* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
As a dietary supplement, take one to two soft chews before bedtime. Do not exceed recommended dosage in any 24 hour period.
|Serving Size 1 soft chew|
|Servings Per Container 60|
|Amount Per Serving||% DV|
|Total Carbohydrate||4.00 g||1%|
|** Daily Value (DV) not established|
Other Ingredients: Maltitol Syrup, lsomalt, Corn Syrup Solids, Palm Oil, Modified Potato Starch, Egg Yolk, Cacao, Natural Flavors, Soy Lecithin, Glycerin, Sodium Chloride, Carrageenan, Caramel Color, Sucralose
Warning: For adult use only at bedtime. This product is not to be taken by pregnant or lactating women. If you are taking medication or have a medical condition, consult a physician before using this product. Do not use in conjunction with alcoholic beverages, when driving a vehicle or while operating machinery.
CONTAINS: Eggs and Soybeans. Contributes trivial amount of sugar.
Distributed by: General Nutrition Corporation Pittsburgh, PA 15222
Our proprietary "Star-Rating" system was developed to help you easily understand the amount of scientific support behind each supplement in relation to a specific health condition. While there is no way to predict whether a vitamin, mineral, or herb will successfully treat or prevent associated health conditions, our unique ratings tell you how well these supplements are understood by the medical community, and whether studies have found them to be effective for other people.
For over a decade, our team has combed through thousands of research articles published in reputable journals. To help you make educated decisions, and to better understand controversial or confusing supplements, our medical experts have digested the science into these three easy-to-follow ratings. We hope this provides you with a helpful resource to make informed decisions towards your health and well-being.
In a preliminary trial, supplementation with melatonin (3 mg per day at bedtime for at least three months) resulted in an improvement in the abnormalities observed on eye examination in the majority of cases.1 Melatonin is believed to work by regulating eye pigmentation (and, consequently, the amount of light reaching the retina) and by functioning as an antioxidant.
In a double-blind trial, supplementation with prolonged-release melatonin (2 mg each night for 24 weeks) significantly improved cognitive function and sleep quality, compared with a placebo, in patients with Alzheimer's disease.1 The beneficial effect of melatonin was more pronounced in patients who were suffering from insomnia than in those who were not, suggesting that poor sleep quality contributes to impaired cognitive function in people with Alzheimer's disease.
Melatonin is a hormone secreted by the pineal gland in the brain. It is partially responsible for regulating sleep-wake cycles. Cognitive function is linked to adequate sleep and normal sleep-wake cycles. Cognitive benefits from melatonin supplementation have been suggested by preliminary research in a variety of situations and may derive from the ability of melatonin to prevent sleep disruptions.1, 2, 3, 4 A double-blind trial of ten elderly patients with mild cognitive impairment showed that 6 mg of melatonin taken two hours before bedtime significantly improved sleep, mood, and memory, including the ability to remember previously learned items.5 However, in a double-blind case study of one healthy person, 1.6 mg of melatonin had no immediate effect on cognitive performance.6
The long-term effects of regularly taking melatonin supplements remain unknown, and many healthcare practitioners recommend that people take no more than 3 mg per evening. A doctor familiar with the use of melatonin should supervise people who wish to take it regularly.
1. Myers BL, Badia P. Changes in circadian rhythms and sleep quality with aging: mechanisms and interventions. Neurosci Biobehav Rev 1995;19(4):553-71. Published erratum appears in Neurosci Biobehav Rev 1996;20(2):I-IV.
2. Dollins AB, Zhdanova IV, Wurtman RJ, et al. Effect of inducing nocturnal serum melatonin concentrations in daytime on sleep, mood, body temperature, and performance. Proc Natl Acad Sci U S A 1994;91(5):1824-8.
3. Dori D, Casale G, Solerte SB, et al. Chrono-neuroendocrinological aspects of physiological aging and senile dementia. Chronobiologia 1994;21(1-2):121-6.
4. Comperatore CA, Lieberman HR, Kirby AW, et al. Melatonin efficacy in aviation missions requiring rapid deployment and night operations. Aviat Space Environ Med 1996;67(6):520-4.
5. Jean-Louis G, von Gizycki H, Zizi F. Melatonin effects on sleep, mood, and cognition in elderly with mild cognitive impairment. J Pineal Res 1998;25(3):177-83.
