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Effects vary widely by individual, dose, and context.
The physical effects of modafinil can be broken down into several components.
The cognitive effects of modafinil can be broken down into several components.
These combinations are considered extremely harmful and should always be avoided. Reactions to these drugs taken in combination are highly unpredictable and have a potential to cause death.
These combinations are not usually physically harmful, but may produce undesirable effects, such as physical discomfort or overstimulation. Extreme use may cause physical health issues. Synergistic effects may be unpredictable. Care should be taken when choosing to use this combination.
Modafinil exhibits a low propensity for abuse compared to classical stimulants, as it lacks significantly expressed pleasurable or euphoric effects. However, emerging evidence suggests it works at similar neurobiological mechanisms as other addictive stimulants, warranting some caution.
The dependence liability of modafinil is considered low. However, due to its effects on dopamine balance, there is some potential for physical dependence with regular use, particularly when consumed for performance enhancement purposes with the intention of functioning on reduced sleep.
The human LD50 has not been established. Clinical trials involving 1000-1600 mg daily for 7-21 consecutive days produced no life-threatening effects. Acute overdoses of 4000-5000 mg in humans have resulted in symptoms including severe headache, nausea, agitation, insomnia, tremor, and tachycardia, but have not been life-threatening or fatal.
| Species | Route | Value |
|---|---|---|
| rat | oral | 3400 mg/kg |
| rat | injection | 1250 mg/kg |
| mouse | injection | 1250 mg/kg |
Modafinil can cause notable increases in heart rate and blood pressure through effects on autonomic cardiovascular regulation; these effects are primarily concerning for individuals with pre-existing cardiac conditions such as hypertension, arrhythmia, or structural heart abnormalities.
Modafinil can cause slight elevations in aminotransferase enzymes; there is no evidence of serious liver damage when enzyme levels remain within reference ranges.
Rare but serious cutaneous adverse reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome have been reported; these are uncommon immune-mediated reactions rather than dose-dependent toxicity.
Psychiatric symptoms including psychosis, mania, hallucinations, and delusions may occur, primarily in overdose situations. These reactions have been reported in individuals both with and without preexisting psychiatric history and may persist after discontinuation of the drug.
Seizures are a rare neurological complication that may arise primarily in overdose situations. The risk may be elevated when modafinil is combined with substances that lower the seizure threshold.
Modafinil was developed in France by neurophysiology professor Michel Jouvet and Lafon Laboratories. The compound emerged from research into a series of benzhydryl sulfinyl compounds initiated in the late 1970s. The first of these compounds to reach clinical use was adrafinil, which was offered as…
Officially regulated as a prescription medicine. Reports suggest pharmacies may sell without prescription due to limited familiarity with regulations.
Classified as prescription-only with repeated dispense prohibited. Requires a new prescription for each dispensing.
Not classified as a controlled substance but regulated as a prescription drug. As of February 2011, pharmacies do not typically stock modafinil and the European Medicines Agency recommends restricting its use to narcolepsy treatment only.
Classified as a prescription medicine under Anlage 1 of the Arzneimittelverschreibungsverordnung. In February 2008, it was removed from Anlage III of the Betäubungsmittelgesetz (similar to US Schedule III-IV) and is now available with a standard prescription.
Sold under the brand name Modiodal. Does not appear to be scheduled as a controlled substance, though it is marketed as a prescription pharmaceutical.
Classified as a controlled substance. Importing through mail order without proper authorization may result in fines up to 3000 Euro.
Available by prescription under the brand name Modiodal. Reports indicate some pharmacies may dispense without prescription for indicated conditions, though this practice is not officially sanctioned.
Listed as a Category B pharmaceutical, which requires a physician's prescription for dispensing.
Licensed as a prescription-only medicine but not scheduled as a controlled substance. Possession without a valid prescription is not a criminal offense. Legal personal import permitted under Section 13 of the Medicines Act 1968. Prescribing restrictions were reduced in 2004.
Classified as a prescription-only medicine under the Poisons Standard. Can be prescribed for sleep apnea and narcolepsy. Sold under the brand name Modavigil.
Listed in Part I of Schedule F of Canada's Food and Drug Regulations. Requires a prescription for both human and veterinary use. Available under brand names including Alertec since 1999.
Available by prescription since 1994 under the brand name Modiodal. Subject to EMA recommendations limiting use to excessive sleepiness associated with narcolepsy.
Available by prescription under the brand name Provigil.
Classified as a prescription medicine under the Medicines Act 1981. Sold under the brand name Modavigil. The Act prohibits importing, procuring, receiving, storing, using, or possessing any prescription medicine without reasonable excuse.
Listed in Schedule II of controlled substances. Banned for personal possession, sale, and from most medical use.
Classified as a Schedule 4 drug. Prescribed for narcolepsy and hypersomnia. Sold under the brand name Modiodal in 100mg tablets.
Available without prescription from pharmacies. Not classified as a controlled substance.
Controlled under the Controlled Substances Act. Illegal to sell without DEA license and illegal to buy or possess without a valid prescription. Approved by the FDA in 1998 for narcolepsy, obstructive sleep apnea, and shift work sleep disorder.
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