Drug reference

Melatonin

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 533, 534

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

Insomnia [short-term use] ▶BY MOUTH USING MODIFIED-RELEASE TABLETS ▶Adult 55 years and over: 2 mg once daily for up to 13 weeks, dose to be taken 1–2 hours before bedtime Jet lag [short-term use] ▶BY MOUTH USING IMMEDIATE-RELEASE MEDICINES ▶Adult: 3 mg once daily, increased if necessary to 6 mg once daily for up to 5 days, the ﬁrst dose should be taken at the habitual bedtime after arrival at destination. Doses should not be taken before 8pm or after 4am. Maximum of 16 treatment courses per year Insomnia in patients with learning disabilities [where sleep hygiene measures have been insufficient] (initiated under specialist supervision) ▶BY MOUTH USING MODIFIED-RELEASE TABLETS ▶Adult: Initially 2 mg once daily, increased if necessary to 4–6 mg once daily, dose to be taken 30–60 minutes before bedtime; maximum 10 mg per day

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Pharmacokinetics

▶The intake of food with immediate-release melatonin may increase the bioavailability of melatonin l UNLICENSED USE g Melatonin is used for insomnia in patients with learning disabilities, l but is not licensed for this indication.

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Cautions

Autoimmune disease (manufacturer advises avoid—no information available)

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Safety

Interactions

→Appendix 1: melatonin

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Side Effects

▶Common or very common Arthralgia. headaches. increased risk of infection. pain ▶Uncommon Anxiety. asthenia. chest pain. dizziness. drowsiness. dry mouth. gastrointestinal discomfort. hyperbilirubinaemia. hypertension. menopausal symptoms. mood altered. movement disorders. nausea. night sweats. oral disorders. skin reactions. sleep disorders. urine abnormalities. weight increased ▶Rare or very rare Aggression. angina pectoris. arthritis. concentration impaired. crying. depression. disorientation. electrolyte imbalance. excessive tearing. gastrointestinal disorders. haematuria. hot ﬂush. hypertriglyceridaemia. leucopenia. memory loss. muscle complaints. nail disorder. palpitations. paraesthesia. partial complex seizure. prostatitis. sexual dysfunction. syncope. thirst. thrombocytopenia. urinary disorders. vertigo. vision disorders. vomiting ▶Frequency not known Angioedema. galactorrhoea. hyperglycaemia

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Pregnancy

No information available—avoid.

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Breast Feeding

Present in milk—avoid.

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Hepatic Impairment

Manufacturer advises avoid (risk of decreased clearance; limited information available).

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Renal Impairment

No information available—use with caution.

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Dose and formulations

Directions For Administration

Manufacturers advise that modiﬁed-release tablets should be taken with or after food. Licensed immediate-release formulations should be taken on an empty stomach, 2 hours before or 2 hours after food—intake with carbohydrate-rich meals may impair Nervous system blood glucose control.

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Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: tablet, modiﬁed- release tablet, oral solution Modified-release tablet CAUTIONARY AND ADVISORY LABELS 2, 21, 25 ▶Melatonin (Non-proprietary) Melatonin 3 mg Melatonin 3mg modified-release tablets | 120 tablet P s ▶Circadin (Flynn Pharma Ltd) Melatonin 2 mg Circadin 2mg modified-release tablets | 30 tablet P £15.39 DT = £15.39 ▶Slenyto (Flynn Pharma Ltd) Melatonin 1 mg Slenyto 1mg modified-release tablets | 60 tablet P £41.20 DT = £41.20 Melatonin 5 mg Slenyto 5mg modified-release tablets | 30 tablet P £103.00 DT = £103.00 Tablet CAUTIONARY AND ADVISORY LABELS 2, 25 ▶Melatonin (Non-proprietary) Melatonin 1 mg Melatonin 1mg tablets | 90 tablet P s Melatonin 3 mg Melatonin 3mg tablets | 30 tablet P £15.95– £65.00 DT = £52.74 Melatonin 5 mg Melatonin Extra Strength 5mg tablets | 60 tablet P s ▶VesPro (Imported (United States)) Melatonin 500 microgram VesPro Melatonin 500microgram tablets | 1000 tablet P s Oral solution CAUTIONARY AND ADVISORY LABELS 2 EXCIPIENTS: May contain Ethanol, propylene glycol, sorbitol ▶Melatonin (Non-proprietary) Melatonin 1 mg per 1 ml Melatonin 1mg/ml oral solution sugar-free | 150 ml P £130.00 DT = £130.00

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Dose text by age group

Adult 55 years and over

2 mg once daily for up to

First-line fragment. Read the complete Indications and Dose section above.

PDF page 533

Adult

3 mg once daily, increased if necessary to 6 mg

First-line fragment. Read the complete Indications and Dose section above.

PDF page 533

Adult

Initially 2 mg once daily, increased if necessary

First-line fragment. Read the complete Indications and Dose section above.

PDF page 533

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.

Drug reference

Melatonin

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 533, 534

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

PDF page 533

Pharmacokinetics

PDF page 533

Cautions

Autoimmune disease (manufacturer advises avoid—no information available)

PDF page 533

Safety

Interactions

→Appendix 1: melatonin

PDF page 533

Side Effects

PDF page 533

Pregnancy

No information available—avoid.

PDF page 533

Breast Feeding

Present in milk—avoid.

PDF page 533

Hepatic Impairment

Manufacturer advises avoid (risk of decreased clearance; limited information available).

PDF page 533

Renal Impairment

No information available—use with caution.

PDF page 534

Dose and formulations

Directions For Administration

PDF page 534

Medicinal Forms

PDF page 534

Dose text by age group

Adult 55 years and over

2 mg once daily for up to

First-line fragment. Read the complete Indications and Dose section above.

PDF page 533

Adult

3 mg once daily, increased if necessary to 6 mg

First-line fragment. Read the complete Indications and Dose section above.

PDF page 533

Adult

Initially 2 mg once daily, increased if necessary

First-line fragment. Read the complete Indications and Dose section above.

PDF page 533

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.