1. Introduction
obesity, Anxiety, sleep disturbance, anxiety, sleep disturbances, pain, Sleep disturbance
REGRESSION, OBESITY, SIDE EFFECTS, INFLAMMATION
Inadequate 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 one of three study products. Sleep A (contained lower (0.35 mg THC and higher levels of botanicals (75 mg each hops oil and valerian oil), Sleep B (contained higher THC (0.85 mg) and lower botanicals (20 mg each hops oil and valerian oil) or placebo) for 4 weeks. 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.Inadequate sleep became a global public health concern, leading to greater awareness of the negative impact from a lack of sleep. Inadequate sleep is related to increased obesity and inflammation, impairs immune and antioxidant defenses, and negatively impacts mood [It is recommended that anyone suffering with sleep disturbances consult a health professional and consider a multidimensional assessment, recognizing that an intervention that targets sleep onset may not accurately address sleep latency. Furthermore, because sleep involves multiple mechanisms, it may be advantageous to consider a multi-ingredient therapeutic approach targeting a variety of pathways to support sleep. There are many treatments aimed at improving sleep, including behavioral management, lifestyle management, exercise, diet, pharmacological interventions, and dietary supplements [Cannabinoids are a potential plant-based alternative to prescription products for improving sleep. The cannabis plant is composed of 120 different phytocannabinoids. Delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD) are perhaps the most widely known and researched, but others, such as cannabinol (CBN) are growing in popularity [Other non-pharmacological alternatives were investigated. For example, γ-aminobutyric acid (GABA) is a non-protein amino acid, well known for its role as an inhibitory neurotransmitter in the central nervous system, promoting relaxation and sleep [Botanical essential oils are also gaining popularity for their effectiveness in improving sleep. Hops are herbaceous perennial plants belonging to the class Magnoliopsida, subclass Hamamelididae, order Urticales, family Cannabaceae, genus Humulus. It was known for centuries for its many health benefits, including its sedative effects [Another popular oil often used together with hops, is Though each of the botanicals discussed thus far showed promise for improving sleep, it is intriguing to consider the concept of synergy, especially because sleep is multidimensional and complex, thus warranting a multi-ingredient approach. The discussion of botanical synergy is not new. In recent years, it is commonly called “the entourage effect” when discussed in reference to the potential therapeutic effects of the synergy between phytocannabinoids and the many other compounds found in the cannabis plant [The aim of this study was to assess the effects of two different softgel dietary supplements, one with lower THC and higher levels of other botanicals (Sleep A), and one with higher THC and lower levels of other botanicals (Sleep B), on sleep disturbance relative to placebo.