Melatonin Monograph

Scientific name of Melatonin:
N-Acetyl-5-Methoxytryptamine

Action of Melatonin:
Neurohormone that promotes sleep wellness

Melatonin is used for these common wellness concerns:
Occasional sleep difficulty caused by restlessness, nervous tension, occasional anxiety, mild to moderate mood changes or jet lag; daytime drowsiness caused by occasional sleeplessness

Find Melatonin in these Clarocet blends:

Clarocet NRI® Immediate Response Capsules™
promote fast-acting relaxation when you need it most.

Clarocet ERT® Extended Release Tablets™
promote positive mood balance all day strong.

Clarocet CS® Controlled Release Tablets™
promote long-lasting energy and mental sharpness.

Clarocet PM® Rapid Release Capsules™
promote a deep, restful night's sleep.

Clarocet Junior® Easy-to-Swallow Tablets™
support Emotional Wellness in kids ages 7 thru 13.

An Overview of Melatonin

Melatonin is a hormone produced in the pineal gland that regulates the sleep-wake cycle and related body functions. Scientists classify the two types of Melatonin as endogenous, which means "arising from within" the body, and exogenous, or "arising from outside" the body. The secretion of endogenous Melatonin is largely dependent on light-dark cycles, so it is inhibited during the day and stimulated at night. Exogenous Melatonin is usually in the form of synthetic dietary supplement.

Clinical research shows that taking a supplement that contains Melatonin may help to provide positive support for:

  • Occasional sleep difficulty caused by restlessness, nervous tension, occasional anxiety, mild to moderate mood changes or jet lag
  • Daytime drowsiness and fatigue caused by occasional sleeplessness

Exogenous Melatonin maintains an excellent safety profile. It can be especially helpful for those experiencing sleep difficulties due to jet lag, unpredictable shift work and insufficient exposure to daytime sunlight. In low-dose studies (under three milligrams), exogenous Melatonin has been shown to have no adverse side effects and does not cause next-day grogginess.

Science and Pharmacology of Melatonin

The exact mechanism of action of supplementary Melatonin is not yet understood. There are, however, multiple factors to explain its potential benefits:

  • Facilitates a shift in the natural production of melatonin
  • Modifies core body temperature, which in turn produces sleepiness

It is known that endogenus Melatonin, which occurs naturally in the body, affects Circadian rhythm patterns. These patterns work like internal clocks to regulate the schedules of bodily functions such as the sleep-wake cycle. Multiple factors can affect how the body produces this neurohormone, including underexposure to bright light and dramatic time-zone shifts. When the body’s ability to produce Melatonin is compromised, exogenous Melatonin can help by imitating the action of naturally occurring Melatonin to regulate sleep.

Melatonin Safety and Usage

Melatonin maintains an excellent safety profile when it is used as directed. For occasional sleep difficulty caused by restlessness, nervous tension, occasional anxiety, mild to moderate mood changes or jet lag, a dose of 0.5 to 1 milligram is recommended nightly for two to six weeks.

What are the potential side effects of Melatonin?

Side effects have not been reported as a result of Melatonin use.

Is Melatonin safe for children?

Clinical study data regarding Melatonin use in children is limited. Melatonin should not be administered without the supervision of a professional healthcare provider.

Does Melatonin adversely interact with prescription drugs?

Taking Melatonin in combination with prescription medications such as benzodiazepines, SSRIs (selective serotonin reuptake inhibitors), or SNRIs (serotonin-norepinephrine reuptake inhibitors) may cause drowsiness. If you are taking a prescription medication, it is recommended that you consult with your prescribing doctor before making any changes or additions to your current treatment plan.

What precautions should I take before beginning Melatonin?

Consult with your healthcare provider before beginning a wellness plan that includes dietary supplements like Melatonin.

