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Pharmacovigilance01:19

Pharmacovigilance

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
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Therapeutic Drug Monitoring: Affecting Factors01:29

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Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
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Cognitive Enhancers: Cholinesterase Inhibitors and NMDA Receptor Antagonists01:30

Cognitive Enhancers: Cholinesterase Inhibitors and NMDA Receptor Antagonists

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Cognitive enhancers, also known as "smart drugs," are substances used to enhance memory, mental alertness, and concentration. These can be natural or synthetic and improve cognition in conditions like Alzheimer's disease (AD) and other neurodegenerative diseases. Some common examples include caffeine, amphetamines, methylphenidate, modafinil, arecoline, donepezil, vortioxetine, and piracetam. These enhancers work on the principle of synaptic plasticity and altered circuit function.
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Antidepressant Drugs: MAOIs and Other Agents01:23

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Atypical antidepressants, including bupropion (Wellbutrin), mirtazapine (Remeron), nefazodone (Serzone), trazodone (Desyrel), and vilazodone (Viibryd), offer unique mechanisms of action. Bupropion weakly inhibits dopamine and norepinephrine reuptake, aiding depression treatment and smoking cessation, with a low risk of sexual dysfunction. Mirtazapine enhances serotonin and norepinephrine neurotransmission, leading to sedation, increased appetite, and weight gain. As a result, it helps treat...
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Therapeutic Drug Monitoring: Overview and Classification01:16

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Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood at designated intervals to ensure the drug concentration stays within a therapeutic range. This monitoring is crucial for optimizing individual dosage regimens, enhancing therapeutic efficacy, and minimizing drug-related toxicity. TDM is vital for drugs with narrow therapeutic windows, significant variability in pharmacokinetics, and a clear correlation between plasma levels and...
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Factors Affecting Drug Response: Overview01:21

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When it comes to infants and young children, they are typically administered smaller doses of medication in comparison to adults. This is primarily because their organ functions still need to fully develop, meaning their bodies are not as efficient at metabolizing or eliminating drugs. Additionally, their blood-brain barrier is more permeable than in adults. As a result, high concentrations of drugs can easily penetrate the central nervous system (CNS), potentially leading to neurological...
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Assessing Condition-Specific Adverse Event Profiles of Modafinil for Labelled and Off-Label Uses: A Systematic Review

Jaehee Jung1, Jaeyoon Youm2, Jihyun Kang3

  • 1College of Pharmacy, Yonsei Institute of Pharmaceutical Sciences, Yonsei University, Incheon, South Korea.

Basic & Clinical Pharmacology & Toxicology
|December 10, 2025
PubMed
Summary

Modafinil use, both approved and off-label, is linked to various adverse events. Specific risks like insomnia and anxiety differ significantly across conditions such as narcolepsy and ADHD.

Keywords:
AEmeta‐analysismodafiniloff‐label usesystematic review

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Area of Science:

  • Pharmacovigilance
  • Clinical Pharmacology
  • Sleep Medicine

Background:

  • Modafinil is prescribed for narcolepsy, obstructive sleep apnea (OSA), and shift work sleep disorder (SWSD).
  • Off-label modafinil use is prevalent, prompting safety evaluations.
  • Adverse events (AEs) associated with modafinil require detailed investigation across different patient populations.

Purpose of the Study:

  • To assess the risk of adverse events (AEs) linked to both approved and off-label modafinil usage.
  • To identify condition-specific AE profiles for modafinil.
  • To inform clinical prescribing practices and the consideration of alternative treatments.

Main Methods:

  • A systematic literature search was conducted across PubMed, Embase, and Cochrane databases.
  • Fifty-four relevant studies were included in the analysis.
  • Risk ratios (RR) and confidence intervals (CI) were calculated to quantify AE risks in various patient groups.

Main Results:

  • Narcolepsy patients showed increased risks of diarrhea and nausea.
  • OSA/hypopnea syndrome patients experienced higher rates of insomnia, anxiety/nervousness, and headache.
  • SWSD patients had elevated risks of insomnia, anxiety/nervousness, and nausea.
  • Off-label use in ADHD patients was associated with higher risks of insomnia and decreased appetite.
  • Off-label use in major depressive disorder patients showed increased anxiety/nervousness.

Conclusions:

  • While common AEs exist, modafinil's adverse event profile varies significantly among different patient groups and conditions.
  • Understanding these condition-specific risks is crucial for safe modafinil prescribing.
  • The findings support cautious use of modafinil and careful evaluation of alternative therapeutic options.