natgillin/translations-raw huggingface dataset:
LIST OF EXCIPIENTS Also contains: lactose monohydrate See leaflet for further information. 
SEZNAM POMOŽNIH SNOVI Vsebuje tudi: laktozo monohidrat Za nadaljnje informacije glejte navodilo za uporabo.
All of zaleplon's metabolites are inactive in both animal behavioural models and in vitro activity assays. 
Vsi presnovki zaleplona so neaktivni tako v živalskih vedenjskih modelih kot pri in vitro določanju aktivnosti.
Paediatric patients Sonata is contraindicated in children and adolescents under 18 years of age (see section 4.3). 
Uporaba zdravila Sonata je kontraindicirana pri otrocih in mladostnikih, mlajših od 18 let (glejte poglavje
Marketing Authorisation holder: Meda AB 
Imetnik dovoljenja za promet: Meda AB
In patients with moderate impairment and those on dialysis there was a reduction of approximately 23% in peak plasma concentration compared to healthy volunteers. 
Pri bolnikih z zmerno ledvično okvaro in pri tistih na dializi so v primerjavi z zdravimi prostovoljci zaznali približno 23% zmanjšanje največje plazemske koncentracije.
Therefore, in view of available data regarding next day effects on driving and mental alertness, the PRAC considered that changes to the product information were warranted. 
Zato je bil PRAC glede na razpoložljive podatke v zvezi z vplivom na sposobnost vožnje in miselno zbranost, ki se pojavi naslednji dan, mnenja, da so spremembe informacij o zdravilu upravičene.
If for compelling medical reasons, the medicinal product is administered during the late phase of pregnancy, or during labour at high doses, effects on the neonate, such as hypothermia, hypotonia and moderate respiratory depression, can be expected, due to the pharmacological action of the compound. 
Če zaradi nujnih zdravstvenih razlogov zdravilo predpišete v velikih odmerkih v pozni fazi nosečnosti ali med porodom, lahko pričakujete učinke na novorojenčku, kot so podhladitev, hipotonija in zmerno poslabšanje dihanja zaradi farmakoloških učinkov zdravilne učinkovine.
In elderly patients, sleep latency was often significantly decreased with Sonata 5 mg and was consistently decreased with Sonata 10 mg compared with placebo in 2-week studies. 
Pri starostnikih se je spalna latenca pogosto bistveno zmanjšala pri uporabi zdravila Sonata 5 mg in dosledno zmanjšala pri uporabi zdravila Sonata 10 mg v primerjavi s placebom v 2-tedenskih raziskavah.
Grounds recommending the variation to the terms of the Marketing Authorisation On the basis of the scientific conclusions for zaleplon the CHMP is of the opinion that the benefit-risk balance of the medicinal product containing zaleplon is favourable subject to the proposed changes to the product information 
Podlaga za spremembo pogojev dovoljenja za promet z zdravilom Na podlagi znanstvenih zaključkov za zaleplon odbor CHMP meni, da je je razmerje med koristjo in tveganjem zdravila, ki vsebuje zdravilno učinkovino zaleplon, ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
It may be accompanied by other reactions including mood changes, anxiety, or sleep disturbances and restlessness. 
Lahko ga spremljajo tudi druge reakcije, med drugim spremembe razpoloženja, tesnoba, motnje spanja in nemir.
Overdose of benzodiazepine or benzodiazepine-like agents is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. 
Prevelik odmerek benzodiazepinov ali snovi, podobnih benzodiazepinom, se običajno odraža z različnimi stopnjami depresije osrednjega živčevja, od zaspanosti do kome.
Because zaleplon is excreted in the breast milk, Sonata should not be administered to breast-feeding mothers. 
Ker se zaleplon izloča v materino mleko, se zdravilo Sonata ne sme dajati doječim materam.
In mild cases patients should sleep under control of respiratory and circulatory function. 
V blagih primerih je treba pri bolnikih med spanjem nadzorovati delovanje dihal in obtočil.
