping children sleep, Dr. Rosenbaum says that time typically solves the problem.

"At some point, all kids will become normal sleepers," he says. "Just like walking and other developmental milestones, it's going to take its own time. There is probably little that parents can do to make this happen."

Another pediatrician thinks sleep problems in children result from having to sleep alone.

"The authors are correct in noting that we as clinicians have little education about dealing with sleep disturbances, but we are also one of the few nations who believe that infants should sleep alone in a room away from parents," says Dr. Carol D. Berkowitz, a professor of clinical pediatrics at the University of California, Los Angeles' David Geffen School of Medicine.

"I once heard a comment from a 4-year-old who came into her parent's room complaining about having to sleep alone," Dr. Berkowitz adds. "She said, 'How come you are grownups, and you get to sleep with someone, and I'm just a little kid, and I have to sleep alone?' "

In their article, the study authors state, "Many in the medical and lay community accept diphenhydramine as effective treatment for sleep problems. Unfortunately, this attitude is based on anecdote and studies of adult physiological interactions."

The results of this study "demonstrated that at the most commonly used dose, diphenhydramine may play no role in treating infant sleep problems," the authors continue.

More rigorous studies are needed regarding effective treatment for sleep problems in children, the authors conclude.

Always consult your child's physician for more information.