A randomized, double-blind, placebo-controlled, cross-over pilot study to investigate the efficacy of Rest-ZZZ formula in healthy participants with occasional sleeplessness

Abstract The purpose of this study was to investigate the safety and efficacy Rest-ZZZ, a natural sleep supplement, in healthy adults without diagnosed disorder. This randomized, double-blind, placebo-controlled, cross-over consisted three 7-day supplementation periods with either Diphenhydramine (DPH), or Placebo, washout. Twenty-seven participants were randomized one intervention sequences Healthy People Sleep Quality Index (HPSQI), Life (QoL), Profile Mood States (POMS) questionnaires assessed at beginning end each period. Rest-ZZZ Placebo showed improvements sleep-related QoL ( p ≤ 0.044) total mood disturbance (TMD) = 0.028). Fatigue–Inertia reduced by all products 0.031). DPH did not result any significant on quality parameters. A subgroup analysis 45 years found enhanced improvement vs. 0.007), as well duration debt 0.011), 0.033). resulted only 0.038). had safe hematology chemistry profile. restful that generated corresponding overall mood. is an efficacious supplement favorable profile, particularly those aged 25–45 years.