FrancophonIA/ELRC3.0 huggingface dataset:
English: You or your child should be monitored by your doctor at regular intervals (recommended every 6 months) to check that Slenyto is still the right treatment for you/them.
Danish: Du eller dit barn bør kontrolleres af lægen med jævne mellemrum (hver 6. måned anbefales) for at sikre, at Slenyto stadig er den rigtige behandling for dig/barnet.
English: The effect of any stage of renal impairment on melatonin pharmacokinetics has not been studied.
Danish: Effekten af enhver grad af nedsat nyrefunktion på farmakokinetikken af melatonin er ikke undersøgt.
English: If the tablets are mixed with these foods, they should be given immediately and not left or stored, as this may affect the way the tablets work.
Danish: Når tabletterne er blandet i sådanne fødevarer, skal de gives straks og ikke henstå eller opbevares, da dette kan påvirke den måde, tabletterne virker på.
English: If a tablet is forgotten, it could be taken before the patient goes to sleep that night, but after this time, no other tablet should be given before the next scheduled dose.
Danish: Hvis en tablet glemmes, kan den tages, før patienten går i seng samme aften, men efter dette tidspunkt bør der ikke gives endnu en tablet før næste planlagte dosis.
English: Two liver-mediated metabolic pathways account for around 90% of melatonin metabolism.
Danish: To hepatisk medierede metaboliseringsveje tegner sig for omkring 90 % af melatonins metabolisering.
English: Externalizing behaviours
Danish: Eksternaliserende adfærd
English: Slenyto is available in two strengths: 1 mg and 5 mg.
Danish: Slenyto fås i to styrker: 1 mg og 5 mg.
English: Therefore, interactions between melatonin and other active substances as a consequence of their effect on CYP1A enzymes is possible.
Danish: Interaktioner mellem melatonin og andre aktive stoffer kan derfor forekomme som følge af deres virkning på CYP1Aenzymerne.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 September 2018
Danish: Dato for første markedsføringstilladelse: 20. september 2018
English: Clearance of the active substance is expected within 12 hours after ingestion.
Danish: Clearance af det aktive stof forventes afsluttet inden for 12 timer efter indtagelse.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Danish: Prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagen dosering, genotoksicitet, karcinogent potentiale eller reproduktions- og udviklingstoksicitet.
English: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: Slenyto is for oral use.
Danish: Slenyto er til oral brug.
English: Beta-blockers may supress the night-time release of endogenous melatonin and thus should be administered in the morning.
Danish: Betablokkere kan undertrykke frigivelsen af endogent melatonin om natten og bør derfor administreres om morgenen.
English: If the tablets are mixed with food or drink, they should be taken immediately and the mixture not stored.
Danish: Hvis tabletterne er blandet i mad eller drikke, skal de indtages straks; blandingen må ikke opbevares.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from melatonin therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre, eller behandlingen med Slenyto seponeres/undlades, under hensyntagen til fordelene ved amning for barnet og den terapeutiske fordel for kvinden.
English: The improvements in total sleep time (TST), sleep latency (SL) and duration of uninterrupted sleep (LSE; longest sleep episode) seen in the double blind-phase were maintained throughout the 39 weeks' follow up period.
Danish: Forbedringerne i total søvntid (TST), søvnlatens (SL) og varighed af uafbrudt søvn (LSE, længste søvnepisode), der sås i dobbeltblindfasen, var vedvarende i hele den 39 ugers opfølgningsperiode.
English: • is breast-feeding or planning to breast-feed.
Danish: • ammer eller planlægger at amme.
English: Therefore the medicinal product should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety (see section 4.7).
Danish: Lægemidlet bør derfor anvendes med forsigtighed, hvis virkningerne af døsighed forventes at kunne medføre en sikkerhedsrisiko (se pkt.
English: Smoking is known to induce CYP1A2 metabolism, therefore if patients stop or start smoking during treatment with melatonin, dose adjustment may be required.