Some patients taking sedative-hypnotics have had additional symptoms such as dyspnoea, throat closing, or nausea and vomiting. 
Nekateri bolniki, ki so jemali sedative/hipnotike, so imeli še dodatne simptome, na primer dispneo, zaporo žrela ali navzeo in bruhanje.
Insomnia that persists or worsens after a short course of zaleplon treatment may indicate a need to re-evaluate the patient. 
Nespečnost, ki je trdovratna ali se poslabša po kratkem zdravljenju z zaleplonom, lahko pomeni, da morate bolnika ponovno pregledati.
Benzodiazepine and benzodiazepine-like agents are not indicated to treat patients with severe hepatic insufficiency as they may precipitate encephalopathy (see section 4.2). 
Jetrna okvara Benzodiazepini in njim podobne snovi niso indicirani za zdravljenje bolnikov s hudo jetrno insuficienco, saj lahko povzročijo encefalopatijo (glejte poglavje 4.2).
Frequency not known: 
Pogostnost neznana:
Literature articles regarding next day effects on driving and mental alertness were published during the reporting period which examined these effects with zaleplon and other agents of the class. 
Članki v zvezi z vplivom na sposobnost vožnje in miselno zbranost, ki se pojavi naslednji dan, so bili v literaturi objavljeni v obdobju poročanja, v katerem so preučevali te učinke pri zdravilni učinkovini zaleplon in drugih zdravilnih učinkovinah iz tega razreda.
Fifty-seven percent (57%) of the dose is recovered in urine in the form of 5-oxo-zaleplon and its glucuronide metabolite, an additional 9% is recovered as 5-oxo-desethylzaleplon and its glucuronide metabolite. 
57% odmerka najdemo v seču v obliki 5-okso-zaleplona in njegovega glukuronidnega presnovka, dodatnih 9% pa kot 5okso-desetilzaleplona in njegovega glukuronidnega presnovka.
Sonata has been designed so that if the contents of the capsule are dissolved in a liquid, the liquid will change colour and become cloudy. 
Zdravilo Sonata je zasnovano tako, da tekočina, v kateri se vsebina kapsule raztopi, spremeni barvo in postane motna.
Manufacturer: 
Izdelovalec
Sonata can be taken immediately before going to bed or after the patient has gone to bed and is experiencing difficulty falling asleep. 
Zdravilo Sonata lahko bolnik vzame tik preden gre v posteljo ali potem, ko je že v postelji in ne more zaspati.
Do not use this medicine after the expiry date which is stated on the carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
The increased incidence of benign liver tumors in mice was likely an adaptive event. 
Povečana incidenca benignih jetrnih tumorjev je bila verjetno posledica prilagoditvene reakcije.
• Never drink alcohol while you are being treated with Sonata. 
• Med zdravljenjem z zdravilom Sonata nikoli ne pijte alkohola.
Symptoms of overdose 
Simptomi prevelikega odmerjanja
Co-administration of Sonata together with inducers of CYP3A4 such as rifampicin, carbamazepine and phenobarbitone, may result in a reduction of zaleplon's efficacy. 
Sočasno dajanje zdravila Sonata skupaj z induktorji CYP3A4, kot so rifampicin, karbamazepin in fenobarbiton, lahko povzroči zmanjšanje učinkovitosti zaleplona.
Very common (1/10) 
Zelo redki (<1/10.000)
Sleep latency in outpatient studies was decreased for up to 4 weeks in non-elderly patients with Sonata 10 mg. 
Spalna latenca se je v ambulantnih študijah zmanjšala za čas do 4 tednov pri nestarostnikih, ki so prejemali zdravilo Sonata 10 mg.
Diphenhydramine is reported to be a weak inhibitor of aldehyde oxidase in rat liver, but its inhibitory effects in human liver are not known. 
Poročali so, da je difenhidramin šibak zaviralec aldehid oksidaze v jetrih podgan, njegovi zaviralni učinki v človeških jetrih pa niso znani.
