General Overview
Modalert 100 mg is a pharmaceutical-grade medication containing modafinil, a central nervous system (CNS) stimulant classified as a wakefulness-promoting agent (eugeroic). Manufactured primarily by Sun Pharmaceutical Industries, Modalert is widely used to treat excessive daytime sleepiness and is a popular alternative to branded Provigil.
Product Details
- Brand Name: Modalert 100
- Generic Name: Modafinil
- Strength: 100 mg per tablet
- Form: Oral tablet
- Manufacturer: Sun Pharma (India)
- Prescription Status: Prescription-only (Rx)
Therapeutic Class
- Class: Eugeroic (Wakefulness-Promoting Agent)
- Schedule: Schedule IV controlled substance in the U.S.
Indications (Uses)
Modalert 100 is FDA-approved for:
- Narcolepsy
– To reduce excessive daytime sleepiness associated with the condition. - Obstructive Sleep Apnea (OSA)
– As an adjunct to CPAP therapy to alleviate residual sleepiness. - Shift Work Sleep Disorder (SWSD)
– To promote alertness in individuals working non-traditional hours.
Off-label uses (consult a physician before use):
- Attention Deficit Hyperactivity Disorder (ADHD)
- Chronic fatigue syndrome
- Depression-related fatigue
- Cognitive enhancement / nootropic purposes
Mechanism of Action
While the exact mechanism is not fully understood, modafinil is known to:
- Inhibit dopamine reuptake by binding to the dopamine transporter (DAT)
- Increase levels of norepinephrine, serotonin, histamine, and orexin
- Promote wakefulness without the typical side effects of amphetamine-based stimulants (e.g., jitteriness or rebound crash)
Dosage & Administration
Standard adult dosing:
- Narcolepsy/OSA: 100–200 mg once daily in the morning
- SWSD: 100–200 mg taken 1 hour before the start of the work shift
Administration guidelines:
- Swallow tablet whole with water
- Can be taken with or without food
- Do not exceed 400 mg/day
Pharmacokinetics
- Bioavailability: ~80% (high)
- Onset of Action: 30–60 minutes
- Peak Plasma Levels: 2–4 hours post-dose
- Half-life: 12–15 hours
- Metabolism: Primarily in the liver (CYP3A4 pathway)
- Excretion: Mainly via the kidneys
Side Effects
Common side effects:
- Headache (most reported)
- Nausea
- Nervousness or anxiety
- Dry mouth
- Insomnia
- Dizziness
Less common but serious effects:
- Skin rashes (including Stevens-Johnson Syndrome)
- Chest pain
- Irregular heartbeat
- Hypertension
- Depression or mood swings
- Suicidal ideation (rare)
Warnings & Precautions
- Not recommended for patients with a history of cardiovascular conditions, psychiatric disorders, or liver impairment unless under close supervision.
- May impair judgment or motor skills during initial use.
- Reduces the effectiveness of hormonal contraceptives for up to 1 month after use – consider alternate birth control.
- Should not be used with alcohol or other CNS stimulants.
Drug Interactions
- Reduces efficacy of: Birth control pills (estrogen-based), some antivirals, anticonvulsants
- Increased risk of side effects with: SSRIs, tricyclic antidepressants, MAO inhibitors, anticoagulants (e.g., warfarin), CNS stimulants
- Modulates CYP450 enzymes, especially CYP3A4, CYP2C19, and CYP2C9
Contraindications
- Known hypersensitivity to modafinil or armodafinil
- History of serious rash or allergic reactions to stimulants
- Uncontrolled high blood pressure
- Severe heart arrhythmias
Pregnancy & Lactation
- Pregnancy Category C – Use only if the potential benefit justifies the risk
- Not recommended during breastfeeding, as it’s unclear whether modafinil is excreted in breast milk
Storage Conditions
- Store at 20°C to 25°C (68°F to 77°F)
- Keep in a dry, cool place away from direct sunlight
- Keep out of reach of children
Legal and Regulatory Status
- U.S. DEA Schedule IV – Low potential for abuse and dependence
- Banned or restricted in some countries without prescription (e.g., UAE, Japan)
- Use responsibly and in accordance with local laws
Market Comparison
Brand Name | Active Ingredient | Strength | Manufacturer | Notes |
---|---|---|---|---|
Modalert | Modafinil | 100/200 mg | Sun Pharma | Generic, widely trusted |
Provigil | Modafinil | 100/200 mg | Cephalon (Teva) | Original brand |
Waklert | Armodafinil | 150 mg | Sun Pharma | Longer half-life, R-enantiomer |
Modvigil | Modafinil | 100/200 mg | HAB Pharma | More cost-effective, slightly milder effect |