‍

What is melatonin?

Melatonin is a dietary supplement and medication as well as a naturally occurring hormone. As a hormone, melatonin is released by the pineal gland and is involved in sleep–wake cycles. As a supplement, it is often used for the attempted short-term treatment of disrupted sleep patterns, such as from jet lag or shift work, and is typically taken orally.  A 2017 review found that sleep onset occurred six minutes faster with use. 

The US Food and Drug Administration (FDA) treats melatonin as a dietary supplement and as such has not approved it for any medical uses. It was approved for medical use in the European Union in 2007. 

What are the potential benefits of melatonin therapy?

  • Improves sleep pattern as well as depth and quality of sleep: promote restorative Stage 4 and REM sleep.
  • Improves energy.
  • Enhances mood.
  • Boosts immune system by increasing "killer T cells."
  • Reduces nighttime urination through deeper sleep.
  • Reduces prostate cancer cell growth.
  • Promotes restorative Stage 4 and REM sleep.
  • Prevents breast cancer.
  • Reduces migraines and cluster headaches. 
  • Reduces blood pressure.
  • Recharges the main intracellular antioxidant in the body, glutathione.

What are the things that melatonin therapy won’t do?

  • Make you addicted to “sleeping medicine.”
  • It is not associated with "tolerance."

What else is in the published literature?

  • It is Second most powerful antioxidant in the body--scavenges the most destructive free radical, the hydroxyl radical.
  • "Recharges" the main antioxidant system in the body, glutathione.
  • compounded prescription has the advantage of being "micronized" for better absorption.

What are the potential side effects of melatonin supplementation?

Side effects from melatonin supplements are minimal at low doses for short durations (in the studies reported about equally for both melatonin and placebo). Side effects of melatonin are rare but may occur in 1 to 10 patients in 1,000. They may include somnolence (sleepiness), headaches, nausea, diarrhea, abnormal dreams, irritability, nervousness, restlessness, insomnia, anxiety, migraine, lethargy, psychomotor hyperactivity, dizziness, hypertension, abdominal pain, heartburn, mouth ulcers, dry mouth, hyperbilirubinemia, dermatitis, night sweats, pruritus, rash, dry skin, pain in the extremities, symptoms of menopause, chest pain, glycosuria (sugar in the urine), proteinuria (protein in the urine), abnormal liver function tests, increased weight, tiredness, mood swings, aggression and feeling hungover. Its use is not recommended during pregnancy or breastfeeding or for those with liver disease. Please consult your prescribing doctor if you are experiencing any of the above symptoms and are concerned. 

