June 29, 2016
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Diphenhydramine helps patients with occasional sleeplessness

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The antihistamine diphenhydramine HCI, which has well-documented sedating properties, provides rapid sleep onset and improves several issues related to occasional sleeplessness when taken in an in-home setting, according to data presented at SLEEP 2016.

“For years, sleep studies have been conducted on people who report chronic insomnia, leaving us to assume that popular sleep aids containing diphenhydramine (DPH) are also effective in those who only have trouble falling asleep from time to time,” Andrew N. Carr, PhD, a clinical scientist for Procter & Gamble and study coauthor, said in an interview. “This research is the first time the compound has been studied in a population of people suffering from occasional sleeplessness and it shows the power of the medication.”

To determine the efficacy of DPH HCI in helping patients with occasional sleeplessness, Carr and colleagues conducted a 4-week, randomized, crossover, double-blind, placebo-controlled, in-home study. The 33 participants self-administered the sleep aide ZzzQuil (Procter & Gamble), in which the active ingredient is DPH HCI 50 mg.

The researchers assessed sleep parameters using ZEO Sleep Manager, Actiwatch 2 and the participants’ completed questionnaires. Occasional sleeplessness was verified with a 7-day baseline period sleep diary. Participants took the treatment as-needed for the first 7 nights of the study, followed by 2 mandatory nights. A period of no treatment lasting at least 5 days occurred between treatments. Of the participants, 22 completed the study and were able to be evaluated.

According to the researchers, DPH improved several sleep parameters, measured by the ZEO Sleep Manager, relative to placebo: Latency to persistent sleep (P = .0312), sleep efficiency (P = .0488) and minutes in “light sleep” (P = .0219). According to patient questionnaires, DPH also positively impacted total sleep time (P = .0023), sleep onset latency (P = .0209), sleep efficiency (P = .0037), sleep quality (P = .0017), time awake after sleep onset (P = .0148), ease of falling asleep (P = .0162) and depth of sleep (P = .0014).

“Essentially, we found that people taking ZzzQuil can expect to fall sleep fast even on the first night, fall back asleep faster if awakened during the night and, when they allow themselves adequate time to sleep, they can wake up feeling well-rested,” Carr said. – by Jason Laday

Disclosure: Carr reports employment with Procter & Gamble, which funded the study.

Reference:

Carr AN, et al. Abstract 0595. Presented at: SLEEP 2016; June 11-15; Denver.