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A review of modafinil film-coated tablets for attention-deficit/hyperactivity disorder in children and adolescents.

Rugino T - Neuropsychiatr Dis Treat (2007)

Bottom Line: Several studies, including three double-blind, placebo-controlled studies with intent-to-treat analyses, have demonstrated the efficacy of modafinil film-coated tablets in reducing symptoms of ADHD and associated problem behaviors in children and adolescents.Modafinil is generally well tolerated, with adverse events (such as insomnia, headache, loss of appetite, weight loss, and gastrointestinal discomfort) that are generally mild to moderate, rarely leading to medication discontinuation.Due to reports of skin rash (including one case of possible erythema multiforme/Stevens Johnson Syndrome during pivotal studies), additional studies have been requested to better evaluate the risks of developing severe cutaneous adverse reactions.

View Article: PubMed Central - PubMed

Affiliation: Children's Specialized Hospital, 94 Stevens Road, Toms River, NJ 08755, USA. trugino@childrens-specialized.org

ABSTRACT
Modafinil, a wakefulness-promoting agent unrelated to classical sympathomimetic stimulants, has been studied in a total of 933 children and adolescents as a treatment for attention-deficit/hyperactivity disorder (ADHD). Several studies, including three double-blind, placebo-controlled studies with intent-to-treat analyses, have demonstrated the efficacy of modafinil film-coated tablets in reducing symptoms of ADHD and associated problem behaviors in children and adolescents. Modafinil is generally well tolerated, with adverse events (such as insomnia, headache, loss of appetite, weight loss, and gastrointestinal discomfort) that are generally mild to moderate, rarely leading to medication discontinuation. To minimize treatment-emergent side effects, titration to the target dose of 355-425 mg once a day should take place over 2-3 weeks. Due to reports of skin rash (including one case of possible erythema multiforme/Stevens Johnson Syndrome during pivotal studies), additional studies have been requested to better evaluate the risks of developing severe cutaneous adverse reactions.

No MeSH data available.


Related in: MedlinePlus

Indirect activation of the cerebral cortex by modafinil action on the tuberomammillary nucleus. Adapted from Swanson et al (1998).Abbreviations: SN, suprachiasmatic nucleus; TMN, tuberomammilary nucleus; VTA, ventral tegmental area.
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f2-ndt-3-293: Indirect activation of the cerebral cortex by modafinil action on the tuberomammillary nucleus. Adapted from Swanson et al (1998).Abbreviations: SN, suprachiasmatic nucleus; TMN, tuberomammilary nucleus; VTA, ventral tegmental area.

Mentions: Although approved by the US Food and Drug Administration for improving wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea, and shift work sleep disorder 16 years of age and older (Cephalon 2004), its mechanism of action in humans is not fully understood. After administration of modafinil, functional MRI (fMRI) has shown activation of the anterior cingulate cortex during a task of working memory (Spence et al 2005), and an activation of other cortical areas (particularly in individuals with low initial activation levels; Ellis et al 1999). This is very significant, considering that the anterior cingulate cortex was notably deficient in fMRI activity in individuals with ADHD during a working memory task (Bush et al 1999). A likely hypothesis regarding modafinil’s physiologic effects is that modafinil indirectly activates the cerebral cortex (including areas implicated in ADHD pathology) via ascending arousal pathways arising from the hypothalamus (eg, the tuberomammillary nucleus; see Figure 2).


A review of modafinil film-coated tablets for attention-deficit/hyperactivity disorder in children and adolescents.

Rugino T - Neuropsychiatr Dis Treat (2007)

Indirect activation of the cerebral cortex by modafinil action on the tuberomammillary nucleus. Adapted from Swanson et al (1998).Abbreviations: SN, suprachiasmatic nucleus; TMN, tuberomammilary nucleus; VTA, ventral tegmental area.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2654790&req=5

f2-ndt-3-293: Indirect activation of the cerebral cortex by modafinil action on the tuberomammillary nucleus. Adapted from Swanson et al (1998).Abbreviations: SN, suprachiasmatic nucleus; TMN, tuberomammilary nucleus; VTA, ventral tegmental area.
Mentions: Although approved by the US Food and Drug Administration for improving wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea, and shift work sleep disorder 16 years of age and older (Cephalon 2004), its mechanism of action in humans is not fully understood. After administration of modafinil, functional MRI (fMRI) has shown activation of the anterior cingulate cortex during a task of working memory (Spence et al 2005), and an activation of other cortical areas (particularly in individuals with low initial activation levels; Ellis et al 1999). This is very significant, considering that the anterior cingulate cortex was notably deficient in fMRI activity in individuals with ADHD during a working memory task (Bush et al 1999). A likely hypothesis regarding modafinil’s physiologic effects is that modafinil indirectly activates the cerebral cortex (including areas implicated in ADHD pathology) via ascending arousal pathways arising from the hypothalamus (eg, the tuberomammillary nucleus; see Figure 2).

Bottom Line: Several studies, including three double-blind, placebo-controlled studies with intent-to-treat analyses, have demonstrated the efficacy of modafinil film-coated tablets in reducing symptoms of ADHD and associated problem behaviors in children and adolescents.Modafinil is generally well tolerated, with adverse events (such as insomnia, headache, loss of appetite, weight loss, and gastrointestinal discomfort) that are generally mild to moderate, rarely leading to medication discontinuation.Due to reports of skin rash (including one case of possible erythema multiforme/Stevens Johnson Syndrome during pivotal studies), additional studies have been requested to better evaluate the risks of developing severe cutaneous adverse reactions.

View Article: PubMed Central - PubMed

Affiliation: Children's Specialized Hospital, 94 Stevens Road, Toms River, NJ 08755, USA. trugino@childrens-specialized.org

ABSTRACT
Modafinil, a wakefulness-promoting agent unrelated to classical sympathomimetic stimulants, has been studied in a total of 933 children and adolescents as a treatment for attention-deficit/hyperactivity disorder (ADHD). Several studies, including three double-blind, placebo-controlled studies with intent-to-treat analyses, have demonstrated the efficacy of modafinil film-coated tablets in reducing symptoms of ADHD and associated problem behaviors in children and adolescents. Modafinil is generally well tolerated, with adverse events (such as insomnia, headache, loss of appetite, weight loss, and gastrointestinal discomfort) that are generally mild to moderate, rarely leading to medication discontinuation. To minimize treatment-emergent side effects, titration to the target dose of 355-425 mg once a day should take place over 2-3 weeks. Due to reports of skin rash (including one case of possible erythema multiforme/Stevens Johnson Syndrome during pivotal studies), additional studies have been requested to better evaluate the risks of developing severe cutaneous adverse reactions.

No MeSH data available.


Related in: MedlinePlus