References

  1. Files JA, Ko MG, Pruthi S (2011). "Bioidentical hormone therapy". Mayo Clin. Proc. 86 (7): 673–80, quiz 680. doi:10.4065/mcp.2010.0714. PMC 3127562. PMID 21531972.
  2. ^ Jump up to:a b c d e f g h i j k l m n o p q r s t u v w x y Cirigliano, M (2007). "Bioidentical hormone therapy: a review of the evidence" (PDF). Journal of Women's Health. 16 (5): 600–31. doi:10.1089/jwh.2006.0311. PMID 17627398. Archived from the original (PDF) on 2011-01-06.
  3. ^ Noble RL (April 1966). "J. B. Collip, 1893–1965". J. Reprod. Fertil. 11 (2): 167–170. doi:10.1530/jrf.0.0110167. PMID 5328022.
  4. ^ Vance, DA (2007). "Premarin: The Intriguing History of a Controversial Drug" (PDF). International Journal of Pharmaceutical Compounding. 11 (4): 282–287. PMID 23974785. Archived from the original (PDF) on 2011-01-06.
  5. ^ McCullough, M (1998-09-03). "Hormone Options". Chicago Tribune. p. 7. Archived from the original on 2013-02-18. Retrieved 2009-12-16.
  6. ^ Jump up to:a b c d e f g h i Rosenthal MS (2008). "Ethical problems with bioidentical hormone therapy". Int. J. Impot. Res. 20 (1): 45–52. doi:10.1038/sj.ijir.3901622. PMID 18075509.
  7. ^ Jump up to:a b Watt PJ, Hughes RB, Rettew LB, Adams R (2003). "A holistic programmatic approach to natural hormone replacement". Fam Community Health. 26 (1): 53–63. doi:10.1097/00003727-200301000-00007. PMID 12802128. S2CID 34859665.
  8. ^ Jump up to:a b c d e f g h i j k l Fugh-Berman, A; Bythrow J (2007). "Bioidentical Hormones for Menopausal Hormone Therapy: Variation on a Theme". Journal of General Internal Medicine. 22 (7): 1030–4. doi:10.1007/s11606-007-0141-4. PMC 2219716. PMID 17549577.
  9. ^ Jump up to:a b c d Taylor, M (2005). ""Bioidentical" estrogens: Hope or hype?". Sexuality, Reproduction & Menopause. 3 (2): 69–71. doi:10.1016/j.sram.2005.09.003.
  10. ^ Bhavnani, B. R.; Stanczyk, F. Z. (2011). "Misconception and Concerns about Bioidentical Hormones Used for Custom-Compounded Hormone Therapy". Journal of Clinical Endocrinology & Metabolism. 97 (3): 756–759. doi:10.1210/jc.2011-2492. PMID 22205711.
  11. ^ Jump up to:a b c "Bio-Identicals: Sorting Myth from Fact". FDA. 2008-04-08. Retrieved 2009-12-01.
  12. ^ Jump up to:a b c d e f g h "Compounded Menopausal Hormone Therapy Questions and Answers". FDA. 2009-09-23. Archived from the original on 2009-11-26. Retrieved 2009-12-01.
  13. ^ Jump up to:a b c d e f g h i j "What are bioidentical hormones?". Harvard Women's Health Watch. Harvard Medical School. 2006-08-01. Archived from the original on 2008-10-10. Retrieved 2009-02-27.
  14. ^ Jump up to:a b c "The Endocrine Society – Position Statement: Bioidentical Hormones" (PDF). The Endocrine Society. 2006-10-01. Archived from the original (PDF) on 2009-11-28. Retrieved 2009-02-28.
  15. ^ Jump up to:a b c Kalvaitis, K (2008). "Compounded hormone therapies: unproven, untested – and popular" (web reprint). Endocrine Today. 6 (5).
  16. ^ Jump up to:a b McBane, SE (2008). "Easing vasomotor symptoms: Besides HRT, what works?". Journal of the American Academy of Physician Assistants. 21 (4): 26–31. doi:10.1097/01720610-200804000-00012. PMID 18468366. S2CID 36136887.
  17. ^ Jump up to:a b Rosenthal, MS (2008). "The Wiley Protocol: an analysis of ethical issues". Menopause. 15 (5): 1014–22. doi:10.1097/gme.0b013e318178862e. PMID 18551081. S2CID 196421747.
  18. ^ Jump up to:a b c d "FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs". FDA. 2008-01-09. Retrieved 2009-02-17.
  19. ^ Jump up to:a b c d e Boothby, LA; Doering PL; Kipersztok S (2004). "Bioidentical hormone therapy: a review". Menopause. 11 (3): 356–67. CiteSeerX 10.1.1.539.6950. doi:10.1097/01.GME.0000094356.92081.EF. PMID 15167316. S2CID 16351545.
