Bioclinic Naturals, Melatonin Time Release 5 mg 60 Tablets

Benefits

• Clinically shown to improve sleep quality, morning alertness, sleep onset latency, and quality of life
• Supplementation linked to improved mood and cognitive function among those with impaired sleep
• Provides 5 mg timed released melatonin per tablet
• Timed release formulation sustains plasma levels for a longer period, enhancing sleep initiation, maintenance, and quality
• Non-habit forming

Feature Summary

Sleep is a vital part of health and many of us are not getting enough of it. Changes in sleeping patterns are largely reflective of our circadian rhythms, which are guided by the pineal hormone, melatonin. Melatonin plays a major role in the circadian regulation of the sleep-wake cycle and has proven critically important for both initiation and quality of sleep, with supplementation improving sleep in healthy individuals and in those with insomnia, as well as preventing phase shifts due to jet lag or shift work.1 Timed release melatonin improves not only sleep initiation but also helps maintain and improve sleep quality.

Melatonin is particularly effective in older individuals, regardless of endogenous melatonin levels, in both the short and the long term, with improvements in sleep quality, morning alertness, sleep onset latency, and quality of life, with no relevant adverse effects or dependency.2,3 Furthermore, it has been shown to improve sleep quality in children with diverse sleep complaints, including delayed sleep phase syndrome impaired sleep maintenance, or other sleep-related disorders.4-7 Timed release melatonin has demonstrated clinical improvements in mood in those with sleep disturbances, as well as cognitive performance in those with Alzheimer’s disease.8,9

Non-Medicinal Ingredients

Dibasic calcium phosphate dihydrate, microcrystalline cellulose, carbohydrate gum [cellulose], vegetable grade magnesium stearate (lubricant).

Dosage

Recommended Adult Dose: 1–2 tablets per day at or before bedtime, or as directed by a health care practitioner. Do not drive or use machinery for 5 hours after taking melatonin. For use beyond 4 weeks, consult a health care practitioner. Jet Lag: Take once a day at bedtime after darkness has fallen while traveling, and at your destination until adaptation to the new daily pattern. For occasional short-term use.

Warnings

Consumption of alcohol, other medications or natural health products with sedative properties is not recommended. If you are taking one of the following medications, consult a health care practitioner prior to use: anticoagulant, anticonvulsant, blood pressure medications, immunosuppressive medications, sedative, hypnotic or psychotropic medications, or steroids. If you have one of the following conditions, consult a health care practitioner prior to use: asthma, cardiovascular disease, chronic kidney disease, depression, diabetes or hypoglycemia, hormonal disorder, immune system disease, liver disease, migraine, or seizure disorders. If symptoms persist continuously for more than 4 weeks (chronic insomnia) consult a health care practitioner. Mild gastrointestinal symptoms (such as nausea, vomiting, or cramping) have been known to occur, in which case discontinue use. Rare allergic reactions have been known to occur, in which case discontinue use. Do not use it if you are pregnant or breastfeeding. Keep out of reach of children.

Allergens

Contains no artificial colors, preservatives, or sweeteners; no dairy, starch, sugar, wheat, gluten, yeast, soy, corn, egg, fish, shellfish, animal products, salt, tree nuts, or GMOs. Suitable for vegetarians/vegans. Sealed for your protection. Only use it if the seal is fixed. For freshness, store in a cool, dry place.

Contraindications

Do not use if you are taking immunosuppressive drugs and/or if you are pregnant or breastfeeding. Do not drive or use machinery for 5 hours after taking melatonin.

