MONDAY, July 3, 2006 (HealthDay News) -- Although many pediatricians recommend Benadryl for babies who have trouble sleeping, a new study finds the antihistamine doesn't work as a pediatric sleep aid.
In fact, the researchers found that Benadryl was more likely to keep children awake. Among the children studied, just one out of 22 showed improvement in sleeping after being given Benadryl, compared with three of the 22 children who received a placebo.
Because of Benadryl's lack of effectiveness, a data safety monitoring board shut down the study early.
The report was published Monday in the July issue of the Archives of Pediatrics & Adolescent Medicine.
"Benadryl is widely used, parents use it, physicians recommend it to help kids sleep," said study lead author Dr. Dan Merenstein, a pediatrics specialist at Georgetown University Medical Center.
"But the bottom line is, it doesn't work," he added.
A spokeswoman for Pfizer, the maker of Benadryl (diphenhydramine), said the company doesn't recommend using the drug as a sleep aid for children.
"Benadryl is a very safe and effective medicine to relieve allergy symptoms," said Erica Johnson. "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."
In their study, called TIRED (Trial of Infant Response to Diphenhydramine), Merenstein and his colleagues tracked 44 babies, ages 6 months to 15 months, for six weeks.
During this time, 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, and the days before and after treatment were monitored to record the outcome.
"The kids got more hyperactive on Benadryl," Merenstein said. "Studies show that about 7 to 10 percent of kids do become hyperactive on Benadryl."
Benadryl often makes adults sleepy, so many people think it would have the same effect on children, Merenstein said. "The problem is that certain medicines work differently in an adult than in a kid, and Benadryl might be one of those," he said.
"We really don't have many medicines to get kids to sleep," Merenstein added. "None of the sleep medicines are approved for kids. There is no quick fix for sleep problems for kids."
Merenstein suggested that parents try the so-called Ferber Method, named after Dr. Richard Ferber, the director of the Center for Pediatric Sleep Disorders at Children's Hospital Boston. Under his method, parents simply put their child to bed and comfort him, but if he cries, they let him cry himself to sleep. Over time, babies will learn to sleep if crying isn't reinforced, the method contends.
Parents can also try behavioral therapy, Merenstein said.
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," Rosenbaum said. "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 added.
As far as helping children sleep, Rosenbaum said that time typically solves the problem. "At some point, all kids will become normal sleepers," he said. "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," said 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," Berkowitz added. "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?' "
The National Sleep Foundation can tell you more about helping children sleep.