July 30, 2021
Giancarlo Palmieri, Paola Contaldi, Giuseppe Fogliame
More than 30% of the world’s population currently suffer from sleep-related disorders. From simple cases like restless leg syndrome to life-altering insomnias, individuals are diagnosed to have some form of sleep disorder daily. To date, insomnia is the most common sleep disturbance worldwide.
The Journal of Clinical Sleep Medicine defines insomnia as an individual’s report of difficulty with sleep. In sleep literature, the technical definition of insomnia is the presence of polysomnographic evidence of disturbed sleep, which must meet certain criteria in order for it to be considered a sleep disorder.
The diagnostic criteria include (1) difficulty falling asleep, staying asleep or non-restorative sleep; (2) the difficulty is present despite adequate opportunity and circumstance to sleep; (3) this impairment in sleep is associated with daytime impairment or distress; and (4) this sleep difficulty occurs at least 3 times per week and has persisted for at least one month.
Sleep medications like sedative-hypnotics are widely used for insomnia and other sleep disorders despite their potential side effects. They have risks outweighing benefits especially in the elderly. These risks include dependence and accidents related to intake are the reason why they are recommended to be given at the lowest dose over the shortest possible period.
With the advent of botanical drugs that provide calming and relaxing properties, insomnia can now be addressed with a much better risk/benefit profile compared to sedative-hypnotics. Botanicals such as valerian (Valerianan officinalis), hop (Humulus lupus), and jujube (Ziziphus jujuba) are some of the most widely used plants for sleep disorders.
In the International Medical Journal of Experimental and Clinical Research, valerian root was reported to have anxiolytic and calming properties. Jujube, taken as a supplement, was noted to improve sleep quality, daytime functioning, mood, and cognitive performance according to a study published in the Nutrients Journal.
Sleep disturbance is a common complaint in the clinics. It affects a person’s concentration when performing daily activities. Botanical drugs help alleviate the symptoms of insomnia and other sleep disturbances. They also help improve one’s quality of life especially those who have unfavorable sedative-hypnotic risk-benefit profile.
Following the categorical and diagnostic definition of insomnia, this review article aims to discuss the effectiveness of a herbal compound containing valerian, hop, and jujube in alleviating primary insomnia symptoms.
This review also aims to evaluate the safety of botanicals when administered to individuals suffering from primary insomnia and other sleep disturbances not related to underlying medical conditions. It provides objective clinical basis for such alternatives to help address certain sleep disorders.
Characteristics of botanical drugs
Valerian (Valeriana officinalis) has been shown to alleviate restlessness and anxiety, with a specific effect on the GABA A receptor binding sites that promote and maintain sleep.
Hop (Humulus lupus) has been shown to have calming and sleep-inducing effects through its stimulatory effect on the GABAergic activity of the central nervous system. It has also displayed binding affinities to melatonin and serotonin, both of which are important regulators of the circadian rhythm.
Jujube (Ziziphys jujuba) has long been associated with relief of anxiety and sleep disorders. This plant contains saponins which are associated with the modulation of monoaminergic systems that lead to sleep disturbance reduction.
Assessment of eligible subjects
Subject eligibility was carefully considered ensuring that the characteristics are consistent with the diagnostic criteria specific for insomnia. Included in the study were healthy individuals with no medical or psychiatric condition that would lead to sleep disturbance.
Inclusion criteria were difficulty in sleep onset; more than two-night awakenings; early morning awakening; non-restoring sleep; daily sleepiness, fatigue, difficulty in attention and concentration, anxiety, and irritability as a result of lack of sleep.
One-hundred and twenty subjects were randomized into two groups of 60 persons each. They were given two pills of either the herbal compound composed of valerian, hop, and jujube or placebo, thirty minutes before bedtime for twenty days.
Classification of symptoms
Sleep symptoms or disturbances were defined as experiences of poor sleep described by symptoms like difficulty to fall asleep, difficulty to maintain sleep, early awakening, and non-restoring sleep.
Daytime symptoms include fatigue, sleepiness, difficulty in concentrating, and irritability as a result of nocturnal disturbances. These can in turn lead to impairment in daily activities which can affect health and quality of life. Intensity of symptoms was measured through self-assessment.
Comparison of sleep quality and day activity in response to botanical drugs
Sleep quality and day activities were measured between the study group taking botanicals and the placebo group. No difference was noted regarding baseline characteristics of both groups. A difference was noted on days 10 and 20 of the study, with all sleeping symptoms significantly improved in the group taking botanicals.
Improvements were reported through lower sleep onset, decreased night awakenings, and increased total slept time. Differences in daily symptoms were also noticeable on the days mentioned, with reports of less tension and irritability, fatigue, and improvements in concentration in the botanicals group.
Assessment of safety and effectiveness of drugs
Intake of the herbal compound significantly improved sleep parameters. Its effectiveness was shown through improvements in measured objective factors such as time needed for sleep onset (decreased by 60 minutes), total slept time (increased by 64 minutes), and decreased frequency of night awakenings.
There was also significant reduction in tension and irritability, difficulty in concentrating, and fatigue scores for those taking the herbal compound. Safety was also measured, with none of the participants reporting any adverse reaction at any time.
Insomnia is a common disturbance often associated with a high risk of co-morbid illnesses that lead to great financial burden. Aside from this, insomnia too has been found to have negative impact on the psychological and physical health of those who suffer from it, and even in relation with self-report of depression, fatigue and overall quality of life deterioration.
To help address the problem of insomnia in the primary care setting, dietary sleep supplements from botanicals may be suggested to those who cannot tolerate sedative-hypnotics. The possibility of having safe and effective herbal compounds that can help address primary insomnia and sleep disturbances seems promising despite the need for more quantitative diagnostic parameters because of its documented self-assessed improvement and alleviation of symptoms related to insomnia.