natgillin/translations-raw huggingface dataset:
Unexpected changes in behaviour, such as aggression, may occur commonly (affecting between 1 in 100 to 1 in 10 people). 
Pogosto se lahko pojavijo nepričakovane spremembe vedenja, kot je agresivnost (med 1 od 100 in 1 od 10 ljudi).
Concomitant use of the following medicinal products is not recommended (see section 4.4): 
Sočasna uporaba naslednjih zdravil ni priporočljiva (glejte poglavje 4.4):
Concomitant use of the following medicinal products should be considered with caution: 
Pri sočasni uporabi naslednjih zdravil je potrebna previdnost:
A 3-4-fold increase in Cmax is apparent for women compared to men. 
Pri ženskah je povečanje Cmax od 3- do 4-kratno v primerjavi z moškimi.
- has liver or kidney problems. 
- jetrne ali ledvične težave.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. 
Bolniki z redkimi dednimi težavami galaktozne intolerance, popolnega pomanjkanja laktaze ali malabsorpcije glukoze/galaktoze tega zdravila ne smejo jemati.
After at least 3 months of treatment, the physician should evaluate the treatment effect and consider stopping treatment if no clinically relevant treatment effect is seen. 
Po vsaj treh mesecih zdravljenja mora zdravnik oceniti učinek zdravljenja in razmisliti o ukinitvi zdravljenja, če ni mogoče opaziti nobenega klinično pomembnega učinka zdravljenja.
Do not drink alcohol before, during or after taking Slenyto, because alcohol weakens the effect of the medicine. 
Zdravilo Slenyto z alkoholom Pred, med ali po jemanju zdravila Slenyto ne pijte alkohola, ker alkohol zmanjša učinek zdravila.
If there is no improvement in your/your child's symptoms, your doctor may increase the dose of Slenyto to find the most suitable dose for you/your child. 
Če se vaši simptomi/simptomi vašega otroka ne izboljšajo, vam zdravnik lahko poveča odmerek zdravila Slenyto, da ugotovi najprimernejši odmerek za vas/vašega otroka.
The patient should be monitored at regular intervals (at least every 6 months) to check that Slenyto is still the most appropriate treatment. 
Bolnika je treba redno spremljati (vsaj vsakih šest mesecev), da se preveri, ali je zdravljenje z zdravilom Slenyto še vedno najprimernejše.
74 patients completed 104 weeks of treatment, 39 completed 2 years and 35 completed 21 months of Slenyto treatment. 
74 bolnikov je dokončalo 104 tedne zdravljenja, 39 bolnikov dve leti in 35 bolnikov 21 mesecev zdravljenja z zdravilom Slenyto.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake „EXP“.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 September 2018 
Datum prve odobritve: 20. septembra 2018
• Changes in mood 
• spremembe razpoloženja
Slenyto should be taken in the evening, 30 to 60 minutes before bedtime. 
Zdravilo Slenyto je treba jemati zvečer, od 30 do 60 minut pred spanjem.
Patients had a significantly decreased total excretion of 6-sulfatoxymelatonin compared with controls. 
Pri bolnikih je bilo zelo zmanjšano skupno izločanje 6-sulfatoksimelatonina v primerjavi s kontrolami.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from melatonin therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. 
Odločiti se je treba med prenehanjem dojenja ali prenehanjem/prekinitvijo zdravljenja z melatoninom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
The absorption of orally ingested melatonin is complete in adults and may be decreased by up to 50% in the elderly. 
Absorpcija peroralno zaužitega melatonina je pri odraslih popolna, pri starejših bolnikih pa se lahko zmanjša do 50 %.
This finding is compatible with the short half-life of melatonin in humans. 
Ta ugotovitev je v skladu s kratkim razpolovnim časom melatonina pri ljudeh.
The tablet should not be broken, crushed or chewed because it will lose the prolonged release properties. 
Tableta se ne sme prelomiti, zdrobiti ali žvečiti, ker bi izgubila značilnosti v zvezi s podaljšanim sproščanjem.
In particular, taking Slenyto with the following medicines can increase the risk of side effects, or it can affect the way that Slenyto or the other medicine works: 
Zlasti jemanje zdravila Slenyto skupaj z naslednjimi zdravili lahko poveča tveganje neželenih učinkov ali lahko vpliva na način delovanja zdravila Slenyto ali drugih zdravil:
No clinically significant pharmacokinetic interactions were found in each case. 