Drug Interactions

Melatonin may impair glucose utilization and increase insulin resistance in diabetic patients. However, the clinical significance of this effect on diabetics is unknown.10 Contraceptive drugs can increase endogenous melatonin levels. Theoretically, this may increase the effects and adverse effects of oral melatonin use.11 Fluvoxamine significantly inhibits the elimination of melatonin,12 which some researchers believe could be helpful in the treatment of refractive insomnia.13 However, this interaction may also cause excessive unwanted drowsiness and other adverse effects. Melatonin production and release may be inhibited by beta-blockers and non-steroidal anti-inflammatory drugs.14,15

References

1. Costello, R.B., Lentino, C.V., Boyd, C.C., et al. (2014). The effectiveness of melatonin for promoting healthy sleep: a rapid evidence assessment of the literature. Nutr J. 13(1), 106.
2. Wade, A.G., Ford, I., Crawford, G., et al. (2010). Nightly treatment of primary insomnia with prolonged release melatonin for 6 months: a randomized placebo-controlled trial on age and endogenous melatonin as predictors of efficacy and safety. BMC Med. 8(1), 51.
3. Wade, A.G., Ford, I., Crawford, G., et al. (2007). Efficacy of prolonged-release melatonin in insomnia patients aged 55-80 years: quality of sleep and next day alertness outcomes. Curr Med Res Opin. 23(10), 2597-605.
4. Wasdell, M.B., Jan, J.E., Bomben, M.M. (2008). A randomized, placebo-controlled trial of controlled release melatonin treatment of delayed sleep phase syndrome and impaired sleep maintenance in children with neurodevelopmental disabilities. J Pineal Res. 44(1), 57-64.
5. Carr, R., Wasdell, M.B., Hamilton, D., et al. (2007). Long-term effectiveness outcome of melatonin therapy in children with treatment-resistant circadian rhythm sleep disorders. J Pineal Res. 43(4), 351-9.
6. Chang,Y.S., Lin, M.H., Lee, J.H., et al. (2016). Melatonin supplementation for children with atopic dermatitis and sleep disturbance: a randomized clinical trial. JAMA Pediatr. 170(1), 35-42.
7. De Leersnyder, H., Zisapel, N., Laudon, M. (2011). Prolonged-release melatonin for children with neurodevelopmental disorders. Pediatr Neurol. 45(1), 23-6.
8. Serfaty, M.A., Osborne, D., Buszewicz, M.J., et al. (2010). A randomized double-blind placebo-controlled trial of treatment as usual plus exogenous slow-release melatonin (6 mg) or placebo for sleep disturbance and depressed mood. Int Clin Psychopharmacol. 25(3), 132-42.
9. Wade, A.G., Farmer, M., Harari, G., et al. (2019). Add-on prolonged-release melatonin for cognitive function and sleep in mild to moderate Alzheimer’s disease: a 6-month, randomized, placebo-controlled, multicenter trial. Clin Interv Aging. 9, 947-61.
10. Cagnacci, A., Arangino, S., Renzi, A., et al. (2001) Influence of melatonin administration on glucose tolerance and insulin sensitivity of postmenopausal women. Clin Endocrinol (Oxf). 54(3), 339-46.
11. Wright Jr, K.P., Myers, B.L., Plenzler, S.C., et al. (2000). Acute effects of bright light and caffeine on nighttime melatonin and temperature levels in women taking and not taking oral contraceptives. Brain Res. 873(2), 310-7.
12. Hartter, S., Grozinger, M., Weigmann, H., et al. (2000). Increased bioavailability of oral melatonin after fluvoxamine coadministration. Clin Pharmacol Ther. 67(1), 1-6.
13. Grozinger, M., Hartter, S., Wang, X., et al. (2000). Fluvoxamine strongly inhibits melatonin metabolism in a patient with a low-amplitude melatonin profile. Arch Gen Psychiatry. 57(8), 812-3.
14. Stoschitzky, K., Sakotnik, A., Lercher, P., et al. (1999). Influence of beta-blockers on melatonin release. Eur J Clin Pharmacol. 55, 111-5.
15. Murphy, P.J., Myers, B.L., Badia, P. (1996). Nonsteroidal anti-inflammatory drugs alter body temperature and suppress melatonin in humans. Physiol Behav. 59, 133-9.