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Slenyto® Safety


Slenyto® offers favorable safety, both under short and long term treatment 

The safety profile of Slenyto® has been well characterized during the multi-national two- years Phase III clinical trial program.

Side effects

Favorable safety profile was shown both short and long term. Fatigue, moodswings, headache, irritability, aggression and hangover occurred in 1:10-1:100 children. Overall, similar treatment-related side effects in Slenyto® and placebo groups, except mild to moderate somnolence, which was more common with Slenyto®. The occurrence of side effects was lower with long term use of Slenyto® and there were no reports of dependence, abuse, tolerance, withdrawal or rebound.

In fact, compliance with the mini-tablets was close to 100% throughout the 24 months study.

Concomitant Use

Concomitant use of Slenyto® with fluvoxamine, alcohol, benzodiazepines/non-benzodiazepines hypnotics, thioridazine and imipramine is not recommended. While concomitant use with 5- or 8-methoxypsoralen, Cimetidine, Oestrogens, CYP1A2 inhibitors, CYP1A2 inducers, tobacco products, should be considered with caution.

Prostaglandin synthesis inhibitors (NSAIDs) and Beta-blocker products may affect endogenous melatonin levels and therefore their adminstration with Slenyto® should be avoided in the evening and administered in the morning. 


Hypersensitivity to the active substance or to any excipients listed in the prescribing information.   
For example, Slenyto® contains lactose. Patients with rare hereditary problems of galactose intolerance,
total lactase deficiency or glucose-galactose malabsorption should not take this medicine. 


* For detailed information, please consult with the prescribing information.

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