Erstellt am 10 Jul 2018 15:17
Zuletzt geändert: 07 Sep 2018 12:53

ATC-Code: N07BB04, zentraler Opiatantagonist, verschiedene Präparate mit dem Wirkstoff Naltrexon:

Unterschiedliche Zulassungen / unterschiedliche Präparate:

Zur Anwendung als zusätzliche Behandlung innerhalb eines umfassenden Therapieprogramms einschließlich psychologischer Begleitung für entwöhnte Patienten, die opioidabhängig waren (siehe Abschnitte 4.2 und 4.4), und zur Unterstützung der Abstinenz bei Alkoholabhängigkeit.

  • Nemexin®:
    • Medikamentöse Unterstützung bei der psychotherapeutisch/psychologisch geführten Entwöhnungsbehandlung vormals opiatabhängiger Erwachsener nach erfolgter Opiat-Entgiftung.
  • Mysimba:
    • Kombinationspräparat mit Bupropion
    • als Ergänzung zu einer kalorienreduzierten Diät und verstärkter körperlicher Bewegung bei Adipositas oder Übergewicht mit gewichtsbezogener Begleiterkrankung

Naltrexon bei verschiedenen Indikationen in der Psychiatrie


In this total population cohort study, 21,281 individuals who received treatment with at least one of the four medications between 2005 and 2013 were identified. Data on medication use and outcomes were collected from Swedish population-based registers. A within-individual design (using stratified Cox proportional hazards regression models) was used to compare rates of suicidal behavior, accidental overdoses, and crime for the same individuals during the period when they were receiving the medication compared with the period when they were not.
No significant associations with any of the primary outcomes were found for acamprosate. For naltrexone, there was a reduction in the hazard ratio for accidental overdoses during periods when individuals received treatment compared with periods when they did not (hazard ratio=0.82, 95% CI=0.70, 0.96). Buprenorphine was associated with reduced arrest rates for all crime categories (i.e., violent, nonviolent, and substance-related) as well as reduction in accidental overdoses (hazard ratio=0.75, 95% CI=0.60, 0.93). For methadone, there were significant reductions in the rate of suicidal behaviors (hazard ratio=0.60, 95% CI=0.40-0.88) as well as reductions in all crime categories. However, there was an increased risk for accidental overdoses among individuals taking methadone (hazard ratio=1.25, 95% CI=1.13, 1.38).
Medications currently used to treat alcohol and opioid use disorders also appear to reduce suicidality and crime during treatment.


Antipsychotics, particularly risperidone, appear to be effective in reducing problem behaviors in children with intellectual disability. Evidence in adults is inconclusive. Methylphenidate appears to be effective, and α-agonists appear promising in reducing attention-deficit hyperactivity disorder symptoms. Lithium might be effective in reducing aggression. Evidence is limited to support the use of antiepileptic drugs, anxiolytics, and naltrexone for management of problem behaviors. Antidepressants may be poorly tolerated and might not be effective in reducing repetitive/stereotypic behaviors.In recent trials, glutamatergic and GABAergic agents for fragile X syndrome, and acetylcholinesterase inhibitors for Down's syndrome, failed to show efficacy. Growth hormone treatment might improve cognition and behavior in Prader-Willi syndrome population. Results from oxytocin trials on social behaviors are inconclusive albeit promising. Melatonin appears to improve sleep. Most trials of dietary supplements did not show benefits.
Evidence-based pharmacotherapy options in people with intellectual disability are limited, and many agents can cause substantial adverse events. For this reason, clinicians should consider pharmacotherapy as only a part of comprehensive treatment, and regularly assess drug effects, adverse events, and the feasibility of decreasing dose or withdrawing medications.


There was weak evidence in included trials that any active drug was more effective than placebo for people with intellectual disability demonstrating SIB. Due to sparse data, an absence of power and statistical significance, and high risk of bias for four of the included trials, we are unable to reach any definite conclusions about the relative benefits of naltrexone or clomipramine compared to placebo.

vor 2010

Naltrexone has been used most commonly at doses ranging from 0.5 to 2 mg/kg/day and found to be predominantly effective in decreasing self-injurious behavior. Naltrexone may also attenuate hyperactivity, agitation, irritability, temper tantrums, social withdrawal, and stereotyped behaviors. Patients may also exhibit improved attention and eye contact. Transient sedation was the most commonly reported adverse event. Small sample size, short duration, and inconsistent evaluative methods characterize the available research.
A child affected by AD may benefit from a trial of naltrexone therapy, particularly if the child exhibits self-injurious behavior and other attempted therapies have failed. Serious adverse effects have not been reported in short-term studies.

People with mental retardation, autism, and related developmental disabilities who self-injure are treated with a wide array of behavioral techniques and psychotropic medications. Despite numerous reports documenting short-term and some long-term changes in self-injury associated with the opiate antagonist naltrexone hydrochloride, no quantitative review of its efficacy has been reported. We conducted a quantitative synthesis of the peer-reviewed published literature from 1983 to 2003 documenting the use of naltrexone for the treatment of self-injurious behavior (SIB). Individual-level results were analyzed given subject and study characteristics. A sample of 27 research articles involving 86 subjects with self-injury was reviewed. Eighty percent of subjects were reported to improve relative to baseline (i.e., SIB reduced) during naltrexone administration and 47% of subjects SIB was reduced by 50% or greater. In studies reporting dose levels in milligrams, males were more likely than females to respond. No significant relations were found between treatment outcomes and autism status or form of self-injury. Results are discussed with respect to future efficacy work related to study outcomes and the pharmacological treatment of self-injury.

The strongest recommendations for controlled studies of safety and efficacy in children and adolescents can be given for the following drugs: benzodiazepines for acute anxiety; buspirone (and newer serotonin 1A agonists as they become available) for anxiety and depression; beta-blockers for aggressive dyscontrol; guanfacine for attention-deficit/hyperactivity disorder; and naltrexone for hyperactivity, inattention, and aggression in autistic disorder.

Niedrig dosiertes Naltrexon

Für niedrig dosiertes Naltrexon werden immunologische Wirkungen postuliert:

Psychiatrische Effekte für niedrig dosiertes Naltrexon werden auch vermutet:

Studien zu Low-Dose-Naltrexon

Siehe auch

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Zitat nach: Bach, Otto: ''Über die Subjektabhängigkeit des Bildes von der Wirklichkeit im psychiatrischen Diagnostizieren und Therapieren''. In: Psychiatrie heute, Aspekte und Perspektiven, Festschrift für Rainer Tölle, Urban & Schwarzenberg, München 1994, ISBN 3-541-17181-2, (Zitat: Seite 1)
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