Melatonin (Herbs/Suppl)

Brand and Other Names:N-acetyl-5-methoxytryptamine, pineal hormone melatonin
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Suggested Dosing

Benzodiazepine Withdrawal in Elderly with Insomnia

2 mg controlled-release PO qHS for up to 6 months; taper dose over 6 weeks

Cancer, Adjunctive Therapy

10-50 mg PO daily

Cluster Headache, Prevention

10 mg PO qHS

Migraine Headache

3 mg PO HS

Insomnia

3-5 mg PO qHS

Difficulty falling asleep

  • 5 mg PO 3-4 hour before sleep period x 4 weeks

Difficulty maintaining sleep

  • Use controlled release formulation

Thrombocytopenia, Chemo-related

20 mg PO qHS

Jet Lag

0.5-5 mg PO HS

Eastbound

  • Preflight, early evening dose followed by HS dosing x 4days

Westbound

  • Treat HS x 4days when in new time zone

Chronic Fatique Syndrome

5 mg PO HS

Nicotine Withdrawal

0.3 mg PO 3.5 hours after stopping smoking

Winter Depression

0.125 mg PO twice daily

Premedication for Surgery

0.5 mg/kg SL

Tardive Dyskinesia

10 mg controlled-release PO qDay

Orphan Designations

Sleep disorders

  • Orphan designation for treatment of circadian rhythm sleep disorders in blind people without light perception
  • Orphan sponsors
    • Neurim Pharmaceuticals, Ltd; 8 Hanechoshet St; Tel-Aviv, Israel
    • Sack, Robert, M.D.; Oregon Health Sciences University, 3181 S.W. Sam Jackson Park Road; Portland, OR 97201

Encephalopathy

  • Orphan designation for treatment of neonatal hypoxic ischemic encephalopathy
  • Orphan sponsor: Scharper S.p.A.; Viale Ortles 12; Milan 20139, Italy

Smith-Magenis syndrome

  • Orphan designation for treatment of Smith-Magenis syndrome in combination with a beta-blocker
  • Orphan sponsor: Therapicon SrL; 21 Via Malachia Marchesi de Taddei; Milano, Italy

Acetaminophen overdose

  • Orphan designation for treatment of acute acetaminophen overdose
  • Orphan sponsor: Therapicon SrL; 21 Via Malachia Marchesi de Taddei; Milano, Italy

Short bowel syndrome

  • Orphan designation for treatment of short bowel syndrome
  • Orphan sponsor: Therapicon SrL; 21 Via Malachia Marchesi de Taddei; Milano, Italy

Necrotizing enterocolitis

  • Orphan designation for treatment of necrotizing enterocolitis
  • Orphan sponsor: Therapicon SrL; 21 Via Malachia Marchesi de Taddei; Milano, Italy

Acute radiation syndrome

  • Orphan designation for treatment of acute radiation syndrome
  • Orphan sponsor: WORPHMED Srl; Via Malachia Marchesi de Taddei, 21; Milan, Italy

Hepatocellular carcinoma

  • Orphan designation for treatment of hepatocellular carcinoma
  • Orphan sponsor: Worphmed Srl; Via Malachia Marchesi de Taddei, 21; Milan, Italy

Heat stroke

  • Orphan designation for treatment of heat stroke
  • Orphan sponsor: Worphmed Srl; Via Malachia Marchesi de Taddei, 21; Milan, Italy
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Suggested Uses

Alzheimer's disease, benzodiazepine or nicotine withdrawal, cancer (adjunctive treatment), headache (prevention), insomnia, jet lag, shift-work disorder, sleep disorders, thrombocytopenia (chemo-induced), winter depression, tardive dyskinesia

Efficacy

Circadian rhythm sleep disorders: FDA orphan drug status

Insomnia: Helpful for sleep-wake cycle disorders

Research is continuing

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Interactions

Interaction Checker

and Melatonin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Abdominal cramps

            Alertness decreased

            Circadian rhythm disruption

            Daytime fatigue

            Depression (transient)

            Dizziness

            Drowsiness

            Dysphoria in depressed patients

            Headache

            Irritability

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            Warnings

            Contraindications

            Concurrent immunosuppressive treatment

            Cautions

            Age <20 years old, depression, hypertension, impaired liver function, seizure disorder

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            Pregnancy & Lactation

            Pregnancy: avoid use

            Lactation: avoid use

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Hormone produced by pineal gland; regulates sleep cycle

            Pharmacokinetics

            Not studied

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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.