The sedative effect may be enhanced when the product is used in combination with alcohol which may affect the ability to drive or use machines the next day (see section 4.7). 
Če se zdravilo uporablja v kombinaciji z alkoholom, se lahko poveča sedativni učinek, kar lahko vpliva na sposobnost vožnje ali upravljanja s stroji naslednji dan (glejte poglavje 4.7).
The single dose pharmacokinetics of zaleplon were studied in patients with mild (creatinine clearance 40 to 89 ml/min) and moderate (20 to 39 ml/min) renal impairment, and in patients on dialysis. 
Farmakokinetiko enkratnega odmerka zaleplona so preučevali pri bolnikih z blago (očistek kreatinina 40 do 89 ml/min) in zmerno (20 do 39 ml/min) ledvično okvaro ter pri bolnikih na dializi.
Repeated dose toxicity 
Toksičnost pri ponavljajočih odmerkih
Caution should be observed when prescribing sedative medicinal products to patients with chronic respiratory insufficiency. 
Pri predpisovanju sedativnih zdravil bolnikom s kronično respiratorno insuficienco je potrebna previdnost.
As administration after food delays the time to maximal plasma concentration by approximately 2 hours no food should be eaten with or shortly before intake of Sonata. 
Ker jemanje zdravila po hrani zadrži nastop maksimalne koncentracije v plazmi za približno 2 uri, ne uživajte hrane ob jemanju ali neposredno pred jemanjem zdravila Sonata.
Consequently, the oral clearance of zaleplon was reduced by 70% and 87% in compensated and decompensated cirrhotic patients, respectively, leading to marked increases in mean Cmax and AUC (up to 4-fold and 7-fold in compensated and decompensated patients, respectively) relative to healthy subjects. 
Zaradi tega je bil peroralni očistek zaleplona zmanjšan za 70% oziroma 87% pri bolnikih s kompenzirano in dekompenzirano cirozo ter je povzročil izrazito povečanje povprečne vrednosti Cmax in AUC (do 4-kratno povečanje oz. 7kratno povečanje pri bolnikih s kompenzirano oziroma dekompenzirano cirozo) glede na zdrave preiskovance.
In mild cases, symptoms include drowsiness, mental confusion, and lethargy, in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death. 
V blagih primerih so med simptomi zaspanost, mentalna zmedenost in letargija, v resnejših primerih pa ataksija, hipotonija, hipotenzija, depresija dihanja, redko koma in zelo redko smrt.
In severe cases the following symptoms may occur: unreality, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures. 
V hudih primerih se lahko pojavijo naslednji simptomi: neresničnost, depersonalizacija, hiperakuzija, otopelost in mravljinci v okončinah, preobčutljivost za svetlobo, hrup in telesni stik, halucinacije ali epileptični napadi.
Therefore, caution is advisable in co-administering cimetidine and Sonata. 
Zato svetujemo previdnost pri sočasnem dajanju cimetidina in zdravila Sonata.
This leaflet was last approved in 
Navodilo je bilo nazadnje revidirano dne
In patients with mild to moderate hepatic insufficiency, the bioavailability of zaleplon is increased because of reduced clearance, and the dose will therefore need to be modified in these patients. 
Pri bolnikih s šibko do zmerno jetrno insuficienco je biološka uporabnost zaleplona povečana zaradi zmanjšanega očistka in zato je treba pri teh bolnikih odmerek prilagoditi.
If you forget to take Sonata 
Če ste pozabili vzeti zdravilo Sonata
If you stop taking Sonata 
Če ste prenehali jemati zdravilo Sonata
• if you have severe kidney or liver problems. 
• če imate hudo ledvično ali jetrno okvaro.
If an overdose has been taken you may become increasingly drowsy very quickly, with high doses probably leading to a coma. 
Če ste vzeli prevelik odmerek, se omotičnost lahko zelo hitro poveča, pri velikih odmerkih lahko privede celo do kome.
• There is a chance that you may experience a certain type of temporary memory loss (amnesia) and lack of coordination when taking sleep medicines. 