6. Slotten HA, Krekling S. Does melatonin have an effect on cognitive performance? Psychoneuro-endocrinology 1996;21(8):673-80.
Researchers have found low levels of the hormone melatonin in cluster headache patients.1, 2, 3, 4 In a small double-blind trial, a group of cluster headache sufferers took a 10 mg evening dose of melatonin for 14 days. About half of the group saw a significant decrease in the frequency of their headaches within three to five days, after which no further headaches occurred until melatonin was discontinued.5 Melatonin appears to be effective against both types of cluster headache (e.g., episodic and chronic). 6 More research is needed to establish the long-term effects of melatonin supplementation on cluster headache.
1. Chazot G, Claustrat B, Brun J, et al. A chronobiological study of melatonin, cortisol, growth hormone, and prolactin secretion in cluster headache. Cephalalgia 1984;4:213-20.
2. Waldenlind E, Gustafsson SA, Ekbom KA, Wetterberg L. Circadian secretion of cortisol and melatonin during active cluster periods and remission. J Neurol Neurosurg Psychiatry 1987;50:207-13.
3. Leone M, Lucini V, D'Amico D, et al. Twenty-four-hour melatonin and cortisol plasma levels in relation to timing of cluster headache. Cephalalgia 1995;15:224-9.
4. Leone M, Lucini V, D'Amico D, et al. Abnormal 24-hour urinary excretory pattern of 6-sulphatoxymelatonin in both phases of cluster headache. Cephalalgia 1998;18:664-7.
5. Leone M, D'Amico D, Moschiano F, et al. Melatonin versus placebo in the prophylaxis of cluster headache: a double-blind pilot study with parallel groups. Cephalalgia 1996;16:494-6.
6. Peres MFP, Rozen TD. Melatonin in the preventive treatment of chronic cluster headache. Cephalalgia 2001;21:993-5.
The function of the pineal gland and its cyclic secretion of melatonin may be disturbed in people with migraine headaches.1 Preliminary evidence suggests that 5 mg per day of melatonin, taken 30 minutes before bedtime, may reduce symptoms of migraine headache.2 However, a double-blind trial found that taking 2 mg of melatonin 1 hour before bedtime each day for 8 weeks was not more effective than a placebo for decreasing migraine frequency.3
1. Claustrat B, Brun J, Geoffriau M, et al. Nocturnal plasma melatonin profile and melatonin kinetics during infusion in status migrainosus. Cephalalgia 1997;17:511-7 (discussion 487).
2. Nagtegaal JE, Smits MG, Swart AC, et al. Melatonin-responsive headache in delayed sleep phase syndrome: preliminary observations. Headache 1998;38:303-7.
3. Alstadhaug KB, Odeh F, Salvesen R, Bekkelund SI. Prophylaxis of migraine with melatonin: a randomized controlled trial. Neurology 2010;75:1527-32.
Melatonin supplementation may be useful in the treatment of fibromyalgia. In a preliminary trial, 3 mg of melatonin at bedtime was found to reduce tender points and to improve sleep and other measures of disease severity, though pain and fatigue improved only slightly.1
Melatonin is a natural hormone that regulates the human biological clock. The body produces less melatonin with advancing age, which may explain why elderly people often have difficulty sleeping1 and why melatonin supplements improve sleep in the elderly.2
Middle-aged adults (average age, 54 years) with insomnia also have lower melatonin levels, compared with people of the same age without insomnia.3 However, there is not much research on the use of melatonin for sleep problems in middle-aged people.
Double-blind trials have shown that melatonin facilitates sleep in young adults without insomnia,4 but not in young people who suffer from insomnia.5However, one trial found that children with sleep disturbances stemming from school phobia had improved sleep after taking 1 mg of melatonin per night for one week, then 5 mg per night for one week, then 10 mg per night for a third week.6
The results of one double-blind trial also indicate that a controlled release melatonin supplement providing 2 mg per day improves sleep quality in people with schizophrenia.7
Normally, the body makes melatonin for several hours per night-an effect best duplicated with controlled-release supplements. Trials using timed-release melatonin for insomnia have reported good results.8 Many doctors suggest taking 0.5 to 3 mg of melatonin one and a half to two hours before bedtime. However, because melatonin is a potent hormone, the long-term effects of which are unknown, it should be taken only with the supervision of a doctor.
