A Cannabidiol/Terpene Formulation That Increases Restorative Sleep in Insomniacs: A Double-Blind, Placebo-controlled, Randomized, Crossover Pilot Study

Study ObjectivesCannabidiol (CBD) is increasingly used as a health supplement, though few human studies have demonstrated benefits. The primary objective of this study was to evaluate the effects of an oral CBD-terpene formulation on sleep physiology in insomniacs. MethodsIn this double-blind, placebo-controlled, randomized clinical trial, 125 insomniacs received an oral administration of CBD (300 mg) and terpenes (1 mg each of linalool, myrcene, phytol, limonene, -terpinene, -terpineol, -pinene, and {beta}-caryophyllene) for [≥] four days/week over four weeks using a crossover design. The study medication was devoid of {Delta}9-Tetrahydrocannabinol ({Delta}9-THC). The primary outcome measure was the percentage of time participants spent in the combination of slow wave sleep (SWS) and rapid eye movement (REM) sleep stages, as measured by a wrist-worn sleep-tracking device. ResultsThis CBD-terpene regimen significantly increased the mean nightly percentage of time participants spent in SWS + REM sleep compared to the placebo [mean (SEM), 1.28% (0.60%), 95% C.I. 0.09 to 2.46, P = 0.03]. More robust increases were observed in participants with low baseline SWS + REM sleep, as well as in day-sleepers. For select participants, the increase in SWS + REM sleep averaged as much as 48 min/night over a four-week treatment period. This treatment had no effect on total sleep time (TST), resting heart rate or heart rate variability, and no adverse events were reported. ConclusionsSelect CBD-terpene ratios may increase SWS + REM sleep, and have the potential to provide a safe and efficacious alternative to over-the-counter (OTC) sleep aids and commonly prescribed sleep medications. BRIEF SUMMARYO_ST_ABSCurrent Knowledge/Study RationaleC_ST_ABSPhysicians are increasingly asked by their patients regarding the merits of using CBD for insomnia and other ailments, but lack any rigorous clinical research to support recommending its use. The current study represents the first double-blind, placebo-controlled and randomized crossover clinical trial to investigate how an oral formulation of cannabidiol (CBD) and terpenes influences sleep physiology in insomniacs. Study ImpactIn contrast to many OTC sleep aids and commonly prescribed sleep medicines, the CBD-terpene formulation increased SWS and REM sleep, which are critical for the immune system, tissue regeneration, cognition and memory. These results, if confirmed in larger clinical trials, suggests that CBD might offer a promising alternative to other prescription sleep medications and OTC sleep aids.