  20. ^ Jump up to:a b c d e f g h Boothby LA, Doering PL (August 2008). "Bioidentical hormone therapy: a panacea that lacks supportive evidence". Curr. Opin. Obstet. Gynecol. 20 (4): 400–7. doi:10.1097/GCO.0b013e3283081ae9. PMID 18660693. S2CID 22449765.
  21. ^ Jump up to:a b c d e f g h i "Bioidentical hormones". The Medical Letter on Drugs and Therapeutics. 52 (1339): 43–44. 2010. PMID 20508582.
  22. ^ Jump up to:a b c d e f g Chervenak J (October 2009). "Bioidentical hormones for maturing women". Maturitas. 64 (2): 86–9. doi:10.1016/j.maturitas.2009.08.002. PMID 19766414.
  23. ^ Jump up to:a b Panay N, Fenton A (February 2010). "Bioidentical hormones: what is all the hype about?". Climacteric. 13 (1): 1–3. doi:10.3109/13697130903550250. PMID 20067429. S2CID 244295.
  24. ^ Jump up to:a b "Understanding the Controversy: Hormone Testing and Bioidentical Hormones" (PDF). North American Menopause Society. 2006-10-11. Archived from the original (PDF) on 2010-12-25. Retrieved 2010-01-18.
  25. ^ Jump up to:a b c d Sites CK (March 2008). "Bioidentical hormones for menopausal therapy". Women's Health. 4 (2): 163–71. doi:10.2217/17455057.4.2.163. PMID 19072518. (free subscription required)
  26. ^ Jump up to:a b c d e f g h Derzko, C (2009). "Bioidentical Hormone Therapy at Menopause" (PDF). Endocrinology Rounds. 9 (6): 1–6. Archived from the original (PDF) on 2011-07-16.
  27. ^ Sood, R.; Shuster, L.; Smith, R.; Vincent, A.; Jatoi, A. (2011). "Counseling postmenopausal women about bioidentical hormones: ten discussion points for practicing physicians" (pdf). The Journal of the American Board of Family Medicine. 24 (2): 202–210. doi:10.3122/jabfm.2011.02.100194. PMC 6014967. PMID 21383221.
  28. ^ Korownyk, C.; Allan, G. M.; McCormack, J. (2012). "Bioidentical hormone micronized progesterone". Canadian Family Physician. 58 (7): 755. PMC 3395514. PMID 22859638.
  29. ^ Jump up to:a b c d Barr Laboratories, Inc. (March 2008). "ESTRACE TABLETS, (estradiol tablets, USP)" (PDF). wcrx.com. Retrieved 2010-01-27.
  30. ^ Curcio, J. J.; Wollner, D. A.; Schmidt, J. W.; Kim, L. S. (2006). "Is Bio-Identical Hormone Replacement Therapy Safer than Traditional Hormone Replacement Therapy?: A Critical Appraisal of Cardiovascular Risks in Menopausal Women". Treatments in Endocrinology. 5 (6): 367–374. doi:10.2165/00024677-200605060-00005. PMID 17107222. S2CID 38687173.
  31. ^ "Pharmacy Compounding/Compounding of Bio-identical Hormone Replacement Therapies". FDA. 2007-04-19. Retrieved 2010-03-16.
  32. ^ 2008 Compendium of Selected Publications (v. 1 2). American Congress of Obstetricians and Gynecol. 15 Feb 2008. p. 299. ISBN 978-1-932328-44-8.
  33. ^ "Bioidentical Hormones: Sound Science or Bad Medicine" (PDF). United States Senate. 2007-04-19. Archived from the original (PDF) on 2012-02-25. Retrieved 2010-03-16.
  34. ^ Simon, JA (2009-06-07). "Bioidentical Hormone Therapy: What Is It, Might It Have Advantages, and What We Simply Don't Know! Expert Interview With Dr. James A. Simon". Medscape. Retrieved 2010-03-16.
  35. ^ Columbia Laboratories, Inc. (November 2004). "Prochieve (progesterone gel)" (PDF). Archived from the original (PDF) on 2009-04-19.
  36. ^ Whelan, A. M.; Jurgens, T. M.; Trinacty, M. (2012). "Bioidentical Progesterone Cream for Menopause-Related Vasomotor Symptoms: Is it Effective?". Annals of Pharmacotherapy. 47 (1): 112–116. doi:10.1345/aph.1R362. PMID 23249728. S2CID 19402574.
  37. ^ Jump up to:a b c Gallenberg, M (2007-08-21). "Bioidentical hormones: Are they safer?". Mayo Clinic. Retrieved 2010-01-14.
  38. ^ Jump up to:a b c d "ACOG News Release: ACOG Reiterates Stance on So-Called "Bioidentical" Hormones". American Congress of Obstetricians and Gynecologists. 2009-02-03. Archived from the original on 2014-11-17. Retrieved 2009-09-18.
