Is Adrafinil legal in the US
ModafinilDrug groupsModafinil is an active ingredient from the group of stimulants that promotes alertness and is approved in Switzerland for the treatment of narcolepsy. In other countries it is also used against complaints related to shift work. The most common adverse effects include headache and nervousness. Rare severe skin reactions and neuropsychiatric disorders such as suicidal ideation and mania have been reported. In July 2010, the European Medicines Agency (EMA) recommended that the medicine only be used against narcolepsy due to the possible risks. Modafinil, because it keeps you awake, can be misused as a smart drug, doping agent and party drug.
synonymous: Modafinilum, Provigil®Products
Modafinil is commercially available in the form of tablets (CH: Modasomil-100®, Modafinil-Acino®, DL: Vigil®, USA: Provigil®). It has been approved in the EU since 1992, in the USA since 1998 and in Switzerland since 2000.Structure and properties
Modafinil or 2-benzhydrylsulfinylacetamide (C.15H15NO2S, Mr = 273.35 g / mol) is a racemate and is a white, crystalline powder that is practically insoluble in water. In the US it is too R.-Enantiomer Armodafinil available (Nuvigil®). The enantiomers are very similar pharmacologically, but differ in pharmacokinetics.
Armodafinil has a significantly longer half-life than that S.-Enantiomer. Modafinil has no structural similarities to the amphetamines. Adrafinil is a prodrug of Modafinil that is no longer commercially available.
Modafinil (ATC N06BA07) centrally promotes alertness and alertness and increases motor activity. It has effects on various neurotransmitter systems; the exact mechanism of action is not known. Modafinil is pharmacologically different from other stimulants.
Whether it influences and euphorizes the mood is controversial. For example, the FDA writes: "Modafinil produces psychoactive and euphoric effects, alterations in mood, perception, thinking, and feelings typical of other CNS stimulants in humans". On the other hand, in numerous publications attention is being drawn to the lack of the euphoric effect.Indications
Modafinil is approved in Switzerland for the treatment of narcolepsy ("sleeping sickness"). In other countries it is also approved for the indication “Shift Work Sleep Disorder”. It is taken before night work and keeps you awake.
In July 2010, the European Medicines Agency (EMA) recommended that the drug should only be used for the treatment of narcolepsy and no longer for idiopathic hypersomnia, sleep apnea syndrome and shift work due to the undesirable effects and potential for abuse. Swissmedic later followed this recommendation. There are numerous potential uses in the literature, from motion sickness to Parkinson's disease, but Modafinil has not been approved by the authorities for this purpose.abuse
Modafinil keeps you awake and can be misused as a performance enhancer, as a smart drug, party drug and doping agent. It's on the doping list. Whether it causes euphoria is controversial (see above).dosage
According to the specialist information. The drug is used as a stimulant in the morning, possibly also at noon, resp. Taken 1 hour before shift work. The intake is independent of meals. The maximum daily dose is 400 mg.Contraindications
Modafinil is contraindicated in case of hypersensitivity, simultaneous treatment with prazosin (not commercially available in Switzerland), previous drug addiction, drug or alcohol abuse, during pregnancy and breastfeeding, in the case of severe hypertension, a history of left heart hypertrophy and in patients who respond to stimulants with Symptoms of mitral valve prolapse responded. It must not be used on children and adolescents. The complete precautionary measures can be found in the medicinal product information sheet.Interactions
Modafinil induces CYP3A4, CYP1A1 and CYP2B6 and inhibits CYP2C19 and CYP2C9; appropriate drug interactions are possible.unwanted effects
Very common undesirable effects include headache and nervousness. Central disorders, cardiovascular disorders and digestive problems often occur. Modafinil has come under fire because it can rarely cause severe hypersensitivity reactions and skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis, as well as neuropsychiatric disorders such as psychosis, mania, delusions, hallucinations and suicidal ideation. These side effects can occur, but only affect very few patients.see also
- Medicinal product information (CH, D, EMA, USA)
- Ballon J.S., Feifel D. A systematic review of modafinil: Potential clinical uses and mechanisms of action. J Clin Psychiatry, 2006, 67 (4), 554-66 Pubmed
- European Medicines Agency EMA
- US Food and Drug Administration FDA http://www.fda.gov
- Keating G.M., Raffin M.J. Modafinil: a review of its use in excessive sleepiness associated with obstructive sleep apnea / hypopnoea syndrome and shift work sleep disorder. CNS Drugs, 2005, 19 (9), 785-803 Pubmed
- Kruszewski S.P., Klotz S.G. Modafinil: mischaracterization. J Clin Psychiatry, 2007, 68 (6), 970-1 Pubmed
- Kumar R. Approved and investigational uses of modafinil: an evidence-based review. Drugs, 2008, 68 (13), 1803-39 Pubmed
- McBeth B.D., McNamara R.M., Ankel F.K., Mason E.J., Ling L.J., Flottemesch T.J., Asplin B.R. Modafinil and zolpidem use by emergency medicine residents. Acad Emerg Med, 2009, 16 (12), 1311-7 Pubmed
- Myrick H, Malcolm R, Taylor B, LaRowe S. Modafinil: preclinical, clinical, and post-marketing surveillance - a review of abuse liability issues. Ann Clin Psychiatry, 2004, 16 (2), 101-9 Pubmed
- O'Brien C.P., Dackis C.A., Kampman K. Does modafinil produce euphoria? Am J Psychiatry, 2006, 163 (6), 1109 Pubmed
- Repantis D., Schlattmann P., Laisney O., Heuser I. Modafinil and methylphenidate for neuroenhancement in healthy individuals: A systematic review. Pharmacol Res, 2010, 62 (3), 187-206 Pubmed
- Schwartz J.R. Modafinil in the treatment of excessive sleepiness. Drug Des Devel Ther, 2009, 2, 71-85 Pubmed
- Spiller H.A. et al. Toxicity from modafinil ingestion. Clin Toxicol (Phila), 2009, 47 (2), 153-6 Pubmed
- Tobin M.L. Why choose modafinil for excessive daytime sleepiness? Issues Ment Health Nurs, 2007, 28 (3), 313-7 Pubmed
- Valentino R.M., Foldvary-Schaefer N. Modafinil in the treatment of excessive daytime sleepiness. Cleve Clin J Med, 2007, 74 (8), 561-6, 568-71 Pubmed
Conflicts of Interest: None / Independent. The author has no relationships with the manufacturers and is not involved in the sale of the products mentioned.additional Information
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This article was last changed on December 3, 2020.
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