natgillin/translations-raw huggingface dataset:
Oral administration of zaleplon to rats for 104 consecutive weeks at dosage levels up to 20 mg/kg/day did not result in compound-related tumorigenicity. 
Perralna primjena zaleplona kod štakora tijekom 104 uzastopna tjedna pri razini doze do 20 mg/kg/dan nije rezultirala tumorogenošću vezanom uz lijek.
Additionally, zaleplon is metabolised by CYP3A4 to form desethylzaleplon which is further metabolised by aldehyde oxidase to form 5-oxo-desethylzaleplon. 
Pored toga, zaleplon se metabolizira i putem CYP3A4 u dezetilzaleplon, koji se dalje metabolizira putem aldehid-oksidaze u 5-okso-dezetilzaleplon.
The no-effect dose for postnatal development was 1 mg/kg/day (equivalent to 0.5-times the MRHD on a mg/m2 basis). 
Doza koja nije imala učinak na postnatalni razvoj iznosila je 1 mg/kg/dan (odgovara 0,5 puta većoj dozi od MRHD, na osnovu mg/m2).
Sleep latency in outpatient studies was decreased for up to 4 weeks in non-elderly patients with Sonata 10 mg. 
Vrijeme do usnivanja u ispitivanjima ambulantnih bolesnika bilo je smanjeno tijekom do 4 tjedna primjene Sonate od 10 mg u bolesnika koji nisu bili stariji.
Due to zaleplon's short plasma half-life, alternative therapy should be considered if early morning awakening is experienced. 
Zbog kratkog poluvijeka zaleplona u plazmi, u slučaju ranog jutarnjeg buđenja potrebno je razmotriti primjenu drugog lijeka.
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 
Na temelju znanstvenih zaključaka za zaleplon, CHMP smatra da je omjer koristi i rizika za lijek koji sadrži djelatnu tvar zaleplon povoljan, uz predložene izmjene informacija o lijeku.
INFORMATION IN BRAILLE Sonata 10 mg 
16. PODACI NA BRAILLEOVOM PISMU Sonata 10 mg
In contrast, rifampicin, a strong inducer of several hepatic enzymes, including CYP3A4 resulted in a four fold reduction in zaleplon plasma concentration. 
Suprotno tome, rifampicin, snažni induktor nekoliko jetrenih enzima, uključujući CYP3A4, doveo je do četverostrukog smanjenjem koncentracije zaleplona u plazmi.
If affected do not drive or operate machinery. 
Ako ste pod utjecajem lijeka, nemojte upravljati vozilima niti raditi sa strojevima.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU
If the medicinal product is prescribed to a woman of child-bearing potential, she should be warned to contact her physician regarding discontinuance of the medicinal product if she intends to become or suspects that she is pregnant. 
Ako se lijek propiše ženi u reproduktivnoj dobi, potrebno ju je upozoriti da se, ako ima namjeru ostati trudna ili u slučaju sumnje na trudnoću, obrati svom liječniku zbog prekida primjene lijeka.
dysmenorrhea 
dismenoreja
Nervous system disorders Common: 
Poremećaji živčanog sustava Često:
Talk to your doctor or pharmacist before taking Sonata. 
Obratite se svojem liječniku ili ljekarniku prije nego uzmete Sonatu • Tijekom liječenja Sonatom nikad ne konzumirajte alkohol.
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. 
U ispitivanjima starijih bolesnika u trajanju od 2 tjedna, vrijeme do usnivanja često je bilo znatno smanjeno kod primjene Sonate od 5 mg te se konzistentno smanjivalo kod primjene Sonate od 10 mg u usporedbi s placebom.
If you suffer from these symptoms, ask your doctor for advice. 
Ako imate ove simptome, posavjetujte se sa svojim liječnikom.
Once physical dependence has developed, abrupt termination of treatment may be accompanied by withdrawal symptoms. 
Nakon razvijanja fizičke ovisnosti, nagli prekid liječenja može biti popraćen simptomima apstinencije.
INFORMATION IN BRAILLE Sonata 5 mg 
16. PODACI NA BRAILLEOVOM PISMU Sonata 5 mg
These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic experienced persons. 
Navedeno se može dogoditi u osoba koje prvi put uzimaju sedativ-hipnotik kao i u osoba koje su se već liječile sedativom-hipnotikom.
Complex behaviours such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported in patients taking sedativehypnotics. 
U bolesnika koji su uzimali sedative-hipnotike zabilježena su kompleksna ponašanja kao što su “vožnja u snu” (tj. vožnja u stanju nepotpune budnosti nakon uzimanja sedativa-hipnotika, s amnezijom o događaju).