V nobenem primeru niso bile ugotovljene klinično pomembne farmakokinetične interakcije.
If the tablets are mixed with these foods, they should be given immediately and not left or stored, as this may affect the way the tablets work. 
Če se tablete zmešajo s temi živili, jih je treba vzeti takoj in se jih ne sme pustiti ali shraniti, ker to lahko vpliva na način njihovega delovanja.
In a clinical trial, there was clear evidence for a transitory pharmacodynamic interaction between melatonin and zolpidem one hour following co-dosing. 
V kliničnem preskušanju so se pokazali jasni znaki prehodnega farmakodinamičnega medsebojnega delovanja melatonina in zolpidema eno uro po sočasnem prejemu odmerkov.
The effect of melatonin on newborns/infants is unknown. 
Učinek melatonina na novorojenčke/dojenčke ni znan.
Smoking can increase the breakdown of melatonin by the liver, which may make this medicine less effective. 
Kajenje lahko poveča razkroj melatonina v jetrih, zaradi česar se lahko zmanjša učinek tega zdravila.
Adjusted treatment means (SE) [95% CI] 
Prilagojeno povprečje zdravljenja (SE) [95 % CI]
Please tell your doctor if you or your child starts or stops smoking during treatment. 
Obvestite zdravnika, če ste vi ali vaš otrok med zdravljenjem začeli ali prenehali kaditi.
• Swelling and inflammation of the sinuses associated with pain and blocked nose (sinusitis) 
• otekanje in vnetje sinusov, povezano z bolečino in zamašenim nosom (sinuzitis)
It is possible that melatonin is passed into human breast milk, therefore your doctor will decide whether you or your daughter should breastfeed whilst taking melatonin. 
Mogoče je, da melatonin prehaja v materino mleko, zato bo zdravnik odločil, ali vi ali vaša hči med jemanjem melatonina lahko dojite.
What Slenyto is and what it is used for 
Kaj je zdravilo Slenyto in za kaj ga uporabljamo
A slight effect on post-natal growth and viability was found in rats only at very high doses, equivalent to approximately 2000 mg/day in humans. 
Na podganah je bil ugotovljen manjši učinek na rast in sposobnost preživetja po rojstvu samo pri zelo visokih odmerkih, ki so ustrezali približno 2 000 mg/dan pri ljudeh.
It is for the treatment of insomnia (sleeplessness) when a healthy sleeping routine (such as a regular bedtime and soothing sleeping environment) has not worked well enough. 
Namenjeno je zdravljenju insomnije (nespečnosti), kadar zdrave spalne navade (kot sta odhajanje v posteljo ob istem času in pomirjujoče spalno okolje) ne zadostujejo.
If the tablets are mixed with food or drink, they should be taken immediately and the mixture not stored. 
Če se tablete zmešajo s hrano ali pijačo, jih je treba vzeti takoj, mešanica pa se ne sme shraniti.
In the absence of specific studies in children, the drug interactions with melatonin are those known in adults. 
Ker posebne študije pri otrocih niso bile izvedene, so interakcije melatonina interakcije, znane pri odraslih.
Combination with thioridazine and imipramine should be avoided. 
Kombinaciji s tioridazinom in imipraminom se je treba izogibati.
The principal metabolite is 6-sulfatoxy-melatonin (6-S-MT), which is inactive. 
Najpomembnejši metabolit je 6-sulfatoksi-melatonin (6-S-MT), ki ni aktiven.
The activity of melatonin at the melatonin receptors (MT1, MT2 and MT3) is believed to contribute to its sleep-promoting properties, as these receptors (mainly MT1 and MT2) are involved in the regulation of circadian rhythms and sleep regulation. 
Predvideva se, da aktivnost melatonina pri receptorjih melatonina (MT1, MT2 in MT3) prispeva k njegovim lastnostim, ki spodbujajo spanje, saj ti receptorji (pretežno MT1 in MT2) sodelujejo pri uravnavanju cirkadianega ritma in uravnavanju spanja.
