FrancophonIA/ELRC3.0 huggingface dataset:
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera koristi i rizika, odnosno kada je omjer koristi i rizika rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: Potential effect of alcohol on tasimelteon
Croatian: Mogući utjecaj alkohola na tazimelteon
English: Tasimelteon may cause somnolence.
Croatian: Tazimelteon može uzrokovati somnolenciju.
English: As a precautionary measure, it is preferable to avoid the use of tasimelteon during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavanje uporabe tazimelteona tijekom trudnoće.
English: After taking tasimelteon, patients should limit their activity to preparing to go to bed and not use machines because tasimelteon can impair performance of activities requiring complete mental alertness.
Croatian: Nakon uzimanja tazimelteona, bolesnici bi svoje aktivnosti trebali ograničiti na pripremu za odlazak na spavanje te ne bi trebali upravljati strojevima, jer tazimelteon može uzrokovati smanjenje sposobnosti obavljanja aktivnosti za koje je potrebna potpuna mentalna budnost.
English: CYP2C9 (18.8%) and CYP2C19 (15.1%) also contribute to the metabolism of tasimelteon.
Croatian: CYP2C9 (18,8%) i CYP2C19 (15,1%) također doprinose metabolizmu tazimelteona.
English: The mean terminal elimination half-life ± standard deviation of the main metabolites ranges from 1.3 ± 0.5 to 3.7 ± 2.2.
Croatian: Srednji terminalni poluvijek eliminacije ± standardno odstupanje glavnih metabolita u rasponu je od 1,3 ± 0,5 do 3,7 ± 2,2.
English: - Keep this leaflet.
Croatian: − Sačuvajte ovu uputu.
English: Subsequently, 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.
Croatian: Slijedom navedenog, nositelj odobrenja ta izvješća podnosi u skladu s referentnim popisom datuma EU-a (EURD popis) predviđenim člankom 107.(c) stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: The recommended dose is one capsule every night, taken one hour before you go to bed.
Croatian: Preporučena je doza jedna kapsula svake večeri jedan sat prije odlaska na spavanje.
English: This includes the GABA receptor complex, the binding site for sedative hypnotics, and receptors that bind neuropeptides, cytokines, serotonin, noradrenaline, acetylcholine, and opiates.
Croatian: To uključuje GABA receptorski kompleks, mjesto vezivanja za sedativne hipnotike, i receptore koji vežu neuropeptide, citokine, serotonin, noradrenalin, acetilkolin i opijate.
English: See section 4.2 for information on paediatric use.
Croatian: Vidjeti dio 4.2. za informacije o pedijatrijskoj primjeni.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from tasimelteon therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Mora se odlučiti treba li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja tazimelteonom, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: The pharmacokinetics of tasimelteon and its metabolites did not change with repeated daily dosing.
Croatian: Farmakokinetika tazimelteona i njegovih metabolita nije se promijenila pri ponovljenim dnevnim doziranjima.
English: The most frequent adverse reactions leading to discontinuation were: somnolence (0.23%), nightmare (0.23%), and headache (0.17%).
Croatian: Najčešće nuspojave koje su rezultirale prekidom uporabe lijeka bile su: somnolencija (0,23%), noćne more (0,23%) i glavobolja (0,17%).
English: The mean absolute oral bioavailability of tasimelteon is 38%.
Croatian: Srednja apsolutna oralna bioraspoloživost tazimelteona iznosi 38 %.
English: While haemodialysis was effective at clearing tasimelteon and the majority of its major metabolites in patients with renal impairment, it is not known if hemodialysis will effectively reduce exposure in the case of overdose.
Croatian: Iako se hemodijaliza pokazala učinkovitom u uklanjanju tazimelteona i većine njegovih glavnih metabolita u bolesnika s oštećenjem bubrega, nije poznato hoće li hemodijaliza učinkovito smanjiti izloženost u slučaju predoziranja.
English: An example is rifampicin, which is used to treat tuberculosis (TB).