Danish: Rygning er kendt for at inducere metabolisering gennem CYP1A2; hvis en patient holder op med at ryge eller begynder at ryge under behandling med melatonin, kan dosisjustering være nødvendig.
English: The most frequently reported adverse reactions with Slenyto in clinical studies were somnolence, fatigue, mood swings, headache, irritability, aggression and hangover occurring in 1:100-1:10 children.
Danish: De hyppigst indberettede bivirkninger med Slenyto i kliniske studier var somnolens, træthed, humørsvingninger, hovedpine, irritabilitet, aggression og tømmermænd, der forekom hos 1:100-1:10 børn.
English: However as melatonin is mainly eliminated via liver metabolism, and the metabolite 6SMT is inactive, renal impairment is not expected to influence clearance of melatonin.
Danish: Da melatonin imidlertid hovedsagelig elimineres via metabolisering i leveren, og da metabolitten 6-SMT er inaktiv, forventes nedsat nyrefunktion ikke at påvirke clearance af melatonin.
English: The doctor may want you/your child to stop taking this medicine.
Danish: Lægen kan muligvis afgøre, at du eller dit barn bør holde op med at tage dette lægemiddel.
English: Besides shortening of SL, increase in the longest sleep episode (LSE) = uninterrupted sleep duration compared to placebo was observed.
Danish: Foruden kortere SL sås en stigning i den længste søvnepisode (LSE) = uafbrudt søvnvarighed i forhold til placebo.
English: Data with 2 mg prolonged release melatonin tablets and data with 1 mg and 5 mg mini-tablets indicate that there is no accumulation of melatonin after repeated dosing.
Danish: Data med 2 mg depottabletter af melatonin og data med 1 mg og 5 mg minitabletter viser, at der ikke forekommer akkumulering af melatonin efter gentagen dosering.
English: If overdose occurs, drowsiness is to be expected.
Danish: Ved overdosering må forventes døsighed.
English: In particular, taking Slenyto with the following medicines can increase the risk of side effects, or it can affect the way that Slenyto or the other medicine works:
Danish: Navnlig medfører det øget risiko for bivirkninger at tage Slenyto sammen med følgende lægemidler, eller det kan påvirke den måde, som Slenyto eller det andet lægemiddel virker på:
English: The recommended starting dose is 2 mg of Slenyto.
Danish: Den anbefalede startdosis er 2 mg Slenyto.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Danish: ENTYDIG IDENTIFIKATOR - 2D STREGKODE Der er anført en 2D-stregkode, som indeholder den entydige identifikator.
English: Concomitant use not recommended
Danish: Samtidige anvendelser, der frarådes
English: HDPE bottles closed with induction sealed polypropylene caps.
Danish: HDPE-flaske med induktionsforseglet polypropylenlåg.
English: In studies performed in both adult and juvenile animals, melatonin had no effect on male or female fertility (see section 5.3).
Danish: I studier hos både voksne og unge dyr var melatonin uden effekt på fertiliteten hos hanner og hunner (se pkt.
English: (only applicable for outer carton, not applicable for bottle label)
Danish: (gælder kun for yderkartonen, ikke for flaskeetiketten)
English: Group Adjusted treatment means (SE) [95% CI]
Danish: Gruppe Justerede behandlingsmiddelværdier (SE) [95% CI]
English: Adjusted treatment means (SE) [95% CI]
Danish: Justerede behandlingsmiddelværdier (SE) [95 % CI]
English: The second, less significant, pathway is 5-demethylation to yield a physiological melatonin precursor, N-acetylserotonin.
Danish: Den anden, mindre betydende, metaboliseringsvej er 5-demethylering, der resulterer i den fysiologiske melatonin-precursor N-acetylserotonin.
English: • Fits (epilepsy)
Danish: • Anfald (epilepsi)
English: For the total SDQ score after 13 weeks of double blind treatment, there was a trend to benefit in favour of Slenyto (p=0.077).