• Obstaja možnost, da boste zaradi jemanja uspaval imeli določeno vrsto izgube spomina (amnezijo) in slabo koordinacijo gibov.
If affected do not drive or operate machinery. 
Če opazite take znake, ne vozite avtomobila in ne upravljajte strojev.
Should this occur, use of this product should be discontinued. 
V primeru, da do njih pride, mora bolnik prenehati z uporabo tega zdravila.
Pre-and postnatal growth of rats was reduced at the maternally toxic dose of 100 mg/kg/day. 
Pred- in poporodna rast podgan je bila zmanjšana pri odmerku 100 mg/kg/dan, ki je toksičen za mater.
Co-administration of Sonata with a single 800 mg dose of erythromycin, a strong, selective CYP3A4 inhibitor, produced a 34% increase in zaleplon's plasma concentrations. 
Sočasna uporaba zdravila Sonata z enkratnim 800 mg odmerkom eritromicina, močnega, selektivnega zaviralca CYP3A4, je povzročila 34% povečanje koncentracije zaleplona v plazmi.
What Sonata looks like and contents of the pack 
Izgled zdravila Sonata in vsebina pakiranja
Animal studies suggest that flumazenil is an antagonist to zaleplon and should be considered in the management of Sonata overdose. 
Študije na živalih kažejo, da je flumazenil antagonist zaleplona in se lahko uporablja pri zdravljenju prevelikega odmerjanja zdravila Sonata.
Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. 
Ko se pojavi telesna odvisnost, nenadno prekinitev zdravljenja spremljajo odtegnitveni sindromi.
Combination with other CNS-acting compounds should be taken into account. 
Upoštevati je treba tudi kombinacijo z drugimi sestavinami, ki vplivajo na osrednje živčevje.
photosensitivity reaction angioedema 
fotosenzitivnost angioedem
Zaleplon plasma concentrations increased linearly with dose, and zaleplon showed no signs of accumulation following administration of up to 30 mg/day. 
Koncentracije zaleplona v plazmi so rasle linearno z odmerkom in zaleplon ni pokazal znakov kopičenja po odmerkih do 30 mg/dan.
Abuse of benzodiazepines and benzodiazepine-like active substances has been reported. 
Poročali so o zlorabi benzodiazepinov in njim podobnih zdravilnih učinkovin.
Benzodiazepines and benzodiazepine-like agents should not be used alone to treat depression or anxiety associated with depression (suicide may be precipitated in such patients). 
Benzodiazepini in njim sorodne učinkovine se ne smejo uporabljati samostojno pri zdravljenju depresije ali tesnobe, povezane z depresijo (pri teh bolnikih obstaja nevarnost samomora).
In a fertility and reproductive performance study in rats, mortality and decreased fertility were observed in males and females at an oral zaleplon dose of 100 mg/kg/day (equivalent to 49-times the maximum recommended human dose (MRHD) of 20 mg on a mg/m2 basis). 
V študiji plodnosti in sposobnosti razmnoževanja pri podganah so opazovali smrtnost in zmanjšano plodnost pri samcih in samicah pri peroralnem odmerku zaleplona 100 mg/kg/dan (kar ustreza 49-kratniku najvišjega priporočenega odmerka za človeka (MRHD), ki je 20 mg, izračunano v mg/m2).
At these doses, a significant reduction in the weight of both prostate and testes was apparent in a three month study in prepubescent dogs. 
Pri teh odmerkih so v trimesečni študiji pri predpubertetnih psih opazili očitno zmanjšanje mase tako prostate kot mod.
Concomitant use of zaleplon with these drugs may increase the risk of next day drowsiness, including impaired driving ability (see section 4.7). 
Sočasna uporaba zaleplona s temi zdravili lahko poveča tveganje za zaspanost, ki se pojavi naslednji dan, vključno z zmanjšano sposobnostjo vožnje (glejte poglavje 4.7).
In the case of narcotic analgesics enhancement of the euphoria may occur leading to an increase in physiological dependence. 
