Practice Parameter for the Use of Stimulant Medications in the Treatment of Children, Adolescents, and Adults
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Psychostimulants have been used routinely for the treatment of the disabling daytime sleepiness associated with narcolepsy. However, the perceived and real potential for abuse of amphetamine and amphetaminelike stimulants prompted a search for new wake-promoting compounds with lower dependency and abuse liabilities. Modafinil is a novel wake-promoting agent with a mechanism of action that differs markedly from that of amphetamine and amphetamine-like stimulants. In controlled clinical trials, modafinil has been shown to be an effective and well-tolerated treatment for excessive daytime sleepiness (EDS) in patients with narcolepsy. With a benzhydrylsulfinylacetamide structure, modafinil has a low level of solubility in water (<1 mg/mL) and is unstable at temperatures ≥180°C, physicochemical properties that reduce the potential for its abuse via intravenous injection and smoking, respectively. Available preclinical and clinical data on the abuse liability of modafinil suggest a much lower potential for abuse and dependency than amphetaminelike stimulants commonly used for treating EDS in patients with narcolepsy. Therefore, modafinil represents a valuable therapeutic option for the treatment of EDS associated with narcolepsy.
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Excessive daytime sleepiness (EDS) is a common and debilitating symptom of narcolepsy and other sleep disorders. Modafinil is a novel stimulant which effectively treats EDS, yet lacks many of the undesirable side-effects commonly encountered with currently available compounds. The specific mode of action of modafinil is not well understood, but it may promote sleep by indirectly influencing adrenergic or GABAergic neurotransmission. Modafinil-induced wakefulness is not associated with rebound hypersomnolence or the potential for abuse as is often encountered with other stimulants such as amphetamines. At typical therapeutic doses, modafinil may produce dry mouth but generally has a low incidence of minor side-effects. Many preclinical and clinical studies have demonstrated the effectiveness of modafinil in promoting wakefulness and vigilance in normal subjects and in those with EDS. Modafinil significantly improves the EDS of narcolepsy and also may improve the EDS of idiopathic hypersomnia and obstructive sleep apnoea. Modafinil's low prevalence of side-effects, minimal potential for abuse, and lack of rebound hypersomnia indicate that it has potential to become a widely prescribed drug for the treatment of narcolepsy.
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(1) Narcolepsy (daytime bouts of drowsiness) is sometimes associated with cataplexy, and can be incapacitating. The best-assessed treatment is modafinil, which has no demonstrated efficacy on cataplexy. (2) After many years of off-license use in the treatment of narcolepsy, methylphenidate is now licensed for this indication in France. (3) According to the results of our literature search, which includes a clinical expert report from Novartis Pharma, the file on methylphenidate in narcolepsy is mainly based on "clinical experience": only three case series, totalling fewer than 200 patients, have been published. (4) These non comparative studies suggest an effect of high dose methylphenidate on daytime drowsiness and cataplexy. (5) The adverse effects of methylphenidate are those of amphetamine psychostimulants, i.e. mainly neuropsychological disorders, cardiovascular effects, loss of appetite and a limited risk of excessive use by some patients.
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Narcolepsy is a chronic neurologic disorder characterized by excessive daytime sleepiness and cataplexy arising from dysregulation of pathway controlling the wake and sleep states. Despite advances in our understanding of the pathophysiology of narcolepsy, to date, only symptomatic treatments exist for this disease. Especially in Korea, only limited medication for narcolepsy has been available. In general, psychostimulants such as modafinil, armodafinil, and methylphenidate were prescribed to improve wakefulness, and cataplexy was managed with antidepressants. Recently many new agents has been developed and widely used in the United States and European countries. Some of those medications are expected to be available in Korea soon. Education of lifestyle modification and regular naps are also important strategy for the treatment of narcolepsy. This review summarizes briefly current and future medication, and nonpharmacological management of narcolepsy as well. Keywords: Narcolepsy, Modafinil, Armodafinil, Pitolisant, Methylphenidate, Disorders of excessive somnolence
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Successful treatment of narcolepsy requires an accurate diagnosis to exclude patients with other sleep disorders, which have different treatments, and to avoid unnecessary complications of drug treatment. Treatment objectives should be tailored to individual circumstances. Modafinil, amphetamine, methamphetamine, dextroamphetamine, methylphenidate, selegiline, pemoline, tricyclic antidepressants, and fluoxetine are effective treatments for narcolepsy, but the quality of published clinical evidence supporting them varies. Scheduled naps can be beneficial to combat sleepiness, but naps seldom suffice as primary therapy. Regular follow up of patients with narcolepsy is necessary to educate patients and their families, monitor for complications of therapy and emergent of other sleep disorders, and help the patient adapt to the disease.
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Two experiments were conducted to determine whether methylphenidate or modafinil, two potential pharmacotherapies for stimulant dependence, would impair inhibitory behavior in cocaine users. Eleven cocaine abusers were administered methylphenidate (0, 15, 30, and 45 mg) or modafinil (0, 150, 300, and 450 mg) across four experimental sessions. A cued go–no-go task was used to measure response execution and inhibition. Subjective and cardiovascular measures were collected. Neither methylphenidate nor modafinil impaired inhibitory control, but produced prototypical subject-rated and cardiovascular effects. The results of these studies may have implications for the use of these drugs as agonist-replacement therapies for stimulant dependence.
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