Modafinil

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Modafinil is a wakefulness-promoting drug used for treatment of disorders such as narcolepsy , shift work sleep disorder , and excessive daytime sleepiness associated with obstructive sleep apnea. In English-speaking countries it is sold under the brand names Alertec , Modavigil , and Provigil. In the United States modafinil is classified as a schedule IV controlled substance and restricted in availability and usage, due to concerns about possible addiction potential. In most other countries it is a prescription drug but not otherwise legally restricted. Modafinil acts as an atypical, selective, and weak dopamine reuptake inhibitor which indirectly activates the release of orexin neuropeptides and histamine from the lateral hypothalamus and tuberomammillary nucleus , respectively, by unknown mechanisms, all of which contribute to heightened arousal. Modafinil is a eugeroic used for treatment of narcolepsy , shift work sleep disorder , and excessive daytime sleepiness associated with obstructive sleep apnea. Because of the risk for development of skin or hypersensitivity reactions and serious adverse psychiatric reactions, the European Medicines Agency has recommended that new patient prescriptions should only be to treat sleepiness associated with narcolepsy. Modafinil has also found off-label use with the neurological fatigue reported by some with multiple sclerosis. A group of 72 people with MS of varying degrees of severity tested two different doses of modafinil and an inactive placebo over nine weeks. Fatigue levels were self-evaluated on standardized scales. Participants taking a lower dose of modafinil reported feeling less fatigued and there was a statistically significant difference in fatigue scores for the lower dose versus the placebo. The higher dose of modafinil was not reported to be significantly more effective. Armed forces of several countries are known to have expressed interest in modafinil as an alternative to amphetamine —the drug traditionally employed in combat situations or lengthy missions where troops face sleep deprivation. The French government indicated that the Foreign Legion used modafinil during certain covert operations. In the United States military, modafinil has been approved for use on certain Air Force missions, and it is being investigated for other uses. The Canadian Medical Association Journal also reports that modafinil is used by astronauts on long-term missions aboard the International Space Station. Modafinil is 'available to crew to optimize performance while fatigued' and helps with the disruptions in circadian rhythms and with the reduced quality of sleep astronauts experience. Allergy and hypersensitivity are the only contraindications of the drug, \\\\\\\\\\\\\\[30\\\\\\\\\\\\\\] but literature distributed by Cephalon advises that it is important to consult a physician before using it, as problems may arise for people who are sensitive to constituents of the tablets, people with cirrhosis which may impair the metabolism of the drug , and people with various cardiovascular problems. Rare occurrences have been reported of more serious adverse effects, including severe skin rashes and other symptoms that are probably allergy-related. The FDA issued a relevant alert. In the same alert, the FDA also noted that angioedema and multi-organ hypersensitivity reactions have also been reported in postmarketing experiences. The long term safety and effectiveness of modafinil have not been determined. Modafinil may have an adverse effect on hormonal contraceptives for up to a month after discontinuation. The addiction and dependence liabilities of modafinil are very low. Psychological dependence upon modafinil has only been noted in case reports involving daily overdoses on modafinil for an extended period of time. Large-scale clinical studies have found no evidence of tolerance with modafinil at therapeutic dosages even with prolonged use for 40 weeks and as long as three years. Coadministration with modafinil alongside opioids such as hydrocodone , oxycodone , and fentanyl , as well as various other drugs, may experience a drop in plasma concentrations. The reasoning behind this action is because modafinil is an inducer of the CYP3A4 enzymes. If not monitored closely, reduced efficacy or withdrawal symptoms can occur. As of , \\\\\\\\\\\\\\[update\\\\\\\\\\\\\\] the therapeutic mechanism of action of modafinil for narcolepsy and sleep-wake disorders remains unknown. Research found that modafinil elevates histamine levels in the hypothalamus in animals. As such, 'modafinil is an exceptionally weak, but apparently very selective, \\\\\\\\\\\\\\[DAT\\\\\\\\\\\\\\] inhibitor'. Modafinil has been described as an 'atypical' DAT inhibitor, and shows a profile of effects that is very different from those of other dopaminergic stimulants. Against the hypothesis that modafinil exerts its effects by acting as a DRI, tyrosine hydroxylase inhibitors which deplete dopamine fail to block the effects of modafinil in animals. In any case, there is nonetheless a good deal of evidence to indicate that modafinil is producing at least a portion of its wakefulness-promoting effects by acting as a DRI, or at least via activation of the dopaminergic system. In support of modafinil acting as a dopaminergic agent, its wakefulness-promoting effects are abolished in DAT knockout mice although it is important to note that DAT knockout mice show D 1 and D 2 receptor and norepinephrine compensatory abnormalities, which might confound this finding , reduced by both D 1 and D 2 receptor antagonists although conflicting reports exist , \\\\\\\\\\\\\\[62\\\\\\\\\\\\\\] and completely blocked by simultaneous inactivation of both D 1 and D 2 receptors. Modafinil may possess yet an additional mechanism of action. Both modafinil and its metabolite , modafinil sulfone , possess anticonvulsant properties in animals, and modafinil sulfone is nearly as potent as modafinil in producing this effect. This percentage actually changes very little when the concentration is varied. Food slows absorption, but does not affect the total AUC \\\\\\\\\\\\\\[ clarification needed \\\\\\\\\\\\\\] AUC — area under the curve — meaning, food may slow absorption, but the total amount of the chemical will be absorbed with or without food. Half-life is generally in the 10—12 hour range, subject to differences in CYP genotypes, liver function and renal