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). 
Kada se lijek uzima u kombinaciji s alkoholom sedativni učinak se može pojačati što može utjecati na sposobnost upravljanja vozilima ili rada sa strojevima sljedeći dan (vidjeti dio 4.7).
The no-effect dose for growth of rat offspring was 10 mg/kg (equivalent to 5-times the MRHD on a mg/m2 basis). 
Doza koja nije imala učinak na rast mladunčadi štakora iznosila je 10 mg/kg (odgovara 5 puta većoj dozi od MRHD, na osnovu mg/m2).
Zaleplon plasma concentrations increased linearly with dose, and zaleplon showed no signs of accumulation following administration of up to 30 mg/day. 
Koncentracije zaleplona u plazmi linearno se povećavaju s dozom, a nakon primjene do 30 mg/dnevno, zaleplon nije pokazao znakove akumulacije.
Caution should be observed when prescribing sedative medicinal products to patients with chronic respiratory insufficiency. 
Kod propisivanja sedativnih lijekova bolesnicima s kroničnom respiratornom insuficijencijom potreban je oprez.
A transient syndrome whereby the symptoms that led to the treatment with a benzodiazepine or benzodiazepine-like agent recur in an enhanced form, may occur on withdrawal of treatment. 
Kod ustezanja liječenja može doći do prolaznog sindroma kod kojeg se simptomi koji su doveli do liječenja benzodiazepinima ili lijekova srodnih benzodiazepinima vraćaju u pojačanom obliku.
Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. 
Nakon razvijanja fizičke ovisnosti, nagli prekid liječenja popratit će simptomi ustezanja.
There have been post-marketing reports of dependence associated with zaleplon, predominantly in combination with other psychotropic agents. 
Nakon stavljanja lijeka u promet zabilježeni su slučajevi ovisnosti povezani s primjenom zaleplona, pretežno kada se kombinira s drugim psihotropnim tvarima.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 5 mg of zaleplon. 
KVALITATIVNI I KVANTITATIVNI SASTAV Svaka kapsula sadrži 5 mg zaleplona.
Patients who develop angioedema after treatment with zaleplon should not be rechallenged with the active substance. 
U bolesnika u kojih se nakon liječenja zaleplonom razvio angioedem, djelatna tvar se ne smije ponovno primjenjivati.
The majority of the faecal recovery consists of 5-oxo-zaleplon. 
Većinu lijeka izlučenog u stolici čini 5-okso-zaleplon.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 10 mg of zaleplon. 
KVALITATIVNI I KVANTITATIVNI SASTAV Svaka kapsula sadrži 10 mg zaleplona.
If you have any further questions, please consult your doctor or pharmacist. 
Ako imate bilo kakvih dodatnih pitanja, molimo obratite se svom liječniku ili ljekarniku.
Therefore, no dose adjustment is necessary in patients with mild to moderate renal impairment. 
Stoga nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega.
Abuse of benzodiazepines and benzodiazepine-like active substances has been reported. 
Zabilježena je zloupotreba benzodiazepina i lijekova srodnih benzodiazepinima.
In patients with mild to moderate renal impairment, the pharmacokinetic profile of zaleplon is not significantly different than that in healthy subjects. 
farmakokinetički profil zaleplona nije značajno drugačiji od onog u zdravih ispitanika.
Psychiatric disorders Uncommon: 
Psihijatrijski poremećaji Manje često:
As with other benzodiazepines or benzodiazepine-like agents, overdose should not present a threat to life unless combined with other CNS depressants (including alcohol). 
Kao i kod drugih benzodiazepina ili lijekova srodnih benzodiazepinima , predoziranje ne predstavlja opasnost po život, osim ako se ne kombiniraju s drugim depresorima središnjeg živčanog sustava
Printing inks on the shell contain the following (gold ink SB-3002): shellac, ammonium hydroxide, yellow iron oxide (E172). 
Tinta kojom je otisnuta oznaka na ovojnici sadrži sljedeće (zlatna tinta SB-3002): šelak, amonijev hidroksid, željezov oksid, žuti (E172).
Suomi/Finland 
Suomi/Finland Meda Oy
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 10 MG CAPSULE BLISTERS 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI S KAPSULAMA OD 10 MG
• if you have severe kidney or liver problems. 
• ako imate teške probleme s bubrezima ili jetrom
Solvang 8 
Krijgsman 20
The active substance in each Sonata hard capsule is zaleplon 10 mg. 
Djelatna tvar u svakoj Sonata tvrdoj kapsuli je 10 mg zaleplona.
