In a 2023 clinical trial investigating the effects of CBD, melatonin, and minor cannabinoids (CBN and CBC) on sleep improvement, CBD isolate alone was found to be equally effective as all other tested formulations. The study revealed that chronic use of low dose CBD isolate at 15mg was safe and led to significant improvements in sleep quality, comparable to formulations containing melatonin or minor cannabinoids. Notably, all study arms exhibited favorable safety profiles, with mostly mild reported side effects.
The addition of low doses of CBN and CBC to formulations containing CBD or melatonin isolate did not provide significant clinical improvements in sleep quality. These findings indicate that CBD isolate alone can yield similar effects to combined formulas when it comes to improving sleep. Moreover, no significant differences were observed in overall sleep disturbance scores between formulations containing CBD and melatonin and CBD isolate alone. These results suggest that both low dose CBD and 5mg melatonin may offer comparable effects in enhancing sleep quality.
The study employed a randomized, double-blinded, controlled design, evaluating six distinct study arms. The primary objective was to assess the safety and effects of CBD isolate in comparison to CBD combination formulations with melatonin and minor cannabinoids. Secondary aims included examining the impact of different formulations on sleep disturbance and the odds of achieving a clinically important difference (MCID).
The study sample consisted of participants experiencing sleep disturbances, and data were collected through online surveys over a 4-week period. The results of this study contribute to the growing body of evidence regarding the therapeutic potential of CBD and melatonin for sleep improvement and shed light on the role of minor cannabinoids in these formulations.
The study enrolled 1,298 participants who were randomly assigned to six different study arms, receiving various formulations of CBD isolate, full-spectrum CBD, melatonin, and the minor cannabinoids CBN and CBC. Over a period of four weeks, participants completed regular online surveys to assess sleep disturbance using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance 8A scale. The study was designed to evaluate the changes in sleep quality, side effects, and the odds of achieving a minimal clinically important difference (MCID) among the study arms.
The clinical trial consisted of six different study arms, each receiving specific product formulas for daily use. Participants were provided with clear instructions on how to take the capsules. The instructions stated, "Take 1 capsule each day with food before going to sleep. You may increase to 2 capsules taken at the same time, with food and before going to sleep. Do not take more than 2 capsules per day." The study arm groups and their respective product formulas were as follows:
- Arm 1: 15mg CBD isolate + 15mg CBN + 5mg melatonin
- Arm 2: 15mg CBD isolate + 15mg CBN
- Arm 3: 15mg CBD isolate
- Arm 4: 5mg melatonin
- Arm 5: 15mg Full Spectrum CBD + 15mg CBN
- Arm 6: 15mg CBD isolate + 15mg CBN + 5mg CBC
These six study arms allowed for comparisons between CBD alone, melatonin alone, and various combinations of CBD, melatonin, and the minor cannabinoids CBN and CBC, providing valuable insights into the effects of different formulations on sleep outcomes.
Contrary to popular belief in the industry, the study results revealed that CBD isolate alone (Arm 3) was equally effective compared to the CBD, melatonin, and CBN formulation (Arm 1), which is often promoted as a powerful combination for sleep improvement. These findings challenge the notion that complex formulations with multiple sleep aid ingredients are necessary, suggesting that CBD isolate alone may be sufficient for achieving the desired sleep-enhancing effects.
The results of the study indicated that CBD isolate, at a very low dose of 15mg, led to significant improvements in sleep disturbance over the four-week period. Interestingly, the addition of melatonin to CBD, at a dose of 5mg, did not show superior effects compared to CBD alone. The formulations with 15mg CBD and 5mg melatonin by themselves demonstrated comparable therapeutic effects on overall sleep disturbance scores. These findings suggest that CBD could be a viable alternative to melatonin for individuals seeking natural sleep aids.
The study also investigated the potential impact of minor cannabinoids, specifically cannabinol (CBN) and cannabichrome (CBC), on sleep outcomes when combined with CBD. Surprisingly, the addition of CBN and CBC did not show any clinically significant improvement in sleep quality compared to CBD isolate alone. Despite recent industry claims of CBN's sleep-inducing properties, the scientific literature is almost entirely devoid of clinical research supporting CBN's benefits for improving sleep quality. The study's findings suggest that the inclusion of CBN or CBC in CBD formulations may not contribute to the therapeutic effectiveness for sleep improvement that is typically claimed by many people in the industry.
