MedeliX
Start asking

Melatonin

Circadin, Melatonin Neurim, Slenyto · ATC code N05CH01

Also known as: Melatonina, Mélatonine · Brand names: Circadin, Melatonin Neurim, Slenyto, Evoqi, Melatal, Mellozzan, Melozostrin, Pinealin, Voquily, Abdi İbrahim Melatonin, Baymela, Circaday, Cozymel, İlko Melatonin, Insovef …

Key facts
Active substance
Melatonin
Drug class
Melatonin receptor agonist
ATC code
N05CH01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Circadin 2 mg prolonged-release tablets · Melatonin Neurim 2 mg prolonged-release tablets · Slenyto 1 mg prolonged-release tablets / Slenyto 5 mg prolonged-release tablets
Marketing authorisation holder
RAD Neurim Pharmaceuticals EEC SARL
Information as of
2026-11-03

Key facts

Melatonin is the pineal sleep hormone. This page covers the EU prolonged-release tablets: Circadin and Melatonin Neurim (2 mg) for primary insomnia in patients aged 55 or over, and Slenyto (1 mg and 5 mg) for insomnia in children and adolescents with autism spectrum disorder, neurogenetic disorders or ADHD.

What it is used for

  • Circadin, Melatonin Neurim: short-term monotherapy of primary insomnia with poor quality of sleep in patients aged 55 or over
  • Slenyto: insomnia in children and adolescents aged 2-18 years with autism spectrum disorder and/or neurogenetic disorders (e.g. aberrant melatonin secretion, nocturnal awakenings) when sleep hygiene has been insufficient
  • Slenyto: insomnia in children and adolescents aged 6-17 years with ADHD when sleep hygiene has been insufficient

Dosing

  • Circadin, Melatonin Neurim: 2 mg once daily, 1-2 hours before bedtime and after food, for up to thirteen weeks
  • Slenyto (ASD/neurogenetic disorders): start 2 mg, increase to 5 mg if response is inadequate, maximum 10 mg
  • Slenyto (ADHD): start 1-2 mg, adjustable to 5 mg per day, maximum 10 mg if clinically needed
  • Slenyto once daily 0.5-1 hour before bedtime with or after food; evaluate effect after about 3 months and review at least every 6 months
  • Swallow tablets whole (Slenyto may be put into food such as yoghurt); not recommended in hepatic impairment; caution in renal impairment

Contraindications

  • Hypersensitivity to melatonin or any excipient

Important warnings

  • Drowsiness and daytime fatigue; caution where drowsiness is a safety risk (e.g. driving); in ADHD may worsen daytime inattention or behaviour
  • Not recommended in autoimmune diseases (no clinical data)
  • Contains lactose: not for patients with hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption

Side effects

  • Adults (Circadin): headache, nasopharyngitis, back pain and arthralgia were most common, at rates similar to placebo
  • Uncommon in adults: irritability, nervousness, restlessness, abnormal dreams, migraine, dizziness, somnolence, hypertension, abdominal pain, rash
  • Children (Slenyto): somnolence, fatigue, hangover, mood swings, irritability, aggression, headache, sudden onset of sleep, sinusitis

Interactions

  • Fluvoxamine raises melatonin levels (17-fold higher AUC) via CYP1A2 and CYP2C19 inhibition: avoid
  • Alcohol reduces the effect; benzodiazepines and Z-hypnotics (zaleplon, zolpidem, zopiclone) have enhanced sedation
  • CYP1A2 inhibitors (quinolones, cimetidine), oestrogens and methoxypsoralen increase melatonin; carbamazepine, rifampicin and smoking reduce it
  • Slenyto: NSAIDs in the evening and beta-blockers may suppress endogenous melatonin

Pregnancy and breastfeeding

  • No clinical data in pregnancy; use not recommended (Circadin) or preferably avoided (Slenyto)
  • Probably passes into breast milk; breast-feeding not recommended during treatment with Circadin; with Slenyto weigh breast-feeding against therapy

