Modafinil Brand Name– Provigil
What is Modafinil
Modafinil is a racemic compound with unique properties in promoting wakefulness; modafinil’s mechanism of action appears to be distinct from that of other CNS stimulants.
The potential for abuse liability with modafinil is apparently lower than that of other controlled stimulants, though still present. In clinical trials for narcolepsy, modafinil improved daytime vigilance, as assessed by decreases in the number and duration of daytime sleep episodes.
Surveys of patient satisfaction in clinical trials for narcolepsy noted that modafinil produces a decreased sense of fatigue and an increase in mental alertness.
Modafinil appears to selectively decrease somnolence and does not affect activities of memory, concentration, or learning, or sleep latency/sleep structure in narcoleptic patients; the drug has no appreciable effects on the incidence of cataplectic attacks associated with narcolepsy. Due to its unique pharmacologic profile, modafinil has shown promise in clinical trials as a treatment for fatigue or excessive sleepiness associated with sleep apnea, or Parkinson’s disease.
Proposed military applications include the use of modafinil as an alternative to amphetamines to fight fatigue during prolonged combat missions.
Modafinil (Provigil) was FDA-approved for use in patients with narcolepsy in December 1998; at that time, it was the first new molecular entity for use in narcolepsy in 20 years. On October 24, 2003 the FDA approved modafinil for the Shift Work Sleep Disorder (SWSD) indication and on January 26, 2004 for obstructive sleep apnea/hypopnea syndrome (OSAHS) in adults.
In July 2000, Cephalon Inc. reported that, compared to placebo, modafinil therapy did not reduce the symptoms of attention-deficit hyperactivity disorder (ADHD) in adults, as measured by the DSM-IV ADHD Rating Scale in a phase III trial.
Modafinil has not been proven safe or effective for pediatric patients for any condition; the drug was no more effective than placebo in children with narcolepsy.
Modafinil was studied for ADHD in pediatric patients age 6 years and older; however, the FDA denied pediatric approval due to the risk for serious side effects, including reported cases of serious dermatologic reactions, Stevens-Johnson syndrome, potential risks for hepatic impairment or multi-organ hypersensitivity, and reported psychiatric and other side effects in children
Indications
- attention-deficit hyperactivity disorder (ADHD)
- depression
- fatigue
- narcolepsy
- obstructive sleep apnea
- shift work sleep disorder
For the treatment of narcolepsy to improve wakefulness in patients with excessive sleepiness
Side Effects
- agitation
- agranulocytosis
- anaphylactoid reactions
- angioedema
- anorexia
- anxiety
- asystole
- back pain
- bronchospasm
- chest pain (unspecified)
- chills
- confusion
- constipation
- depression
- diarrhea
- dizziness
- drowsiness
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- dysgeusia
- dyskinesia
- dysmenorrhea
- dyspepsia
- dyspnea
- edema
- elevated hepatic enzymes
- emotional lability
- eosinophilia
- epistaxis
- erythema multiforme
- euphoria
- fever
- flatulence
- hallucinations
- headache
- hostility
- hyperhidrosis
- hyperkinesis
- hypertension
- hypertonia
- insomnia
- irritability
- leukopenia
- mania
- nausea
- oral ulceration
- palpitations
- paresthesias
- peripheral vasodilation
- pharyngitis
- polydipsia
- pruritus
- psychological dependence
- psychosis
- rash
- rhinitis
- sinus tachycardia
- Stevens-Johnson syndrome
- suicidal ideation
- Tourette’s syndrome
- toxic epidermal necrolysis
- tremor
- vertigo
- visual impairment
- xerostomia
Monitoring Parameters
- blood pressure
- heart rate
- LFTs
Contraindications
- acute myocardial infarction
- angina
- angioedema
- bipolar disorder
- breast-feeding
- cardiac disease