V primeru povečanja evforije zaradi sočasne uporabe narkotičnih analgetikov lahko pride do večje fiziološke odvisnosti od zdravila.
Sonata 10 mg hard capsules, which contain a light blue powder, have a white cap and white body, with pink imprint “10 mg”. 
Sonata 10 mg trde kapsule, ki vsebujejo svetlo moder prašek, imajo bel pokrovček in belo telo z roza odtisom »10 mg«.
Coadministration of a single zaleplon 10 mg dose and venlafaxine (extended release) 75 mg or 150 mg daily did not produce any interaction on memory (immediate and delayed word recall) or psychomotor performance (digit symbol substitution test). 
Sočasna uporaba enkratnega 10 mg odmerka zaleplona in venlafaksina (s podaljšanim sproščanjem) 75 mg ali 150 mg na dan ni vplivala na spomin (takojšnji in zapozneli priklic besed) ali psihomotorično sposobnost (test zamenjave številčnih simbolov).
Zaleplon undergoes presystemic metabolism, resulting in an absolute bioavailability of approximately 
Zaleplon je podvržen predsistemski presnovi, katere rezultat je približno 30% absolutna biološka uporabnost.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.Ne jemljite nobenih drugih zdravil, ne da bi se prej posvetovali s svojim zdravnikom ali farmacevtom.
Scientific conclusions and grounds recommending the variation to the terms of the Marketing 
Znanstveni zaključki in podlaga za spremembo pogojev dovoljenja za promet z zdravilom
As with other benzodiazepines or benzodiazepine-like agents, overdose should not present a threat to life unless combined with other CNS depressants (including alcohol). 
Kot pri drugih benzodiazepinih ali njim sorodnih učinkovin prevelik odmerek ne bi smel biti smrtno nevaren, razen če zdravilo kombinirate z uporabo drugih zdravil, ki povzročajo depresijo osrednjega živčevja (vključno z alkoholom).
In contrast, rifampicin, a strong inducer of several hepatic enzymes, including CYP3A4 resulted in a four fold reduction in zaleplon plasma concentration. 
Nasprotno pa je rifampicin močan induktor nekaterih jetrnih encimov, vključno s CYP3A4, privedel do štirikratnega zmanjšanja koncentracije zaleplona v plazmi.
Insomnia may represent an underlying physical or psychiatric disorder. 
Nespečnost lahko predstavlja skrito telesno ali duševno motnjo.
Sonata has major influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Sonata ima velik vpliv na sposobnost vožnje in upravljanja s stroji.
14 hard capsules 
14 trdih kapsul
In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken. 
Pri zdravljenju prevelikega odmerjanja s katerim koli zdravilom morate upoštevati, da je bolnik lahko zaužil več zdravil naenkrat.
Oral administration of zaleplon to mice for 65 or 104 consecutive weeks at high dosage levels (≥100 mg/kg/day) elicited a statistically significant increase in benign but not in malignant liver tumors. 
Peroralno dajanje zaleplona mišim v obdobju 65 ali 104 zaporednih tednov v visokih odmerkih (≥100 mg/kg/dan) je privedlo do statistično značilnega povečanja pogostnosti benignih, ne pa tudi malignih tumorjev.
These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. 
Le-ti vključujejo glavobole, bolečino v mišicah, izredno tesnobo, napetost, nemir, zmedenost in razdražljivost.
Elderly patients may be sensitive to the effects of hypnotics; therefore, 5 mg is the recommended dose of Sonata. 
Starejši bolniki so lahko občutljivi za učinke uspaval, zato je zanje priporočeni odmerek zdravila Sonata 5
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V. 4.9 Preveliko odmerjanje
Benzodiazepine and benzodiazepine-like agents are not recommended for the primary treatment of psychotic illness. 
Benzodiazepini in njim sorodne učinkovine niso priporočljive za primarno zdravljenje psihotičnih motenj.
