A randomized double blind placebo controlled trial was conducted in patients with chronic primary insomnia in West Bengal, India. Individuals were randomly assigned to receive 1 tablet of an herbal combination or 10 mg of zolpidem for 2 weeks. The herbal combination contained 300 mg valerian extract (standardized to 0.8% total valerenic acid), 80 mg passionflower extract (standardized to 4% isovitexin), and 30 mg hops extract (standardized to 0.35% rutin). Dosing was 1 tablet at bedtime and a sleep diary was conducted along with the Insomnia Severity Index and Epworth Sleepiness Scale.
Individuals ranged in age from 20-80 y.o. Of the 91 patients enrolled, 78 completed the study with 39 in each group. Eligibility was determined if they had an average of < 6 hours of sleep per night and a score of > 7 on the Insomnia Severity Index. Patients were excluded if they were taking medications that affect sleep, had a psychiatric diagnosis, had a history of substance abuse, had a dependence on sedative-hypnotic drugs, or if they worked night shifts.
The average sleep duration increased significantly from 3.4 to 5.9 hours in the herbal combination group and from 3.5 to 5.7 hours in the zolpidem group after the 2 week study period, which was considered similar results for both treatments. The average amount of time it took to fall asleep, called sleep latency, was also similar in both groups and decreased significantly from 84.0 to 23.6 minutes in the herbal group and from 90.0 to 26.4 minutes in the zolpidem. Night time awakenings decreased and quality of life scores improved in both groups, compared to baseline and with no significant differences between the two treatment groups. Daytime sleepiness was not a problem in either group, adverse events were similar in both groups, and no serious adverse events were reported in either group.
Commentary: Chronic insomnia is fraught with significant quality of life issues including mood and cognitive changes. The results of this study indicate that this combination of valerian, hops and passion flower is a safe and effective alternative to zolpidem, at least for short term treatment of insomnia. Chronic insomnia is more common in women, with an exacerbation in perimenopause and early menopause. This herbal combination, along with seeing their insomnia as a perimenopause/menopause symptom and addressing the core physiological changes, bodes well for using these three herbs to treat insomnia.
Maroo N, Hazra A, Das T. Efficacy and safety of a polyherbal sedative-hypnotic formulation NSF-3 in primary insomnia in comparison to zolpidem: A randomized controlled trial. Indian J Pharmacol. January-February 2013;45(1):34-39.