A sleep formulation based on cannabinoids and botanical oils by MDbio – The Doctors Brand was proven to significantly improve sleep compared to placebo, according to a study published in Nutrients.
Results showed the formulation enhanced sleep onset and supported restful and healthy sleep. Furthermore, the product led to significant improvements in feelings of anxiety, stress, and well-being compared to placebo.
Radicle Science conducted the double-blind, randomized, placebo-controlled clinical trial in conjunction with faculty from the University of California, Los Angeles, the University of Maryland School of Medicine, and Harvard T.H. Chan School of Public Health.
The study involved 620 volunteers across the United States who were randomly assigned to take the placebo or one of two formulations of MDSleep containing federally legal limits of cannabinoids and other botanical ingredients.
One MDSleep formulation contained lower amounts of THC per serving (.35 mg) and higher amounts of GABA and botanical oils, hops oil, and valerian oil. The second formulation contained higher amounts of THC per serving (.85 mg) and lower amounts of GABA, valerian, and hops oil, while the other botanicals (CBD, CBN, and L-Theanine) were in the same amounts as the first formulation.
When compared to placebo, MDSleep’s formulation with lower THC and higher amounts of select botanicals was shown to improve reported sleep quality, feelings of anxiety, stress, and overall well-being, with no serious side effects. When compared to placebo, this formulation showed:
- A significant improvement in sleep quality (measured by the rate of mean change in the PROMIS Sleep Disturbance 8a score)
- While not statistically significant, 57.3% of participants experienced a minimal clinically important difference in their sleep quality relative to 42.2% of participants in the placebo group.
- A significant improvement in feelings of anxiety (measured by the rate of change in PROMIS Anxiety 4a score)
- A significant improvement in feelings of stress (measured by the rate of change in the PROMIS Stress 4a score)
- A significant improvement in well-being (measured by the rate of mean change in the World Health Organization-5 Well-being index score)
There were no serious side effects reported in any study group and no significant differences in side effects between either MDSleep product group and the placebo.
This formulation of lower THC and higher select botanicals was clinically shown to:
- Improve sleep disturbance (sleep quality)
- Enhance sleep onset
- Support restful and healthy sleep
- Improve feeling well-rested upon waking
- Reduce feelings of anxiety and stress
- Promote well-being
The formulation with higher cannabinoids and lower amounts of select botanicals did not show significant differences in any of these measures.
“Our commitment to medical-grade botanical formulations is reflected in the results of this study, which shows how precision dosing of multiple ingredients (polypharmacology) makes a significant difference in clinical effectiveness. We are thrilled that the medical community can now proudly recommend a clinically proven sleep aid that is backed by the scientific rigor we expect as practitioners,” says Babak Larian, MD, FACS, co-founder of MDbio – The Doctors Brand, in a release.
Emily Pauli, PharmD, chief research officer of Radicle Science, says in a release, “This study suggests that lower levels of THC in combination with CBD, CBN, and higher levels of GABA and GABA-elevating botanical oils from valerian and hops, may improve sleep quality. While further exploration is necessary, this research supports the idea of synergism between botanical compounds, allowing for variable amounts of them without additional side effects. It highlights the importance of methodical formulation development and testing through rigorous clinical trials such as Radicle Rest.”
Jeff Chen, MD, cofounder/CEO of Radicle Science, emphasizes that neither formulation contained melatonin. “In other countries like England, melatonin requires a prescription, while in other countries like Japan, melatonin is banned. Thus it is particularly important that Americans have non-melatonin sleep aids that are clinically effective, and MDSleep is now a proven new option for the sleep market,” says Chen in a release.
Photo caption: MDsleep
Photo credit: MDbio
