RESUMO
OBJECTIVES: Currently available pharmaceutical therapies for sleep disorders have significant side effects and dependence potential, thus necessitating the need for alternative treatment approaches. This study investigated the effect of a combination of melatonin, vitamin B6 and medicinal plants in patients with mild-to-moderate sleep disorders. DESIGN AND SETTING: This was a 4-week, single-center, single-arm, open-label study conducted in 40 participants with mild-to-moderate insomnia, in Poland. INTERVENTION: Participants received Novanuit® Triple Action (melatonin, vitamin B6, California poppy extract, passionflower extract, and lemon balm extract) capsules per day for two weeks. OUTCOMES: Using a daily electronic sleep diary, information was collected on sleep quality (assessed on a 0-10 scale), total sleep duration, sleep onset latency, sleep-related daytime impairment, and safety of the study medication. RESULTS: There was a statistically significant (pâ¯<â¯0.001) improvement in sleep quality by the end of the 2-week treatment period, with mean sleep quality score increasing by 1.9 points from pre-treatment (5.4 points) to post-treatment (7.3 points). Similarly, statistically significant improvements were observed following treatment completion in sleep onset latency, total sleep duration, and sleep-related daytime parameters (pâ¯<â¯0.01 for all outcomes). Administration of the combination of melatonin, vitamin B6, and medicinal plants was associated with high compliance (39/40; 97.5%). No serious adverse events were reported. CONCLUSIONS: This pilot study suggests that the combination of melatonin, vitamin B6, and medicinal plants may be beneficial in mild-to-moderate insomnia.