• Fits (epilepsy) 
• napadi (epilepsija)
Published data demonstrate markedly elevated endogenous melatonin levels during daytime hours due to decreased clearance in patients with hepatic impairment (see Section 4.2). 
Objavljeni podatki kažejo izrazito povišane ravni endogenega melatonina podnevi zaradi zmanjšanega čiščenja pri bolnikih z jetrno okvaro (glej poglavje 4.2).
Externalizing behaviours 
Eksternalizirano vedenje
• Skin lesion 
• kožna lezija
France e-mail: regulatory@neurim.com 
Francija e-naslov: regulatory@neurim.com
Therefore, interactions between melatonin and other active substances as a consequence of their effect on CYP1A enzymes is possible. 
Interakcije med melatoninom in drugimi zdravilnimi učinkovinami so zato mogoče kot posledica njihovega učinka na encime CYP1A.
Pharmacotherapeutic group: Psycholeptics, melatonin receptor agonists, ATC code: N05CH01 Mechanism of action 
Farmakoterapevtska skupina: psiholeptiki, agonisti receptorjev melatonina, oznaka ATC: N05CH01 Mehanizem delovanja
Interactions with other medicines 
Medsebojno delovanje z drugimi zdravili
Slenyto shortens the time it takes to fall asleep and lengthens the duration of sleep. 
Zdravilo Slenyto skrajša čas, potreben, da zaspimo, in podaljša trajanje spanja.
You or your child should be monitored by your doctor at regular intervals (recommended every 6 months) to check that Slenyto is still the right treatment for you/them. 
Vaš zdravnik mora vas ali vašega otroka redno spremljati (priporočljivo je vsakih šest mesecev), da preveri, ali je zdravilo Slenyto še vedno pravo zdravljenje za vas/njih.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Concomitant administration resulted in increased impairment of attention, memory and co-ordination compared to zolpidem alone. 
Sočasno dajanje je vplivalo na poslabšanje pozornosti, spominskih funkcij in koordinacije v primerjavi z dajanjem samega zolpidema.
The tablets should be swallowed whole and NOT broken, crushed or chewed. 
Tablete je treba pogoltniti cele; NE smejo se prelomiti, zdrobiti ali žvečiti.
In studies performed in both adult and juvenile animals, melatonin had no effect on male or female fertility (see section 5.3). 
V študijah, izvedenih na odraslih živalih in mladičih, melatonin ni imel učinka na plodnost samcev ali samic (glej poglavje 5.3).
• non-steroidal anti-inflammatory medicines such as aspirin and ibuprofen (used for treating pain and inflammation). 
• nesteroidnimi protivnetnimi zdravili, kot sta aspirin in ibuprofen (ki se uporabljajo za zdravljenje bolečine in vnetja).
Tell your doctor or pharmacist if you or your child is taking, has recently taken or might take any other medicines. 
Obvestite zdravnika ali farmacevta, če vi ali vaš otrok jemljete, sta pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
If the tablets are mixed with any other type of food, the tablets may not work properly. 
Če se tablete zmešajo z drugimi vrstami živil, morda ne bodo pravilno delovale.
The effect of any stage of renal impairment on melatonin pharmacokinetics has not been studied. 
Učinka ledvične okvare katere koli stopnje na farmakokinetiko melatonina še niso raziskovali.
Animal studies do not indicate reproductive toxicity (see section 5.3). 
Študije na živalih ne navajajo strupenosti za razmnoževanje (glej poglavje 5.3).
Concomitant use with fluvoxamine, alcohol, benzodiazepines/non-benzodiazepines hypnotics, thioridazine and imipramine is not recommended (see section 4.5). 
Sočasna uporaba s fluvoksaminom, alkoholom, benzodiazepinskimi/nebenzodiazepinskimi hipnotiki, tioridazinom in imipraminom ni priporočljiva (glejte poglavje 4.5).
Taking more than the recommended daily dose may make you/your child feel drowsy. 
Zaradi odmerka, ki presega priporočeni dnevni odmerek, se boste lahko vi/vaš otrok počutili zaspani.
Alcohol should not be taken with melatonin, because it reduces the effectiveness of melatonin on sleep. 
Alkohol Pri jemanju melatonina ni dovoljeno uživati alkohola, ker zmanjšuje učinek melatonina na spanje.