function. It is metabolized in the liver, and its inactive metabolite is excreted in the urine. Instrumental techniques involving gas or liquid chromatography are usually employed for these purposes. Reagent testing can be used to screen for the presence of modafinil in samples. Modafinil was originally developed in France by neurophysiologist and emeritus experimental medicine professor Michel Jouvet and Lafon Laboratories. Modafinil originated with the late s invention of a series of benzhydryl sulfinyl compounds, including adrafinil , which was first offered as an experimental treatment for narcolepsy in France in Modafinil is the primary metabolite of adrafinil, lacking the polar -OH group on its terminal amide, \\\\\\\\\\\\\\[80\\\\\\\\\\\\\\] and has similar activity to the parent drug but is much more widely used. It has been prescribed in France since under the name Modiodal, and in the US since as Provigil. In , modafinil was approved by the U. It was approved for use in the UK in December Modafinil is marketed in the US by Cephalon Inc. Cephalon began to market the R-enantiomer armodafinil of modafinil in the U. After protracted patent litigation and negotiations see below , generic versions of modafinil became available in the U. Patent 4,, was issued to Laboratoire L. Lafon on May 22, , covering the chemical compound modafinil. On October 6, , Cephalon filed an additional patent, covering modafinil in the form of particles of defined size. Patent 5,, was issued on April 8, , but was reissued in as RE 37,, which surrendered the patent. With pediatric exclusivity, this patent expired on April 6, On December 24, , anticipating the expiration of exclusive marketing rights, generic drug manufacturers Mylan, Teva, Barr, and Ranbaxy applied to the FDA to market a generic form of modafinil. There is some question whether a particle size patent is sufficient protection against the manufacture of generics. Pertinent questions include whether modafinil may be modified or manufactured to avoid the granularities specified in the new Cephalon patent, and whether patenting particle size is invalid because particles of appropriate sizes are likely to be obvious to practitioners skilled in the art. However, under United States patent law, a patent is entitled to a legal presumption of validity, meaning that in order to invalidate the patent, much more than 'pertinent questions' are required. As of October 31, , U. RE 37, has been declared invalid and unenforceable. Lafon ; 3 was obvious at the time the invention was made to a person having ordinary skill in the art under 35 U. Cephalon made an agreement with four major generics manufacturers Teva , Barr Pharmaceuticals , Ranbaxy Laboratories , and Watson Pharmaceuticals between and to delay sales of generic modafinil in the US until April by these companies in exchange for upfront and royalty payments. In the United Kingdom, Mylan Inc. Modafinil is currently \\\\\\\\\\\\\\[update\\\\\\\\\\\\\\] classified as a Schedule IV controlled substance under United States federal law; it is illegal to import by anyone other than a DEA -registered importer without a prescription. In mainland China , modafinil is strictly controlled like other stimulants, such as amphetamines and methylphenidate , and not approved for medical use. In Japan , modafinil is Schedule I psychotropic drug. In Russia modafinil is Schedule II controlled substance like cocaine and morphine. Possession of few modafinil pills can lead to 3—10 years imprisonment. The regulation of modafinil as a doping agent has been controversial in the sporting world, with high-profile cases attracting press coverage since several prominent American athletes have tested positive for the substance. Some athletes who were found to have used modafinil protested that the drug was not on the prohibited list at the time of their offenses. The Agency added modafinil to its list of prohibited substances on August 3, , ten days before the start of the Summer Olympics. Modafinil has received some publicity in the past when several athletes such as sprinter Kelli White in , cyclist David Clinger \\\\\\\\\\\\\\[\\\\\\\\\\\\\\] and basketball player Diana Taurasi \\\\\\\\\\\\\\[\\\\\\\\\\\\\\] in , and rower Timothy Grant in \\\\\\\\\\\\\\[\\\\\\\\\\\\\\] were discovered allegedly using it as a performance-enhancing doping agent. Taurasi and another player, Monique Coker, tested at the same lab, were later cleared. Modafinil has been used non-medically as a ' smart drug ' by students, office workers, soldiers and transhumanists. Double-blind randomized controlled trials have demonstrated the efficacy and tolerability of modafinil in pediatric ADHD, \\\\\\\\\\\\\\[\\\\\\\\\\\\\\] \\\\\\\\\\\\\\[\\\\\\\\\\\\\\] however there are risks of serious side effects such as skin reactions and modafinil is not recommended for use in children. Modafinil used alone has been reported to be effective in a subgroup of individuals with depersonalization disorder ; \\\\\\\\\\\\\\[ citation needed \\\\\\\\\\\\\\] the subgroup of people with depersonalization disorder most likely to respond are those who have attentional impairments, under-arousal, and hypersomnia. However, clinical trials have not been conducted. Evan Torch calls a combination of an SSRI and modafinil 'the hidden pearl that can really help depersonalization disorder. Modafinil may also be an effective and well-tolerated treatment in patients with seasonal affective disorder. A randomized double-blind study of modafinil showed that normal healthy volunteers between the ages of 30—44 showed general improvement in alertness as well as mood. The conclusion demonstrated that modafinil may have general mood-elevating effects in particular for the adjunctive use in treatment-resistant depression. Modafinil is under investigation as a possible method to treat cocaine dependence , for several reasons involving biochemical mechanisms of the two drugs, as well as the observation that clinical effects of modafinil are largely opposite to symptoms of cocaine withdrawal. The pilot 8-week double-blind study of modafinil for cocaine dependence produced inconclusive results. The number of cocaine-positive urine samples was significantly lower in the modafinil group as compared to the placebo group in the middle of the trial, but by the end of the 8 weeks the difference stopped being significant. Even before the treatment began, the modafinil group had lower cocaine consumption further