  • Do not take Melatonin if you are pregnant or nursing
  • Do not take Melatonin if you are currently taking a prescription MAOI
  • Do not take Melatonin if you are currently taking a protease inhibitor for HIV/AIDS
  • Do not operate vehicles or heavy machinery until you know how Melatonin affects you

Melatonin Clinical Studies

1. Melatonin for Treatment of Sleep Disorders. Evidence Report and Technology Assessment.
N. Buscemi, B Vandermeer, R Pandya, N Hooton, L Tjosvold, L Hartling, G Baker, S Vohra, T Klassen
University of Alberta Evidence-based Practice Center, Edmonton, Alberta, Canada
USA Department of Health and Human Services, AHRQ Pub., Nov. 2004, No. 05-E002-2 [Read the Report]

2. Effect of inducing nocturnal serum melatonin concentrations in daytime on sleep, mood, body temperature, and performance.
Dollins AB, Zhdanova IV, Wurtman RJ, Lynch HJ, Deng MH.
Department of Brain and Cognitive Sciences, Massachusetts Institute of Technology, Cambridge, USA
Proc Natl Acad Sci U S A. 1994 Mar 1;91(5):1824-8. PMID: 8127888 [Read the Abstract]

3. Sleep-inducing effects of low doses of melatonin ingested in the evening.
Zhdanova IV, Wurtman RJ, Lynch HJ, Ives JR, Dollins AB, Morabito C, Matheson JK, Schomer DL.
Clinical Research Center, Massachusetts Institute of Technology, Cambridge
Clin Pharmacol Ther. 1995 May;57(5):552-8. PMID: 7768078 [Read the Abstract]

4. Effects of low oral doses of melatonin, given 2-4 hours before habitual bedtime, on sleep in normal young humans.
Zhdanova IV, Wurtman RJ, Morabito C, Piotrovska VR, Lynch HJ.
Clinical Research Center, Massachusetts Institute of Technology, Cambridge, USA.
Sleep. 1996 Jun;19(5):423-31. Related Articles, Links PMID: 8843534 [Read the Abstract]

5. Melatonin, Circadian Rhythms, and Sleep.
Zhdanova IV, Tucci V.
Department of Anatomy and Neurobiology, Boston University Medical School, Boston, USA
Curr Treat Options Neurol. 2003 May;5(3):225-229. PMID: 12670411 [Read the Abstract]

6. Effects of exogenous melatonin on sleep: a meta-analysis.
Brzezinski A, Vangel MG, Wurtman RJ, Norrie G, Zhdanova I, Ben-Shushan A, Ford I.
Department of Obstetrics and Gynecology, Hadassah Medical Center, Israel
Sleep Med Rev. 2005 Feb;9(1):41-50. PMID: 15649737 [Read the Abstract]

7. Spontaneous central melatonin secretion and resorption kinetics of exogenous melatonin: a ventricular CSF study.
Debus OM, Lerchl A, Bothe HW, Bremer J, Fiedler B, Franssen M, Koehring J, Steils M, Kurlemann G.
Department of Neuropediatrics, University Children's Hospital, University of Munster, Germany.
J Pineal Res. 2002 Nov;33(4):213-7. PMID: 12390503 [Read the Abstract]

8. Feasibility and functionality of OROS melatonin in healthy subjects.
Shah J, Langmuir V, Gupta SK.
Department of Clinical Pharmacology, ALZA Corporation, USA.
J Clin Pharmacol. 1999 Jun;39(6):606-12. PMID: 10354964 [Read the Abstract]

9. The effect of exogenous melatonin on stimulated neurohypophysial hormone release in man.
Forsling ML, Williams AJ.
Neuroendocrine Laboratories, Guy's, King's and St Thomas' School of Medicine, London, UK.
Clin Endocrinol (Oxf). 2002 Nov;57(5):615-20. PMID: 12390335 [Read the Abstract]

10. Low, but not high, doses of melatonin entrained a free-running blind person with a long circadian period.
Lewy AJ, Emens JS, Sack RL, Hasler BP, Bernert RA.
Department of Psychiatry, Oregon Health & Science University, Portland, USA.
Chronobiol Int. 2002 May;19(3):649-58. PMID: 12069043 [Read the Case Report]

11. Efficacy of melatonin as a sleep-promoting agent.
Zhdanova IV, Wurtman RJ.
Massachusetts Institute of Technology, Cambridge, USA.
J Biol Rhythms. 1997 Dec;12(6):644-50. PMID: 9406040 [Read the Abstract]

12. Melatonin: clinical relevance.
Reiter RJ.
Department of Cellular and Structural Biology, The University of Texas Health Science Center, USA
Best Pract Res Clin Endocrinol Metab. 2003 Jun;17(2):273-85. PMID: 12787552 [Read the Abstract]

13. The Biological and Clinical Uses of the Pineal Hormone Melatonin
Timothy C. Birdsall, ND
Thorne Research, Inc.
Alt Med Rev. 1996, 1(2):94-102. [Read the Report]

Related online research destinations

Last Updated: February 2012 [PHMF-02-0]