natgillin/translations-raw huggingface dataset:
These levels are considerably higher than levels achieved with therapeutic doses. 
Te koncentracije so bistveno večje kot koncentracije, dosežene pri terapevtskih odmerkih.
Then add about 60 ml of water to each dosing cup (60 mL is about 4 tablespoons). 
Nato dodajte okoli 60 ml vode v vsako od odmernih meric (60 mililitrov je približno 4 velike žlice).
If the patient stops taking the medicinal product for more than 14 consecutive days, titration should be restarted from the lowest dose. 
Če bolnik prekine zdravljenje z zdravilom za več kot 14 zaporednih dni, je treba odmerek ponovno titrirati od najmanjšega odmerka.
If you take more Xyrem than you were told to take, or take it by accident, get emergency medical help right away. 
Če ste vzeli večji odmerek zdravila Xyrem, kot so vam naročili, ali če ste ga vzeli po nesreči, takoj poiščite nujno medicinsko pomoč.
Patients have exhibited varying degrees of depressed consciousness that may fluctuate rapidly between a confusional, agitated combative state with ataxia and coma. 
Pri bolnikih se pokažejo različne stopnje zožene zavesti, ki lahko hitro prehajajo med zmedenim, agitiranim bojevitim stanjem z ataksijo in komo.
Just before going to sleep, place your second dose near your bed. 
Tik pred spanjem postavite drugi odmerek poleg svoje postelje.
You should have received a Xyrem Information Pack from your physician, which includes a booklet on how to take the medicine, a Frequently Asked Questions patient information sheet and a patient alert card. 
Od zdravnika morate prejeti tudi Zavitek z informacijami o zdravilu Xyrem, ki vsebuje brošuro o tem, kako jemati zdravilo, list z bolnikovimi pogosto zastavljenimi vprašanji in opozorilno kartico za bolnike.
You may need to set an alarm clock to make sure you wake up to take the second dose. 
Morda si boste morali nastaviti budilko, da se boste zagotovo zbudili za drugi odmerek zdravila.
When you wake up 2.5 to 4 hours later, remove the cap from the second dosing cup. 
Ko se boste čez 2,5 do 4 ure kasneje zbudili, odstranite zaporko iz druge odmerne merice.
Injury, poisoning and procedural complications Common: fall 
Poškodbe, zastrupitve in zapleti pri posegih pogosti: padec
Date for first authorisation: 13 October 2005 Date of latest renewal: 08 September 2015 
Datum zadnjega podaljšanja: 08. september 2015
For at least 6 hours after taking sodium oxybate, patients must not undertake activities requiring complete mental alertness or motor co-ordination, such as operating machinery or driving. 
Vsaj 6 ur po aplikaciji natrijevega oksibata bolniki ne smejo izvajati aktivnosti, ki zahtevajo popolno mentalno budnost ali motorično koordinacijo, kot je upravljanje s stroji ali vožnja.
Investigations Common: blood pressure increased, weight decreased 
Preiskave pogosti: povišan krvni tlak, zmanjšanje telesne mase
There are reports of compromise in the rate and depth of respiration and of life-threatening respiratory depression, necessitating intubation and ventilation. 
Na voljo so tudi poročila o kompromisu med hitrostjo in globino dihanja ter o življenje ogrožajoči depresiji dihanja, ki zahteva intubacijo in ventilacijo.
It is recommended that both doses of Xyrem should be made up at the same time upon retiring to bed. 
Priporočljivo je, da sta oba odmerka zdravila Xyrem pripravljena istočasno, pred odhodom v posteljo.
This needs only to be done the first time that the bottle is opened. 
To boste morali storiti le ob prvem odprtju plastenke.
Data from a limited number of pregnant women exposed in the first trimester indicate a possible increased risk of spontaneous abortions. 
Podatki dobljeni iz omejenega števila nosečnic, ki so bile izpostavljene natrijevemu oksibatu v prvem trimesečju nosečnosti nakazujejo na možnost povečanega tveganja spontanih splavov.
The primary measure of efficacy was excessive daytime sleepiness as measured by objective response in MWT. 
Primarno merilo učinkovitosti je bila čezmerna dnevna zaspanost, ki je bila izmerjena z objektivnim odzivom pri preskusu budnosti (MWT).