Summary of the official product information, written with AI on 2026-11-03. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • CircadinRAD Neurim Pharmaceuticals EEC SARL · EMEA/H/C/000695
  • Melatonin NeurimRAD Neurim Pharmaceuticals EEC SARL · EMEA/H/C/005603
  • SlenytoRAD Neurim Pharmaceuticals EEC SARL · EMEA/H/C/004425

Source: European Medicines Agency (EMA), product information

Germany

  • EvoqiMedice Arzneimittel Pütter Gmbh & Co. Kg · 1 register entry
  • MelatalVitabalans Oy · 1 register entry
  • MelatoninMedice Arzneimittel Pütter Gmbh & Co. Kg, Fairmed Healthcare Gmbh, Unimedic Pharma Ab, Neuraxpharm Arzneimittel Gmbh, Pharma Nord Aps (Vojens), Ratiopharm Gmbh, Vitabalans Oy, Bluefish Pharmaceuticals Ab, Orifarm Generics A/S, Aspire Pharma (Malta) Limited, Przedsiębiorstwo Farmaceutyczne Lek-Am Sp. Zo.O., Puren Pharma Gmbh & Co. Kg, Stadapharm Gmbh, Aliud Pharma Gmbh · 14 register entries
  • MellozzanMedice Arzneimittel Pütter Gmbh & Co. Kg · 1 register entry
  • MelozostrinFairmed Healthcare Gmbh · 1 register entry
  • PinealinAgb-Pharma Ab · 2 register entries
  • VoquilyRad Neurim Pharmaceuticals Eec Sarl · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-11-03

Austria

  • MelatoninMedice Arzneimittel Pütter Gmbh & Co. Kg, Bluefish Pharmaceuticals Ab · 2 register entries
  • MellozzanMedice Arzneimittel Pütter Gmbh & Co. Kg · 1 register entry
  • MelozostrinFairmed Healthcare Gmbh · 1 register entry
  • PinealinAgb-Pharma Ab · 1 register entry
  • VoquilyRad Neurim Pharmaceuticals Eec Sarl · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-11-03

Turkey

  • Abdi İbrahim MelatoninABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • BaymelaEMPHARMA İLAÇ LTD. ŞTİ. · 1 register entry
  • CircadayORZAKS İLAÇ VE KİMYA SAN TİC. A.Ş. · 1 register entry
  • CozymelBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • İlko MelatoninİLKO İLAÇ SAN.VE TİC. A.Ş. · 1 register entry
  • InsovefVEFA İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • MelabiemBİEM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • MelaforALİ RAİF İLAÇ SAN. A.Ş. · 1 register entry
  • MellarestDEVA HOLDİNG A.Ş. · 1 register entry
  • MelogenGENSU PHARMA İLAÇ SAN VE TİC LTD ŞTİ · 1 register entry
  • MelonisenkARGİS İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • MihadaHADA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry
Show all 14 brand names
  • Tab MelatoninTAB İLAÇ SAN. A.Ş. · 1 register entry
  • Vefarma MelatoninVEFARMA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-11-03

