melatonin

Therapeutic Classification: sedative/hypnotics

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 (insomnia, jet lag, circadian rhythm disorders).

Secreted by the pineal glad. Regulates secretion of growth hormone and gonadotropic hormones. It also possesses antioxidant activity.

Therapeutic effects:

Improved sleep pattern.

Absorption: Unknown.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

	ONSET	PEAK	DURATION
PO	unknown	unknown	unknown

Contraindicated in:

Hypersensitivity;
Autoimmune diseases.

Use Cautiously in:

Diabetes;
Hypertension;
Hypotension;
Seizure disorders;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

CV: hypotension

GI: abdominal cramps, nausea, vomiting

Neuro: dizziness, drowsiness, excessive daytime somnolence, headache, irritability, nightmares

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 ↓ 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, and valerian.
May ↑ risk of bleeding with herbs that have antiplatelet/anticoagulant properties, such as clove, garlic, ginger, gingko, and ginseng.

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

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

Assess sleep patterns before and periodically throughout therapy.

Lab Test Considerations:

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

PO: Administer before bedtime.

Explain purpose and side effects of herb to patient. Advise patient to take at bedtime as directed.
Advise patient to consult with health care provider before using any herbal supplement, especially when taken concurrently with Rx or OTC medications or vitamins.
Advise patient to avoid driving and other activities requiring alertness until response to medication is known.
Advise patient to avoid concurrent use of alcohol or other CNS depressants.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding before using this herb.

Improved sleep pattern.

pineal hormone, N-acetyl-5-methoxtryptamine

NDC Code

10695- Willow Birch Pharma, Inc.
- 10695-315-
  - 10695-315-10- 1 kg in 1 CONTAINER (10695-315-10)

10695- Willow Birch Pharma, Inc.
- 10695-315-
  - 10695-315-14- .1 kg in 1 CONTAINER (10695-315-14)

10695- Willow Birch Pharma, Inc.
- 10695-315-
  - 10695-315-20- 2 kg in 1 CONTAINER (10695-315-20)

10695- Willow Birch Pharma, Inc.
- 10695-315-
  10695-315-50- 5 kg in 1 CONTAINER (10695-315-50)

10695- Willow Birch Pharma, Inc.
- 10695-315-
  10695-315-70- 25 kg in 1 DRUM (10695-315-70)

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)

51927- Professional Compounding Centers of America
- 51927-5114-
  - 51927-5114-0- 1 kg in 1 BOTTLE (51927-5114-0)

52119- Swati Spentose Private Limited
- 52119-017-
  52119-017-01- 1 kg in 1 DRUM (52119-017-01)

52119- Swati Spentose Private Limited
- 52119-017-
  52119-017-02- 2 kg in 1 DRUM (52119-017-02)

52119- Swati Spentose Private Limited
- 52119-017-
  52119-017-05- 5 kg in 1 DRUM (52119-017-05)

52119- Swati Spentose Private Limited
- 52119-017-
  52119-017-10- 10 kg in 1 DRUM (52119-017-10)

52119- Swati Spentose Private Limited
- 52119-017-
  52119-017-15- 15 kg in 1 DRUM (52119-017-15)

52119- Swati Spentose Private Limited
- 52119-017-
  52119-017-20- 20 kg in 1 DRUM (52119-017-20)

52119- Swati Spentose Private Limited
- 52119-017-
  52119-017-25- 25 kg in 1 DRUM (52119-017-25)

52119- Swati Spentose Private Limited
- 52119-018-
  52119-018-01- 1 kg in 1 DRUM (52119-018-01)

52119- Swati Spentose Private Limited
- 52119-018-
  52119-018-02- 2 kg in 1 DRUM (52119-018-02)

52119- Swati Spentose Private Limited
- 52119-018-
  52119-018-05- 5 kg in 1 DRUM (52119-018-05)

52119- Swati Spentose Private Limited
- 52119-018-
  52119-018-10- 10 kg in 1 DRUM (52119-018-10)

52119- Swati Spentose Private Limited
- 52119-018-
  52119-018-15- 15 kg in 1 DRUM (52119-018-15)

52119- Swati Spentose Private Limited
- 52119-018-
  52119-018-20- 20 kg in 1 DRUM (52119-018-20)

52119- Swati Spentose Private Limited
- 52119-018-
  52119-018-25- 25 kg in 1 DRUM (52119-018-25)

52119- Swati Spentose Private Limited
- 52119-021-
  52119-021-01- 1 kg in 1 DRUM (52119-021-01)

52119- Swati Spentose Private Limited
- 52119-021-
  52119-021-02- 2 kg in 1 DRUM (52119-021-02)

52119- Swati Spentose Private Limited
- 52119-021-
  52119-021-05- 5 kg in 1 DRUM (52119-021-05)

52119- Swati Spentose Private Limited
- 52119-021-
  52119-021-10- 10 kg in 1 DRUM (52119-021-10)

52119- Swati Spentose Private Limited
- 52119-021-
  52119-021-15- 15 kg in 1 DRUM (52119-021-15)

52119- Swati Spentose Private Limited
- 52119-021-
  52119-021-20- 20 kg in 1 DRUM (52119-021-20)

52119- Swati Spentose Private Limited
- 52119-021-
  52119-021-25- 25 kg in 1 DRUM (52119-021-25)

54236- Flamma S.p.A.
- 54236-040-
  54236-040-01- 20 kg in 1 DRUM (54236-040-01)

68210- Spirit Pharmaceuticals LLC
- 68210-0204-
  68210-0204-0- 48 POUCH in 1 BOX (68210-0204-0) / 1000 CAPSULE, LIQUID FILLED in 1 POUCH

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Code ⬆