  39. ^ Jump up to:a b Pastner, B (2008). "Pharmacy Compounding of Bioidentical Hormone Replacement Therapy (BHT): A Proposed New Approach to Justify FDA Regulation of These Prescription Drugs". Food & Drug L.J. 63 (2): 459–91. PMID 18561473.
  40. ^ "Bioidentical Hormone Therapy". North American Menopause Society. 2009-10-11. Archived from the original on 2010-01-17. Retrieved 2010-01-18.
  41. ^ "Bioidentical hormone therapy". Society of Obstetricians and Gynaecologists of Canada. Archived from the original on 2010-01-22. Retrieved 2010-01-18.
  42. ^ Smith NL, Heckbert SR, Lemaitre RN, Reiner AP, Lumley T, Weiss NS, Larson EB, Rosendaal FR, Psaty BM (2004). "Esterified estrogens and conjugated equine estrogens and the risk of venous thrombosis" (PDF). JAMA. 292 (13): 1581–7. doi:10.1001/jama.292.13.1581. hdl:1887/5083. PMID 15467060.
  43. ^ Kreatsoulas, C.; Anand, S. S. (2013). "Menopausal hormone therapy for the primary prevention of chronic conditions. U.S. Preventive Services Task Force Recommendation Statement" (PDF). Polskie Archiwum Medycyny Wewnetrznej. 123 (3): 112–117. PMID 23396275.
  44. ^ American College of Obstetricians and Gynecologists Committee on Gynecologic Practice; American Society for Reproductive Medicine Practice Committee (2012). "Compounded bioidentical menopausal hormone therapy". Fertility and Sterility. 98 (2): 308–312. doi:10.1016/j.fertnstert.2012.06.002. PMID 22831824.
  45. ^ Jump up to:a b Ellin, A (2006-10-15). "A Battle Over 'Juice of Youth'". The New York Times. Retrieved 2009-10-27.
  46. ^ "The Bioidentical Debate". The Oprah Winfrey Show. Archived from the original on 2009-02-21. Retrieved 2009-12-01.
  47. ^ Jump up to:a b c Burrell BA (September 2009). "The replacement of the replacement in menopause: hormone therapy, controversies, truth and risk". Nurs Inq. 16 (3): 212–22. doi:10.1111/j.1440-1800.2009.00456.x. PMID 19689648.
  48. ^ MacLennan AH, Sturdee DW (February 2006). "The 'bioidentical/bioequivalent' hormone scam". Climacteric. 9 (1): 1–3. doi:10.1080/13697130500487166. PMID 16428119. S2CID 38845262.
  49. ^ The Board of Trustees of The North American Menopause Society (2008). "Estrogen and progestogen use in postmenopausal women: July 2008 position statement of The North American Menopause Society" (PDF). Menopause. 15 (4): 584–603. doi:10.1097/gme.0b013e31817b076a. PMC 2756246. PMID 18580541. Archived from the original (PDF) on 2010-12-24. Retrieved 2009-08-27.
  50. ^ Writing Group for the Women's Health Initiative Investigators (2002). "Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results From the Women's Health Initiative Randomized Controlled Trial". JAMA. 288 (3): 321–333. doi:10.1001/jama.288.3.321. PMID 12117397.
  51. ^ Chlebowski, RT; Kuller LH; Prentice RL; Stefanick ML; Manson JE; Gass M; et al. (2009). "Breast cancer after use of estrogen plus progestin in postmenopausal women". NEJM. 360 (6): 573–87. doi:10.1056/NEJMoa0807684. PMC 3963492. PMID 19196674.
  52. ^ "Breast Cancer: Early Detection - The importance of finding breast cancer early". American Cancer Society. 2009-09-22. Archived from the original on 2010-02-03. Retrieved 2010-01-18.
  53. ^ Davis, SR; Kruger J (2008-08-14). "2003 November 29 - Bioidentical hormones (troches) advice for doctors". Australian Menopause Society. Retrieved 2009-08-25.
  54. ^ Davis, SR; Kruger J (2003-11-29). "2003 November 29 - Bioidentical hormones (troches) advice to consumers". Australian Menopause Society. Retrieved 2009-08-25.
  55. ^ Pines A, Sturdee DW, Birkhäuser MH, Schneider HP, Gambacciani M, Panay N (June 2007). "IMS updated recommendations on postmenopausal hormone therapy". Climacteric. 10 (3): 181–94. doi:10.1080/13697130701361657. PMID 17487645. S2CID 39430081.
  56. ^ Jump up to:a b "American Medical Association Women Physicians Congress: Policy Compendium" (PDF). American Medical Association. 2007-10-01. Retrieved 2010-01-06.