Danish: For den samlede SDQ-score efter 13 ugers dobbeltblindbehandling var der tendens til fordel for Slenyto (p = 0,077).
English: The adjusted estimated treatment differences were 43.2 minutes in the all Randomized Set (MI, p=0 .039).
Danish: Den justerede estimerede behandlingsforskel var 43,2 minutter i stikprøven af alle randomiserede (MI, p = 0,039).
English: There are no data from the use of melatonin in pregnant women.
Danish: Der foreligger ingen data om anvendelse af melatonin hos gravide kvinder.
English: It is possible that melatonin is passed into human breast milk, therefore your doctor will decide whether you or your daughter should breastfeed whilst taking melatonin.
Danish: melatonin går muligvis over i modermælk; lægen vil derfor afgøre, om du/din datter bør amme under behandlingen med melatonin.
English: 28.8% patients were diagnosed with ADHD before study initiation and 77% had abnormal SDQ hyperactivity/inattention score (>=7) at baseline.
Danish: 28,8 % af patienterne blev diagnosticeret med ADHD før initiering af studiet, og 77 % havde ved baseline unormal (> = 7) score for hyperaktivitet/uopmærksomhed i henhold til Strength and Difficulties Questionnaire (SDQ).
English: Both 6hydroxymelatonin and N-acetylserotonin are ultimately conjugated to sulfate and glucoronic acid, and excreted in the urine as their corresponding 6-sulfatoxy and 6-glucoronide derivatives.
Danish: Både 6-hydroxymelatonin og N-acetylserotonin konjugeres til sidst til sulfat og glucuronsyre og udskilles i urinen som de tilsvarende 6-sulfatoxy- og 6-glucuronidderivater.
English: Melatonin is mainly bound to albumin, alpha1-acid glycoprotein and high density lipoprotein.
Danish: Melatonin bindes hovedsagelig til albumin, alpha1-syre glykoprotein og højdensitetslipoprotein.
English: The tablets should be swallowed whole and NOT broken, crushed or chewed.
Danish: Tabletterne synkes hele og må IKKE deles, knuses eller tygges.
English: Elimination is by renal excretion of metabolites, 89% as sulfated and glucoronide conjugates of 6-hydroxymelatonin (over 80% as 6-sulfatoxy melatonin) and 2% is excreted as melatonin (unchanged active substance).
Danish: Eliminationen finder sted ved renal udskillelse af metabolitterne, 89 % som sulfaterede og glucuroniderede konjugater af 6-hydroxymelatonin (over 80 % som 6-sulfatoxymelatonin), og 2 % udskilles som uændret aktivt melatonin).
English: • Abnormal behaviour
Danish: • Abnorm adfærd
English: Plasma melatonin levels in patients with cirrhosis were significantly increased during daylight hours.
Danish: Plasmakoncentrationen af melatonin hos patienter med cirrose var ikke signifikant øget ved dagslys.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs webside http://www.ema.europa.eu.
English: Slenyto is a medicine that contains the active ingredient, melatonin.
Danish: Slenyto er et lægemiddel, der indeholder det aktive stof melatonin.
English: This leaflet was last revised in { month/YYYY}.
Danish: Denne indlægsseddel blev senest ændret {måned ÅÅÅÅ}.
English: The following adverse reactions (frequency unknown) have been reported with off-label use of the adult formulation, 2 mg prolonged-release melatonin tablets: epilepsy, visual impairment, dyspnoea, epistaxis, constipation, decreased appetite, swelling face, skin lesion, feeling abnormal, abnormal behaviour and neutropenia.
Danish: Følgende bivirkninger (hyppighed ukendt) er indberettet ved ikke godkendt anvendelse af formuleringen til voksne, 2 mg melatonin-depottabletter: epilepsi, synsnedsættelse, dyspnø, epistaxis, obstipation, nedsat appetit, hævet ansigt, hudforandringer, unormal følelse, unormal adfærd og neutropeni.
English: Tablets can be put into food such as yoghurt, orange juice or ice-cream to facilitate swallowing and improve compliance.