Zaleplon is primarily metabolised by aldehyde oxidase to form 5-oxo-zaleplon. 
Zaleplon se primarno presnavlja s pomočjo aldehidne oksidaze in tvori 5-okso-zaleplon.
Enhancement of the central sedation may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, anti-epileptic medicinal products, anaesthetics, and sedative antihistamines. 
Povečanje centralne sedacije lahko nastopi v primerih sočasne uporabe z antipsihotiki (nevroleptiki), hipnotiki, anksiolitiki/sedativi, antidepresivnimi sredstvi, narkotičnimi analgetiki, antiepileptiki, anestetiki in sedativnimi antihistaminiki.
Extension beyond these periods should not take place without clinical re-evaluation of the patient. 
Pred podaljšanjem tega roka morate bolnika ponovno klinično pregledati.
Sonata belongs to a class of substances called benzodiazepine-related medicinal products, which consists of preparations with hypnotic actions. 
Zdravilo Sonata sodi v skupino zdravil, ki jih imenujemo benzodiazepinom sorodna zdravila oz. zdravila z uspavalnim delovanjem.
Contact a doctor immediately and say how many capsules you have taken. 
Če ste vzeli večji odmerek zdravila Sonata, kot bi smeli Nemudoma pokličite zdravnika in mu povejte, koliko kapsul ste vzeli.
These reactions may be active substance-induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. 
Te reakcije lahko povzroči zdravilna učinkovina, lahko so spontane ali pa so posledica prikrite psihične ali telesne motnje.
You should not take a second dose within a single night. 
V isti noči ne smete vzeti drugega odmerka.
If you suffer from these symptoms, ask your doctor for advice. 
Če imate te simptome, se posvetujte z zdravnikom.
Taking into account the PRAC Assessment Report on the PSUR for zaleplon, the scientific conclusions of CHMP are as follows: 
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za zaleplon, je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
There have been post-marketing reports of dependence associated with zaleplon, predominantly in combination with other psychotropic agents. 
V obdobju spremljanja zdravila na tržišču so o odvisnosti, povezani z zaleplonom, poročali predvsem v kombinaciji z drugimi psihoaktivnimi snovmi.
Common (1/100 to <1/10) 
Pogosti (≥1/100 do <1/10)
Additionally, zaleplon is metabolised by CYP3A4 to form desethylzaleplon which is further metabolised by aldehyde oxidase to form 5-oxo-desethylzaleplon. 
Poleg tega se zaleplon presnavlja s pomočjo encima CYP3A4 in tvori desetilzaleplon, ki se naprej presnovi s pomočjo aldehidne oksidaze in tvori 5-okso-desetilzaleplon.
Due to zaleplon's short plasma half-life, alternative therapy should be considered if early morning awakening is experienced. 
Zaradi kratke razpolovne dobe zaleplona morate premisliti o uporabi drugega načina zdravljenja v primeru zgodnjega jutranjega zbujanja bolnika.
Zaleplon is metabolised primarily by the liver and undergoes significant presystemic metabolism. 
Jetrna okvara Zaleplon se presnavlja predvsem v jetrih in je podvržen pomembni predsistemski presnovi.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
In embryofetal development studies, oral administration of zaleplon up to 100 mg/kg/day and 50 mg/kg/day to pregnant rats and rabbits, respectively, produced no evidence of teratogenicity (equivalent to 49- (rat) and 48-(rabbit) times the MRHD on a mg/m2 basis). 
Študije embriofetalnega razvoja po peroralni uporabi aleplona v odmerku do 100 mg/kg/dan in 50 mg/kg/dan, ki so ga prejele breje podgane oziroma kunci, niso pokazale teratogenosti (odmerek ustreza 49-kratniku (podgane) in 48-kratniku (kunci) MRHD, izračunano v mg/m2).
Benzodiazepines and benzodiazepine-like agents may induce anterograde amnesia and psychomotor impairment. 
Benzodiazepini in njim podobne snovi lahko sprožijo anterogradno amnezijo in psihomotorične motnje.