confounding the results. As compared to placebo, modafinil did not reduce cocaine craving or self-reported cocaine use, and the physicians ratings were only insignificantly better. A later double-blind study of modafinil in people seeking treatment for cocaine dependence found no statistically significant effect on the rate of change in percentage of cocaine non-use days, but noted a significant improvement in the maximum number of consecutive non-use days for cocaine and reduced craving. However, the prescribing information for Provigil notes that 'There were no clinically significant differences in body weight change in patients treated with Provigil compared to placebo-treated patients in the placebo-controlled clinical trials. In experimental studies, the appetite reducing effect of modafinil appears to be similar to that of substituted amphetamines , but, unlike substituted amphetamines, the dose of modafinil that is effective at decreasing food intake does not significantly increase heart rate. After three years, his weight stabilized at a pound weight loss The authors conclude that placebo controlled studies should be conducted on using modafinil as a weight loss agent. Modafinil has been studied as a possible treatment for delayed sleep phase syndrome , which causes excessive daytime somnolence when the natural delayed diurnal rhythm is replaced by a socially determined earlier or forward shifted sleep schedule. There is disagreement to whether the cognitive effects modafinil showed in healthy non-sleep-deprived people are sufficient to consider it to be a cognitive enhancer. Researchers from the University of Oxford and Harvard Medical School evaluated all research papers on cognitive enhancement with modafinil from January to December and found 24 studies dealing with benefits that include planning, decision making , flexibility, learning, memory and creativity associated with taking modafinil. Modafinil has been used off-label in trials with people with symptoms of post-chemotherapy cognitive impairment , also known as 'chemobrain', but in it was found to be no better than placebo. Modafinil has been evaluated alone and in combination with scopolamine as an anti-motion sickness medication. It did not help by itself, but appeared to help in combination with scopolamine, acting to reduce symptoms of drowsiness associated with scopolamine. From Wikipedia, the free encyclopedia. C Risk not ruled out. S4 Prescription only UK: List of drugs used by militaries. Pharmacy and Pharmacology portal. He reported sleep disturbance, increased sense of body warmth, lethargy and low mood during the process of tapering the drug. Low dose of clonazepam was added to reduce the withdrawal symptoms. Because of the relatively low risk of addiction, modafinil can be more easily prescribed in patients without a clear, biochemically defined central hypersomnia syndrome, and is also easier to stop, if needed. It is also a schedule IV compound. Drug Metabolism and Disposition. United States Food and Drug Administration. Retrieved July 18, A review of current research'. Neuropsychiatric Disease and Treatment. An American Academy of Sleep Medicine report'. Retrieved December 31, Journal of Neurology, Neurosurgery, and Psychiatry. Journal of Medical Internet Research. The Journal of Clinical Psychiatry. Journal of Clinical Psychopharmacology. Journal of Child Neurology. Retrieved July 4, United States Department of the Air Force. Retrieved September 18, Food and Drug Administration. Archived from the original on June 10, Retrieved July 21, Retrieved August 16, Drug and Alcohol Dependence. Potential clinical uses and mechanisms of action'. European Journal of Pharmacology. Journal of Neuroscience Research. The Journal of Pharmacology and Experimental Therapeutics. Novel 2-\\\\\\\\\\\\\\[ Diphenylmethyl sulfinyl\\\\\\\\\\\\\\]acetamide Modafinil Analogues'. Journal of Medicinal Chemistry. The International Journal of Neuropsychopharmacology. Walker 22 May The Neuroscience of Sleep. Search for next generation modafinil, lessons learned: Clinical Pharmacology and Therapeutics. Journal of Pharmaceutical and Biomedical Analysis. The Journal of Clinical Pharmacology. Journal of Clinical Pharmacology. Disposition of Toxic Drugs and Chemicals in Man. Retrieved 18 December Expert Review of Neurotherapeutics. Pennsylvania Eastern District Court:: Retrieved August 29, Teva will also grant non-exclusive U. Archived from the original on April 25, United States Drug Enforcement Administration. United States Department of Justice. Archived from the original on February 23, China Food and Drug Administration. Retrieved Nov 11, Archived from the original — Scholar search on July 6, Federal Commission for Protection against Health Risks. Archived from the original on July 13, Retrieved April 3, Retrieved 8 January Retrieved October 8, Retrieved July 2, Medicine and Science in Sports and Exercise. Military Drug New Rage'. Now they take them to get higher grades'. Retrieved 9 April A Real-Life Superhero Pill? Archived from the original PDF on July 21, Retrieved 2 July A New Look at a Neglected Syndrome. Depersonalization Disorder and the Loss of the Self. Annals of Clinical Psychiatry. The American Journal of Psychiatry. Journal of Affective Disorders. Pharmacology, Biochemistry, and Behavior. Lay summary — Live Science. A double-blind, randomised controlled trial'. Current Opinion in Supportive and Palliative Care. The Cochrane Database of Systematic Reviews. Aviation, space, and environmental medicine. Adapromine Amantadine Bromantane Memantine Rimantadine. Oxiracetam Phenylpiracetam Phenylpiracetam hydrazide. Selective norepinephrine reuptake inhibitors: Amoxapine Maprotiline Mianserin Oxaprotiline Setiptiline. Selective serotonin reuptake inhibitors: A Amoxapine Antihistamines e. Amantadine Memantine Rimantadine Aminotetralins: Retrieved from ' https: Pages using citations with accessdate and no URL All pages needing factual verification Wikipedia articles needing factual verification from June CS1 errors: Views Read Edit View history. In other projects Wikimedia Commons. This page was last edited on 4 November , at By using this site, you agree to the Terms of Use and Privacy Policy. Very low \\\\\\\\\\\\\\[1\\\\\\\\\\\\\\] Physical: Very low to low \\\\\\\\\\\\\\[2\\\\\\\\\\\\\\]. IUPAC name 2-\\\\\\\\\\\\\\[ diphenylmethyl sulfinul\\\\\\\\\\\\\\]acetamide. Modafinil analogs and their effects on the central nervous system.