Croatian: Primjer je rifampicin koji se koristi za liječenje tuberkuloze (TB).
English: In sighted people, the change in light levels between day and night helps to synchronise internal body rhythms, including feeling sleepy at night and being active during the day.
Croatian: Kod osoba koje vide, promjena razina svjetlosti između dana i noći pomaže uskladiti unutarnje tjelesne ritmove, uključujući osjećaj pospanosti noću i aktivnost tijekom dana.
English: Tasimelteon and its most abundant metabolites have no appreciable affinity for more than 160 other pharmacologically relevant receptors.
Croatian: Tazimelteon i njegovi najzastupljeniji metaboliti ne pokazuju značajan afinitet za više od 160 ostalih farmakološki bitnih receptora.
English: Repeated once daily dosing with tasimelteon does not result in changes in pharmacokinetic parameters or significant accumulation of tasimelteon.
Croatian: Ponovljeno doziranje tazimelteona jednom dnevno ne dovodi do promjena u farmakokinetičkim parametrima ili znatnog nakupljanja tazimelteona.
English: - If HETLIOZ is not taken every night, the body rhythms will lose alignment with the usual 24-hour day and night cycle again.
Croatian: - Ako se HETLIOZ ne uzima svake večeri, tjelesni ritmovi ponovno neće biti usklađeni s uobičajenim 24-satnim ciklusom dana i noći.
English: Timing of sleep
Croatian: Vrijeme nastupa sna
English: - Skip the missed dose.
Croatian: - Preskočite propuštenu dozu.
English: As with the management of any overdose, general symptomatic and supportive measures should be used, along with immediate gastric lavage, where appropriate.
Croatian: Kao i u slučaju svakog drugog predoziranja, potrebno je poduzeti simptomatske i potporne mjere uz hitno ispiranje želuca kada je to potrebno.
English: It aligns body rhythms with the usual 24-hour day and night cycle and so improve sleep patterns.
Croatian: Usklađuje tjelesne ritmove s uobičajenim 24-satnim ciklusom dana i noći te stoga poboljšava uzorke spavanja.
English: The components of the scale can be found in Table 2.
Croatian: Sastavne dijelove skale sadrži Tablica 2.
English: The observed mean elimination half-life for tasimelteon is 1.3 ± 0.4 hours.
Croatian: Primijećeni srednji poluvijek eliminacije tazimelteona iznosi 1,3 ± 0,4 sata.
English: CGI-C
Croatian: Skala CGI-C
English: If you eat a high-fat meal close to the time you would normally take the medicine, it is best to wait 2 hours before taking HETLIOZ.
Croatian: Ako pojedete obrok koji sadržava visok udio masti približno u vrijeme kad uobičajeno uzimate lijek, najbolje je pričekati 2 sata prije uzimanja lijeka HETLIOZ.
English: Nightmare
Croatian: Noćne more
English: Sleep disorder, insomnia, abnormal dreams
Croatian: nesanica, abnormalni snovi
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Croatian: U nekliničkim ispitivanjima zapaženi su učinci samo pri izloženostima koje su bile znatno veće od maksimalne izloženosti u ljudi, što ukazuje na njihov mali značaj za kliničku primjenu.
English: Threshold of Response
Croatian: Prag odgovora
English: The pharmacokinetics of tasimelteon is linear over doses ranging from 3 to 300 mg (0.15 to 15 times the recommended daily dosage).
Croatian: Farmakokinetika tazimelteona linearna je u rasponu doza od 3 do 300 mg (0,15 do 15 puta više od preporučene dnevne doze).
English: Metabolism of tasimelteon consists primarily of oxidation at multiple sites and oxidative dealkylation resulting in opening of the dihydrofuran ring followed by further oxidation to give a carboxylic acid.
Croatian: Metabolizam tazimelteona sastoji se ponajprije od oksidacije na višestrukim lokacijama i oksidativne dealkilacije koja dovodi do otvaranja dihidrofuranskog prstena uz daljnju oksidaciju do karboksilne kiseline.
