Melatonin
Melatonin Receptor Agonists
Sold as Slenyto · Circadin · MELLOZZAN · GUNA-MALE
- Drug class
- Melatonin Receptor Agonists
- Availability
- Over-the-counter
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 123
- FDA reports (12 mo)
- 4,424
Overview
Plain-language summary, compiled from the cited regulatory records
Melatonin is a naturally occurring hormone that regulates the sleep-wake cycle [1]. It is classified as a melatonin receptor agonist [1].
This active ingredient is available under various brand names, including GUNA-MALE [1]. It is approved for use 15 minutes before meals [1].
In the past 12 months, there have been 4,424 adverse event reports associated with melatonin [2]. The most frequently reported reactions include fatigue, off-label use, headache, the perception of the drug being ineffective, and nausea [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 117 | May 29, 2026 |
| EU European Union | EMA | 3 | November 11, 2025 |
| US United States | FDA | 1 | December 21, 2018 |
| CA Canada | Health Canada | 2 | October 23, 2025 |
GBUnited Kingdom· MHRA
117 products
Uses
Melatonin Neurim is indicated as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
How to take
EUEuropean Union· EMA
3 products
Uses
Slenyto is indicated for: - treatment of insomnia in children and adolescents aged 2-18 years with Autism Spectrum Disorder (ASD), and / or neurogenetic disorders with aberrant diurnal melatonin secretion and /or nocturnal awakenings, where sleep hygiene measures have been insufficient.
- treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient. 3
How to take
USUnited States· FDA
1 product
Uses
Take 15 minutes before meals.
How to take
CACanada· Health Canada
2 products
2 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [4].
Brands in Canada (1)
Drug interactions
Known interactions involving Melatonin. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB523480005 · revised February 17, 2025
- [2]European Medicines Agency · EMEA/H/C/004425 · revised November 11, 2025
- [3]FDA DailyMed · 176425c5-0be9-4c… · revised December 21, 2018 [PDF]
- [4]Health Canada (DPD) · 02560798 · revised October 23, 2025
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.