The whole tablets can be put into food like yoghurt, orange juice or ice-cream to help with swallowing. 
Cele tablete se lahko dajo v hrano, na primer v jogurt, pomarančni sok ali sladoled, da se lažje pogoltnejo.
Other medicines and Slenyto 
Druga zdravila in zdravilo Slenyto
• beta-blockers (used to control blood pressure). 
• beta zaviralci (ki se uporabljajo za obvladovanje krvnega tlaka).
Thioridazine and imipramine 
Tioridazin in imipramin
Beta-blockers may supress the night-time release of endogenous melatonin and thus should be administered in the morning. 
Beta zaviralci lahko ponoči zmanjšajo sproščanje endogenega melatonina, zato jih je treba jemati zjutraj.
5 mg strength 
jakost 5 mg
However, melatonin co-administration resulted in increased feelings of tranquility and difficulty in performing tasks compared to imipramine alone, and increased feelings of “muzzyheadedness” compared to thioridazine alone. 
Vendar je hkratno dajanje melatonina povzročilo povečan občutek mirnosti in težave pri izvajanju nalog v primerjavi z dajanjem samega imipramina, ter povečan občutek „topoglavosti“ v primerjavi s samim tioridazinom.
The improvements in total sleep time (TST), sleep latency (SL) and duration of uninterrupted sleep (LSE; longest sleep episode) seen in the double blind-phase were maintained throughout the 39 weeks' follow up period. 
Izboljšanje skupnega časa spanja (TST), latence uspavanja (SL) in neprekinjenega trajanja spanja (LSE; najdaljša epizoda spanja), opaženo v dvojno slepi fazi, se je ohranilo vseh 39 tednov nadaljevalnega obdobja.
The in vitro plasma protein binding of melatonin is approximately 60%. 
Vezava in vitro melatonina na plazemske beljakovine je približno 60 %.
Prepubertal children and young adults metabolize melatonin faster than adults. 
Otroci pred puberteto in mladi odrasli presnavljajo melatonin hitreje kot odrasli.
Melatonin does not induce CYP1A2 or CYP3A enzymes in vitro at supra-therapeutic concentrations. 
Melatonin ne inducira encimov CYP1A2 ali CYP3A in vitro pri koncentracijah, višjih, kot so terapevtske.
The adjusted estimated treatment differences were 43.2 minutes in the all Randomized Set (MI, p=0 .039). 
Prilagojena ocenjena razlika v zdravljenju je v celotni randomizirani skupini znašala 43,2 minute (MI, p = 0,039).
Data in animals indicate maternal transfer of melatonin to the foetus via the placenta or in the milk. 
Podatki pri živalih kažejo, da se melatonin iz matere prek placente prenaša v zarodek ali v mleko.
After 2 weeks withdrawal on placebo, a descriptive reduction in most scores was seen but levels were still significantly better than baseline levels with no signs of rebound effects. 
Po dveh tednih prenehanja jemanja zdravila Slenyto in začetku jemanja placeba je bilo opaženo opisno znižanje večine ocen, vendar so bile ravni še vedno bistveno višje od izhodiščnih, brez znakov povratnega učinka.
If a lower treatment effect is seen after titration to a higher dose, the prescriber should first consider a down-titration to a lower dose before deciding on a complete discontinuation of treatment. 
Če je po povečanju odmerka opaziti manjši učinek zdravljenja, mora zdravnik, ki predpiše zdravilo, najprej razmisliti o zmanjšanju odmerka, preden se odloči za popolno ukinitev zdravljenja.
However as melatonin is mainly eliminated via liver metabolism, and the metabolite 6SMT is inactive, renal impairment is not expected to influence clearance of melatonin. 
Ker se melatonin izloči večinoma prek jetrnega metabolizma in ker metabolit 6-SMT ni aktiven, ni mogoče pričakovati vpliva ledvične okvare na čiščenje melatonina.
30 months (PVC/PVDC blister) 18 months (HDPE bottle) 
30 mesecev (pretisni omot PVC/PVDC) 18 mesecev (plastenka HDPE)
The kinetics of melatonin are linear over the range of 2-8 mg. 
Kinetika melatonina je linearna v razponu od 2 mg do 8 mg.
Combination with benzodiazepines and non-benzodiazepine hypnotics should be avoided. 