Uncommon side effects include: dizziness; weakness; reduced coordination of movements; unsteadiness and/or falls (ataxia); decreased concentration; apathy; restlessness; depression; agitation; irritability; confusion; abnormal thinking and behaviour (extroversion that seems out of character, decreased inhibition, aggressiveness, rages, delusion, depersonalisation, psychosis); nightmares; hallucinations; double vision or other sight problems; increased sensitivity to noise (hyperacusis); smell disorder (parosmia); speech disorders, including slurred speech; numbness, e.g. in the extremities (hypoaesthesia); nausea; decreased appetite; increased sensitivity to light (sunlight, UV light); feeling vaguely ill (malaise). 
Manje česte nuspojave uključuju: omaglicu; slabost; smanjenu koordinaciju pokreta; zanošenje pri hodu i/ili padanje (ataksija); smanjenu koncentraciju; apatiju; nemir; depresiju; uznemirenost; razdražljivost; smetenost, abnormalno razmišljanje i ponašanje (ekstrovertnost koja se čini neuobičajena, smanjena inhibicija, agresivnost, bijes, deluzija, depersonalizacija, psihoza); noćne more; halucinacije; dvoslike ili druge probleme s vidom; povećanu osjetljivost na buku (hiperakuzija);
anaphylactic/anaphylactoid reactions 
anafilaktične/anafilaktoidne reakcije
Co-administration of Sonata with medicinal products known to influence CYP3A4 is expected to result in changes in zaleplon's plasma concentrations. 
Istodobna primjena Sonate i lijekova za koje je poznato da utječu na CYP3A4 može rezultirati promjenama koncentracije zaleplona u plazmi (vidjeti dio 4.5).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 5 MG CAPSULE BLISTERS 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI S KAPSULAMA OD 5 MG
Uncommon: 
Vrlo rijetko:
Zaleplon binds selectively to the benzodiazepine type I receptor. 
Zaleplon se selektivno veže za benzodiazepinski receptor tipa I.
Rebound insomnia and anxiety 
Povratna (engl. rebound) nesanica i tjeskoba
Reproductive system and breast disorders Common: 
Poremećaji reproduktivnog sustava i dojki
Sonata has major influence on the ability to drive and use machines. 
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Sonata značajno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
These medicines include: substances used in the treatment of mental conditions (antipsychotics, hypnotics, anxiolytics/sedatives, antidepressants), medicines used for strong pain relief (narcotic analgesics), medicines used for the treatment of seizures/convulsions (antiepileptic medicines), medicines used for loss of feeling/ insensibility (anaesthetics), and medicines used in the treatment of allergies (sedative antihistamines). 
hipnotici, anksiolitici/sedativi, antidepresivi), lijekove koji se koriste za ublažavanje jake boli (narkotički analgetici), lijekove koji se koriste za liječenje napadaja/konvulzija (antiepileptici), lijekove koji se koriste za gubitak osjeta/neosjetljivost (anestetici) i lijekove koji se koriste za liječenje alergija (sedativni antihistaminici).
Common (1/100 to <1/10) 
Česte (≥1/100 do <1/10) Manje česte (≥1/1,000 do <1/100)
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. 
depersonalizacija, hiperakuzija, obamrlost i trnci u ekstremitetima, preosjetljivost na svjetlo, buku i fizički kontakt, halucinacije ili epileptički napadaji.
Sonata is not indicated to treat patients with severe renal impairment as it has not been adequately studied in those patients. 
Oštećenje funkcije bubrega Sonata nije indicirana za liječenje bolesnika s teškim oštećenjem funkcije bubrega jer još nije dovoljno ispitana u tih bolesnika.
The active substance in each Sonata hard capsule is zaleplon 5 mg. 
Djelatna tvar u svakoj Sonata tvrdoj kapsuli je 5 mg zaleplona.
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. 
Posljedično, oralni klirens zaleplona smanjen je za 70% u bolesnika s kompenziranom, odnosno 87% u bolesnika s dekompenziranom cirozom jetre što dovodi do značajnih povećanja srednje vrijednosti
How to store Sonata 
Kako čuvati Sonatu
Capsules have an opaque white and opaque light brown hard shell with the strength “5 mg”. 