Drug discrimination studies show that GHB produces a unique discriminative stimulus that in some respects is similar to that of alcohol, morphine and certain GABA-mimetic medicinal products. 
Študije razlikovanja zdravil so pokazale, da GHB povzroči edinstven stimulus, ki je različen od drugih, čeprav je v nekaterih pogledih podoben tistim, ki jih povzročajo alkohol, morfin in določena gabamimetično delujoča zdravila.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP. 
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Do not use this medicine after the expiry date stated on the bottle after (EXP). 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki (EXP).
Also tell your doctor or pharmacist if your are taking any of the following types of medicines: 
Prav tako obvestite zdravnika ali farmacevta, če jemljete naslednja zdravila:
Placebo 3.0 g/day 6.0 g/day 9.0 g/day 
mediana napadi/teden placebo 3,0 g/dan 6,0 g/dan 9,0 g/dan
Remove the syringe from the centre opening of the bottle. 
Odstranite injekcijsko brizgo iz osrednje odprtine plastenke.
Selfadministration studies in rats, mice and monkeys have produced conflicting results, whereas tolerance to GHB as well as cross-tolerance to alcohol and baclofen has been clearly demonstrated in rodents. 
Študije samoaplikacije pri podganah, miših in opicah so dale nasprotujoče si rezultate, medtem ko so lahko toleranco na GHB in navzkrižno toleranco z alkoholom in baklofenom pri glodalcih jasno pokazali.
At sodium oxybate concentrations ranging from 3 to 300 µg/mL, less than 1% is bound to plasma proteins. 
V območju koncentracij natrijevega oksibata med 3 in 300 g/ml ga je manj kot 1 % vezanega na plazemske beljakovine.
Trial 4 was designed specifically to evaluate the continued efficacy of sodium oxybate after long-term use. 
Četrto preskušanje je bilo specifično namenjeno oceni nadaljnje učinkovitosti natrijevega oksibata pri dolgotrajnem zdravljenju.
Other medicines and Xyrem 
Druga zdravila in zdravilo Xyrem
Pharmacotherapeutic group: Other nervous system drugs, ATC code: N07XX04. 
Farmakoterapevtska skupina: Druga zdravila z delovanjem na živčevje Oznaka ATC: N07XX04
• Patient Alert Card (to be given to the patient): to remind patients, physicians and/or pharmacists of the important safety information related to the use of Xyrem. 
• Opozorilna kartica za bolnike (prejme bolnik): bolnike, zdravnike in/ali farmacevte opomni glede pomembnih varnostnih informacij v povezavi z uporabo zdravila Xyrem.
You may need to set an alarm so you wake up to take your second dose no earlier than 2.5 hours and no later than 4 hours after your first dose. 
Morda boste morali nastaviti budilko, da se boste zbudili za drugi odmerek, ki ga ne smete vzeti prej kot po 2,5 urah in ne kasneje kot po 4 urah po prvem odmerku.
Bradycardia has been responsive to atropine intravenous administration. 
Bradikardija se odziva na intravensko aplikacijo atropina.
EU/1/05/312/001 
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/05/312/001
Apnoea and respiratory depression have been observed in a fasting healthy subject after a single intake of 4.5 g (twice the recommended starting dose). 
Apnejo in respiratorno depresijo so opazili pri teščih, zdravih osebah po enkratnem vnosu 4,5 g (dvakratni priporočeni začetni odmerek).
Once you open a bottle of Xyrem, any contents that you have not used with 40 days of opening should be disposed of. 
Po odprtju plastenke zdravila Xyrem morate vsebino, ki je ne boste porabili v 40 dneh po odprtju, zavreči.
What you need to know before you take Xyrem 
Kaj morate vedeti, preden boste vzeli zdravilo Xyrem
Patients taking Xyrem should not breast feed since it is known that Xyrem passes into breast milk. 
Bolnice, ki jemljejo zdravilo Xyrem, ne smejo dojiti, ker je znano, da Xyrem prehaja v materino mleko.
If you stop taking Xyrem for more than 14 consecutive days you should consult your doctor as you should restart taking Xyrem at a reduced dose. 