English: Analyses of entrainment at month 7 in a subset of patients demonstrated that 59% of tasimelteon-treated patients entrained by month 7 indicating that response to treatment may take weeks or months for some patients to respond.
Croatian: Analizama usklađivanja u sedmom mjesecu u podskupini bolesnika pokazalo se da je u 59 % bolesnika liječenih tazimelteonom došlo do usklađivanja do sedmog mjeseca, što ukazuje na to da su nekim bolesnicima potrebni tjedni ili mjeseci da odgovore na terapiju.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su prikazane slijedom prema sve manjoj ozbiljnosti.
English: HETLIOZ is intended for chronic use.
Croatian: HETLIOZ je namijenjen za kroničnu primjenu.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA PovEZANI S OPSKRBOM I PRIMJENOM
English: Tasimelteon exposure decreased by approximately 40% in smokers compared to non-smokers (see section 5.2).
Croatian: Izloženost tazimelteonu smanjila se u pušača za otprilike 40 % u usporedbi s nepušačima (vidjeti dio 5.2).
English: The most common adverse reactions (>3%) during clinical trials were headache (10.4%), somnolence (8.6%), nausea (4.0%), and dizziness (3.1%).
Croatian: Najčešće nuspojave (>3 %) tijekom kliničkih ispitivanja bile su glavobolja (10,4 %), somnolencija (8,6 %), mučnina (4,0 %) i omaglica (3,1 %).
English: Elderly No dose adjustment is recommended for individuals older than 65 years of age (see section 5.2).
Croatian: Ne preporuča se prilagodba doze u osoba starijih od 65 godina (vidjeti dio 5.2.).
English: Due to the overall inter-subject variability of tasimelteon, this increase is not clinically meaningful and dose adjustment is not recommended.
Croatian: Zbog ukupne varijabilnosti tazimelteona među ispitanicima, ovo povećanje nije klinički važno i ne preporučuje se prilagodba doze.
English: The master body clock regulates the circadian rhythms of hormones including melatonin and cortisol and aligns/synchronises the physiological processes of the sleep-wake cycle and metabolic and cardiovascular homeostasis.
Croatian: Glavni tjelesni sat regulira cirkadijalni ritam hormona, uključujući melatonin i kortozol, te usklađuje/sinkronizira fiziološke procese ciklusa budnosti i spavanja i metaboličke i kardiovaskularne homeostaze.
English: The average timing of sleep relative to an individual's desired period for consolidated sleep over at least one circadian period was assessed.
Croatian: Procijenjeno je prosječno vrijeme nastupa sna u odnosu na željeno razdoblje neprekinutog sna tijekom najmanje jednog cirkadijanog ciklusa.
English: Therefore, tasimelteon should be taken without food; if patients eat a high-fat meal, it is recommended to wait at least 2 hours before taking tasimelteon.
Croatian: Stoga, tazimelteon treba uzimati bez hrane; ako bolesnici jedu obrok s visokim udjelom masti, prije uzimanja tazimelteona preporučuje se pričekati najmanje dva sata.
English: Excipient(s) with known effect: Each hard capsule contains 183.25 mg of lactose (as anhydrous) and 0.03 mg of Orange Yellow S (E110).
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom: Svaka tvrda kapsula sadrži 183,25 mg laktoze (bezvodne) i 0,03 mg boje Orange Yellow S (E110).
English: Tasimelteon clearance does not appear to be affected by polymorphisms in these enzymes.
Croatian: Izgleda da na klirens tazimelteona ne utječe polimorfizam u tim enzimima.
English: What you need to know before you take HETLIOZ 3.
Croatian: Što morate znati prije nego počnete uzimati HETLIOZ
English: Because of individual differences in each person's body rhythms, it could take weeks or months for you to notice an improvement in your symptoms.
Croatian: Zbog individualnih razlika u tjelesnim ritmovima svake osobe može biti potrebno nekoliko tjedana ili mjeseci kako biste primijetili poboljšanje u pogledu simptoma.
