A randomized, double-blind, placebo-controlled decentralized trial to assess sleep, health outcomes, and overall well-being in healthy adults reporting disturbed sleep, taking a melatonin-free supplement

Abstract

AbstractInadequate sleep is a global health concern. Sleep is multidimensional and complex; new multi-ingredient agents are needed. This study assessed the comparative effects of two multi-ingredient supplements on sleep relative to placebo. Adults (N=620) seeking better sleep were randomly assigned to receive 1 of 3 study products (Sleep A, Sleep B or placebo) for 4 weeks. Both active products contained federally legal hemp-derived cannabinoids, botanical oils, GABA and L-theanine. Sleep disturbance was assessed at baseline and weekly using NIH’s Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance SF 8A survey. Anxiety, stress, pain, and well-being were assessed using validated measures at baseline and weekly. A linear mixed-effects regression model was used to assess the change in health outcome score between active product groups and the placebo. There was a significant difference in sleep disturbance, anxiety, stress, and well-being between Sleep A and placebo. There was no significant difference in any health parameter between Sleep B and placebo. Side effects were mild or moderate. There were no significant differences in the frequency of side effects between the study groups. A botanical blend containing a low concentration of THC improved sleep disturbance, anxiety, stress, and well-being in healthy individuals that reported better sleep as a primary health concern.