Efficacy and safety of dietary supplementation in targeting sleep quality: an evidence-based approach for supporting informed choices

Food supplements (FS) are regulated as foods, which are marketed in pharmaceutical formulations, such as tablets, capsules, drops, sprays, etc. In contrast to medicines, FS are not intended for prevention or treating diseases, but can be legally labelled and marketed with health claims, which need to be approved as provided in Reg. 1924/2006. People use FS as a strategy to combat nutritional deficiencies and to promote general health. It is expected that almost half of the adult population regularly uses food supplements, and use of FS further increased during pandemic. This can be linked with expectations of users, that FS affect functioning of the immune system, but it should be noted that COVID-19 pandemic also affected mental health, and that higher prevalence of anxiety and sleep disorders were observed in some populations. Sleep quality is one of the basic needs of human beings and important for health, and can be affected by wide range of causes including genetic, medical and psychological conditions. Other factors that affect sleep also include age, medications, and environmental factors. Sleep problems are commonly characterized by one or more of symptoms like inability to fall asleep at night, inability to stay asleep at night, excessive daytime sleepiness, etc. Data show that about 20% of the population is experiencing sleep quality difficulties. In medicine sleep disorders are commonly treated with prescription drugs, while many people – particularly those with milder sleep disorders, are not on medical pharmacotherapy and can be also without any medical diagnoses. This population is a major user of food supplements targeting sleep quality. Such FS can be classified into: (a) FS containing melatonin – which is the only constituent for which sleep-related health claim was authorised in the EU at dosage 1 mg, but lower dosages of melatonin are commonly marketed without labelled health claims. Question arises, whether such usage has any meaningful effects. (b) plant based FS, which are commonly formulated with Valerian root (Valeriana officinalis), which has not yet been subject to scientific evaluation of health claims by the EFSA, but its traditional use is established in monographs. Question arises, if the effects of valerian are strong enough to be supported with results of human intervention studies, conducted using EFSA standards for substantiation of health claims. Objectives of this applied research project are: O1: Assessment of labelling data from FS and investigation of possible misleading practices and potential risks for consumers. O2: Assessment of the efficiency and safety of food supplements containing standardised Valeriana officinalis extract for improving sleep quality, using melatonin as active comparator. O3: Investigation of consumer knowledge, behaviour and experiences related to dietary supplementation practices, particularly focusing on herbal products. O4: Support of key stakeholders, including producers and policymakers. Project goals are harmonised with national and European Union strategic documents, including EGD, which highlight improving health and well-being of European citizens. Additionally, project is addressing Slovenian national programme Nutrition and Physical Activity for Health 2015–2025, where one of key goals is to assure non-misleading labelling and communication practices.