English: During SET, patient diaries were recorded for an average of 88 days during screening and 133 days during randomisation.
Croatian: Bolesnici su tijekom ispitivanja SET vodili dnevnike tijekom prosječno 88 dana tijekom probira te 133 dana tijekom randomizacije.
English: Tasimelteon is extensively metabolised.
Croatian: Tazimelteon se ekstenzivno metabolizira.
English: Smoking (moderate CYP1A2 inducer)
Croatian: Pušenje (umjereni CYP1A2 induktor)
English: Following oral administration of radiolabeled tasimelteon, 80% of total radioactivity was excreted in urine and approximately 4% in feces, resulting in a mean recovery of 84%.
Croatian: Nakon peroralne primjene radioaktivno označenog tazimelteona, 80 % ukupne radioaktivnosti izlučeno je u urin te oko 4 % u feces, stoga srednji povrat iznosi 84 %.
English: An example is ketoconazole, which is used to treat fungal infections.
Croatian: Primjer je ketokonazol koji se koristi za liječenje gljivičnih infekcija.
English: After taking HETLIOZ, patients should limit their activity to preparing for going to bed.
Croatian: Nakon uzimanja lijeka HETLIOZ bolesnici trebaju svoje aktivnosti ograničiti na pripremu za odlazak na spavanje.
English: If you accidentally take more HETLIOZ than your doctor recommended, contact your doctor at once or contact the nearest hospital for advice.
Croatian: Ako slučajno uzmete više lijeka HETLIOZ nego što vam je liječnik preporučio, obratite se svom liječniku ili najbližoj bolnici za savjet.
English: Because of individual differences in each person's body rhythms, it could take weeks or up to 3 months for an improvement in symptoms to be noticed.
Croatian: Zbog individualnih razlika u tjelesnim ritmovima svake osobe može biti potrebno nekoliko tjedana do 3 mjeseca kako bi se primijetilo poboljšanje u pogledu simptoma.
English: Tell your doctor if you have an allergy to Orange Yellow S (E110).
Croatian: Recite svom liječniku ako ste alergični na boju Orange Yellow S (E110).
English: The mean overall exposure of tasimelteon was approximately 1.6-fold greater in female than in male subjects.
Croatian: Srednja ukupna izloženost tazimelteonu bila je otprilike 1,6 puta veća u ženskih ispitanika u odnosu na muške.
English: There are no data on the effects of tasimelteon on human fertility.
Croatian: Ne postoje podaci o učincima tazimelteona na plodnost u ljudi.
English: >45 minutes increase in average nighttime sleep duration
Croatian: > 45- minutno produljenje prosječnog trajanja noćnog sna
English: Titanium dioxide Brilliant Blue FCF Erythrosine
Croatian: Boja Brilliant Blue FCF
English: On some psychomotor test measures (intoxication, drunk, alertness/drowsiness, balance platform test), there was a trend towards greater effects of tasimelteon plus ethanol versus ethanol alone, but the effects were not deemed significant.
Croatian: Neki su testovi psihomotorike (intoksikacija, alkoholizirano stanje, budnost/omamljenost, test ravnoteže) pokazivali trend povećanja učinaka kod primjene tazimelteona uz etanol naspram samog etanola, no učinci nisu smatrani značajnima.
English: In pregnant rats administered tasimelteon during the period of organogenesis, there were no effects on embryofoetal development.
Croatian: U gravidnih štakora koji su tijekom organogeneze primali tazimelteon nije bilo utjecaja na embriofetalni razvoj.
English: Tasimelteon is a circadian regulator that resets the master body clock in the suprachiasmatic nucleus (SCN).
Croatian: Tazimelteon je regulator cirkadijalnog ritma koji resetira glavni tjelesni sat u suprahijazmatskoj jezgri (SCN).
