Modafinil is a Schedule IV Controlled Substance
Yes, modafinil (Provigil) is classified as a Schedule IV federally controlled substance in the United States due to its potential for abuse or dependency. 1, 2
Regulatory Classification and Implications
Modafinil's Schedule IV classification means:
- It requires a prescription from a licensed healthcare provider
- Prescriptions typically have limitations on refills
- There are restrictions on how the medication can be transferred between patients
- Special record-keeping requirements exist for pharmacies and prescribers
Legal Framework
As a Schedule IV controlled substance, modafinil is regulated under the Controlled Substances Act, which categorizes drugs based on their medical use and potential for abuse. Schedule IV substances are considered to have:
- A currently accepted medical use in treatment
- A lower potential for abuse relative to Schedule III substances
- Limited physical or psychological dependence liability compared to Schedule III substances 2
Clinical Uses and Prescribing Context
Modafinil is FDA-approved for treating excessive daytime sleepiness associated with:
- Narcolepsy
- Obstructive sleep apnea (as an adjunct to primary treatments)
- Shift work sleep disorder 2
It has also been used off-label in various conditions including:
- Hypersomnia secondary to medical conditions such as:
- Parkinson's disease
- Multiple sclerosis
- Myotonic dystrophy
- Traumatic brain injury
- Dementia with Lewy bodies 1
Important Prescribing Considerations
Abuse Potential
While modafinil is classified as a controlled substance, studies indicate it has lower abuse potential compared to traditional stimulants like amphetamines 3. However, it does produce psychoactive and euphoric effects consistent with other CNS stimulants, which necessitates careful monitoring, particularly in patients with a history of substance abuse 2.
Pregnancy Risks
- Based on animal data, modafinil may cause fetal harm
- Human data are insufficient to determine risk
- A 2018 report from the ongoing armodafinil/modafinil pregnancy registry showed higher rates of major congenital anomalies in children exposed in utero 1, 2
Contraception Concerns
- Modafinil may reduce the effectiveness of hormonal contraceptives
- Women should use alternative or additional contraceptive methods during treatment and for one month after discontinuation 2
- Cases of pregnancy occurring while using oral contraceptives with modafinil have been reported 4
Special Populations
- Not approved for pediatric use due to serious skin reactions including Stevens-Johnson Syndrome 2
- Dose adjustment recommended for elderly patients and those with hepatic impairment 2
Common Adverse Effects
The most frequently reported adverse effects include:
Practical Prescribing Pitfalls to Avoid
Failure to recognize non-FDA approved products: Some dietary supplements may contain modafinil analogs (like adrafinil) that are marketed as cognitive enhancers or "nootropics" 6
Inadequate contraceptive counseling: Ensure female patients of childbearing potential are on effective contraception before prescribing 4
Inappropriate off-label prescribing: While modafinil has been studied for various off-label uses including ADHD, depression, and cognitive enhancement, evidence for these uses varies in quality 7
Overlooking drug interactions: Modafinil can interact with various medications through CYP enzyme induction, particularly affecting hormonal contraceptives 2
Inadequate monitoring: Patients should be monitored for psychiatric adverse effects, cardiovascular effects, and rare but serious skin reactions 4