Če boste za več kot 14 zaporednih dni prekinili jemanje zdravila Xyrem, se morate posvetovati s svojim zdravnikom, saj boste ponovno jemanje zdravila Xyrem začeli z zmanjšanim odmerkom.
The pharmacodynamic interaction with zolpidem has not been assessed. 
Farmakodinamične interakcije z zolpidemom niso ocenili.
Repeat administration of sodium oxybate to rats (90 days and 26 weeks) and dogs (52 weeks) did not result in any significant findings in clinical chemistry and micro- and macro pathology. 
Pri dajanju ponavljajočih se odmerkov natrijevega oksibata podganam (90 dni in 26 tednov) in psom (52 tednov) niso odkrili nobenih pomembnih dejstev na področju klinične kemije ter mikro- in makropatologije.
The dose of 9 g/day should not be exceeded due to the possible occurrence of severe symptoms at doses of 18 g/day or above (see section 4.4). 
Odmerka 9 g/dan ne smemo prekoračiti zaradi možnega pojava hudih simptomov pri odmerkih 18 g/dan ali več (glejte poglavje 4.4).
Sodium oxybate has major influence on the ability to drive and use machines. 
Natrijev oksibat ima pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
Sodium oxybate is rapidly and almost completely absorbed after oral administration; absorption is delayed and decreased by a high fat meal. 
Natrijev oksibat se po peroralnem jemanju hitro in skoraj popolnoma absorbira; absorpcija je po obroku z veliko vsebnostjo maščob zakasnjena in zmanjšana.
Although gag reflex may be absent in deeply comatose patients, even unconscious patients may become combative to intubation, and rapid sequence induction (without the use of sedative) should be considered. 
Čeprav je lahko refleks bruhanja pri bolnikih v globoki komi odsoten, pa lahko tudi nezavestni bolniki postanejo agresivni pri intubaciji in je treba razmisliti o hitri zaporedni indukciji (brez uporabe sedativa).
The most serious adverse reactions are suicidal attempt, psychosis, respiratory depression and convulsion. 
Najresnejši neželeni učinki so poskus samomora, psihoza, depresija dihanja in konvulzija.
• Benzodiazepines 
• Benzodiazepini
In Trial 4, the response was numerically similar for patients treated with doses of 6 to 9 g/day, but there was no effect seen in patients treated with doses less than 6 g/day. 
V 4. preskušanju je bil odgovor številčno podoben pri bolnikih, ki so jemali odmerke 6 do 9 g/dan, pri odmerkih, manjših od 6 g/dan, pa pri bolnikih niso opazili učinka.
If you miss the second dose, skip that dose and do not take Xyrem again until the next night. 
Če ste pozabili vzeti drugi odmerek, preskočite ta odmerek in zdravilo Xyrem ponovno vzemite šele naslednjo noč.
Trial 4 enrolled 55 narcoleptic patients who had been taking open-label sodium oxybate for 7 to 44 months. 
V 4. preskušanje je bilo vključenih 55 bolnikov z narkolepsijo, ki so v odprti študiji že prej 7 do 44 mesecev prejemali natrijev oksibat.
Whether this affected respiration during the night is unknown. 
Ni znano, ali je to ponoči vplivalo na dihanje.
Faecal excretion is negligible. 
Izločanje z blatom je zanemarljivo.
Given the possibility of increasing the risk of respiratory depression, the concomitant use of benzodiazepines and sodium oxybate should be avoided. 
Zaradi možnosti povečanja tveganja za nastanek respiratorne depresije se je treba izogibati sočasni uporabi benzodiazepinov in natrijevega oksibata.
UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, United Kingdom. 
UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, Velika Britanija
In the clinical trial database, greater than 80 % of patients maintained concomitant stimulant use. 
Na podlagi baze podatkov iz kliničnih preskušanj je več kot 80 % bolnikov sočasno jemalo stimulanse.
Before increasing the sodium oxybate dose (see section 4.2), prescribers should be aware that sleep apnoea occurs in up to 50% of patients with narcolepsy. 
Pred povečanjem odmerka natrijevega oksibata (glejte poglavje 4.2) se morajo zdravniki, ki predpisujejo zdravilo, zavedati, da se sindrom apneje v spanju pojavi pri do 50 % bolnikov z narkolepsijo.
