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 required.
Results. PSQUI and HAM-A scores evidenced reduction in mood
alterations, including anxiety, panic, paranoia, depression (P < 0.03),
in pain (P < 0.02) and good general health perceptions.
Conclusions. These data suggest that the formula CBD-melatonin
could be competitive with the classic hypnotic synthetic drugs, the
antioxidant activity of melatonin offers a further benefit to the brain
network, restoring the biological clock functions, while CBD, reducing chronic pain perception, helps to complete the neuromuscular
relaxation and to relieve anxiety fulfilling a very balanced sensation
of wellbeing during the sleep. Clin Ter 2022; 173 (1):91-96. doi:
10.7417/CT.2022.2399
Key words: insomnia, cannabis, melatonin, natural compound,
CBD