Kapsule s neprozirnom bijelom i neprozirnom svijetlosmeđom tvrdom ovojnicom jačine “5 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). 
od 75 mg ili 150 mg dnevno nije imala utjecaj na pamćenje (neposredno i odgođeno prisjećanje riječi)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR SONATA 10 MG - PACK SIZES 7, 10 AND 14 CAPSULES 
TEKST ZA SONATU OD 10 MG - VELIČINE PAKIRANJA OD 7, 10 I 14 KAPSULA
Chaussée de la Hulpe 166/ Terhulpsesteenweg 166 B-1170 Brussels Belgique/Belgien Tél/Tel: +32 2 5 04 08 11 
Luxembourg/Luxemburg MEDA Pharma S.A./N.V. Chaussée de la Hulpe 166/ Terhulpsesteenweg 166 B-1170 Brussels Belgique/Belgien Tél/Tel: +32 2 5 04 08 11
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili ljekarniku
If you have any further questions, ask your doctor or pharmacist. 
− Ako imate bilo kakvih dodatnih pitanja, obratite se svom liječniku ili ljekarniku.
Sonata belongs to a class of substances called benzodiazepine-related medicinal products, which consists of preparations with hypnotic actions. 
Što je Sonata i za što se koristi Sonata pripada skupini tvari zvanih lijekovi srodni benzodiazepinima, koja sadržava pripravke uspavljujućeg djelovanja.
The dose of zaleplon should be reduced in patients with mild to moderate hepatic impairment, and zaleplon is not recommended for use in patients with severe hepatic impairment. 
U bolesnika s blagim do umjerenim oštećenjem funkcije jetre dozu zaleplona potrebno je smanjiti te se zaleplon ne preporučuje u bolesnika s teškim oštećenjem funkcije jetre.
Name and address of the manufacturer responsible for batch release 
Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet MEDA Manufacturing GmbH
Ear and labyrinth disorders Uncommon: 
Poremećaji uha i labirinta Manje često:
D-61352 Bad Homburg v.d.H. 
D-61352 Bad Homburg v.d.H. Tel: + 49 6172 888 01
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. 
objavljeni su tijekom izvještajnog razdoblja te su istražili te učinke sa zaleplonom i drugim lijekovima iste skupine.
Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zaleplon. 
Nakon uzimanja prve ili sljedećih doza sedativa-hipnotika, uključujući zaleplon, zabilježeni su slučajevi angioedema koji zahvaća jezik, glotis ili grkljan.
MARKETING AUTHORISATION NUMBERS EU/1/99/102/001-003 
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/102/001-003
NAME OF THE MARKETING AUTHORISATION HOLDER Meda AB 
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Meda AB
Therapy of overdose 
Terapija predoziranja
MEDA PHARMA Hungary Kereskedelmi Kft. H-1139 Budapest 
H-1139 Budapest
As clearance is reduced, patients with mild to moderate hepatic impairment should be treated with Sonata 5 mg. For severe hepatic impairment see section 4.3. 
Zbog smanjenja klirensa, bolesnici s blagim do umjerenim oštećenjem funkcije jetre moraju se liječiti dozom Sonate od 5 mg.
MARKETING AUTHORISATION NUMBERS EU/1/99/102/004-006 
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/102/004-006
The other ingredients are microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171). 
Druge pomoćne tvari su mikrokristalična celuloza, prethodno geliran škrob, silicijev dioksid, natrijev laurilsulfat, magnezijev stearat, laktoza hidrat, indigo carmine (E132), titanijev dioksid (E171).
Capsules have an opaque white hard shell with the strength “10 mg”. 
Kapsule s neprozirnom bijelom i neprozirnom svijetlosmeđom tvrdom ovojnicom jačine “10 mg”.
Side effects that may occur commonly: drowsiness; memory difficulties; sensations like tingling, e.g. in the extremities (paraesthesia); painful menstruation. 
nepoznato (učestalost nije moguće procijeniti iz dostupnih podataka) Nuspojave koje se mogu pojaviti često su: omamljenost; otežano pamćenje; osjećaj poput trnaca, npr. u udovima (parestezija); bolne mjesečnice.
In a subsequent cross-fostering study, adverse effects on offspring viability and growth appeared to result from both in utero and lactational exposure to zaleplon. 
U narednom „cross-fostering“ ispitivanju (u kojem je mladunčad prebačena iz svog legla u drugo) pojavili su se štetni događaji za preživljenje i rast mladunčadi koji su bili rezultat njihovog izlaganja zaleplonu u maternici i tijekom laktacije.
Immune system disorders Very rare: 
Poremećaji probavnog sustava Manje često:
Sonata has been shown to preserve sleep stages in controlled studies that measured the percentage of sleep time spent in each sleep stage. 
U kontroliranim ispitivanjima koja su mjerila postotak vremena provedenog u svakoj fazi sna pokazalo se da Sonata održava faze sna.
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. 