Patients being treated with opioids or barbiturates. 
Pri bolnikih, ki se zdravijo z opiodi ali barbiturati.
Very common (may affect more than 1 in 10 people): Nausea, dizziness, headache 
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): siljenje na bruhanje, omotičnost, glavobol
Events associated with withdrawal syndrome have been observed outside the therapeutic range. 
Učinke, povezane z odtegnitvenim sindromom, so opazili pri odmerkih zunaj terapevtskega območja.
Take doses within 24 hours after preparation. 
Odmerke zaužijte v roku 24 ur od časa priprave.
Studies in male and female rats at doses up to 1,000 mg/kg/day GHB have shown no evidence of an adverse effect on fertility. 
Študije na samcih in samicah podgan pri odmerkih do 1000 mg/kg/dan GHB niso pokazale neželenih učinkov na plodnost.
Because food significantly reduces the bioavailability of sodium oxybate, patients should eat at least several (2-3) hours before taking the first dose of Xyrem at bedtime. 
Ker hrana značilno zmanjša biološko uporabnost natrijevega oksibata, morajo bolniki jesti vsaj nekaj ur (2 - 3) preden vzamejo prvi odmerek zdravila Xyrem tik pred spanjem.
Trial 1 EDS (ESS); CGIc 
1. preskušanje EDS (ESS); CGIc
Xyrem has a well-known abuse potential. 
Pri zdravilu Xyrem je dobro znana možnost zlorabe.
Epileptic patients 
Bolniki z epilepsijo
Elimination half-life was significantly longer in Class C and Class A patients than in control subjects (mean t1/2 of 59 and 32 versus 22 minutes). 
Biološka razpolovna doba izločanja je bila značilno daljša pri bolnikih iz razreda C in A kot pri preiskovancih iz kontrolne skupine (srednja vrednost t1/2 59 in 32 proti 22 minutam).
A possible additive effect of antidepressants and sodium oxybate cannot be excluded. 
Možnosti aditivnega učinka antidepresivov in natrijevega oksibata ni mogoče izključiti.
Because of the higher risk of sleep apnoea, patients with a BMI ≥40 kg/m should be monitored closely when taking sodium oxybate. 
Zaradi povečanega tveganja za apnejo med spanjem se mora bolnike z ITM (BMI) ≥ 40 kg/m2 med jemanjem natrijevega oksibata skrbno spremljati.
There have been case reports of dependence after illicit use of GHB at frequent repeated doses (18 to 250 g/day) in excess of the therapeutic dose range. 
O primerih odvisnosti so poročali pri prepovedani uporabi GHB v pogostih, ponavljajočih se odmerkih (18 do 250 g/dan), ki presegajo terapevtsko območje odmerkov.
Rinse out the syringe with water. 
Injekcijsko brizgo sperite z vodo.
Sodium oxybate is the sodium salt of GHB. 
Natrijev oksibat je natrijeva sol GHB.
Additionally, patient response and tolerability should be carefully monitored and dose should be adapted accordingly. 
Dodatno je treba skrbno spremljati bolnikov odziv in prenašanje ter odmerek ustrezno prilagoditi.
If you have kidney problems, you should consider a dietary recommendation to reduce sodium intake. 
Če imate težave z ledvicami, morate razmisliti o dietnih priporočilih za zmanjšanje vnosa natrija.
Myoclonus and tonic-clonic seizures have been reported. 
Poročali so tudi o mioklonusu in toničnokloničnih konvulzijah.
In a limited number of patients greater than the age of 65 years the pharmacokinetics of sodium oxybate was not different compared to patients younger than 65 years of age. 
Starejši: Pri omejenem številu bolnikov, starejših od 65 let, se farmakokinetika natrijevega oksibata v primerjavi s farmakokinetiko pri bolnikih, mlajših od 65 let, ni razlikovala.
Cardiac disorders Common: palpitations 
Srčne bolezni pogosti: palpitacije
Sodium Oxybate should not be used during breastfeeding. 
Natrijev oksibat se ne sme uporabljati med dojenjem.
Repeat this step for the second dosing cup. 
Korak ponovite tudi pri drugi odmerni merici.
You should continue to take Xyrem for as long as instructed by your doctor. 
