Maplelife TM Nutrition And Formula Sleep Aid

Advertencias oficiales (Health Canada)

Health Canada publica advertencias sobre estos ingredientes:

• Mélatonine
  Leer la advertencia, cuándo se aplica y los estudios citados

  Texto original oficial en inglés.

  MELATONIN - Oral

  Precauciones y advertencias

  Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are taking medications for seizure, blood pressure, to suppress the immune system, to affect mental state or increase sedation, steroids or blood thinners (Wirtz et al. 2008; IOM 2004; Herxheimer and Petrie 2002; Lusardi et al. 2000; Maestroni 1993).

  Fuentes citadas por Health Canada (5)

  • Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database of Systematic Reviews 2002 Issue 2. Art. No.: CD001520. DOI: 10.1002/14651858.CD001520. [Accessed 2023 August 22]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8958662/pdf/CD001520.pdf DOI
  • IOM 2004: Institute of Medicine Committee on the Framework for Evaluating the Safety of Dietary Supplements. Prototype monograph on melatonin. Dietary Supplement Ingredient Prototype Monographs, Developed as Examples for the Report Dietary Supplements: A Framework for Evaluating Safety. Institute of Medicine and the National Research Council of the National Academies, Washington (DC): National Academies Press 2004: D1-D71.
  • Lusardi P, Piazza E, Fogari R. Cardiovascular effects of melatonin in hypertensive patients well controlled by nifedipine: a 24-hour study. British Journal of Clinical Pharmacology 2000;49:423-427. PubMed Ensayo aleatorizado
  • Maestroni GJM. The immunoneuroendocrine role of melatonin. Journal of Pineal Research 1993;14(1):1-10. PubMed Artículo de revisión
  • Wirtz PH, Spillmann M, Bärtschi C, Ehlert U, von Känel R. Oral melatonin reduces blood coagulation activity: a placebo-controlled study in healthy young men. Journal of Pineal Research 2008;44:127-133. PubMed Ensayo aleatorizado

  Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have cardiovascular, immune, liver or kidney disease, seizure disorder, asthma or diabetes (Peschke and Mühlbauer 2010; Carrillo-Vico et al. 2005; IOM 2004; der Marderosian and Beuttlers 2003; Sutherland et al. 2003; Calvo et al. 2002; Herxheimer and Petrie 2002; Sutherland et al. 2002; Cagnacci et al. 2001a; Arangino et al. 1999; Sheldon 1998; Maestroni 1993).

  Fuentes citadas por Health Canada (12)

  • Arangino S, Cagnacci A, Angiolucci M, Vacca AMB, Longu G, Volpe A, Melis GB. Effects of melatonin on vascular reactivity, catecholamine levels, and blood pressure in healthy men. American Journal of Cardiology 1999; 83(9):1417-1419. PubMed Ensayo aleatorizado
  • Cagnacci A, Arangino S, Renzi A, Paoletti AM, Melis GB, Cagnacci P, Volpe A. Influence of melatonin administration on glucose tolerance and insulin sensitivity of postmenopausal women. Clinical Endocrinology (Oxford) 2001a;54(3):339-346. PubMed Ensayo aleatorizado
  • Calvo JR, Guerrero JM, Osuna C, Molinero P, Carrillo-Vico A. Melatonin triggers Crohn's disease symptoms. Journal of Pineal Research 2002;32(4):277-278. PubMed Caso clínico
  • Carrillo-Vico A, Guerrero JM, Lardone PJ, Reiter RJ. A review of the multiple actions of melatonin on the immune system. Endocrine 2005;27:189-200. PubMed Artículo de revisión
  • der Marderosian A, Beutler JA, editors. 2003. The Review of Natural Health Products, 3rd edition. St. Louis (MO): Facts and Comparisons®, a Wolters Kluwer Company.
  • Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database of Systematic Reviews 2002 Issue 2. Art. No.: CD001520. DOI: 10.1002/14651858.CD001520. [Accessed 2023 August 22]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8958662/pdf/CD001520.pdf DOI
  • IOM 2004: Institute of Medicine Committee on the Framework for Evaluating the Safety of Dietary Supplements. Prototype monograph on melatonin. Dietary Supplement Ingredient Prototype Monographs, Developed as Examples for the Report Dietary Supplements: A Framework for Evaluating Safety. Institute of Medicine and the National Research Council of the National Academies, Washington (DC): National Academies Press 2004: D1-D71.
  • Maestroni GJM. The immunoneuroendocrine role of melatonin. Journal of Pineal Research 1993;14(1):1-10. PubMed Artículo de revisión
  • Peschke E, Mühlbauer E. New evidence for a role of melatonin in glucose regulation. Best practice & research. Clinical endocrinology & metabolism 2010;24(5):829-841. PubMed Artículo de revisión
  • Sheldon SH. Pro-convulsant effects of oral melatonin in neurologically disabled children. Lancet 1998;351:1254. PubMed
  • Sutherland ER, Martin RJ, Ellison MC, Kraft M. Immunomodulatory effects of melatonin in asthma. American Journal of respiratory and critical care medicine 2002;166:1055-1061. PubMed
  • Sutherland ER, Ellison MC, Kraft M, Martin RJ. Elevated serum melatonin is associated with the nocturnal worsening of asthma. Journal of Allergy and Clinical Immunology 2003;112(3):513-517. PubMed

