Insomnia treatment: a new multitasking natural compound based on melatonin and cannabis extracts.
Study Goal
The researchers aimed to investigate the short-term therapeutic effects, safety, and tolerability of a compound containing melatonin and CBD in patients with sleep disorders.
Results Summary
The study found reductions in mood alterations, anxiety, pain, and improved general health perceptions, suggesting the melatonin-CBD combination could be competitive with synthetic hypnotic drugs.
Population
20 patients aged 43-96 years with sleep disorders and anxiety.
Effective Dosage
1.5 mg melatonin and 2.5 mg CBD (20 drops sublingually overnight).
Duration
3 months.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
natural compound, composed of melatonin (1,5 mg) and cannabis extracts (2.5 mg CBD) | decrease | mood alterations, including anxiety, panic, paranoia, depression | patients with sleep disorders | P < 0.03 | evidenced reduction | #1 |
natural compound, composed of melatonin (1,5 mg) and cannabis extracts (2.5 mg CBD) | decrease | pain | patients with sleep disorders | P < 0.02 | evidenced reduction | #2 |
natural compound, composed of melatonin (1,5 mg) and cannabis extracts (2.5 mg CBD) | increase | good general health perceptions | patients with sleep disorders | - | evidenced | #3 |
melatonin | increase | brain network, restoring the biological clock functions | - | - | offers a further benefit | #4 |
CBD | decrease | chronic pain perception | - | - | reducing | #5 |
CBD | increase | neuromuscular relaxation | - | - | helps to complete | #6 |
CBD | decrease | anxiety | - | - | to relieve | #7 |
CBD | increase | a very balanced sensation of wellbeing during the sleep | - | - | fulfilling | #8 |
OBJECTIVES: Our main aim was to investigate the short-term thera-peutic 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, "compas-sionate-use," observational, open-label study, 20 patients (age 43-96 years) were appealed to our "Second Opinion Medical Consulting Net-work" (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, redu-cing chronic pain perception, helps to complete the neuromuscular relaxation and to relieve anxiety fulfilling a very balanced sensation of wellbeing during the sleep.