Optisana Sommeil OptiBears
Food supplement declared in France, decision dated 3 October 2025
Optisana Sommeil OptiBears (Optisana) is a food supplement declared in France. Status: déclaré en France, commercialisation possible : l'administration ne s'est pas opposée à la déclaration (ce n'est ni une autorisation ni une évaluation de sécurité). None of the rules we check flags an issue with its declared composition.
- Brand
- Optisana
- Food business operator placing the product on the market
- SWEET TEC GmbH
- Status
- Déclaré en France, commercialisation possible : l'administration ne s'est pas opposée à la déclaration (ce n'est ni une autorisation ni une évaluation de sécurité)
- Form
- Gomme
- Daily dose
- 4g (2 pièces)
- Directions for use
- Prendre deux gummies par jour.
- Objectives stated by the manufacturer (these are not authorised claims)
- Sommeil
Declaration 342530, procedure Article 15. Compl'Alim, food supplement declarations (France), retrieved 23 October 2026.
Regulatory points
None of the rules we check applies to the declared ingredients.
Declared composition
Substances
| Name | Per day |
|---|---|
| mélatonine | 1 mg |
Additives
E903, E331, E330
Other ingredients
Concentre de carotte et pomme, Concentré de spiruline et pomme, amidon, sucre, sirop de glucose
List from the declaration, administrative decision dated (Compl'Alim, food supplement declarations (France)).
Has the product changed? Photograph the packaging.
Label warnings
La mélatonine ne doit pas être utilisée régulièrement et uniquement sur une courte durée. La consommation journalière recommandée indiquée ne doit pas être dépassée. Les compléments alimentaires ne peuvent se substituer à une alimentation équilibrée et variée et à un mode de vie sain, qui sont essentiels. Les nourrissons, les enfants et les adolescents, les femmes enceintes, les femmes qui allaitent et celles qui souhaitent avoir un enfant, les personnes dont la fonction hépatique et/ou rénale est limitée, ainsi que les personnes souffrant de maladies auto-immunes ou d'épilepsie ne doivent pas utiliser ce complément alimentaire. Les personnes qui utilisent des médicaments devraient demander un avis médical avant de prendre des compléments alimentaires contenant de la mélatonine. Ce complément peut entraîner une somnolence. Ne pas utiliser avant de conduire un véhicule ou de manipuler des machines. La mélatonine ne doit pas être utilisée régulièrement et seulement pendant une courte période.
This information reproduces the manufacturer's declaration to the administration (DGAL). It does not say whether the product is effective and does not replace advice from a doctor or pharmacist, particularly during pregnancy or when taking medication.
Official warnings (Health Canada)
Health Canada publishes warnings on these ingredients:
- mélatonine
Read the warning, when it applies and the studies cited
MELATONIN - Oral
Cautions and warnings
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are taking medications for seizure, blood pressure, to suppress the immune system, to affect mental state or increase sedation, steroids or blood thinners (Wirtz et al. 2008; IOM 2004; Herxheimer and Petrie 2002; Lusardi et al. 2000; Maestroni 1993).
5 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have cardiovascular, immune, liver or kidney disease, seizure disorder, asthma or diabetes (Peschke and Mühlbauer 2010; Carrillo-Vico et al. 2005; IOM 2004; der Marderosian and Beuttlers 2003; Sutherland et al. 2003; Calvo et al. 2002; Herxheimer and Petrie 2002; Sutherland et al. 2002; Cagnacci et al. 2001a; Arangino et al. 1999; Sheldon 1998; Maestroni 1993).
12 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
When using this product avoid taking with alcohol or products that cause drowsiness (Herxheimer and Petrie 2002; Holliman and Chyka 1997).
2 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
When using this product avoid driving or using machinery for 5 hours (Avery et al. 1998; Suhner et al. 1998b).
2 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
Ask a health care practitioner/health care provider/health care professional/doctor/physician if sleeplessness persists for more than 4 weeks (chronic insomnia) (Buscemi et al. 2004; IOM 2004; Dipiro et al. 2002).
3 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
Contraindications
Do not use if you are pregnant or breastfeeding (IOM 2004).
1 study cited in the text has no matching reference in the monograph (see the anomalies listed on the sources page).
Known adverse reactions
Stop use if allergy occurs or if you experience headache, confusion, or nausea (Herxheimer and Petrie 2002).
1 study cited in the text has no matching reference in the monograph (see the anomalies listed on the sources page).
Health Canada monograph dated 19 December 2025
MELATONIN - Sublingual
Cautions and warnings
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you are taking medications for seizure, blood pressure, to suppress the immune system, to affect mental state or increase sedation, steroids or blood thinners (Wirtz et al. 2008; IOM 2004; Herxheimer and Petrie 2002; Lusardi et al. 2000; Maestroni 1993).
5 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
Ask a health care practitioner/health care provider/health care professional/doctor/physician before use if you have a cardiovascular, immune, liver or kidney disease, seizure disorder, asthma or diabetes (Peschke and Mühlbauer 2010; Carrillo-Vico et al. 2005; IOM 2004; der Marderosian and Beuttlers 2003; Sutherland et al. 2003; Calvo et al. 2002; Herxheimer and Petrie 2002; Sutherland et al. 2002; Cagnacci et al. 2001a; Arangino et al. 1999; Sheldon 1998; Maestroni 1993).
12 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
When using this product avoid taking with alcohol or products that cause drowsiness (Herxheimer and Petrie 2002; Holliman and Chyka 1997).
2 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
When using this product avoid driving or using machinery for 5 hours (Avery et al. 1998; Suhner et al. 1998b).
2 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
Ask a health care practitioner/health care provider/health care professional/doctor/physician if sleeplessness persists for more than 4 weeks (chronic insomnia) (Buscemi et al. 2004; IOM 2004; Dipiro et al. 2002).
3 studies cited in the text have no matching reference in the monograph (see the anomalies listed on the sources page).
Contraindications
Do not use if you are pregnant or breastfeeding (IOM 2004).
1 study cited in the text has no matching reference in the monograph (see the anomalies listed on the sources page).
Known adverse reactions
Stop use if allergy occurs or if you experience headache, confusion, or nausea (Herxheimer and Petrie 2002).
1 study cited in the text has no matching reference in the monograph (see the anomalies listed on the sources page).
They concern the ingredient, not this product or its dose. They do not replace medical advice.
Brand : Optisana
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