Danish: Tabletter kan kommes i madvarer som yoghurt, appelsinjuice eller is for at gøre det lettere at synke dem og opnå bedre compliance.
English: INFORMATION IN BRAILLE Slenyto 1 mg
Danish: INFORMATION I BRAILLESKRIFT Slenyto 1 mg
English: Slenyto is for use in the treatment of insomnia.
Danish: Slenyto anvendes til behandling af søvnløshed.
English: The predominant metabolic flux is through hydroxylation at C6 via the hepatic microsome P-450 system to yield 6-hydroxymelatonin.
Danish: Den dominerende metaboliseringsvej er hydroxylering ved C6 via det hepatiske mikrosom-P-450-system, der resulterer i 6-hydroxymelatonin.
English: • Sudden onset of sleep
Danish: • Pludselig falden i søvn
English: Pharmacotherapeutic group: Psycholeptics, melatonin receptor agonists, ATC code: N05CH01 Mechanism of action
Danish: Farmakoterapeutisk klassifikation: Psykoleptika, melatoninreceptoragonister, ATC-kode: N05CH01 Virkningsmekanisme
English: Melatonin does not induce CYP1A2 or CYP3A enzymes in vitro at supra-therapeutic concentrations.
Danish: Melatonin inducerer ikke enzymerne CYP1A2 eller CYP3A in vitro ved supraterapeutiske koncentrationer.
English: Melatonin's metabolism is mainly mediated by CYP1A enzymes.
Danish: Metaboliseringen af melatonin formidles hovedsagelig af CYP1A-enzymer.
English: Table 2: PARENTS WELL BEING (13 weeks Double- blind)
Danish: Tabel 2: FORÆLDRES VELBEFINDENDE (13 ugers dobbeltblind)
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Døsighed
English: 30 months (PVC/PVDC blister) 18 months (HDPE bottle)
Danish: 30 måneder (blister af PVC/PVDC) 18 måneder (HDPE-flaske)
English: Under fasted conditions Cmax was lower (1.73 ng/ml) and tmax was earlier (within 2 hours) with a minor effect on AUC-∞ that was slightly reduced (-14%) as compared to fed state.
Danish: I fastende tilstand var Cmax lavere (1,73 ng/ml), og tmax var tidligere (inden for 2 timer), mens AUC-∞ var let reduceret (-14 %) i forhold til postprandial tilstand.
English: Carmellose sodium (E466) Maltodextrin
Danish: Filmovertræk Carmellosenatrium (E466) Maltodextrin
English: - feels drowsy (see section below on “Driving and using machines”).
Danish: - føler dig/sig døsig (se afsnittet under "Trafik- og arbejdssikkerhed").
English: Combination with benzodiazepines and non-benzodiazepine hypnotics should be avoided.
Danish: Kombination med benzodiazepiner og andre hypnotika bør undgås.
English: Caution should be exercised in patients on 5- or 8-methoxypsoralen (5 or 8-MOP), which increases melatonin levels by inhibiting its metabolism.
Danish: Forsigtighed bør udvises hos patienter, der får 5- eller 8-methoxypsoralen (5 eller 8-MOP), som øger koncentrationen af melatonin ved at hæmme dets metabolisering.
English: However, melatonin co-administration resulted in increased feelings of tranquility and difficulty in performing tasks compared to imipramine alone, and increased feelings of “muzzyheadedness” compared to thioridazine alone.
Danish: Koadministration af melatonin førte til øget følelse af afslappethed og vanskelighed ved at udføre opgaver i forhold til imipramin alene, og øget omtågethed i forhold til thioridazin alene.
English: • beta-blockers (used to control blood pressure).
Danish: • betablokkere (anvendes til kontrol af blodtrykket).
English: Melatonin may cause drowsiness.
Danish: Melatonin kan forårsage døsighed.
English: Melatonin may cause drowsiness, therefore melatonin should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety.