Brand names in 25 more European countries
Belgium
Melatonin Ab, Melatonin Ace Pharmaceuticals, Melatonin Orifarm, Melatonin Orion, Melatonin Unimedic Pharma, Melatonine Pharma Nord, Melatonine Viatris, Noxarem, Pinealin, Voquily
Cyprus
Melatonin Medicair
Czechia
Melatonin Orion, Melatonin Vitabalans
Denmark
Adaflex, Mecastrin, Melatal, Melatonin, Mellozzan, Melozostrin, Orimelan, Senaxa
Estonia
Melatonin Orion, Melatonin Pharma Nord, Melatonin Vitabalans
Finland
Ceyesta, Dagravit, Mecastrin, Melatonin, Mellozzan, Noxarem, Orimelan, Roter, Senaxa, Vemedia
France
Adaflex, Aphelys, Melatonine Bluefish, Melatonine Lp Arrow, Melatonine Lp Venipharm, Melatonine Viatris Lp, Melatonine Zentiva Lp, Noxarem, Voquily
Greece
Medynote, Melatonin Medicair, Nidymo
Hungary
Bio-Melatonin Pharmyn, Melatonin Orion, Melatonin Pharma Nord, Melatonin-Valerosolv Teva Gyógyszergyár, Melatonin Vitabalans, Voquily
Iceland
Circadin, Lestinora, Melatonin Bluefish, Melatonin Evolan, Melatonin Medice, Melatonin Neurim, Melatonin Teva, Melatonin Viatris, Melatonin Vitabalans, Pinealin, Slenyto
Ireland
Calasu, Meladura, Melatonin Pharma Nord, Melnite, Voquily
Italy
Baldinas, Eusom, Melatonina Adoh, Melatonina Aurobindo, Melatonina Doc, Melatonina Noxarem, Melatonina Viatris, Melatonina Zentiva, Mellozzan, Sloremina, Syncropine, Voquily, Yayoi
Latvia
Melatonin Orion Pharma, Melatonin Pharma Nord, Melatonin Vitabalans
Liechtenstein
Circadin, Melatonin Neurim, Slenyto
Lithuania
Melatonin Orion, Melatonin Vitabalans, Melatoninas Pharma Nord
Luxembourg
Melatonin Pharma Nord, Melatonine Pharma Nord, Melatonine Viatris, Noxarem, Pinealin
Malta
Melatonin Senaxa
Netherlands
Davitamon, Kruidvat, Melatonine, Shiepz, Trekpleister, Valdispert, Voquily
Norway
Circadin, Mallozen, Melatal, Melatonin Ace Pharmaceuticals, Melatonin Agb, Melatonin Aspire, Melatonin Bluefish, Melatonin Glenmark, Melatonin Neurim, Melatonin Newbury, Melatonin Orifarm, Melatonin Orion Pharma, Melatonin Pharma Nord, Melatonin Teva, Melatonin Unimedic Pharma, Melatonin Viatris, Orimelan, Pinealin, Senaxa, Slenyto
Poland
Melabiorytm, Melanoc Pr, Melasolaren, Melatonin Orion, Melatonin Vitabalans, Melatonina Lek-Am, Melatonina Noctis, Melatonina Olimp, Melatonina Pharma Nord, Melatonina Polfarmex, Melatonina Polski Lek, Meldream Pr, Senaxa Pr, Sental, Voquily
Portugal
Adaflex, Melatonina Alter, Melatonina Bluefish, Melatonina Generis, Melatonina Mylan, Melatonina Noxarem, Melatonina Pharma Nord, Melatonina Teva
Slovakia
Melatonin Vitabalans
Slovenia
Melatonin
Spain
Conciliax, Melatonina Aristo, Melatonina Aurovitas, Melatonina Bluefish, Melatonina Cinfa, Melatonina Fairmed, Melatonina Perrigo, Melatonite, Noxarem, Senaxa, Voquily
Sweden
Aritonin, Mecastrin, Meladura, Melatan, Melatonin, Mellaras, Mellozzan, Melozostrin, Orimelan, Pinealin, Senaxa, Voquily

EMA – Article 57 product data (EU/EEA), 2026-11-03

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Circadin – EPAR, Product Information. 2026-11-03. https://www.ema.europa.eu/en/documents/product-information/circadin-epar-product-information_en.pdf
  2. European Medicines Agency. Melatonin Neurim – EPAR, Product Information. 2026-11-03. https://www.ema.europa.eu/en/documents/product-information/melatonin-neurim-epar-product-information_en.pdf
  3. European Medicines Agency. Slenyto – EPAR, Product Information. 2026-11-03. https://www.ema.europa.eu/en/documents/product-information/slenyto-epar-product-information_en.pdf
  4. EMA – Article 57 product data (EU/EEA), 2026-11-03. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  5. EMA – Article 57 product data (EU/EEA), 2026-11-03. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  6. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-11-03. https://www.titck.gov.tr/dinamikmodul/85
  7. Wikidata (CC0): ATC N05CH.

Editorial: Medelix editorial team · last updated 2026-11-03 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.