English: Reproductive and developmental toxicity studies showed that oestrous cycles were prolonged in rats treated with high doses of tasimelteon, with no effect on mating performance or male fertility, and only a marginal effect on female fertility.
Croatian: Ispitivanja reproduktivne i razvojne toksičnosti pokazala su da je u štakora koji su uzimali velike doze tazimelteona produljen spolni ciklus bez učinka na sposobnost parenja ili mušku plodnost te uz tek marginalan učinak na žensku plodnost.
English: The following terms and frequencies are applied and presented by MedDRA System Organ Class: Very common (≥1/10); Common (≥1/100 to <1/10);
Croatian: Primijenjeni su sljedeći pojmovi i učestalosti na osnovi MedDRA klasifikacije organskih sustava: vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do
English: Tasimelteon exposure was increased by approximately 50% when co-administered with ketoconazole 400 mg (after 5 days of ketoconazole 400 mg per day).
Croatian: Izloženost tazimelteonu povećala se za otprilike 50 % kad se primijenio istodobno s ketokonazolom od 400 mg (nakon 5 dana uzimanja ketokonazola od 400 mg dnevno).
English: Somnolence, dizziness
Croatian: Somnolencija, omaglica
English: The following are adverse reactions that were reported in tasimelteon-treated adult patients, derived from patient trials in 1772 patients treated with tasimelteon.
Croatian: Slijedi prikaz nuspojava zabilježenih u odraslih bolesnika liječenih tazimelteonom na osnovi ispitivanja s 1772 bolesnika liječenih tazimelteonom.
English: - The shell of the capsule consists of gelatin, titanium dioxide, Brilliant Blue FCF, Erythrosine, and Orange Yellow S (E110).
Croatian: − Ovojnica kapsule sastoji se od želatine, titanijeva dioksida, boje Brilliant Blue FCF, eritrozina i boje Orange Yellow S (E110).
English: When administered with a high-fat meal, the Cmax of tasimelteon was 44% lower than when administered in a fasted state, and the median Tmax was delayed by approximately 1.75 hours.
Croatian: Kada se davao uz obrok s visokim sadržajem masti, Cmaks. tazimelteona bio je 44 % niži nego kada se davao natašte, a medijan Tmaks. nastupio je otprilike 1,75 sati kasnije.
English: High density polyethylene (HDPE) bottle containing 30 hard capsules with polypropylene child-resistant closures containing polypropylene resin induction seals.
Croatian: Boca od polietilena visoke gustoće (HDPE) koja sadržava 30 tvrdih kapsula s polipropilenskim sigurnosnim zatvaračem za djecu koji sadrži zalijepljenu zaštitnu foliju od polipropilenske smole.
English: SET and RESET assessed entrainment of the master body clock as measured by aMT6s and cortisol.
Croatian: Ispitivanjima SET i RESET ocjenjivalo se usklađivanje ritma glavnog tjelesnog sata mjereno prema aMT6s i kortizolu.
English: It is unknown whether tasimelteon/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuje li se tazimelteon/metaboliti u majčino mlijeko u ljudi.
English: Patients in whom the calculated time of peak melatonin level (melatonin acrophase) occurred at approximately the same time of day (in contrast to the expected daily delay) during the run-in phase were randomised to receive placebo or continue daily treatment with tasimelteon 20 mg for 8 weeks.
Croatian: Bolesnici u kojih je izračunato vrijeme vršne razine melatonina (melatoninska akrofaza) bilo u otprilike isto vrijeme dana (u suprotnosti s očekivanim dnevnim kašnjenjem) tijekom faze uključivanja randomizirani su u skupinu koja je primala placebo ili nastavila s liječenjem tazimelteonom u dozi od 20 mg dnevno tijekom 8 tjedana.
English: Patients should be instructed to initiate HETLIOZ treatment without regard to circadian phase.
Croatian: Bolesnike treba uputiti da liječenje lijekom HETLIOZ započnu neovisno o fazi cirkadijanog ritma.