1. Haimov I, Laudon M, Zisapel N, et al. Sleep disorders and melatonin rhythms in elderly people. BMJ 1994;309:167.
2. Singer C, McArthur A, Hughes R, et al. Melatonin and sleep in the elderly. J Am Geriatr Soc 1996;44:51 [abstr #A1].
3. Attenburrow MEJ, Dowling BA, Sharpley AL, Cowen PJ. Case-control study of evening melatonin concentration in primary insomnia. BMJ 1996;312:1263-4.
4. 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.
5. James SP, Sack DA, Rosenthal NE, Mendelson WB. Melatonin administration in insomnia. Neuropsychopharmacology 1989;3:19-23.
6. Tomoda A, Miike T, Iwatani N, et al. Effect of long-term melatonin administration on school-phobic children and adolescents with sleep disturbances. Curr Ther Res 1999;60:607-12.
7. Shamir E, Laudon M, Barak Y, et al. Melatonin improves sleep quality of patients with chronic schizophrenia. J Clin Psychiatry 2000;61:373-7.
8. Garfinkel D, Laudon M, Nof D, Zisapel N. Improvement of sleep quality in elderly people by controlled-release melatonin. Lancet 1995;346:541-4.
Melatonin is a natural hormone that regulates the human biological clock and may be helpful in relieving symptoms of jet lag, according to some,1, 2 though not all,3, 4 double-blind studies. One double-blind trial, involving international flight crew members, found that melatonin supplementation was helpful when started after arriving at the destination but not when started three days before leaving.5 Another double-blind study compared various amounts and forms of melatonin taken at bedtime for four days after the flight by people who traveled through six to eight time zones.6 Fast-release melatonin supplements were found to be more effective than the controlled-release supplements. A 5 mg and 0.5 mg fast-release melatonin were almost equally effective for improving sleep quality, time it took to fall asleep, and daytime sleepiness.
1. Petrie K, Conaglen JV, Thompson L, Chamberlain K. Effect of melatonin on jet lag after long haul flights. BMJ 1989;298:705-7.
2. Claustrat B, Brun J, David M, et al. Melatonin and jet lag: confirmatory result using a simplified protocol. Biol Psychiatry 1992;32:705-11.
3. Edwards BJ, Atkinson G, Waterhouse J, et al. Use of melatonin in recovery from jet-lag following an eastward flight across 10 time-zones. Ergonomics 2000;43:1501-13.
4. Spitzer RL, Terman M, Williams JB, et al. Jet lag: clinical features, validation of a new syndrome-specific scale, and lack of response to melatonin in a randomized, double-blind trial. Am J Psychiatry 1999;156:1392-6.
5. Petrie K, Dawson AG, Thompson L, et al. A double-blind trial of melatonin as a treatment for jet lag in international cabin crew. Bio Psych 1993;33(7):526-30.
6. Suhner A, Schlagenhauf P, Johnson R, et al. Comparative study to determine the optimal melatonin dosage form for the alleviation of jet lag. Chronobiol Int 1998;15:655-66.
In a double-blind trial, melatonin supplementation (3 mg taken nightly) improved symptoms of tinnitus.1 Although improvement did not reach statistical significance for all participants, the results were significant in those who reported more severe symptoms (such as two-sided vs. one-sided tinnitus). Among participants who had difficulty sleeping due to tinnitus, 47% of those who took melatonin reported sleep improvement after one month, compared with only 20% of those who took the placebo. Similar improvements in tinnitus were reported in a preliminary trial that used 3 mg of melatonin each night for four weeks.2
1. Rosenberg SI,Silverstein H,Rowan PT, et al. Effect of melatonin on tinnitus. The Laryngoscope. 1998 Mar;108(3):305-10
2. Megwalu UC,Finnell JE,Piccirillo JF. The effects of melatonin on tinnitus and sleep. Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery. 2006 Feb;134(2):210-3
Antioxidants have been studied as topical agents for protection against sunburn. Animal studies have found sunscreen-like effects from topical application of a vitamin C and vitamin E combination, and a controlled human study reported ultraviolet protection from the use of a lotion containing 0.02% to 0.05% of the selenium-containing amino acid known as selenomethionine.1, 2 The topical use of the hormone melatonin has been shown to protect human skin against ultraviolet rays in double-blind research.3, 4 A double-blind human trial tested topical vitamins C and E and melatonin, alone and in combinations, and found the highest degrees of protection from combination formulations containing 2% vitamin E, 5% vitamin C, and 1% to 2.5% melatonin.5 Other studies in which topical antioxidants were applied after ultraviolet exposure have found no benefits.6, 7
1. Lin JY, Selim MA, Shea CR, et al. UV photoprotection by combination topical antioxidants vitamin C and vitamin E. J Am Acad Dermatol 2003;48:866-74.
