Trouble putting the kids to sleep?

July 03, 2006

Washington, D.C. − Although about half of pediatricians recommend that children under age 2 can be given diphenhydramine to help them sleep, the first study to look at effectiveness of the agent in children who are that young found no benefit.

In fact, the national study, conducted by researchers from Georgetown University Medical Center and published in the July issue of Archives of Pediatrics & Adolescent Medicine, found that the drug appeared to perform worse than a placebo agent. Only 1 out of 22 children showed improvement in sleeping after using diphenhydramine compared to 3 in 22 children who used a placebo. The drug, an antihistamine, is available over-the-counter in generic forms or as the name-brand drug, Benadryl®.

Because of diphenhydramine's obvious lack of effectiveness, the clinical trial's Data Safety Monitoring Board shut down the study early, says lead author, Dan Merenstein, M.D., an assistant professor in the Department of Family Medicine at Georgetown.

"This is a small study, but one with big implications, because it is looking at the effectiveness of a widely used drug that has not been examined for infant and toddler use," says Merenstein. Half of pediatricians recommend use of diphenhydramine, according to surveys, and many child-rearing books offer the same advice, "but because the drug works as a sleep aide for some adults, we pretend it works for everyone," he says.

Merenstein cautions that a larger study is needed to definitively prove that diphenhydramine doesn't work as thought in young children, but adds, "At this point I would advise parents to think about different methods to help a child sleep," Merenstein says.

Researchers at Johns Hopkins University, Virginia Fairfax University, and the University of Hawaii worked with Merenstein on the study, which he conducted at Johns Hopkins before coming to Georgetown.

The clinical trial, known as TIRED (Trial of Infant Response to Diphenhydramine), enrolled 44 children, age 6-15 months, with the participation of their parents, and followed the families for six weeks. During this time, parents kept diaries to record the sleep habits of their children throughout the night. Treatment with a placebo agent or diphenhydramine occurred during one week, and the days before and after treatment were recorded for comparison purposes. The study was blinded in that neither researchers nor parents knew which children received which treatment.

The investigators had hypothesized that, based on the sedative properties of diphenhydramine in adults, treated children would be more likely to fall asleep without any other help from their parents, and that doing so would lead them to associate the crib with sleep and comfort, helping them to fall back asleep if they woke up.

But Merenstein says the results were surprising. Diphenhydramine use was no more effective than a placebo in reducing nighttime awakening, "or improving overall parental happiness with sleep for infants," he says.

Merenstein also notes that while it is generally reported about 7 percent of diphenhydramine users become "hyperactive," and so have increased sleep problems, only one child showed some evidence of hyperactivity. Still, he says, "it is possible that diphenhydramine caused low-level hyperactivity in children, negating the sleep benefits seen in some adults, but we really don't know why it didn't work."

"The bottom line here is that parents and pediatricians should rely on evidence-based medicine and not on leaps of logic that border on folklore," Merenstein says.
-end-
The study was funded by grants from the Robert Wood Johnson Clinical Scholars Program.

The study's co-authors include Marie Diener-West, Ph.D. and Ann Halbower, M.D., from Johns Hopkins University; Alex Krist, M.D., from Virginia Commonwealth University, and Haya R. Rubin, M.D., Ph.D., from the University of Hawaii.

Editor's Note: To speak with Dr. Merenstein or to obtain a copy of the study, contact Liz McDonald at 202-687-5100.

About Georgetown University Medical Center
Georgetown University Medical Center is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through our partnership with MedStar Health). Our mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis--or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing and Health Studies, both nationally ranked, and the world renowned Lombardi Comprehensive Cancer Center. For more information, go to http://gumc.georgetown.edu.

Georgetown University Medical Center

Related Sleep Articles from Brightsurf:

Size and sleep: New research reveals why little things sleep longer
Using data from humans and other mammals, a team of scientists including researchers from the Santa Fe Institute has developed one of the first quantitative models that explains why sleep times across species and during development decrease as brains get bigger.

Wind turbine noise affects dream sleep and perceived sleep restoration
Wind turbine noise (WTN) influences people's perception of the restorative effects of sleep, and also has a small but significant effect on dream sleep, otherwise known as REM (rapid eye movement) sleep, a study at the University of Gothenburg, Sweden, shows.

To sleep deeply: The brainstem neurons that regulate non-REM sleep
University of Tsukuba researchers identified neurons that promote non-REM sleep in the brainstem in mice.

Chronic opioid therapy can disrupt sleep, increase risk of sleep disorders
Patients and medical providers should be aware that chronic opioid use can interfere with sleep by reducing sleep efficiency and increasing the risk of sleep-disordered breathing, according to a position statement from the American Academy of Sleep Medicine.

'Short sleep' gene prevents memory deficits associated with sleep deprivation
The UCSF scientists who identified the two known human genes that promote 'natural short sleep' -- nightly sleep that lasts just four to six hours but leaves people feeling well-rested -- have now discovered a third, and it's also the first gene that's ever been shown to prevent the memory deficits that normally accompany sleep deprivation.

Short sleep duration and sleep variability blunt weight loss
High sleep variability and short sleep duration are associated with difficulties in losing weight and body fat.

Nurses have an increased risk of sleep disorders and sleep deprivation
According to preliminary results of a new study, there is a high prevalence of insufficient sleep and symptoms of common sleep disorders among medical center nurses.

Common sleep myths compromise good sleep and health
People often say they can get by on five or fewer hours of sleep, that snoring is harmless, and that having a drink helps you to fall asleep.

Sleep tight! Researchers identify the beneficial role of sleep
Why do animals sleep? Why do humans 'waste' a third of their lives sleeping?

Does extra sleep on the weekends repay your sleep debt? No, researchers say
Insufficient sleep and untreated sleep disorders put people at increased risk for metabolic problems, including obesity and diabetes.

Read More: Sleep News and Sleep Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.