  57. ^ "Bioidentical hormone replacement: Safety requires oversight". American Medical Association. 2006-12-11. Retrieved 2010-01-08.
  58. ^ Moskowitz, D (2006). "A comprehensive review of the safety and efficacy of bioidentical hormones for the management of menopause and related health risks" (PDF). Alternative Medicine Review. 11 (3): 208–23. PMID 17217322. Archived from the original (PDF) on 2009-06-11.
  59. ^ Barrett, S (2008-01-19). "Steer Clear of "Bioidentical" Hormone Therapy". Quackwatch. Retrieved 2010-09-13.\
  60. ^ "Statement of Steven K. Galson, M.D., M.P.H., Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration before Senate Special committee on Aging, "Bio-Identical Hormones: Sound Science or Bad Medicine"". FDA. 2007-04-19. Archived from the original on 2007-10-09. Retrieved 2007-12-01.
  61. ^ Romero, M (2002). "Bioidentical hormone replacement therapy. Customizing care for perimenopausal and menopausal women". Adv Nurse Pract. 10 (11): 47–48, 51–52. PMID 12478948.
  62. ^ "The American Association of Clinical Endocrinologists (AACE) strongly supports the FDA in its concerns regarding the marketing and use of so called Bio-identical Hormones". American Association of Clinical Endocrinologists. 2008-01-23. Archived from the original on 2010-05-19. Retrieved 2010-01-18.
  63. ^ "Senators Join Thousands of Patients, Doctors, Pharmacists in Supporting Women's Access to Critical Hormone Treatments" (PDF). International Academy of Compounding Pharmacists. 2008-06-16. Archived from the original (pdf) on 2011-07-23. Retrieved 2010-01-18.
  64. ^ "Court rules compounded products are neither uniformly exempt from nor subject to new drug approval requirements". American Pharmacists Association. 2008-07-31. Archived from the original on 2011-06-15. Retrieved 2010-01-21.
  65. ^ Sherr L, Ruppel G (2007-02-16). "Suzanne Somers: Super Saleswoman: Has Somers Found the Fountain of Youth?". ABC News. Retrieved 2007-12-01.
  66. ^ Kantrowitz B, Wingert P (2006-11-13). "A Real Somers Storm: At war over Suzanne Somers's book on 'bioidenticals'". Newsweek. Retrieved 2007-12-01. "Melatonin – Drugs.com". Drugs.com. Retrieved 12 October 2018.
  67. ^ "Melatonin". Sleepdex. Retrieved 17 August 2011.
  68. ^ Jump up to:a b https://www.tga.gov.au/resources/auspar/auspar-melatonin-1
  69. ^ Jump up to:a b c "Pros and cons of melatonin". Mayo Clinic. Retrieved 20 August 2022.
  70. ^ https://www.tga.gov.au/resources/auspar/auspar-melatonin-link-immela-melakso-voquily
  71. ^ Jump up to:a b c d Tordjman S, Chokron S, Delorme R, Charrier A, Bellissant E, Jaafari N, et al. (April 2017). "Melatonin: Pharmacology, Functions and Therapeutic Benefits". Current Neuropharmacology. 15 (3): 434–443. doi:10.2174/1570159X14666161228122115. PMC 5405617. PMID 28503116.
  72. Sargis, Robert M. (21 October 2019). "How Your Thyroid Works". endocrineweb.com. Retrieved 20 May 2023.
  73. ^ Ijaz Ahsan (1997). Textbook of Surgery. CRC Press. p. 376. ISBN 9789057021398.
  74. ^ "How long does thyroxine stay in your system?". Drugs.com. Retrieved 6 August 2022.
  75. ^ Irizarry L (23 April 2014). "Thyroid Hormone Toxicity". Medscape. WedMD LLC. Retrieved 2 May 2014.
  76. ^ Pilo A, Iervasi G, Vitek F, Ferdeghini M, Cazzuola F, Bianchi R (April 1990). "Thyroidal and peripheral production of 3,5,3′-triiodothyronine in humans by multicompartmental analysis". The American Journal of Physiology. 258 (4 Pt 1): E715–E726. doi:10.1152/ajpendo.1990.258.4.E715. PMID 2333963.
  77. ^ Tran, Le Trung; Park, Sohee; Kim, Seul Ki; Lee, Jin Sun; Kim, Ki Woo; Kwon, Obin (April 2022). "Hypothalamic control of energy expenditure and thermogenesis". Experimental & Molecular Medicine. 54 (4): 358–369. doi:10.1038/s12276-022-00741-z. ISSN 2092-6413. PMC 9076616. PMID 35301430.

‍