  1 estudio citado en el texto no tiene referencia correspondiente en la monografía (véanse las anomalías en la página de fuentes).

  When using this product avoid taking with alcohol or products that cause drowsiness (Herxheimer and Petrie 2002; Holliman and Chyka 1997).

  Fuentes citadas por Health Canada (1)

  • Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database of Systematic Reviews 2002 Issue 2. Art. No.: CD001520. DOI: 10.1002/14651858.CD001520. [Accessed 2023 August 22]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8958662/pdf/CD001520.pdf DOI

  1 estudio citado en el texto no tiene referencia correspondiente en la monografía (véanse las anomalías en la página de fuentes).

  When using this product avoid driving or using machinery for 5 hours (Avery et al. 1998; Suhner et al. 1998b).

  Fuentes citadas por Health Canada (2)

  • Avery D, Lenz M, Landis C. Guidelines for prescribing melatonin. Annals of Medicine 1998;30(1):122-130. PubMed Artículo de revisión
  • Suhner A, Schlagenhauf P, Tschopp A, Hauri-Bionda R, Friedrich-Koch A, Steffen R. Impact of melatonin on driving performance. Journal of Travel Medicine 1998b;5(1):7-13. PubMed Ensayo aleatorizado

  Ask a health care practitioner/health care provider/health care professional/doctor/physician if sleeplessness persists for more than 4 weeks (chronic insomnia) (Buscemi et al. 2004; IOM 2004; Dipiro et al. 2002).

  Fuentes citadas por Health Canada (3)

  • Buscemi N, Vandermeer B, Pandya R, Hooton N, Tjosvold L, Hartling L, Baker G, Vohra S, Klassen T 2004. Melatonin for treatment of sleep disorders. Evidence Report/Technology Assessment No. 108. AHRQ Publication No. 05-E002-2. Rockville (MD): U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality. November, 2004.
  • DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM. Pharmacotherapy: A Pathophysiological Approach. 5th edition. New York (NY): McGraw-Hill Co. Inc.; 2002.
  • IOM 2004: Institute of Medicine Committee on the Framework for Evaluating the Safety of Dietary Supplements. Prototype monograph on melatonin. Dietary Supplement Ingredient Prototype Monographs, Developed as Examples for the Report Dietary Supplements: A Framework for Evaluating Safety. Institute of Medicine and the National Research Council of the National Academies, Washington (DC): National Academies Press 2004: D1-D71.

  Contraindicaciones

  Do not use if you are pregnant or breastfeeding (IOM 2004).

  Fuentes citadas por Health Canada (1)

  • IOM 2004: Institute of Medicine Committee on the Framework for Evaluating the Safety of Dietary Supplements. Prototype monograph on melatonin. Dietary Supplement Ingredient Prototype Monographs, Developed as Examples for the Report Dietary Supplements: A Framework for Evaluating Safety. Institute of Medicine and the National Research Council of the National Academies, Washington (DC): National Academies Press 2004: D1-D71.

  Reacciones adversas conocidas

  Stop use if allergy occurs or if you experience headache, confusion, or nausea (Herxheimer and Petrie 2002).

