Novel Formulation for Sleep Among People With Poor Sleep Quality

Sleep disorders are highly prevalent all around the world and have a strong negative impact on quality of life (QoL). In Colombia, up to 60% of adults report any sleep disturbance and more than 45% have required medical assistance for this. There is abundant anecdotal and scientific evidence supporting the efficacy and safety of several plant extracts on sleep quality. In this context, the development of safe and effective natural products may have a positive impact on sleep and general QoL.

Inclusion Criteria:Age >=18, male or female.PSQI >=5Provision of informed consentAdherence >= 85%Exclusion Criteria:Medical history of a specific sleep disorder according to the DSM-5Taking any specific pharmacologic treatment to improve sleep or planning to take it in the next two monthsMedical history of generalized anxiety disorder, depression or other serious psychiatric / neurological diseaseUncontrolled hypothyroidismMedical history of deficit or excess of corticosteroids (Cushing syndrome, Addison syndrome, chronic steroid use)Alcohol intake (more than two standard drinks/day, on average)Caffeine intake more than 400 mg per day, on averageFrequent sleep deprivation over the last two monthsWomen with desire to become pregnant