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Science Behind The Alteril® Formulation

With Alteril® nighttime capsule, you get the benefit of over 25 years of scientific research into restorative sleep solutions with the triple-threat combination of Melatonin, Serotonin, and Valerian.

Here's a look at a small handful of the MANY medical studies proving the effectiveness of L-Tryptophan, Melatonin, and Valerian, as well as L-Theanine, for purposes of sleep restoration.

Sleep-Inducing Effect of L-Tryptophan
European Neurology, 1986; 25:75-81

Quote: "Night sleep recordings were performed in 10 patients with sleep disturbance in falling asleep as well as in maintaining sleep using a mobile 4-channel EEG registration system. Three consecutive nights, which were spent under different conditions, were evaluated automatically. The first night without treatment was used as a baseline night to objectify the disturbed sleep, the second night was measured following an infusion of a physiological saline solution and prior to the third recording 5 g l-tryptophan were applied to the patients.

Besides a significant decrease of delayed latency times until the appearance of the light sleep stages, an influence was seen on the quantitative sleep parameters such as sleep period time and total sleep time.

In parallel, an improvement of the subjective feeling measured by a self-rating scale resulted after l-tryptophan. On the other hand, no definite influence on the other sleep parameters such as an increase of slow wave sleep was observed, so that the use of this treatment might be recommended in disturbances in falling asleep particularly."

The Effects of Dietary Neurotransmitter Precursors on Human Behavior
American Journal of Clinical Nutrition, 1985 August; 42(2):366-70

Quote: "The neurotransmitter precursors tryptophan and tyrosine are present in a variety of foods. In order to document possible effects of tryptophan and tyrosine on human behavior, single oral doses of these substances and matched placebos were administered to 20 men in a double-blind, crossover study. Various tests of mood state and performance were then administered.

Tryptophan increased subjective fatigue and decreased self-ratings of vigor and alertness, but did not impair performance on any of the tests.

It may be concluded that tryptophan has significant sedative-like properties, but unlike other sedatives may not impair performance."

Psychopharmacology for the Clinician
Journal of Psychiatry Neuroscience, 2010 March; 35(2):144

Quote: "A trial of l-tryptophan, starting at a dose of 1 g in the evening was begun in June 2007, and within 3 weeks, the subject began to report an improvement in her ability to get to sleep and wake on time in the morning. Over a few more weeks, the dosage was increased to 3.5 g daily combined with over-the-counter pyridoxine to limit the buildup of potentially toxic metabolites of tryptophan. After about 10 weeks of treatment, she began to consistently arrive at work at 9 am, and her depressive symptoms cleared. Two years after l-tryptophan was initiated, she continued to show a normal sleep–wake pattern and remained free of depressive and hypomanic symptoms."

L-Tryptophan: Basic Metabolic Functions, Behavioral Research and Therapeutic Indications
International Journal of Tryptophan Research, 2009 March; 23(2):45-60

Quote: "Tryptophan has also been used for the treatment of sleep disorders, and is thought to produce its therapeutic effects through melatonin mechanisms. Improvement in sleep latency has been reported with doses as low as 1 g and improved Stage IV sleep has been reported with doses as low as 250 mg.

An important feature of tryptophan treatment is that, unlike many other medications administered for sleep disorders, it does not limit cognitive performance or inhibit arousal from sleep. Tryptophan also produces significant improvements in obstructive sleep apnea, but not central sleep apnea. After an average dose of 2.5 mg of tryptophan administered at bedtime, patients with obstructive sleep apnea showed significant improvement while those with central sleep apnea did not."

Effect Of L-Tryptophan and Other Amino Acids on Sleep
Nutrition Reviews, 1986 May; 44(s3):70-73

Quote: "A number of studies from our laboratory and others demonstrate that the amino acid L-tryptophan, has an effect in increasing sleepiness and inducing sleep in human beings and in animals.

Tryptophan may be useful as a mild hypnotic agent or an over-the-counter sleep-aid and it may be of use in certain patients. Although the clinical usefulness of L-tryptophan is not yet certain, there is no question that when administered in therapeutic doses, this dietary constituent has a clear-cut effect on behavior."