Zdravilo Xyrem morate jemati tako dolgo, kot vam je naročil vaš zdravnik.
The MAH has established a controlled distribution program that enhances existing controls for Xyrem to allow reaching the intended population of narcolepsy patients while minimizing the risk of Xyrem being diverted by those seeking to misuse it. 
Imetnik dovoljenja za promet je vzpostavil nadzorovani program distribucije, ki poveča že obstoječi nadzor zdravila Xyrem ter s tem doseže populacijo bolnikov z narkolepsijo, medtem ko zmanjšuje tveganje, da bi zdravilo Xyrem prišlo do tistih, ki ga želijo zlorabiti.
In addition to the adverse reactions reported during clinical studies, adverse reactions have been reported in post-marketing experience. 
Poleg neželenih učinkov, o katerih so poročali v kliničnih študijah, obstajajo še neželeni učinki v okviru izkušenj po začetku trženja zdravila.
5 How to store Xyrem Contents of the pack and other information 
5 Shranjevanje zdravila Xyrem Vsebina pakiranja in dodatne informacije
• Healthcare Professional Checklist (i.e. treatment initiation forms): to remind physicians to check the contraindications, warnings, and precautions in the SmPC and specifically highlighting that Xyrem can cause CNS and respiratory depression, that alcohol may result in the potentiation of CNS depression and that Xyrem has an abuse potential. 
• Kontrolni seznam za zdravnike (obrazec za začetek zdravljenja): zdravnike opomni, da preverijo kontraindikacije in previdnostne ukrepe v SmPC in še posebej poudari, da lahko zdravilo Xyrem povzroči depresijo CŽS in depresijo dihanja, da lahko alkohol potencira depresijo CŽS in da ima zdravilo Xyrem potencial zlorabe.
The primary measures of efficacy were changes in excessive daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS), and the change in the overall severity of the patient's narcolepsy symptoms as assessed by the investigator using the Clinical Global Impressions of Change (CGI-c) measure. 
Primarno merilo učinkovitosti so bile spremembe v pretirani dnevni zaspanosti, ki so bile izmerjene z Epworthovo lestvico zaspanosti (ESS), in sprememba celotne resnosti bolnikovih simptomov narkolepsije, ki jo je preiskovalec ocenil z uporabo lestvice celostnega kliničnega odziva (CGI-c).
Table 3 Summary of CGI-c in Trial 1 
Preglednica 3 Pregled CGI-c pri 1. preskušanju
Patients should be questioned regarding signs of Central Nervous System (CNS) or respiratory depression. 
Bolnike je treba vprašati po znakih, povezanih z zaviranjem centralnega živčnega sistema ali dihanja.
There is a plastic covered foil seal on the top of the bottle, which must be removed before using the bottle for the first time. 
Vrh plastenke pokriva pečat iz plastične folije, ki jo morate pred prvo uporabo plastenke odstraniti.
Sodium oxybate administered before nocturnal sleep increases Stages 3 and 4 sleep and increases sleep latency, whilst reducing the frequency of sleep onset REM periods (SOREMPs). 
Natrijev oksibat, apliciran pred nočnim spanjem, podaljša fazi spanja 3 in 4 ter poveča latenco spanja, medtem ko zmanjša pogostnost pojavljanja faze REM ob začetku spanja (SOREMP - sleep onset REM period).
Rebound effects and withdrawal syndrome 
Povratno delovanje in odtegnitveni sindrom
If sodium oxybate and valproate are used concomitantly (see section 4.5), a decrease in sodium oxybate dose by 20% is recommended. 
Če se natrijev oksibat in valproat uporabljata sočasno (glete poglavje 4.5), je priporočljivo zmanjšanje odmerka natrijevega oksibata za 20 %.
If you have the impression that the effect of Xyrem is too strong or too weak, talk to your doctor or pharmacist. 
Če menite, da je učinek zdravila Xyrem premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
Sodium oxybate is a hydrophilic compound with an apparent volume of distribution averaging 190384 mL/kg. 
Porazdelitev: Natrijev oksibat je hidrofilna spojina s povprečnim navideznim volumnom porazdelitve 190 384 ml/kg.