2. Burke KE, Burford RG, Combs GF Jr, et al. The effect of topical L-selenomethionine on minimal erythema dose of ultraviolet irradiation in humans. Photodermatol Photoimmunol Photomed 1992;9:52-7.
3. Bangha E, Elsner P, Kistler GS. Suppression of UV-induced erythema by topical treatment with melatonin (N-acetyl-5-methoxytryptamine). Influence of the application time point. Dermatology 1997;195:248-52.
4. Bangha E, Elsner P, Kistler GS. Suppression of UV-induced erythema by topical treatment with melatonin (N-acetyl-5-methoxytryptamine). A dose response study. Arch Dermatol Res 1996;288:522-6.
5. Dreher F, Gabard B, Schwindt DA, Maibach HI. Topical melatonin in combination with vitamins E and C protects skin from ultraviolet-induced erythema: a human study in vivo. Br J Dermatol 1998;139:332-9.
6. Dreher F, Denig N, Gabard B, et al. Effect of topical antioxidants on UV-induced erythema formation when administered after exposure. Dermatology 1999;198:52-5.
7. Fuchs J. Potentials and limitations of the natural antioxidants RRR-alpha-tocopherol, L-ascorbic acid and beta-carotene in cutaneous photoprotection. Free Radic Biol Med 1998;25:848-73 [review].
Supplementing with 0.5 mg of melatonin lowered intraocular pressure of healthy people,1 but there have been no studies on the effects of melatonin in people with glaucoma.
Melatonin plays a role in the regulation of gastrointestinal function and sensation. In a double-blind trial, people with irritable bowel syndrome and associated sleep disturbances received 3 mg of melatonin or a placebo at bedtime for two weeks. Compared with the placebo, melatonin significantly decreased the severity of abdominal pain, although it did not affect bloating, stool frequency, or sleep patterns.1 Melatonin was also effective in another double-blind trial.2
1. Song GH, Leng PH, Gwee KA, et al. Melatonin improves abdominal pain in irritable bowel syndrome patients who have sleep disturbances: a randomised, double blind, placebo controlled study. Gut 2005;54:1402-7.
2. Saha L, Malhotra S, Rana S, et al. A preliminary study of melatonin in irritable bowel syndrome. J Clin Gastroenterol 2007;41:29-32.
In a double-blind study, supplementation with 2 mg of sustained-release melatonin each night for four weeks significantly reduced nighttime systolic blood pressure, compared with a placebo, in people with nocturnal hypertension.1 Normally, blood pressure declines at night. People with hypertension who do not have this nighttime blood pressure decline are at increased risk of developing and dying from heart disease. Melatonin supplementation may therefore be beneficial for this subgroup of people with hypertension.
In a double-blind trial, melatonin supplementation (3 mg taken nightly) improved the symptoms of tinnitus.1 Although improvement did not reach statistical significance for all participants, the results were significant in those who reported more severe symptoms (such as two-sided vs. one-sided tinnitus). Among participants who had difficulty sleeping due to tinnitus, 47% of those who took melatonin reported sleep improvement after one month, compared with only 20% of those who took placebo. Similar improvements in tinnitus were reported in a preliminary trial that used 3 mg of melatonin each night for four weeks.2
Melatonin is a natural hormone that regulates the human biological clock.
Copyright 2015 Aisle7. All rights reserved. Aisle7.com
The information presented in Aisle7 is for informational purposes only. It is based on scientific studies (human, animal, or in vitro), clinical experience, or traditional usage as cited in each article. The results reported may not necessarily occur in all individuals. For many of the conditions discussed, treatment with prescription or over the counter medication is also available. Consult your doctor, practitioner, and/or pharmacist for any health problem and before using any supplements or before making any changes in prescribed medications. Information expires June 2016.