Danish: Melatonin kan forårsage døsighed og skal derfor anvendes med forsigtighed, især hvor døsighedens grad kan være forbundet med en sikkerhedsrisiko.
English: Prostaglandin synthesis inhibitors (NSAIDs) such as acetylsalicylic acid and ibuprofen, given in the evening may suppress endogenous melatonin levels in the early part of the night by up to 75%.
Danish: Hæmmere af prostaglandinsyntesen (NSAID) såsom acetylsalicylsyre og ibuprofen, der gives om aftenen, kan undertrykke endogene koncentrationer af melatonin i den første del af natten med op til 75 %.
English: The whole tablets can be put into food like yoghurt, orange juice or ice-cream to help with swallowing.
Danish: De hele tabletter kan kommes i fødevarer såsom yoghurt, appelsinjuice eller is for at gøre det lettere at synke dem.
English: PVC/PVDC opaque blister with aluminium foil backing.
Danish: Uigennemsigtig blister af PVC/PVDC med underlag af aluminiumfolie.
English: No clinically significant pharmacokinetic interactions were found in each case.
Danish: I ingen af tilfældene fandtes farmakokinetiske interaktioner af betydning.
English: 3 years (PVC/PVDC blister and HDPE bottle)
Danish: 3 år (blister af PVC/PVDC og HDPE-flaske)
English: The study comprises 5 periods: 1) pre-study period (4 weeks), 2) baseline single-blind placebo period (2 weeks), 3) randomized placebo-controlled treatment period (13 weeks), 4) open label treatment period (91 weeks), and 5) single blind run-out period (2 weeks placebo).
Danish: Studiet omfatter 5 faser: 1) en forberedende fase (4 uger), 2) en baseline enkeltblind placebofase (2 uger), 3) en randomiseret placebokontrolleret behandlingsfase (13 uger), 4) en åben behandlingsfase (91 uger) og 5) en enkeltblind udløbsfase (2 ugers placebo).
English: CYP1A2 inhibitors such as quinolones (ciprofloxacin and norfloxacin) may give rise to increased melatonin exposure.
Danish: CYP1A2-hæmmere som quinoloner (ciprofloxacin og norfloxacin) kan medføre øget eksponering for melatonin.
English: If you or your child forgets to take a tablet, it could be taken before going to sleep that night, but after this time, no other tablet should be taken before the next evening.
Danish: Hvis du eller dit barn har glemt at tage Slenyto Hvis du eller dit barn glemmer at tage en tablet, kan den tages før sengetid samme aften, men efter dette tidspunkt bør der ikke tages endnu en tablet før næste aften.
English: The site of biotransformation is the liver.
Danish: Biotransformationen finder sted i leveren.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: (only applicable for outer carton, not applicable for bottle label) SN: (only applicable for outer carton, not applicable for bottle label) NN: (only applicable for outer carton, not applicable for bottle label)
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC: (gælder kun for yderkartonen, ikke for flaskeetiketten) SN: (gælder kun for yderkartonen, ikke for flaskeetiketten) NN: (gælder kun for yderkartonen, ikke for flaskeetiketten)
English: (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare
Danish: Hyppighedskategorierne er angivet med følgende konvention: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1 000 til < 1/100), sjælden (≥ 1/10 000 til < 1/1 000); meget sjælden (< 1/10 000), ikke kendt (kan ikke beregnes af de foreliggende data).
English: Slenyto is indicated for the treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.
Danish: Slenyto er indiceret til behandling af søvnløshed hos børn og unge i alderen 2-18 år med autismespektrumforstyrrelse (ASD) og/eller Smith-Magenis syndrom, hvor foranstaltninger til søvnhygiejne ikke har været tilstrækkelige.
English: CYP1A2 inducers such as carbamazepine and rifampicin may reduce plasma concentrations of melatonin.
Danish: Induktorer af CYP1A2 som carbamazepin og rifampicin kan nedsætte plasmakoncentrationen af melatonin.
