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news.A new US study has found that diphenhydramine, a popular over-the-counter antihistamine marketed as Benadryl by Pfizer, is ineffective in helping young children sleep.
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Although around half of pediatricians recommend that children under age two can be given diphenhydramine to help them sleep, the first study to look at effectiveness of the agent in children of that age found no benefit.
In fact, the study, conducted by researchers from Georgetown University Medical Center in Washington, DC found that the drug appeared to perform worse than a placebo agent. Only one out of 22 children showed improvement in sleeping after using diphenhydramine, compared to three in 22 children who used a placebo.
Because of diphenhydramine’s lack of effectiveness, the clinical trial’s data safety monitoring board shut down the study early.
The clinical trial, known as TIRED, enrolled 44 children aged six to 15 months and followed them 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 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.
“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,” said Dr Dan Merenstein, an assistant professor in the department of family medicine at Georgetown.
Dr Merenstein cautions that a larger study is needed to definitively prove that diphenhydramine doesn’t work as thought in young children, but said he “would advise parents to think about different methods to help a child sleep.”
“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,” he added.