• medicines that may be processed in a similar way by the body (e.g., valproate, phenytoin or ethosuximide which are used for the treatment of fits) 
• zdravila, ki jih lahko telo presnavlja podobno kot natrijev oksibat (npr. valproat, fenitoin ali etosuksimid, ki se uporabljajo za zdravljenje krčev)
Treatmentrelated clinical signs were mainly related to sedation, reduced food consumption and secondary changes in body weight, body weight gain and organ weights. 
Klinični znaki, povezani z zdravljenjem, so bili povezani predvsem s sedacijo, zmanjšanim uživanjem hrane in sekundarnimi spremembami telesne mase, spremembami pri pridobivanju telesne mase ter s spremembami mase organov.
Sodium oxybate is a central nervous system depressant which reduces excessive daytime sleepiness and cataplexy in patients with narcolepsy and modifies sleep architecture reducing fragmented nighttime sleep. 
Natrijev oksibat je zaviralec centralnega živčnega sistema, ki zmanjša prekomerno dnevno zaspanost in katapleksijo pri bolnikih z narkolepsijo ter spremeni arhitekturo spanja tako, da zmanjša prekinitev nočnega spanja.
While sitting in bed, drink all of the second dose right before lying down to continue sleeping. 
Medtem ko sedite v postelji, popijte drugi odmerek v celoti, se nato takoj ulezite in nadaljujte s spanjem.
Sedative hypnotics 
Sedativno delujoči hipnotiki
GHB had no effect on mating, general fertility or sperm parameters and did not produce embryofoetal toxicity in rats exposed to up 1000 mg/kg/day GHB (1.64 times the human exposure calculated in nonpregnant animals). 
GHB ni imel vpliva na parjenje, splošno plodnost ali parametre semena ter ni povzročal toksičnosti za zarodek in plod pri podganah, izpostavljenih odmerkom do 1000 mg/kg/dan (1, 64-kratnik izpostavljenosti pri človeku, izračunan glede na živali, ki niso breje).
In particular Xyrem should not be taken together with sleep inducing medicines and medicines that reduce central nervous system activity (the central nervous system is the part of the body related to the brain and spinal cord). 
Zdravila Xyrem ne smete jemati skupaj z zdravili, ki sprožijo spanje in z zdravili, ki zmanjšajo dejavnost centralnega živčnega sistema (centralni živčni sistem vključuje možgane in hrbtenjačo).
What Xyrem is and what it is used for What you need to know before you take Xyrem How to take Xyrem 
Kaj je zdravilo Xyrem in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Xyrem Kako jemati zdravilo Xyrem Možni neželeni učinki
Two Phase 3 and one Phase 2 double-blind, parallel-group, placebo-controlled studies were performed to assess the indication of sodium oxybate for fibromyalgia. 
Dve študiji faze 3 in ena študija faze 2 (dvojno slepe, z vzporednimi skupinami, nadzorovane s placebom) so bile izvedene za oceno indikacije natrijevega oksibata za fibromialgijo.
GHB dehydrogenase inhibitors 
Zaviralci dehidrogenaze GHB
In patients with epilepsy, the safety and efficacy of sodium oxybate has not been established, therefore use is not recommended. 
Varnost in učinkovitost uporabe natrijevega oksibata pri bolnikih z epilepsijo nista bili ugotovljeni, zato njegova uporaba ni priporočljiva.
Narcolepsy is a sleep disorder that may include attacks of sleep during normal waking hours, as well as cataplexy, sleep paralysis, hallucinations and poor sleep. 
Narkolepsija je motnja spanja, ki lahko vključuje napade spanja v času, ko je človek običajno buden, lahko pa se pojavijo tudi katapleksija, paraliza v spanju, halucinacije in slabo spanje.
During the 8 week double-blind period, patients took modafinil at their established dose or placebo equivalent. 
Med 8-tedenskim dvojno slepim preskušanjem so bolniki jemali modafinil ali placebo v ekvivalentnem odmreku.
Limited data from pregnant patients during second and third trimester indicate no malformative or foeto/neonatal toxicity of sodium oxybate. 
Omejeni podatki od bolnic v drugem in tretjem trimesečju nosečnosti niso pri uporabi natrijevega oksibata pokazali nobenih malformacij ali toksičnosti za plod/novorojenčka.