Evaluation of L-Tryptophan for Treatment of Insomnia: A Review
Psychopharmacology, 1986 May; 89(1):1-7

Quote: "In younger situational insomniacs, whose sleep problem consists solely of longer than usual sleep latencies, l-tryptophan is effective in reducing sleep onset time on the first night of administration in doses ranging from 1 to 15 g.

In more chronic, well-established sleep-onset insomnia or in more severe insomnias characterized by both sleep onset and sleep maintenance problems, repeated administration of low doses of l-tryptophan over time may be required for therapeutic improvement.

In these patients, hypnotic effects appear late in the treatment period or, as shown in some studies, even after discontinuation of treatment. The improvement in sleep measures post-treatment has given rise to use of a treatment regimen known as interval therapy , in which l-tryptophan treatment alternates with an l-tryptophan-free interval until improvement occurs.

The absence of side effects and lack of development of tolerance in long-term use are important factors in the decision to embark upon a trial of l-tryptophan treatment. In addition, l-tryptophan administration is not associated with impairment of visuomotor, cognitive, or memory performance, nor does it elevate threshold for arousal from sleep."

L-Tryptophan Administered to Chronic Sleep-Onset Insomniacs: Late-appearing Reduction of Sleep Latency
Psychopharmacology, 1990 June; 90(2):151-155

Quote: "The effects of 3 g l-tryptophan on sleep, performance, arousal threshold, and brain electrical activity during sleep were assessed in 20 male, chronic sleep-onset insomniacs (mean age 20.3±2.4 years). Following a sleep laboratory screening night, all subjects received placebo for 3 consecutive nights (single-blind), ten subjects received l-tryptophan, and ten received placebo for 6 nights (double-blind). All subjects received placebo on 2 withdrawal nights (single-blind). There was no effect of l-tryptophan on sleep latency during the first 3 nights of administration. On nights 4–6 of administration, sleep latency was significantly reduced. Unlike benzodiazepine hypnotics, l-tryptophan did not alter sleep stages, impair performance, elevate arousal threshold, or alter brain electrical activity during sleep."

Use of Melatonin for Sleep and Circadian Rhythm Disorders
Annals of Medicine. 1998 Feb; 30(1):115-21

Quote: "Melatonin appears to promote sleep by producing corrective circadian phase shifts, thereby improving the alignment of the endogenous sleep propensity rhythm with the desired sleep schedule. Melatonin may also have a direct soporific effect, especially when administered during the day. We suggest that the direct soporific action results from the release of accumulated sleep drive by melatonin's attenuation of the circadian alerting signal."

Efficacy of Prolonged Release Melatonin In Insomnia Patients Aged 55-80 Years: Quality of Sleep and Next-day Alertness Outcomes
Current Medical Research and Opinion. 2007 Oct; 23(10):597-605.

Quote: "Significant differences in favor of PR-melatonin vs. placebo treatment were found in concomitant and clinically relevant improvements in quality of sleep and morning alertness, demonstrated by responder analysis (26% vs. 15%; p = 0.014) as well as on each of these parameters separately.

A significant and clinically relevant shortening of sleep latency to the same extent as most frequently used sleep medications was also found (-24.3 vs.-12.9 minutes; p = 0.028). Quality of life also improved significantly (p = 0.034).

Prolonged release melatonin results in significant and clinically meaningful improvements in sleep quality, morning alertness, sleep onset latency and quality of life in primary insomnia patients aged 55 years and over.

Role of Melatonin in the Regulation of Human Circadian Rhythms and Sleep
Journal of Neuroendocrinology, 2003 April; 15(4):432-437

Quote: "The circadian rhythm of pineal melatonin is the best marker of internal time under low ambient light levels. The endogenous melatonin rhythm exhibits a close association with the endogenous circadian component of the sleep propensity rhythm. This has led to the idea that melatonin is an internal sleep ‘facilitator' in humans, and therefore useful in the treatment of insomnia and the readjustment of circadian rhythms.

There is evidence that administration of melatonin is able: (i) to induce sleep when the homeostatic drive to sleep is insufficient; (ii) to inhibit the drive for wakefulness emanating from the circadian pacemaker; and (iii) induce phase shifts in the circadian clock such that the circadian phase of increased sleep propensity occurs at a new, desired time. Therefore, exogenous melatonin can act as soporific agent, a chronohypnotic, and/or a chronobiotic."

Effects of Exogenous Melatonin on Sleep: A Meta-Analysis
Sleep Medicine Reviews Journal, 2005 February; 9(1): 41-50

Quote: "We reviewed and analyzed (by meta-analysis) available information on effects of exogenous melatonin on sleep. A MEDLINE search (1980 to December 2003) provided English-language articles, supplemented by personal files maintained by the authors. The analysis used information derived from 17 different studies (involving 284 subjects) that satisfied inclusion criteria. Sleep onset latency, total sleep duration, and sleep efficiency were selected as the outcome measures. The study effect size was taken to be the difference between the response on placebo and the mean response on melatonin for each outcome measured. Melatonin treatment significantly reduced sleep onset latency by 4.0 min (95% CI 2.5, 5.4); increased sleep efficiency by 2.2% (95% CI 0.2, 4.2), and increased total sleep duration by 12.8 min (95% CI 2.9, 22.8)."

Sleep-Inducing Effects of Low Doses of Melatonin Ingested in the Evening
Clinical Pharmacology & Therapeutics, 1995; 57:552-558

Quote: "Volunteers received [melatonin] (oral doses of 0.3 or 1.0 mg) or placebo at 6, 8, or 9 PM. Latencies to sleep onset, to stage 2 sleep, and to rapid eye movement (REM) sleep were measured polysomnographically. Either dose given at any of the three time points decreased sleep onset latency and latency to stage 2 sleep. Melatonin did not suppress REM sleep or delay its onset. Most volunteers could clearly distinguish between the effects of melatonin and those of placebo when the hormone was tested at 6 or 8 PM. Neither melatonin dose induced "hangover" effects, as assessed with mood and performance tests administered on the morning after treatment. These data provide new evidence that nocturnal melatonin secretion may be involved in physiologic sleep onset and that exogenous melatonin may be useful in treating insomnia."

Sleep Laboratory Investigations on Hypnotic Properties of Melatonin
Psychopharmacology, 1990 February; 100(2):222-226

Quote: "Melatonin has some sedative and hypnotic properties. To explore this effect further 20 young, healthy volunteers exposed to artificial insomnia participated in a double-blind, placebo controlled, parallel group design study.

They slept in a sleep laboratory for several consecutive nights and were polygraphically monitored and subjected to a battery of psychometric tests and standardized self-report questionnaires each morning.

One night all subjects received only placebo (21:00 hours) and on a second night half of them were subjected to placebo and half to MLT (melatonin). From the data collected it is concluded that a single pharmacological dose of melatonin exerts a hypnotic effect by accelerating sleep initiation, improving sleep maintenance and altering sleep architecture in a similar manner to anxiolytic sedatives; objective and subjective measures for awakening quality indicate good tolerance of one dose of MLT without hangover problems on the following morning."

Use of Melatonin in the Treatment of Pediatric Sleep Disorders
Journal of Pineal Research, 1996 November; 21(4):193-199

Quote: "Children with neurological, neuropsychiatric, and developmental disabilities are predisposed to chronic sleep-wake cycle disturbances. Disorders such as blindness, deaf-blindness, mental retardation, autism, and central nervous system diseases, among others, diminish the ability of these individuals to perceive and interpret the multitude of cues for synchronizing their sleep with the environment. Melatonin, which benefited slightly over 80% of our patients, appears to be a safe, inexpensive, and a very effective treatment of sleep-wake cycle disorders. The oral dose of fast release melatonin taken at bed-time ranged from 2.5 mg to 10 mg. Side effects or the development of tolerance have not been observed."

Effects of Low Oral Doses of Melatonin, Given 2-4 Hours Before Habitual Bedtime, on Sleep in Normal Young Humans
SLEEP, 1996; 19(5):423-431

Quote: "In the present study, 12 young healthy volunteers, free of sleep disturbances, received 0.3 or 1.0 mg of melatonin or placebo at 2100 hours, 2-4 hours prior to their habitual bedtime. Polysomnographic recording of overnight sleep began at 2200 hours and continued until 0700 hours the following morning, when subjects were awakened. Sleep onset latency and latency to stage 2 sleep were significantly decreased as a result of melatonin treatment."

The Treatment Of Sleep Disorders With Melatonin
Developmental Medicine & Child Neurology, 1994 February; 36(2):97-107

Quote: "Fifteen children (most of whom were neurologically multiply disabled) with severe, chronic sleep disorders were treated with 2 10 10mg of oral melatonin, given at bedtime. Nine had fragmented sleep patterns, three had delayed sleep onset and three others had non-specific sleep disturbance of unclear aetiology; all had failed to respond to conventional management. Nine patients had ocular or cortical visual impairment. The health, behavioral and social benefits of treatment were significant, and there were no adverse side-effects. While the response was not always complete, the study clearly showed that melatonin has an important role in the treatment of certain types of chronic sleep disorders."

Effect of Melatonin in Selected Populations of Sleep-Disturbed Patients
Biological Signals & Receptors, 1999; 8:126-131

Quote: "In an open pilot study on the efficacy of melatonin in the treatment of sleep disorders, patients with sleep disturbances alone, patients with sleep disturbances and signs of depression, and patients with sleep disorders and dementia received 3 mg melatonin for 21 days, at bed time. After 2–3 days of treatment, melatonin significantly augmented sleep quality and decreased the number of awakening episodes in patients with sleep disturbances associated or not with depression."

Low Dose Melatonin Improves Sleep in Healthy Middle-aged Subjects
Psychopharmacology, 1996 January; 126(2):179-181

Quote: "We studied the effects of single evening doses of melatonin (0.3 mg and 1.0 mg orally) on polysomnographically measured sleep in 15 healthy middle-aged volunteers, using a placebo-controlled, double-blind, cross-over design.

Compared to placebo, the 1.0 mg dose of melatonin significantly increased Actual Sleep Time, Sleep Efficiency, non-REM Sleep and REM Sleep Latency. These data are consistent with the hypothesis that low dose melatonin has hypnotic effects in humans. It is possible that administered melatonin may have a role to play in the treatment of sleep disorders.

Melatonin and the Circadian Regulation of Sleep Initiation, Consolidation, Structure, and the Sleep EEG
Journal of Biological Rhythms, 1997 December; 12(6):657-665

Quote: "Administration of melatonin during the day increases daytime sleep propensity as indexed by both the latency to sleep onset and sleep consolidation. The EEG during daytime sleep after melatonin administration exhibits characteristics reminiscent of the nocturnal sleep EEG, that is, increased sleep spindle activity and reduced slow-wave sleep and slow-wave activity as detected by quantitative EEG analysis. Administration of higher doses of melatonin (5 mg or more) prior to nocturnal sleep results in an increase in rapid eye movement (REM) sleep. These data demonstrate that melatonin exerts effects on the main characteristics of human sleep, that is, latency to sleep onset, sleep consolidation, slow waves, sleep spindles, an M sleep."

Prolonged-Release Melatonin Improves Sleep Quality and Morning Alertness in Insomnia Patients Aged 55 Years and Older and Has No Withdrawal Effects
Journal of Sleep Research, 2007 Dec; 16(4):372-80.

Quote: "Non-restorative sleep (perceived poor quality of sleep) and subsequently poor daytime functioning are increasingly recognized as a leading syndrome in the diagnostic and therapeutic process of insomnia complaints. The effects of 3-weeks prolonged-release melatonin 2 mg (PR-melatonin) versus placebo treatment were assessed in a multi-center randomized placebo-controlled study in 170 primary insomnia outpatients aged 55 or older. Prolonged-release melatonin is the first drug shown to significantly improve quality of sleep and morning alertness in primary insomnia patients aged 55 years and older, suggesting more restorative sleep, and without withdrawal symptoms upon discontinuation."

L-Theanine Reduces Psychological and Physiological Stress Responses
Biological Psychology, 2007 Jan; 74(1):39-45

Quote: "L-Theanine is an amino acid contained in green tea leaves which is known to block the binding of L-glutamic acid to glutamate receptors in the brain. Because the characteristics of L-Theanine suggest that it may influence psychological and physiological states under stress, the present study examined these possible effects in a laboratory setting using a mental arithmetic task as an acute stressor.

Twelve participants underwent four separate trials: one in which they took L-Theanine at the start of an experimental procedure, one in which they took L-Theanine midway, and two control trials in which they either took a placebo or nothing. The experimental sessions were performed by double-blind, and the order of them was counterbalanced.

The results showed that L-Theanine intake resulted in a reduction in the heart rate (HR) and salivary immunoglobulin A (s-IgA) responses to an acute stress task relative to the placebo control condition. Moreover, analyses of heart rate variability indicated that the reductions in HR and s-IgA were likely attributable to an attenuation of sympathetic nervous activation. Thus, it was suggested that the oral intake of L-Theanine could cause anti-stress effects via the inhibition of cortical neuron excitation."

200 mg of Zen: L-Theanine Boosts Alpha Waves, Promotes Alert Relaxation
Alternative and Complementary Therapies, 2001 April; 7(2): 91-95

Quote: "A volunteer study was undertaken to investigate the mental response to L-theanine. Because it was anticipated that the mental response could vary with an individual's anxiety level, test subjects (18–22 years old) were divided into high-anxiety and low-anxiety groups, as determined by the Manifest Anxiety Scale. Tests were conducted on four high-anxiety and four low-anxiety subjects. Over a 2-month period, each volunteer was given test solutions of water, water containing 50 mg of L-theanine, or water containing 200 mg of L-theanine. Brain waves were measured for 60 minutes after each administration.

The experiment indicated that alpha brain waves were observed from the back to the top surface of a person's head within approximately 40 minutes after the subject had taken the L- theanine solutions. In a separate study it was noted that "[the]he intensity of alpha waves were determined to be dose dependent and detectable after thirty minutes. The perceived relaxation effect was incidental with the detection of alpha waves."

These results are consistent with the previously men- tioned study,1 which reported that L-thea- nine reached the brain within 30 minutes. These studies consistently support the conclusion that consumption of 200 mg of L-theanine results in an increase of alpha- wave activity in the brain within 30–40 minutes. This fosters a state of alert relaxation."

Nutrients and Botanicals for Treatment of Stress: Adrenal Fatigue, Neurotransmitter Imbalance, Anxiety, and Restless Sleep
Alternative Medicine Review, 2009; 14(2): 114-140

Quote: "L-theanine is an amino acid extracted from green or black tea. A cup of black tea contains approximately 20 mg theanine. In the brain L-theanine increases dopamine, serotonin, and the inhibitory neurotransmitter glycine. Green tea is often used as a relaxing beverage. Although it can contain more caffeine than coffee, theanine appears to counteract its stimulant effect to some degree. When given by itself in a smaller dose (20-40% of the original dose), theanine administration resulted in excitatory effects, suggesting a dual activity of theanine depending on the dose. Studies show L-theanine induces alpha-brain wave activity, which correlates with a perceived state of relaxation."

Kava and Valerian in the Treatment of Stress-Induced Insomnia
Phytotherapy Research, 2001 September; 15(6):549-551

Quote: "Kava and valerian are herbal remedies, claimed to have anxiolytic and sedative properties respectively, without dependence potential or any appreciable side-effects. In this pilot study, 24 patients suffering from stress-induced insomnia were treated for 6 weeks with kava 120mg daily. This was followed by 2 weeks off treatment and then, 5 having dropped out, 19 received valerian 600mg daily for another 6 weeks. Stress was measured in three areas: social, personal and life-events; insomnia in three areas also: time to fall asleep, hours slept and waking mood. Total stress severity was significantly relieved by both compounds (p<0.01) with no significant differences between them; as was also insomnia (p<0.01). The proportion of patients with no side-effects was 58% with each drug respectively and the ‘commonest' effect was vivid dreams with valerian (16%), followed by dizziness with kava (12% )."