Modafinil

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Препарат 'Модафинил': отзывы, применение, противопоказания, побочные эффекты

Модафинил — так ли он эффективен и можно ли купить «умный» ноотроп в России?

Препарат 'Модафинил': отзывы, применение, противопоказания, побочные эффекты

Препарат 'Модафинил': отзывы, применение, противопоказания, побочные эффекты

Модафинил — так ли он эффективен и можно ли купить «умный» ноотроп в России?

Препарат 'Модафинил': отзывы, применение, противопоказания, побочные эффекты

Препарат 'Модафинил': отзывы, применение, противопоказания, побочные эффекты

Модафинил — так ли он эффективен и можно ли купить «умный» ноотроп в России?

Модафинил — так ли он эффективен и можно ли купить «умный» ноотроп в России?

Модафинил — так ли он эффективен и можно ли купить «умный» ноотроп в России?

Препарат 'Модафинил': отзывы, применение, противопоказания, побочные эффекты

Модафинил — так ли он эффективен и можно ли купить «умный» ноотроп в России?

Препарат 'Модафинил': отзывы, применение, противопоказания, побочные эффекты

Препарат 'Модафинил': отзывы, применение, противопоказания, побочные эффекты

Модафинил — так ли он эффективен и можно ли купить «умный» ноотроп в России?

Модафинил — так ли он эффективен и можно ли купить «умный» ноотроп в России?

Препарат 'Модафинил': отзывы, применение, противопоказания, побочные эффекты

Препарат 'Модафинил': отзывы, применение, противопоказания, побочные эффекты

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