Conditions: Occasional Sleeplessness
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 33
Healthy volunteers: yes

Brief summary:
The present study was conducted to investigate the impact of diphenhydramine hydrochloride on the ability to initiate sleep.

Detailed description:
Diphenhydramine hydrochloride (herein referred to as diphenhydramine) is an antihistamine of the ethanolamine classes with known sleep-inducing properties and is approved by the Food \& Drug Administration to reduce the time to sleep onset in individuals having difficulty falling asleep. The goal of the study is to investigate diphenhydramine versus placebo with regard to several sleep parameters, including time to sleep onset, in healthy adult subjects suffering from occasional sleeplessness.

Arms:
arm 1: Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep arm 2: Placebo elixir taken when subjects had trouble falling asleep

Interventions: intervention 1: Diphenhydramine Hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: 30 mL at bedtime intervention 2: 30 mL at bedtime

Protocol document: