MELLODYN - Clinical Research

MELLODYN combines melatonin, a natural human hormone that regulates the sleep-wake cycle, with high-quality extracts of Valerian, Lemon Balm, Chamomile and Passion Flower. Numerous scientific studies, including controlled clinical trials, support the efficacy of these ingredients for improving sleep quality and relieving insomnia and other sleep disturbances. Ultimately, clinical research is your best assurance that a supplement actually works. Please take a moment to review the research below to learn why MELLODYN is the best sleep supplement on the market.

Melatonin Facilitates Sleep in Young Adults Without "Hangover" Effects
  (randomized, placebo-controlled, double-blind trial)
"Volunteers received the [melatonin] (oral doses of 0.3 or 1.0 mg) or placebo at 6, 8, or 9 PM... Either dose given at any of the three time points decreased sleep onset latency and latency to stage 2 sleep. [In other words, the people receiving melatonin fell asleep faster.] 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."¹

Middle-Aged Adults with Insomnia Have Lower Melatonin Levels Compared with Adults Without Insomnia
"Our findings add to data suggesting that some patients with insomnia have decreased melatonin secretion... Our findings support the possibility that some patients with insomnia may benefit from treatment with exogenous melatonin."²

Melatonin Promotes Sleep When Taken Before Bed
  (randomized, placebo-controlled, double-blind trial)
"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... Sleep onset latency and latency to stage 2 sleep were significantly decreased as a result of melatonin treatment. Neither dose of melatonin significantly altered sleep architecture... Neither melatonin dose caused "hangover effects", as assessed by self-reports or by mood and performance tests administered on the morning following treatment. These observations provide additional evidence that nocturnal melatonin secretion has a sleep-promoting function."³

Melatonin Improves Sleep Quality in Elderly with Insomnia
  (randomized, placebo-controlled, double-blind trial)
"Among elderly people, even those who are healthy, the frequency of sleep disorders is high and there is an association with impairment of melatonin production. We investigated the effect of a controlled-release formulation of melatonin on sleep quality in 12 elderly subjects who were receiving various medications for chronic illnesses and who complained of insomnia... In a randomized, double-blind, crossover study the subjects were treated for 3 weeks with 2 mg per night of controlled-release melatonin and for 3 weeks with placebo, with a week's washout period... Sleep efficiency was significantly greater after melatonin than after placebo and wake time after sleep onset was significantly shorter... Melatonin deficiency may have an important role in the high frequency of insomnia among elderly people... Melatonin replacement therapy effectively improves sleep quality in this population."⁴

Melatonin Deficiency Associated with Sleep Disorders in Elderly
"Our data suggests a relation between deficiency of melatonin or disruption of its rhythms and an increased prevalence of sleep disorders with advancing age... In conclusion, melatonin deficiency seems to be a key variable in the incidence of sleep disorders in elderly people, and melatonin replacement therapy may prove beneficial."⁵

Valerian Decreases Sleep Latency With Few Side Effects
  (randomized, placebo-controlled, double-blind trial)
"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, and with a median age of 49, were included in the study.... We confirmed significant differences between valerian and placebo for parameters describing slow-wave sleep. 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."⁶

Valerian Extract as Effective as Oxazepam for Insomnia
  (randomized, active-controlled, double-blind trial)
Over a period of 28 days, seventy-five patients with non-organic insomnia took either 300mg valerian extract or 10mg oxazepam (a prescription anti-anxiety drug used to treat insomnia) 30 minutes before bed. The researchers found that "in both groups sleep quality improved significantly (p <0.001)" and that "no statistically significant difference could be found" between Valerian and oxazepam. Moreover, more people in the oxazepam group withdrew from the study due to adverse reactions. The researchers concluded that "the study showed no differences in the efficacy of valerian and oxazepam".⁷

Combination of Valerian and Lemon Balm Effectively Improves Sleep
At least two placebo-controlled, double-blind clinical trials demonstrate that combinations of valerian and lemon balm extracts effectively promote sleep.^8,9 The amounts of valerian and lemon balm found in MELLODYN are similar to the doses used in these studies. And a small preliminary trial found valerian and lemon balm extracts to be as effective as the prescription sleep drug triazolam (Halcion®), but only the people taking triazolam had trouble concentrating and felt hung over the next day.¹⁰

Passion Flower as Effective as Oxazepam for Anxiety
  (randomized, active-controlled, double-blind trial)
"A double-blind randomized trial compared the efficacy of Passiflora incarnata extract with oxazepam in the treatment of generalized anxiety disorder. The study was performed on 36 out-patients diagnosed with GAD using DSM IV criteria. Patients were allocated in a random fashion: 18 to the Passiflora extract 45 drops/day plus placebo tablet group, and 18 to oxazepam 30 mg/day plus placebo drops for a 4-week trial. RESULTS: Passiflora extract and oxazepam were effective in the treatment of generalized anxiety disorder. No significant difference was observed between the two protocols at the end of trial. Oxazepam showed a rapid onset of action. On the other hand, significantly more problems relating to impairment of job performance were encountered with subjects on oxazepam. CONCLUSION: The results suggest that Passiflora extract is an effective drug for the management of generalized anxiety disorder, and the low incidence of impairment of job performance with Passiflora extract compared to oxazepam is an advantage."

If you haven't already, please take a moment to learn more about the 100% natural ingredients in MELLODYN or the benefits that only MELLODYN offers. Otherwise, you can order MELLODYN for fast, reliable delivery.

(1) Zhdanova IV, Wurtman RJ, Lynch HJ, et al. Sleep-inducing effects of low doses of melatonin ingested in the evening. Clin Pharmacol Ther 1995;57:552-8.
(2) Attenburrow MEJ, Dowling BA, Sharpley AL, Cowen PJ. Case-control study of evening melatonin concentration in primary insomnia. BMJ 1996;312:1263-4.
(3) Zhdanova IV, Wurtman RJ, Morabito C, Piotrovska VR, Lynch HJ. Effects of low oral doses of melatonin, given 2-4 hours before habitual bedtime, on sleep in normal young humans. Sleep 1996;5:423-31.
(4) Garfinkel D, Laudon M, Nof D, Zisapel N. Improvement of sleep quality in elderly people by controlled-release melatonin. Lancet 1995;346:541-4.
(5) Haimov I, Laudon M, Zisapel N, Souroujon M, Nof D, Shlitner A, et al. Sleep disorders and melatonin rhythms in elderly people. BMJ 1994;309:167.
(6) Donath F, Quispe S, Diefenbach K, et al. Critical evaluation of the effect of valerian extract on sleep structure and sleep quality. Pharmacopsychiatry 2000;33:47-53.
(7) Dorn M. [Efficacy and tolerability of Baldrian versus oxazepam in non-organic and non-psychiatric insomniacs: a randomised, double-blind, clinical, comparative study]. Forsch Komplementarmed Klass Naturheilkd 2000 Apr;7(2):79-84. German.
(8) Dressing H, Köhler S, Müller WE. Improvement of sleep quality with a high-dose valerian/lemon balm preparation: A placebo-controlled double-blind study. Psychopharmakotherapie 1996;6:32-40.
(9) Cerny A, Schmid K. Tolerability and efficacy of valerian/lemon balm in healthy volunteers (a double-blind, placebo-controlled, multicentre study). Fitoterapia 1999;70:221-8.
(10) Dressing H, Riemann D, Low H, et al. Insomnia: Are valerian/balm combination of equal value to benzodiazepine? Therapiewoche 1992;42:726-36 [in German].
(11) Akhondzadeh S, Naghavi HR, Vazirian M, Shayeganpour A, Rashidi H, Khani M. Passionflower in the treatment of generalized anxiety: a pilot double-blind randomized controlled trial with oxazepam. J Clin Pharm Ther 2001 Oct;26(5):363-7.

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Copyright © 2006 BioNeurix Corporation. MELLODYN and the MELLODYN crescent moon logo are trademarks of BioNeurix Corporation. The statements on the mellodyn.com website have not been evaluated by the Food and Drug Administration. MELLODYN is a dietary supplement, not a drug. MELLODYN is not intended to diagnose, treat, cure or prevent any disease. MELLODYN should not be considered a replacement for FDA-approved medication or professional medical treatment. By placing an order, you agree to the Terms and Conditions of Sale.