Common Antihistamine No Help for Getting Children to Sleep

< July 5, 2006 > -- 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.

Children and Sleep

The normal amount of sleep varies depending on the age of your child.

For example, babies from birth to about three months of age generally sleep eight to nine hours a night, waking during the night for feeding. They average about 8 hours of sleep during the daytime.

Infants between six and twelve months generally sleep 10 to 12 hours a night, and about 5 hours during the day.

By two years of age, children sleep about 10 to 12 hours per night, but somewhat less during the day.

Between three and six years of age, children sleep about 10 hours per night, and may not nap during the day, especially after about 4 years of age.

Helping Children with Poor Sleep Habits

Children can easily fall into bedtime habits that are not always healthy habits. The following suggestions can help when a child does not want to go to bed or is having trouble staying in bed:

• If your child cries, speak calmly and reassure him/her, "You are fine. It is time to go to sleep." Then leave the room.

• Do not give a bottle or pick up your child.

• Stretch out the time between trips to the room if your child continues. Do not do anything but talk calmly and leave.

• Your child will calm down and go to sleep if you stick to this routine. It may take several nights for your child to get used to the new plan.

• If your child is used to getting a large amount of milk right at bedtime, start to cut down the amount of milk in the bottle by 1/2 to 1 ounce each night until the bottle is empty and then take it away completely.

• Sometimes children get out of their routine of night sleeping because of an illness or travel. Quickly return to good sleep habits when things are back to normal.

Always consult your child's physician for more information.

Online Resources

(Our Organization is not responsible for the content of Internet sites.)

Centers for Disease Control and Prevention (CDC)

National Center on Sleep Disorders Research

National Institute of Child Health and Human Development

National Institutes of Health (NIH)

National Sleep Foundation - Children and Sleep

Sleep Research Society