English: Slenyto is for use in children and adolescents (2 to 18 years old) with autism spectrum disorder (ASD) and/or Smith-Magenis syndrome, a neurogenetic disease (inherited condition affecting the nerves and brain).
Danish: Slenyto er til anvendelse hos børn og unge (2 til 18 år) med autismespektrumforstyrrelse (ASD) og/eller Smith-Magenis-syndrom, der er en neurogenetisk sygdom (dvs. en arvelig sygdom, som påvirker nerverne og hjernen).
English: Warnings and precautions Talk to your doctor or pharmacist before taking Slenyto if you or your child:
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apoteket før indtagelse af Slenyto, hvis du eller dit barn:
English: Tell your doctor or pharmacist before using Slenyto if you or your daughter:
Danish: Kontakt lægen eller apoteket før indtagelse af Slenyto, hvis du eller din datter:
English: CARTON (BOTTLE AND BLISTER PACKS) AND LABEL (HDPE BOTTLE) - 5 MG
Danish: KARTON (FLASKE OG BLISTER) OG ETIKET (HDPE-FLASKE) - 5 MG
English: Fluvoxamine increases melatonin levels (by 17-fold higher AUC and a 12-fold higher serum Cmax) by inhibiting its metabolism by hepatic cytochrome P450 (CYP) isozymes CYP1A2 and CYP2C19.
Danish: Fluvoxamin øger koncentrationen af melatonin (med 17 gange større AUC og 12 gange højere Cmax i serum) ved at hæmme dets metabolisering gennem de hepatiske cytokrom P450- (CYP) isoenzymer CYP1A2 og CYP2C19.
English: Therefore, when CYP1A2 inducers and melatonin are both given, dose adjustment may be required.
Danish: Når der gives CYP1A2-induktorer sammen med melatonin, kan dosisjustering derfor være nødvendig.
English: Caution should be exercised in patients on cimetidine which is a potent inhibitor of certain cytochrome P450 (CYP450) enzymes, mainly CYP1A2 and thereby increases plasma melatonin levels, by inhibiting its metabolism.
Danish: Forsigtighed bør udvises hos patienter, der får cimetidin, som er en potent hæmmer af visse cytokrom P450- (CYP450) enzymer, hovedsagelig CYP1A2, og derfor øger plasmakoncentrationen af melatonin ved at hæmme dets metabolisering.
English: Patients (51 from the Slenyto group and 44 from the placebo group, mean age 9 ± 4.24 years, range 2-17.0 years) received open-label Slenyto 2/5 mg according to the double-blind phase dose, for 91 weeks with optional dose adjustment to 2, 5 or 10 mg/day after the first 13 weeks of follow-up period.
Danish: Patienterne (51 fra Slenyto-gruppen og 44 fra placebogruppen, gennemsnitsalder 9 ± 4,24 år, variationsbredde 2-17,0 år) fik open-label behandling med Slenyto, 2/5 mg, i henhold til dosis for den dobbeltblindede fase i 91 uger, med valgfri dosisjustering til 2, 5 eller 10 mg/dag efter de første 13 ugers opfølgningsfase.
English: Concomitant use to be considered with caution
Danish: Samtidig brug, der kræver nøje overvejelse
English: • Swelling and inflammation of the sinuses associated with pain and blocked nose (sinusitis)
Danish: • Hævelse og betændelse i bihulerne sammen med smerter og stoppet næse (bihulebetændelse)
English: Efficacy and safety have been assessed in a randomised, placebo-controlled study in children diagnosed with ASDs and neurodevelopmental disabilities caused by Smith-Magenis syndrome who had not shown improvement after standard sleep behavioural intervention.
Danish: Klinisk virkning og sikkerhed hos den pædiatriske population Virkningen og sikkerheden er blevet vurderet i et randomiseret, placebokontrolleret studie hos børn, der var diagnosticeret med ASD og neuro-udviklingsmæssig invaliditet som følge af Smith-Magenis syndrom, og hos hvem der ikke var set bedring efter sædvanlig søvnadfærdsintervention.