From the Guidelines
Yes, modafinil is a controlled substance in the United States, classified as a Schedule IV controlled substance under the Controlled Substances Act. This classification indicates that while modafinil has accepted medical uses, it also has some potential for abuse and dependence, though lower than substances in Schedules I, II, or III 1. Modafinil is prescribed primarily to treat excessive daytime sleepiness associated with narcolepsy, shift work sleep disorder, and obstructive sleep apnea. Typical dosing ranges from 100-200 mg taken once daily in the morning for narcolepsy and obstructive sleep apnea, or about one hour before starting a shift for shift work disorder. As a controlled medication, modafinil requires a prescription from a licensed healthcare provider, cannot be refilled without a new prescription, and may have restrictions on the number of refills allowed. The drug works by affecting certain neurotransmitters in the brain, particularly dopamine, though its exact mechanism of action isn't fully understood. While generally considered to have lower abuse potential than stimulants like amphetamines, patients should be aware that it still carries risks of dependence and should only be used as prescribed.
Some key points to consider when prescribing modafinil include:
- Its potential for abuse or dependency, as noted in the FDA classification as a Schedule IV controlled substance 1
- The potential for fetal harm based on animal data, with human data being insufficient to determine risk 1
- The possibility of reducing the effectiveness of oral contraception 1
- Commonly reported adverse events, including insomnia, nausea, diarrhea, headache, and dry mouth 1
Given the potential benefits and risks, the use of modafinil should be carefully considered and monitored by a healthcare provider, especially in populations such as pregnant or breastfeeding women, and pediatric patients, where the balance of risks and harms may differ 1.
From the FDA Drug Label
Modafinil has reinforcing properties, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine; modafinil was also partially discriminated as stimulant-like. Results from this clinical study demonstrated that modafinil produced psychoactive and euphoric effects and feelings consistent with other scheduled CNS stimulants (methylphenidate).
Modafinil is a controlled substance. It is classified as a Schedule IV controlled substance due to its potential for abuse and dependence, although this is not explicitly stated in the provided text. However, based on the information provided, modafinil exhibits properties consistent with other controlled substances, such as producing psychoactive and euphoric effects and having reinforcing properties 2.
From the Research
Modafinil Classification
- Modafinil is a wakefulness-promoting agent that is pharmacologically distinct from CNS stimulants, such as amfetamine, dexamfetamine, and methylphenidate 3.
- It is approved for use in the US and certain European countries for patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnoea/hypopnoea syndrome (OSA/HS), or shift work sleep disorder (SWSD) 3, 4.
Controlled Substance Status
- Modafinil has a low abuse potential compared to other stimulants 3, 5.
- Studies suggest that modafinil has limited potential for large-scale abuse 6.
- However, it is essential to note that modafinil may have some abuse/addictive potential, although no cases have been reported to date 5.
Regulatory Status
- Modafinil is approved by the US FDA for the treatment of narcolepsy, shift-work sleep disorder, and obstructive sleep apnea with residual excessive sleepiness despite optimal use of continuous positive airway pressure (CPAP) 5, 4.
- It is also used off-label for various conditions, including attention-deficit disorder, postanesthetic sedation, and cocaine dependence and withdrawal 7.