Valerian-Hops Combination and Diphenhydramine for Treating Insomnia: A Randomized Placebo-Controlled Clinical Trial
SLEEP, 2005; 28(11):1465-1471.

Quote: "The results of this study indicate that a valerian-hops combination and di-phenhydramine produce a mild hypnotic effect in the treatment of insomnia. Sleep improvements were obtained on subjective measures of sleep latency, sleep efficiency, and total sleep time. Both treatments produced reductions of patient's Insomnia Severity Index scores relative to placebo, and the valerian-hops combination improved quality of life relative to placebo. There were no significant residual effects and no rebound insomnia after treatment discontinuation, confirming the safety of the investigated valerian-hops combination and diphenhydramine when taken on a daily basis for 4 and 2 weeks, respectively."

Double Blind Study of a Valerian Preparation
Pharmacology Biochemistry and Behavior, 1989 April; 32(4):1065-1066

Quote: "Valerian root contains two substances of special pharmacological interest—valepotriates and sesquiterpenes. The former, which has been used for standardization of the drug, is cytotoxic. The latter has no such effect. Both have sedative effects. A double blind test has been carried out on a preparation (VALERINA NATT) containing primarily sesquiterpenes. When compared with placebo it showed a good and significant effect on poor sleep (p<0.001). Forty-four percent reported perfect sleep and 89% reported improved sleep from the preparation. No side effects were observed."

Critical Evaluation of the Effect of Valerian Extract on Sleep Structure and Sleep Quality
Pharmacopsychiatry 2000; 33(2): 47-53

Quote: "A carefully designed study assessed the short-term (single dose) and long-term (14 days with multiple dosage) effects of a valerian extract on both objective and subjective sleep parameters. The investigation was performed as a randomized, double-blind, placebo-controlled, cross-over study. Sixteen patients (4 male, 12 female) with previously established psychophysiological insomnia (ICSD-code 1.A.1.), and with a median age of 49 (range: 22 to 55), were included in the study. In comparison with the placebo, slow-wave sleep latency was reduced after administration of valerian (21.3 vs. 13.5 min respectively, p < 0.05).

The SWS percentage of time in bed (TIB) was increased after long-term valerian treatment, in comparison to baseline (9.8 vs. 8.1 % respectively, p < 0.05). At the same time point, a tendency for shorter subjective sleep latency, as well as a higher correlation coefficient between subjective and objective sleep latencies, were observed under valerian treatment. A remarkable finding of the study was the extremely low number of adverse events during the valerian treatment periods (3 vs. 18 in the placebo period).

In conclusion, treatment with a herbal extract of valerian demonstrated positive effects on sleep structure and sleep perception of insomnia patients, and can therefore be recommended for the treatment of patients with mild psychophysiological insomnia."

Effect of Valerian on Human Sleep
Psychopharmacology 1985 Dec; 87(4):406-409

Quote: "The effect of an aqueous extract of valerian root on sleep was studied in two groups of healthy, young subjects. One group (N=10) slept at home, the other (N=8) in the sleep laboratory. Sleep was evaluated on the basis of questionnaires, self-rating scales and night-time motor activity. In addition, polygraphic sleep recordings and spectral analysis of the sleep EEG was performed in the laboratory group.

Under home conditions, both doses of valerian extract (450 and 900 mg) reduced perceived sleep latency and wake time after sleep onset. Night-time motor activity was enhanced in the middle third of the night and reduced in the last third. The data suggest a dose-dependent effect. In the sleep laboratory, where only the higher dose of valerian was tested, no significant differences from placebo were obtained. However, the direction of the changes in the subjective and objective measures of sleep latency and wake time after sleep onset, as well as in night-time motor activity, corresponded to that observed under home conditions. There was no evidence for a change in sleep stages and EEG spectra. The results indicate that the aqueous valerian extract exerts a mild hypnotic action."

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