89 ml/min) i umjerenim (20 do 39 ml/min) oštećenjem funkcije bubrega te u bolesnika na dijalizi.
Frequency not known: 
Manje često:
nausea 
Nuspojave
Combination with other CNS-acting compounds should be taken into account. 
U obzir je potrebno uzeti kombinaciju s drugim spojevima koji djeluju na središnji živčani sustav.
Тел. 
Al.
Chaussée de la Hulpe 166/ Terhulpsesteenweg 166 B-1170 Brussels Tél/Tel: +32 2 5 04 08 11 
België/Belgique/Belgien MEDA Pharma S.A./N.V. Chaussée de la Hulpe 166/ Terhulpsesteenweg 166 B-1170 Brussels Tél/Tel: +32 2 5 04 08 11
Microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171). 
Jezgra kapsule celuloza, mikrokristalična škrob, prethodno geliran silicijev dioksid, natrijev laurilsulfat, magnezijev stearat, laktoza hidrat, indigo carmine (E132), titanijev dioksid (E171).
Attention to airway patency and supportive management of ventilation and haemodynamics are usually sufficient. 
Obično je dovoljno obratiti pozornost na prohodnost dišnih puteva i suportivno zbrinjavanje disanja te hemodinamike.
Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines and benzodiazepine-like agents may develop after repeated use for a few weeks. 
Nakon ponovljene primjene tijekom nekoliko tjedana, donekle se može smanjiti djelotvornost hipnotičkog učinka kratko djelujućih benzodiazepina i lijekova srodnih benzodiazepinima.
Excipient with known effect: Lactose monohydrate 54 mg. For the full list of excipients, see section 6.1. 
Pomoćna tvar s poznatim učinkom: 54 mg laktoze hidrata.
Printing inks on the shell contain the following (pink ink SW-1105): shellac, titanium dioxide (E171), ammonium hydroxide, red iron oxide (E172), yellow iron oxide (E172). 
Tinta kojom je otisnuta oznaka na ovojnici sadrži sljedeće (ružičasta tinta SW-1105): šelak, titanijev dioksid (E171),
Excipient with known effect: Lactose monohydrate 49 mg. For the full list of excipients, see section 6.1. 
Pomoćna tvar s poznatim učinkom: 49 mg laktoze hidrata.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svojemu liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek Sonata se ne smije uzimati u navedenim razdobljima budući da nema dovoljno kliničkih podataka dostupnih za procjenu sigurnosti njene primjene tijekom trudnoće i dojenja.
Capsule shell gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), sodium lauryl sulphate, 
Ovojnica kapsule želatina, titanijev dioksid (E171), željezov oksid, crveni (E172), željezov oksid, žuti (E172), željezov oksid, crni (E172), natrijev laurilsulfat,
Ingredients of the capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172) and sodium lauryl sulphate. 
Sastojci ovojnice kapsule: želatina, titanijev dioksid (E171), željezov oksid, crveni (E172), željezov oksid, žuti (E172), željezov oksid, crni (E172) i natrijev laurilsulfat.
Capsule shell gelatin, titanium dioxide (E171), sodium lauryl sulphate, 
Ovojnica kapsule želatina, titanijev dioksid (E171), natrijev laurilsulfat,
Chromaturia (bluegreen urine discolouration) has been reported with zaleplon overdose. 
Kod predoziranja zaleplonom zabilježena je kromaturija (promjena boje mokraće u plavozelenu).
MARKETING AUTHORISATION NUMBER(S) EU/1/99/102/001 7 capsules 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/102/001 7 kapsula
MARKETING AUTHORISATION NUMBER(S) EU/1/99/102/004 7 capsules 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/102/004 7 kapsula
Other complex behaviours (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. 
U bolesnika koji nisu potpuno budni nakon uzimanja sedativa-hipnotika zabilježena su druga kompleksna ponašanja (tj. pripremanje i konzumiranje hrane, vođenje telefonskih razgovora ili spolni odnos).
EU/1/99/102/002 10 capsules EU/1/99/102/003 14 capsules 
EU/1/99/102/003 14 kapsula
Slovenská republika MEDA Pharma spol. 
Slovenská republika MEDA Pharma spol. s r.o..
NAME OF THE MEDICINAL PRODUCT Sonata 10 mg hard capsules 
NAZIV LIJEKA Sonata 10 mg tvrde kapsule
Ingredients of the capsule shell: gelatin, titanium dioxide (E171) and sodium lauryl sulphate. 
Sastojci ovojnice kapsule: želatina, titanijev dioksid (E171) i natrijev laurilsulfat.