Nighttime sleep-aid helps people experiencing occasional sleeplessness, study suggests

The study was presented today at SLEEP 2016, a joint annual meeting of the American Academy of Sleep Medicine and the Sleep Research Society, from June 11 -- 15, 2016 in Denver. Thomas Roth, Ph.D., director of the Sleep Disorders and Research Center at Henry Ford Hospital in Detroit, was one of the study's lead investigators.

The findings from this study answer two important questions for people considering taking a non-prescription sleep aid. "Will it help me get to sleep faster and will I wake up feeling well rested and rejuvenated?," said Dr. Roth. "This study demonstrates that diphenhydramine HCI can provide benefit to people who sometimes need help getting a good night's sleep."

According to the Centers for Disease Control and Prevention (CDC), more than one-quarter of the U.S. population report occasionally not getting enough sleep while nearly 10 percent experience chronic insomnia. Occasional sleeplessness is more prevalent in women than men.

The four-to-six week double-blind, placebo-controlled study analyzed the impact of DPH versus placebo on sleep in 33 people who suffer from occasional sleeplessness. Occasional sleeplessness is defined as those who reported two or more nights of trouble falling asleep (≥ 30 minutes). The sleep assessment was conducted in-home, and used three sleep instruments (two objective, one subjective) to assess the efficacy of diphenhydramine HCI 50 mg.

Study participants were ethnically diverse and in their 40's, on average.

In the study, DPH was found to improve several measures of sleep. Key findings include:

• For the primary endpoint, sleep sufferers fell asleep, on average, 8 minutes faster than placebo (p<0.05) as assessed by the primary objective measure (i.e., ZEO Sleep Manager).
• Sleep sufferers also reported that they fell asleep faster, stayed asleep longer and reported better quality of sleep.
• No differences were found between diphenhydramine and placebo in terms of time in bed or the number of awakenings.

"Previous research has shown the important connection between sleep and overall health. A sleep deficiency of even a small degree can disrupt our lives in a number of ways -- from a setback in daily routine to bringing about or exacerbating existing chronic diseases," said Andrew N. Carr, Ph.D., Clinical Scientist and study co-author, Procter & Gamble. "This study has further validated diphenhydramine's use in helping people with sleep issues fall asleep faster and get the quality sleep they need. This unique approach enables future studies to understand how these products could impact the day-to-day activities of those looking for assistance with their occasional sleep difficulties."

Diphenhydramine HCI was originally approved as a prescription antihistamine in 1946 by the U.S. Food and Drug Administration (FDA) and was subsequently approved in 1982 for over-the-counter use to treat occasional sleeplessness.

The study was funded by Procter & Gamble.