The Pharmaceutical Journal
Vol 277 No 7408 p38
8 July 2006

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Trial shows diphenhydramine does not help infants sleep

Diphenhydramine is no more effective than placebo at reducing night-time wakenings or improving parental happiness with sleep in infants aged six to 15 months, according to research published in the Archives of Pediatrics and Adolescent Medicine (2006;160:707).

A randomised controlled trial in 44 infants given diphenhydramine (1mg/kg) or placebo 30 minutes before bedtime was stopped early because of a lack of effectiveness of diphenhydramine.

Only one of 22 infants receiving diphenhydramine showed improvement compared with three of 22 receiving placebo.