Kombinaciji z benzodiazepinskimi in nebenzodiazepinskimi hipnotiki se je treba izogibati.
Melatonin is mainly bound to albumin, alpha1-acid glycoprotein and high density lipoprotein. 
Melatonin se veže večinoma na albumin, alfa1-kisli glikoprotein in lipoprotein visoke gostote.
- suffers from an autoimmune disease (where the body's own immune (defence) system attacks parts of the body). 
- avtoimunsko bolezen (ko lasten imunski (obrambni) sistem telesa napade dele telesa).
Crushing and chewing damages the special properties of the tablet and means that they will not work properly. 
Z drobljenjem in žvečenjem se poslabšajo posebne značilnosti tablete, kar pomeni, da ne bodo pravilno delovale.
• quinolones (for example ciprofloxacin and norfloxacin) and rifampicin (used in the treatment of bacterial infections) 
• kinoloni (kot sta ciprofloksacin in norfloksacin) in rifampicinom (ki se uporablja za zdravljenje bakterijskih okužb);
For social functioning (CGAS), the differences between Slenyto and placebo were small and not statistically significant (Table 1). 
Razlike v socialnem vedenju (CGAS) so bile med zdravilom Slenyto in placebom majhne in statistično nepomembne (preglednica 1).
Elimination is by renal excretion of metabolites, 89% as sulfated and glucoronide conjugates of 6-hydroxymelatonin (over 80% as 6-sulfatoxy melatonin) and 2% is excreted as melatonin (unchanged active substance). 
Odstrani se z izločanjem metabolitov skozi ledvice, 89 % kot sulfatni in glukuronidni konjugati 6-hidroksimelatonina (več kot 80 % kot 6-sulfatoksi melatonin), 2 % pa se izločita kot melatonin (nespremenjena zdravilna učinkovina).
Caution should be exercised in patients on 5- or 8-methoxypsoralen (5 or 8-MOP), which increases melatonin levels by inhibiting its metabolism. 
Previdnost je potrebna pri bolnikih, ki jemljejo 5- ali 8-metoksipsoralen (5- ali 8-MOP), ki zvišuje ravni melatonina z zaviranjem njegovega metabolizma.
Smoking is known to induce CYP1A2 metabolism, therefore if patients stop or start smoking during treatment with melatonin, dose adjustment may be required. 
Za kajenje je znano, da spodbuja metabolizem CYP1A2, zato je pri bolnikih, ki med zdravljenjem z melatoninom prenehajo ali začnejo kaditi, morda potrebno prilagoditi odmerek.
Melatonin may cause drowsiness. 
Melatonin lahko povzroči zaspanost.
Under fasted conditions Cmax was lower (1.73 ng/ml) and tmax was earlier (within 2 hours) with a minor effect on AUC-∞ that was slightly reduced (-14%) as compared to fed state. 
Če so prejeli zdravilo na tešče, je bil Cmax nižji (1,73 ng/ml), tmax pa je bil dosežen prej (v dveh urah), z manj pomembnim učinkom na AUC-∞, ki se je nekoliko zmanjšal (-14 %) kot v primerjavo po jedi.
Benzodiazepines/non-benzodiazepine hypnotics 
Benzodiazepinski/nebenzodiazepinski hipnotiki
The study comprises 5 periods: 1) pre-study period (4 weeks), 2) baseline single-blind placebo period (2 weeks), 3) randomized placebo-controlled treatment period (13 weeks), 4) open label treatment period (91 weeks), and 5) single blind run-out period (2 weeks placebo). 
Študija zajema pet obdobij: 1) obdobje pred študijo (4 tedne), 2) uvajalno enojno slepo obdobje s placebom (2 tedna), 3) randomizirano obdobje zdravljenja, nadzorovano s placebom (13 tednov), 4) obdobje odprtega zdravljenja (91 tednov) in 5) enojno slepo zaključno obdobje (2 tedna s placebom).
If you or your child takes more Slenyto than you/they should If you/your child has accidentally taken too much medicine, contact the doctor or pharmacist as soon as possible. 
Če ste vi ali vaš otrok vzeli večji odmerek zdravila, kot bi smeli Če ste vi/vaš otrok nenamerno vzeli preveč zdravila, stopite čim prej v stik z zdravnikom ali farmacevtom.
