ABSTRACT- Difficulties falling and/or staying asleep affect over one quarter of adults in the United States. Current management strategies include prescription sleep aids. However, long-term use is associated with serious adverse effects. Therefore, natural alternative sleep aids that may provide safer and more effective relief of sleep disturbances are needed. In this randomized, triple-blind, placebo-controlled clinical trial, 80 healthy adults (n = 40 per group) with difficulties falling and/or staying asleep were supplemented with a standardized corn leaf extract (CLE) or placebo for 28 days. Objective (actigraphy with electroencephalogram) and subjective (Pittsburgh Sleep Quality Index) sleep measures, serum serotonin, plasma melatonin, and gamma-aminobutyric acid
were assessed at baseline (Day 0), Day 14, and Day 28, and safety was assessed at screening and Day 28.