  Fuentes citadas por Health Canada (1)

  • Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database of Systematic Reviews 2002 Issue 2. Art. No.: CD001520. DOI: 10.1002/14651858.CD001520. [Accessed 2023 August 22]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8958662/pdf/CD001520.pdf DOI

  Monografía de Health Canada del 19 de diciembre de 2025

  MELATONIN - Sublingual

  Precauciones y advertencias

  Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are taking medications for seizure, blood pressure, to suppress the immune system, to affect mental state or increase sedation, steroids or blood thinners (Wirtz et al. 2008; IOM 2004; Herxheimer and Petrie 2002; Lusardi et al. 2000; Maestroni 1993).

  Fuentes citadas por Health Canada (5)

  • Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database of Systematic Reviews Issue 2 2002. Art. No.: CD001520. DOI: 10.1002/14651858.CD001520. [Accessed 2023 August 22]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8958662/pdf/CD001520.pdf DOI
  • IOM 2004: Institute of Medicine Committee on the Framework for Evaluating the Safety of Dietary Supplements. Prototype monograph on melatonin. Dietary Supplement Ingredient Prototype Monographs, Developed as Examples for the Report Dietary Supplements: A Framework for Evaluating Safety. Institute of Medicine and the National Research Council of the National Academies, Washington (DC): National Academies Press 2004: D1-D71.
  • Lusardi P, Piazza E, Fogari R. Cardiovascular effects of melatonin in hypertensive patients well controlled by nifedipine: a 24-hour study. British Journal of Clinical Pharmacology 2000;49:423427. PubMed Ensayo aleatorizado
  • Maestroni GJM. The immunoneuroendocrine role of melatonin. Journal of Pineal Research 1993;14(1):1-10. PubMed Artículo de revisión
  • Wirtz PH, Spillmann M, Bärtschi C, Ehlert U, von Känel R. Oral melatonin reduces blood coagulation activity: a placebo-controlled study in healthy young men. Journal of Pineal Research 2008;44:127-133. PubMed Ensayo aleatorizado

  Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have a cardiovascular, immune, liver or kidney disease, seizure disorder, asthma or diabetes (Peschke and Mühlbauer 2010; Carrillo-Vico et al. 2005; IOM 2004; der Marderosian and Beuttlers 2003; Sutherland et al. 2003; Calvo et al. 2002; Herxheimer and Petrie 2002; Sutherland et al. 2002; Cagnacci et al. 2001a; Arangino et al. 1999; Sheldon 1998; Maestroni 1993).

  Fuentes citadas por Health Canada (12)

  • Cagnacci A, Arangino S, Renzi A, Paoletti AM, Melis GB, Cagnacci P, Volpe A. Influence of melatonin administration on glucose tolerance and insulin sensitivity of postmenopausal women. Clinical Endocrinology (Oxford) 2001a;54(3):339-346. PubMed Ensayo aleatorizado
  • Calvo JR, Guerrero JM, Osuna C, Molinero P, Carrillo-Vico A. Melatonin triggers Crohn's disease symptoms. Journal of Pineal Research 2002;32(4):277-278. PubMed Caso clínico
  • Carrillo-Vico A, Guerrero JM, Lardone PJ, Reiter RJ. A review of the multiple actions of melatonin on the immune system. Endocrine 2005;27:189-200. PubMed Artículo de revisión
  • der Marderosian A, Beutters JA, editors. 2003. The Review of Natural Health Products, 3rd edition. St. Louis (MO): Facts and Comparisons®, a Wolters Kluwer Company.
  • Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database of Systematic Reviews Issue 2 2002. Art. No.: CD001520. DOI: 10.1002/14651858.CD001520. [Accessed 2023 August 22]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8958662/pdf/CD001520.pdf DOI
  • IOM 2004: Institute of Medicine Committee on the Framework for Evaluating the Safety of Dietary Supplements. Prototype monograph on melatonin. Dietary Supplement Ingredient Prototype Monographs, Developed as Examples for the Report Dietary Supplements: A Framework for Evaluating Safety. Institute of Medicine and the National Research Council of the National Academies, Washington (DC): National Academies Press 2004: D1-D71.
  • Maestroni GJM. The immunoneuroendocrine role of melatonin. Journal of Pineal Research 1993;14(1):1-10. PubMed Artículo de revisión
  • Peschke E, Mühlbauer E. New evidence for a role of melatonin in glucose regulation. Best practice & research. Clinical endocrinology & metabolism 2010;24(5):829-841. PubMed Artículo de revisión
  • Sheldon SH. Pro-convulsant effects of oral melatonin in neurologically disabled children. Lancet 1998;351:1254. PubMed
  • Sutherland ER, Martin RJ, Ellison MC, Kraft M. Immunomodulatory effects of melatonin in asthma. American Journal of respiratory and critical care medicine 2002;166:1055-1061. PubMed
  • Sutherland ER, Ellison MC, Kraft M, Martin RJ. Elevated serum melatonin is associated with the nocturnal worsening of asthma. Journal of Allergy and Clinical Immunology 2003;112(3):513517.
  • Arangino S, Cagnacci A, Angiolucci M, Vacca AMB, Longu G, Volpe A, Melis GB. Effects of melatonin on vascular reactivity, catecholamine levels, and blood pressure in healthy men. American Journal of Cardiology 1999;83(9):1417-1419. PubMed Ensayo aleatorizado

