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What is Modafinil 100mg used for?

In the pharmaceutical industry, Modafinil 100 mg is classified as a eugeroic or “wakefulness-promoting agent.” As a pharmacist, I categorize this as a unique Central Nervous System (CNS) stimulant; unlike traditional amphetamines or methylphenidate, Modafinil has a lower potential for abuse and does not typically cause the “crash” or intense jitteriness associated with older stimulants.

Primary Clinical Uses

  • Narcolepsy: The gold standard for treating excessive daytime sleepiness associated with narcolepsy.

  • Shift Work Sleep Disorder (SWSD): Prescribed for individuals whose work schedules interfere with normal sleep patterns, helping them stay alert during their shift.

  • Obstructive Sleep Apnea (OSA): Used as an adjunctive therapy when excessive sleepiness persists despite successful use of a CPAP machine.

  • Off-label/Cognitive Enhancement: Widely used as a “nootropic” to improve focus, memory, and productivity in high-pressure environments.

Mechanism of Action: Selective Dopamine Inhibition

While the exact mechanism is complex and multi-faceted, Modafinil is known to work differently than standard stimulants.

DAT Inhibition: It acts as a selective, relatively weak Dopamine Transporter (DAT) inhibitor. By blocking the reuptake of dopamine, it increases extracellular dopamine levels in specific brain regions related to alertness.

Orexin/Hypocretin System: It is believed to activate the orexin system in the hypothalamus, which is the body’s natural “on/off” switch for wakefulness.

GABA/Glutamate Balance: It modulates the levels of Gamma-Aminobutyric Acid (GABA) and Glutamate, leading to heightened alertness without the heavy peripheral “fight or flight” response seen with caffeine.

The Manufacturer’s Perspective: Formulation & Export

From a production and global trade standpoint, Modafinil 100 mg is a high-value “lifestyle” and “specialty” pharmaceutical:

  • BCS Class II Challenges: Modafinil is practically insoluble in water. At our WHO-GMP facility, we focus on micronization of the API and the use of specific surfactants to ensure the 100 mg tablet meets strict BP/USP/IP dissolution standards.

  • Abuse Potential Management: While it is a Schedule IV controlled substance in many markets (like the USA), its low abuse potential makes it a very attractive product for international B2B trading compared to Schedule II stimulants.

  • Stability for Export: We utilize Alu-Alu blister packaging to protect the API from moisture and light, ensuring a 36-month shelf life for export to Zone IVb regions.

  • Dossier Support: Our Mumbai-based facility provides full CTD/eCTD Dossiers to support international registration against the innovator (Provigil).

Modafinil Tablets