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Why a better, clinically validated sleep solution is needed to meet rising demand

Sleep is a bigger problem than ever. People around the world suffered from severe sleep problems as COVID-19 spread, exacerbating a situation that was already bad before the pandemic hit. Worryingly, the sleep problems have persisted even as the acute phase of the pandemic has ended in many parts of the world. The trend has exposed the limitations of existing sleep remedies and revealed the need for new, clinically validated solutions. 

Around half of people globally reported dissatisfaction with their sleep before the pandemic.1​ With the pandemic increasing stress, the top barrier to a good night’s sleep, multiple studies found people around the world struggled to get enough rest during the crisis.2–5​ 

Many of the studies tracked sleep in 2020, when pandemic-related stress was at its peak. However, hopes that falling case numbers would bring improved sleep appear misplaced. A survey conducted in the US in March 2021, a lull between waves of COVID-19 cases, found 25% of people were unable to fall asleep as easily as they did before the pandemic.6,7​ The same number of people were waking up more in the night than they did before COVID-19. 

The persistence of sleep problems has major implications for human health. Researchers have linked a lack of sleep to an array of negative outcomes, including shorter life span, increased susceptibility to viral infection, and heightened risk of metabolic disorders including obesity and type 2 diabetes.8–10​ 

The limitations of existing options 

Consumers are desperate for solutions that help them break the vicious cycles that drive poor sleep, in which stress, anxiety and pain cause poor sleep, which, in turn, causes more stress, anxiety and pain. The sleep aid market is forecast to be worth $163bn by 2030.11​ Yet, as consumers scour online stores and shop shelves for solutions, they encounter the same set of ingredients, all of which have limitations. 

Valerian can bring the sleep people crave, but comes with a downside: drowsiness. The upshot is the herb can negatively affect functioning during the day. Melatonin is also promoted as a sleep remedy, despite not acting directly on the problem. The hormone is involved in the setting of the circadian rhythm. While resetting the circadian rhythm can improve sleep, it is a long-term process and getting the dosing right is hard. Melatonin is not a quick solution to the problem of a restless night. 

Regulations are a barrier to the use of melatonin in some markets, with the European Union treating it as a drug rather than a dietary supplement. Similarly, cannabidiol (CBD), another molecule touted as a sleep aid, is classified as a drug in the US. Critics of CBD see reports of potential adverse events such as developmental toxicity, embryo-fetal mortality and liver abnormalities, plus the challenge of eliminating all traces of the psychoactive delta-9-tetrahydrocannabinol, as further barriers to use.12,13​  

None of the ingredients is the perfect sleep aid. Ideally, an ingredient will be regulated as a dietary supplement around the world and be clinically proven to help people get to sleep quickly and wake up feeling refreshed. 

Validating a sleep solution in the clinic 

Gencor has developed Levagen+ to meet the need for a better sleep ingredient. The product is a formulation of palmitoylethanolamide (PEA), a simple fatty acid amide, which Gencor has improved using bioavailability-boosting delivery technology. Humans make their own PEA, notably in response to injuries and other stresses, and there is evidence that supplementing the endogenous levels of the molecule helps with sleep. 

To confirm the effect of Levagen+ on sleep, researchers enrolled 103 adults in a double-blind, randomized, placebo-controlled clinical trial.14​ Participants received Levagen+ or placebo once a day for eight weeks. The researchers measured sleep quality and quantity using wearable devices, sleep diaries and questionnaires. 

After eight weeks of dosing, the researchers found Levagen+ was linked to reduced sleep onset latency, time to feel completely awake and improved cognition on waking. The data led the authors of the paper to conclude the ingredient is “a potential sleeping aid capable of reducing sleep onset time and improving cognition on waking.” 

The clinical trial data add to evidence from the real-world use of PEA in the sports nutrition and joint pain sectors, which has shown the safety of the legally recognized dietary supplement. With Gencor overcoming the poor bioavailability of PEA, and using its pharmaceutical expertise to subject it to the highest quality of validations and manufacturing control, the body of evidence points to the potential for Levagen+ to address the global need for a validated sleep solution. 

References

1.      Philips. Philips sleep survey shows only half of people worldwide are satisfied with their sleep, but are less likely than before to take action to improve it. https://www.philips.com/a-w/about/news/archive/standard/news/press/2020/20200302-philips-sleep-survey-shows-only-half-of-people-worldwide-are-satisfied-with-their-sleep-but-are-less-likely-than-before-to-take-action-to-improve-it.html (2020).

2.      Philips. Philips survey reveals COVID-19’s negative impact on sleep quality and CPAP use. https://www.philips.com/a-w/about/news/archive/standard/news/press/2021/20210310-philips-survey-reveals-covid-19-s-negative-impact-on-sleep-quality-and-cpap-use.html​ (2021).

3.      Conroy, D. A. et al.​ The effects of COVID-19 stay-at-home order on sleep, health, and working patterns: a survey study of US health care workers. J. Clin. Sleep Med.17​, 185–191 (2021).

4.      Trabelsi, K. et al.​ Globally altered sleep patterns and physical activity levels by confinement in 5056 individuals: ECLB COVID-19 international online survey. (2021) doi:10.5114/biolsport.2021.101605’].

5.      Stewart, N. H. et al.​ Sleep Disturbances in Frontline Health Care Workers During the COVID-19 Pandemic: Social Media Survey Study. J. Med. Internet Res.23​, e27331 (2021).

6.      23andMe. Restless nation: 23andMe data uncovers how the pandemic has disrupted sleep patterns. PR Newswirehttps://www.prnewswire.com/news-releases/restless-nation-23andme-data-uncovers-how-the-pandemic-has-disrupted-sleep-patterns-301283508.html​ (2021).

7.      COVID-19 Data Explorer. https://ourworldindata.org/explorers/coronavirus-data-explorer?zoomToSelection=true&time=2020-03-01..latest&facet=none&pickerSort=desc&pickerMetric=new_cases_smoothed_per_million&Metric=Confirmed+cases&Interval=7-day+rolling+average&Relative+to+Population=true&Align+outbreaks=false&country=~USA​.

8.      Prather, A. A. et al.​ Sleep and antibody response to hepatitis B vaccination. Sleep35​, 1063–1069 (2012).

9.      World Sleep Day 2021. https://www.usa.philips.com/c-e/smartsleep/campaign/world-sleep-day.

10.    Depner, C. M., Stothard, E. R. & Wright, K. P., Jr. Metabolic consequences of sleep and circadian disorders. Curr. Diab. Rep.14​, 507 (2014).

11.    Sleeping aids market to generate revenue worth $162.5 billion by 2030. https://www.psmarketresearch.com/press-release/sleeping-aids-market.

12.    Huestis, M. A. et al.​ Cannabidiol Adverse Effects and Toxicity. Curr. Neuropharmacol.17​, 974–989 (2019).

13.    Montoya, Z., Conroy, M., Vanden Heuvel, B. D., Pauli, C. S. & Park, S.-H. Cannabis Contaminants Limit Pharmacological Use of Cannabidiol. Front. Pharmacol.11​, 571832 (2020).

14.    Rao, A., Ebelt, P., Mallard, A. & Briskey, D. Palmitoylethanolamide for sleep disturbance. A double-blind, randomised, placebo-controlled interventional study. Sleep Sci Pract5​, 12 (2021).

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