  1 estudio citado en el texto no tiene referencia correspondiente en la monografía (véanse las anomalías en la página de fuentes).

  When using this product avoid taking with alcohol or products that cause drowsiness (Herxheimer and Petrie 2002; Holliman and Chyka 1997).

  Fuentes citadas por Health Canada (1)

  • Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database of Systematic Reviews Issue 2 2002. Art. No.: CD001520. DOI: 10.1002/14651858.CD001520. [Accessed 2023 August 22]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8958662/pdf/CD001520.pdf DOI

  1 estudio citado en el texto no tiene referencia correspondiente en la monografía (véanse las anomalías en la página de fuentes).

  When using this product avoid driving or using machinery for 5 hours (Avery et al. 1998; Suhner et al. 1998b).

  Fuentes citadas por Health Canada (2)

  • Avery D, Lenz M, Landis C. Guidelines for prescribing melatonin. Annals of Medicine 1998;30(1):122-130. PubMed Artículo de revisión
  • Suhner A, Schlagenhauf P, Tschopp A, Hauri-Bionda R, Friedrich-Koch A, Steffen R. Impact of melatonin on driving performance. Journal of Travel Medicine 1998b;5(1):7-13. PubMed Ensayo aleatorizado

  Ask a health care practitioner/health care provider/health care professional/doctor/physician if sleeplessness persists for more than 4 weeks (chronic insomnia) (Buscemi et al. 2004; IOM 2004; Dipiro et al. 2002).

  Fuentes citadas por Health Canada (3)

  • Buscemi N, Vandermeer B, Pandya R, Hooton N, Tjosvold L, Hartling L, Baker G, Vohra S, Klassen T. Melatonin for treatment of sleep disorders. Evidence Report/Technology Assessment No. 108. AHRQ Publication No. 05-E002-2. Rockville (MD): U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality. November, 2004.
  • DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM. Pharmacotherapy: A Pathophysiological Approach. 5th edition. New York (NY): McGraw-Hill Co. Inc.; 2002.
  • IOM 2004: Institute of Medicine Committee on the Framework for Evaluating the Safety of Dietary Supplements. Prototype monograph on melatonin. Dietary Supplement Ingredient Prototype Monographs, Developed as Examples for the Report Dietary Supplements: A Framework for Evaluating Safety. Institute of Medicine and the National Research Council of the National Academies, Washington (DC): National Academies Press 2004: D1-D71.

  Contraindicaciones

  Do not use if you are pregnant or breastfeeding (IOM 2004).

  Fuentes citadas por Health Canada (1)

  • IOM 2004: Institute of Medicine Committee on the Framework for Evaluating the Safety of Dietary Supplements. Prototype monograph on melatonin. Dietary Supplement Ingredient Prototype Monographs, Developed as Examples for the Report Dietary Supplements: A Framework for Evaluating Safety. Institute of Medicine and the National Research Council of the National Academies, Washington (DC): National Academies Press 2004: D1-D71.

  Reacciones adversas conocidas

  Stop use if allergy occurs or if you experience headache, confusion, or nausea (Herxheimer and Petrie 2002).

  Fuentes citadas por Health Canada (1)

  • Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database of Systematic Reviews Issue 2 2002. Art. No.: CD001520. DOI: 10.1002/14651858.CD001520. [Accessed 2023 August 22]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8958662/pdf/CD001520.pdf DOI

  Monografía de Health Canada del 19 de diciembre de 2025