A combination of melatonin, vitamin B6 and medicinal plants in the treatment of mild-to-moderate insomnia: A prospective pilot study.

Abstract

OBJECTIVES\nCurrently 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.\n\n\nDESIGN AND SETTING\nThis was a 4-week, single-center, single-arm, open-label study conducted in 40 participants with mild-to-moderate insomnia, in Poland.\n\n\nINTERVENTION\nParticipants received Novanuit® Triple Action (melatonin, vitamin B6, California poppy extract, passionflower extract, and lemon balm extract) capsules per day for two weeks.\n\n\nOUTCOMES\nUsing 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.\n\n\nRESULTS\nThere was a statistically significant (p\u202f<\u202f0.001) 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 (p\u202f<\u202f0.01 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.\n\n\nCONCLUSIONS\nThis pilot study suggests that the combination of melatonin, vitamin B6, and medicinal plants may be beneficial in mild-to-moderate insomnia.