This clinical trial provides critical insights into the comparative effectiveness of CBD and melatonin, two widely used compounds for sleep improvement. The findings highlight the potential of CBD, at a lower dose commonly found in commercially available products, to significantly improve symptoms of sleep disturbance. Moreover, the study indicates that CBD formulations can offer comparable benefits to melatonin, a frequently recommended sleep aid. The research also emphasizes the need for evidence-based studies to guide the development of natural sleep disorder treatments.
The study opted to employ lower doses of CBD in their formulations to align with the dosage ranges commonly found in commercially available products. However, there are varying viewpoints regarding this approach. Some researchers and proponents argue for the use of higher CBD doses based on previous research and anecdotal evidence on the topic, suggesting that these higher doses may offer more efficient effects on sleep for a broader population. In this context, incorporating higher CBD doses, similar to those utilized in other studies and Spekr products, could have facilitated a more comprehensive exploration of the potential therapeutic benefits. Nevertheless, the study's choice to utilize lower doses aimed to provide insights into the effects of CBD at levels commonly encountered by individuals using commercially available CBD products.
The study examined lower doses of CBD and other compounds for sleep improvement; however, it is important to note that my personal formulation theories and extensive research suggest that higher doses are more effective for maximizing sleep benefits in a broader population. Decades of research and anecdotal evidence indicate that higher CBD doses have shown significant improvements in sleep quality for many individuals. That's why I developed the new targeted Spekr sleep products, specifically designed to provide over 100mg of CBD per suggested dose. Spekr Sleep offers 120mg per suggested dose, while Spekr Deep Sleep provides 400mg per suggested dose, aiming to optimize the potential benefits of CBD for sleep in as many people as possible. By offering higher doses, these products aim to enhance the potential effectiveness of CBD for improving sleep quality.
The study findings revealed that CBD at low doses, such as the 15mg used in this trial, was equally effective in improving sleep quality compared to other formulations and melatonin. However, there is a need for further research to explore the efficacy of higher doses of CBD in comparison to the standard dose of melatonin.
Based on my product formulation theories, I strongly believe that higher doses of CBD can have a much more pronounced impact on sleep quality than the standard dose of melatonin. The results of this study, which demonstrated comparable effectiveness with only 15mg of CBD, raise intriguing possibilities for even more significant effects when using higher CBD doses, aligning with the majority of existing research and my own product formulation approach in developing the Spekr Sleep with 120mg CBD per suggested dose and and Spekr Deep Sleep with 400mg CBD per suggested use.
Furthermore, while this study examined minor cannabinoids like CBN and CBC, it is important for future research to investigate the effectiveness of a CBD and THC formulation. I believe that the combination of CBD and THC holds great potential as the most superior natural sleep-inducing combination available. Therefore, additional studies exploring the synergistic effects of CBD and THC on sleep outcomes would contribute valuable insights to the field.
Based on my formulation science theories and deep understanding of CBD's potential, I intentionally developed high-dose CBD isolate formulations while intentionally excluding additional compounds like melatonin and CBN. Despite many requests over the years to include these ingredients, I firmly believed that CBD alone could provide substantial sleep benefits, especially when administered at appropriate dosages and following biphasic dosing standards. The completion of a clinical trial now validates these theories, providing empirical evidence that high-dose CBD isolate can effectively address sleep concerns. This research supports the credibility of my product formulations and reinforces the notion that CBD, when utilized optimally, is capable of promoting significant improvements in sleep outcomes.
In conclusion, this clinical trial investigating the effectiveness of various cannabinoid and melatonin formulations for sleep disturbance has yielded valuable insights. The study demonstrated that all six arms, including the CBD isolate group, exhibited comparable improvements in sleep disturbance scores. These findings suggest that CBD isolate alone may be sufficient for addressing sleep-related concerns, raising questions about the necessity of incorporating additional compounds like melatonin and minor cannabinoids such as CBN in sleep-focused formulations. The study challenges the common belief that combining multiple compounds leads to enhanced therapeutic effects, emphasizing the potential efficacy of CBD isolate in promoting improved sleep outcomes on its own. Future research should delve into optimal dosing, formulation strategies, and specific applications of CBD in the context of sleep disorders to further enhance our understanding and treatment options.
Study Title: The Safety and Comparative Effectiveness of Non-Psychoactive Cannabinoid Formulations for the Improvement of Sleep: A Double-Blinded, Randomized Controlled Trial
Study Link: https://pubmed.ncbi.nlm.nih.gov/37162192