Novel Formulation of THC and CBN in a Repeat-Action Tablet Improves Objective and Subjective Measurements of Sleep
ABSTRACT
OBJECTIVE
BACKGROUND: The use of cannabis to improve sleep quality and treat sleep-related disorders has received increased attention due to the expanded legalization of cannabis for medical use in 36 states and Washington DC. Data on the effects of delta-9-tetrahydrocannabinol (THC), in combination with cannabinol (CBN), on sleep is preliminary; however, preclinical research indicates that CBN may prolong sleep and be particularly effective when combined with other cannabinoids. OBJECTIVE: The aim of this study was to evaluate the effect of a repeat-action tablet containing 10 mg THC and 5 mg CBN on sleep quality, sleep duration, and awakenings in participants (medical cannabis users). The effect of the combination tablet was evaluated using objectively measured and self-reported data.
METHODS
A sleep-tracking device (SleepScore Max)was used to measure objective sleep. Self-report questionnaires were administered to measure perceived sleep quality. The validated, at-home sleep-tracking system uses a patented technology to unobtrusively and objectively track an individual’s gross and micro-movements.
RESULTS
Objective data demonstrated that the 35 participants who completed the study slept an average of 6 hours and 29 minutes per night before starting on the repeat-action tablets. During the combination tablet-use period, participants slept an average of 20 minutes longer (ie, 6 hours and 49 minutes; P<0.001; 5% improvement). There was a 22% increase in reported feelings of restfulness upon awakening (P<0.0001), with an average rating of 53.32 (on a 100-point sleep quality scale) before product use to 65.21 during product use. Additionally, there was an 18% increase in reported overall sleep quality (P<0.0001), with an average rating of 57.36 (on a 100-point sleep quality scale) before product use to 67.90 during product use.
CONCLUSIONS
This validation study found that a repeat-action tablet formulation of THC and CBN was associated with improved sleep quality in a sample of 35 participants who were medical cannabis users. Findings were obtained using both a validated sleep-tracking system to measure objective sleep and self-reported data obtained from questionnaires.
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