English: Propylene glycol Sodium hydroxide Povidone K17
Croatian: Natrijev hidroksid Povidon K17
English: - Store in the original container and keep tightly closed in order to protect from moisture and light.
Croatian: - Čuvati u originalnom spremniku i držati ga čvrsto zatvorenim radi zaštite od vlage i svjetlosti.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with HETLIOZ in one or more subsets of the paediatric population who are totally blind with Non-24.
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka HETLIOZ u jednoj ili više podskupina pedijatrijske populacije koja je potpuno slijepa i ima poremećaj cirkadijanog ritma koji ne traje 24 sata.
English: Because symptoms of nighttime sleep disruption and daytime sleepiness are cyclical in patients with Non-24, with severity varying according to the state of alignment of the individual patient's circadian rhythm with the 24-hour day (least severe when fully aligned, most severe when 12 hours out of alignment), efficacy endpoints for nighttime total sleep time and daytime nap duration were based on the 25% of nights with the least nighttime sleep, and the 25% of days with the most daytime nap time.
Croatian: Budući da su simptomi poremećaja noćnog sna i pospanosti tijekom dana ciklički u bolesnika s poremećajem cirkadijalnog ritma koji ne traje 24 sata, a težina im varira u skladu sa stanjem usklađenosti cirkadijanog ritma pojedinog bolesnika s 24-satnim danom (simptomi su najmanje teški kada je usklađenost potpuna, a najteži kada usklađenost odstupa za 12 sati), ishodi djelotvornosti za ukupno vrijeme noćnog sna i trajanje drijemanja tijekom dana bili su temeljeni na 25 % noći s najmanje noćnog sna te 25 % dana s najduljim razdobljima drijemanja tijekom dana.
English: If you take more HETLIOZ than you should
Croatian: Ako uzmete više lijeka HETLIOZ nego što biste trebali
English: Adverse reactions leading to discontinuation occurred in 2.3% of tasimelteon-treated patients.
Croatian: Nuspojave koje su rezultirale prekidom uporabe lijeka zabilježene su kod 2,3 % bolesnika liječenih tazimelteonom.
English: You are allergic to tasimelteon or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati HETLIOZ ako ste alergični na tazimelteon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: The following side effects may happen with this medicine.
Croatian: Uz ovaj lijek mogu se pojaviti sljedeće nuspojave.
English: Push the cap down and turn counter-clockwise to open the bottle.
Croatian: Pritisnite zatvarač prema dolje i okrenite ga u smjeru suprotnom od smjera kazaljke na satu kako biste otvorili bocu.
English: Foggy feeling in head
Croatian: Mutan osjećaj u glavi
English: If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking HETLIOZ.
Croatian: Ako se nešto od gore navedenog odnosi na vas (ili niste sigurni), obratite se svom liječniku ili ljekarniku prije nego uzmete HETLIOZ.
English: During RESET, patient diaries were recorded for an average of 57 days during the run-in phase and 59 days during the randomised-withdrawal phase.
Croatian: Bolesnici su tijekom ispitivanja RESET vodili dnevnike prosječno 57 dana tijekom faze uključivanja te 59 dana tijekom randomizirane faze prekida liječenja.
English: Physicians should evaluate patient response to tasimelteon 3 months after treatment initiation utilising a clinician interview to assess their overall functioning with an emphasis on sleep-wake complaints.
Croatian: Liječnici trebaju procijeniti odgovor bolesnika na tazimelteon tri mjeseca nakon početka liječenja putem kliničkog razgovora kako bi ocijenili ukupno funkcioniranje bolesnika uz naglasak na pritužbe u pogledu ritma budnosti i spavanja.
English: A composite scale of 4 measures of duration and timing of nighttime and daytime sleep and global functioning was used to evaluate clinical response in SET.
Croatian: Skala koja se sastoji od 4 mjere trajanja i vremena nastupa noćnog i dnevnog sna te općeg funkcioniranja upotrijebljena je za ocjenjivanje kliničkog odgovora u ispitivanju SET.