The recommended starting dose is 2 mg of Slenyto. 
Priporočeni začetni odmerek je 2 mg zdravila Slenyto.
The second, less significant, pathway is 5-demethylation to yield a physiological melatonin precursor, N-acetylserotonin. 
Druga, manj pomembna pot poteka prek 5-demetilacije do tvorbe psihološke predhodne sestavine melatonina, N-acetilserotina.
Altogether, melatonin metabolism declines with age, with pre-pubertal and pubertal metabolism faster than at older age. 
Na splošno se presnova melatonina s starostjo upočasnjuje ter je pred puberteto in med njo hitrejša kot v starejšem obdobju.
There are no data from the use of melatonin in pregnant women. 
Podatkov o uporabi melatonina pri nosečnicah ni.
After taking this medicine, you or your child should not drive a vehicle, ride a bicycle, or use machinery until completely recovered. 
Vi ali vaš otrok potem, ko vzamete to zdravilo, do popolnega okrevanja ne smete voziti vozila ali kolesa ali upravljati strojev.
Both 6hydroxymelatonin and N-acetylserotonin are ultimately conjugated to sulfate and glucoronic acid, and excreted in the urine as their corresponding 6-sulfatoxy and 6-glucoronide derivatives. 
Na koncu 6hidroksimelatonin in N-acetilserotonin konjugirata v sulfat in glukuronsko kislino ter se izločita z urinom kot ustrezna derivata 6-sulfatoksi in 6-glukuronid.
You should speak to your doctor before taking/giving Slenyto as its use is not recommended in such cases. 
Preden vzamete/date zdravilo Slenyto, se posvetujte z zdravnikom, ker njegova uporaba v takih primerih ni priporočljiva;
If a tablet is forgotten, it could be taken before the patient goes to sleep that night, but after this time, no other tablet should be given before the next scheduled dose. 
Če bolnik pozabi vzeti tableto, jo lahko vzame isto noč pred spanjem, vendar po tem ne sme vzeti nobene druge tablete pred naslednjim predvidenim odmerkom.
Melatonin may enhance the sedative properties of benzodiazepines and non-benzodiazepine hypnotics, such as zaleplon, zolpidem and zopiclone. 
Melatonin lahko poveča pomirjevalne lastnosti benzodiazepinskih in nebenzodiazepinskih hipnotikov, kot so zaleplon, zolpidem in zopiklon.
Data with 2 mg prolonged release melatonin tablets and data with 1 mg and 5 mg mini-tablets indicate that there is no accumulation of melatonin after repeated dosing. 
Podatki za 2 mg tablete melatonina s podaljšanim sproščanjem ter podatki za 1 mg in 5 mg mini tabletke kažejo, da se po ponavljajočem se odmerjanju melatonin ne akumulira.
• fluvoxamine (used for the treatment of depression and obsessive compulsive disorder) 
• fluvoksaminom (ki se uporablja za zdravljenje depresije in obsesivno kompulzivne motnje);
If overdose occurs, drowsiness is to be expected. 
Pri prevelikem odmerku se pričakuje zaspanost.
- This medicine has been prescribed for you or your child only. 
- Zdravilo je bilo predpisano samo vam osebno ali za vašega otroka in ga ne smete dajati drugim.
CSDI satisfaction Slenyto 1.43(0.175)(1.08,1.78) Placebo 0.71(0.184)(0.34,1.07) 
Zadovoljstvo CSDI Slenyto 1,43 (0,175) (1,08, 1,78) Placebo 0,71 (0,184) (0,34, 1,07)
The excretion of the metabolite is completed within 12 hours after ingestion. 
Metabolit se izloči v 12 urah po zaužitju.
The predominant metabolic flux is through hydroxylation at C6 via the hepatic microsome P-450 system to yield 6-hydroxymelatonin. 
Glavna metabolična pot poteka od hidroksilacije pri C6, prek jetrnih mikrosomov sistema P-450 do tvorbe 6-hidroksimelatonina.
Melatonin may cause drowsiness, therefore melatonin should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety. 
Lahko povzroči zaspanost, zato ga je treba uporabljati previdno, če so učinki zaspanosti lahko povezani s tveganjem za varnost.