melatonin

Complementary/Alternative Medicine: This monograph describes a natural or herbal product that is not subject to FDA guidelines for medicines. Patients and clinicians are advised to read package labels carefully to ensure safe and efficacious use.

REMS

Sleep disorders (including insomnia, jet lag and circadian rhythm disorders)

Action ⬆ ⬇

Melatonin is a hormone secreted from the pineal gland in a 24-hour circadian rhythm, regulating the normal sleep/wake cycle. As a supplement, melatonin has both phase-shifting and sleep-promoting properties. In addition to promoting sleep, physiologic roles of melatonin include regulation of the secretion of growth hormone and gonadotropic hormones. It also possesses antioxidant activity.

Therapeutic effects:

Improved sleep pattern.

Pharmacokinetics ⬆ ⬇

Absorption: Unknown

Distribution: Unknown

Metabolism/Excretion: Unknown

Half-Life: Unknown

Time/Action Profile ⬆ ⬇

	ONSET	PEAK	DURATION
PO	unknown	unknown	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Pregnancy and lactation.

Use Cautiously in:

Seizure disorders;
Diabetes;
Hypertension.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypotension

GI: abdominal cramps, nausea, vomiting

Neuro: dizziness, drowsiness, headache

Interactions ⬆ ⬇

Natural-Drug Products:

Additive sedation with CNS depressants.
May ↑ bleeding risk with antiplatelet agents and anticoagulants.
May interfere with the glucose-lowering effects of hypoglycemic agents.
May decrease effectiveness of nifedipine.

Natural-Natural Products:

May have additive sedative effects with herbs that have sedative properties including 5–HTP, kava, St.John's wort, valerian and others.
May increase risk of bleeding with herbs that have antiplatelet/anticoagulant properties such asclove, garlic, ginger, gingko, ginseng and others.

Route/Dosage ⬆ ⬇

PO (Adults ): 0.3–10 mg daily at bedtime.

Availability ⬆ ⬇

Capsules: ^OTC
Tablets: ^OTC
Sublingual Tablets: ^OTC
Gummies: ^OTC

Assessment ⬆ ⬇

Assess sleep patterns before and periodically throughout therapy.

Lab Test Considerations:

Monitor blood glucose, coagulation panel, hormone panel, and lipid panel periodically during therapy.

Implementation ⬆ ⬇

PO: Administer before bedtime.

Patient/Family Teaching ⬆ ⬇

Instruct patient to take at bedtime as directed.
Causes drowsiness. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
Caution patient to avoid concurrent use of alcohol or other CNS depressants.
Advise female patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

pineal hormone, N-acetyl-5–methoxtryptamine

Code ⬆

NDC Code

43742- Deseret Biologicals, Inc.
- 43742-0205- Melatonin
  - 43742-0205-1- 30 mL in 1 BOTTLE, DROPPER (43742-0205-1)

43742- Deseret Biologicals, Inc.
- 43742-0771- Melatonin
  - 43742-0771-1- 30 mL in 1 BOTTLE, DROPPER (43742-0771-1)

43857- BioActive Nutritional, Inc.
- 43857-0086- Melatonin
  - 43857-0086-1- 30 mL in 1 BOTTLE, DROPPER (43857-0086-1)

43857- BioActive Nutritional, Inc.
- 43857-0511- Melatonin
  - 43857-0511-1- 30 mL in 1 BOTTLE, DROPPER (43857-0511-1)

44911- Energique, Inc.
- 44911-0194- MELATONIN CORD
  - 44911-0194-1- 30 mL in 1 BOTTLE, DROPPER (44911-0194-1)

44911- Energique, Inc.
- 44911-0247- Melatonin Phenolic
  - 44911-0247-1- 30 mL in 1 BOTTLE, DROPPER (44911-0247-1)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