Abstract Objectives. Our main aim was to investigate the short-term therapeutic effects, safety/tolerability of natural compound, composed of melatonin (1,5 mg) and cannabis extracts (2.5 mg CBD) in patients with sleep disorders Methods. In this spontaneous, anecdotal, retrospective, “compassionate-use,” observational, open-label study, 20 patients (age 43-96 years) were appealed to our “Second Opinion Medical Consulting Network” (Modena, Italy), because of a variable pattern of sleep disorders and anxiety and were instructed to take sublingually the compound (20 drops) overnight for 3 months of treatment. Tolerability and adverse effects were assessed monthly during the treatment period through direct contact (email or telephone) or visit if...