Melatonin: How It Works, What It's Studied For & Safety
Melatonin is a pineal-gland hormone that signals the circadian sleep phase; available OTC as a supplement and as compounded prescription preparations at higher or sustained-release strengths. Clinicians consider it for circadian-rhythm disorders, jet lag, and shift-work sleep difficulties. Not FDA-approved; dispensed by Wells Pharmacy Network only after a clinician evaluation.
Also known as: N-Acetyl-5-methoxytryptamine
How does Melatonin work?
Melatonin is synthesized from serotonin in the pineal gland in response to darkness. It binds the MT1 and MT2 receptors in the suprachiasmatic nucleus and peripheral tissues, signaling sleep readiness and modulating circadian, antioxidant, and immune pathways.
What is Melatonin studied for?
- Circadian-rhythm disorders, jet lag, and shift-work sleep difficulties
- Adjunct in sleep-onset support
- Antioxidant and free-radical research
How is Melatonin taken?
Available OTC as oral tablets and gummies. Compounded preparations include sustained-release tablets, sublingual troches, and high-dose pulses for clinician-directed protocols.
Is Melatonin FDA-approved? Is it safe?
OTC at typical doses is generally well-tolerated. Higher doses (>10 mg) and pediatric chronic use should involve clinician oversight. Compounded prescription-only preparations are dispensed by Wells Pharmacy Network. Eligibility is decided by a licensed clinician based on intake and labs, not by checkout. Compounded products on this site are not FDA-approved and are not generic equivalents of any branded medication.
In the Regen Therapy catalog
This compound does not currently appear in an active Regen Therapy protocol. Browse the full catalog for adjacent options.
What does the research say about Melatonin?
AASM clinical practice guidelines support melatonin for circadian-rhythm sleep-wake disorders; data for primary insomnia is more modest.
Citations & further reading
Considering Melatonin as part of a protocol?
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