Palmieri G, et al. – This study contemplated the safety and effectiveness of a herbal compound composed of valerian, hop, and jujube (Vagonotte) on primary insomnia symptoms and sleep disturbances not associated with medical or psychiatric causes. It was reported that the botanicals dietary supplement with relaxing and soothing properties could assist the practitioner in treating primary insomnia, especially when the risk/benefit profile of a patient did not sustain hypnotic drugs prescription. It brought to light fascinating perspectives on the utility of herbal compound to manage primary insomnia. In order to comprehend the herbal compounds’ effectiveness on sleep disturbances, additional analyses were warranted.

Methods

• 120 enrollees with sleep disturbances symptoms were randomized in two branches of 60 persons each, receiving the herbal compound or placebo at dosage of two pills per day 30 minutes before their scheduled bedtime.
• They were screened for precise items associated with sleep quality and daytime activity at the beginning, after 10 days, and after 20 days of consecutive dietary supplement (or placebo) consumption.
• The candidates remained blind to group assignment until all of them completed the trial.

Results

• Analysis was carried out of the sleep onset, numbers of nocturnal awakenings, and overall nocturnal slept time.
• A statistically significant change was noted between the two groups.
• The group receiving the herbal compound reported a lower time of sleep onset compared to placebo group.
• Similar findings were seen for total slept time and night awakenings frequency (p<0.001).
• Daily symptom improvement in subjects receiving the herbal compound exhibited a marked reduction in tension and irritability, difficulty in concentration, and fatigue intensity if compared to placebo scores (p<0.001).
• The subjects in the verum group did not report adverse reaction related to the herbal compound.
• 98% of the participants judged the product as displaying from good to excellent safety and tolerability.