- children
- contraceptive devices
- depression
- driving or operating machinery
- ethanol ingestion
- geriatric
- heart failure
- hepatic disease
- hypertension
- infants
- mania
- myocardial infarction
- pregnancy
- psychosis
- schizophrenia
- serious rash
- substance abuse
- suicidal ideation
- valvular heart disease
Interactions
- Abacavir; Dolutegravir; Lamivudine
- Abemaciclib
- Acetaminophen; Aspirin, ASA; Caffeine
- Acetaminophen; Butalbital; Caffeine
- Acetaminophen; Butalbital; Caffeine; Codeine
- Acetaminophen; Caffeine
- Acetaminophen; Caffeine; Dihydrocodeine
- Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine
- Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide
- Acetaminophen; Codeine
- Acetaminophen; Hydrocodone
- Acetaminophen; Oxycodone
- Aliskiren; Amlodipine
- Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ
- Amantadine
- Amlodipine
- Amlodipine; Atorvastatin
- Amlodipine; Benazepril
- Amlodipine; Celecoxib
- Amlodipine; Hydrochlorothiazide, HCTZ; Olmesartan
- Amlodipine; Hydrochlorothiazide, HCTZ; Valsartan
- Amlodipine; Olmesartan
- Amlodipine; Telmisartan
- Amlodipine; Valsartan
- Amoxicillin; Clarithromycin; Lansoprazole
- Amoxicillin; Clarithromycin; Omeprazole
- Amphetamine
- Amphetamine; Dextroamphetamine
- Amphetamines
- Apalutamide
- Aprepitant, Fosaprepitant
- Aripiprazole
- Artemether; Lumefantrine
- Aspirin, ASA; Butalbital; Caffeine
- Aspirin, ASA; Butalbital; Caffeine; Codeine
- Aspirin, ASA; Caffeine; Dihydrocodeine
- Aspirin, ASA; Caffeine; Orphenadrine
- Aspirin, ASA; Carisoprodol
- Aspirin, ASA; Carisoprodol; Codeine
- Aspirin, ASA; Oxycodone
- Atazanavir
- Atazanavir; Cobicistat
- Avapritinib
- Axitinib
- Barbiturates
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- Benzhydrocodone; Acetaminophen
- Benzphetamine
- Boceprevir
- Brexpiprazole
- Brigatinib
- Bromocriptine
- Brompheniramine; Guaifenesin; Hydrocodone
- Brompheniramine; Hydrocodone; Pseudoephedrine
- Budesonide
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- Bupivacaine; Lidocaine
- Bupropion
- Bupropion; Naltrexone
- Caffeine
- Caffeine; Ergotamine
- Cannabidiol
- Capmatinib
- Carbamazepine
- Carbinoxamine; Hydrocodone; Phenylephrine
- Carbinoxamine; Hydrocodone; Pseudoephedrine
- Cariprazine
- Carisoprodol
- Ceritinib
- Chlorpheniramine; Codeine
- Chlorpheniramine; Dihydrocodeine; Phenylephrine
- Chlorpheniramine; Dihydrocodeine; Pseudoephedrine
- Chlorpheniramine; Guaifenesin; Hydrocodone; Pseudoephedrine
- Chlorpheniramine; Hydrocodone
- Chlorpheniramine; Hydrocodone; Phenylephrine
- Chlorpheniramine; Hydrocodone; Pseudoephedrine
- Cimetidine
- Cisapride
- Citalopram
- Clarithromycin
- Clobazam
- Clomipramine
- Clopidogrel
- Clozapine
- Cobicistat
- Cobimetinib
- Codeine
- Codeine; Guaifenesin
- Codeine; Phenylephrine; Promethazine
- Codeine; Promethazine
- Conivaptan
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- Conjugated Estrogens; Bazedoxifene
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- Cyclophosphamide
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- Daclatasvir
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- Deflazacort
- Desipramine
- Dexamethasone
- Dexmethylphenidate
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- Diclofenac; Misoprostol
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- Dihydrocodeine; Guaifenesin; Pseudoephedrine
- Diphenhydramine; Hydrocodone; Phenylephrine
- Dolutegravir
- Dolutegravir; Lamivudine
- Dolutegravir; Rilpivirine
- Donepezil
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- Doravirine
- Doravirine; Lamivudine; Tenofovir disoproxil fumarate
- Doxepin
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- Doxorubicin
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- Drospirenone; Estradiol
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- Drospirenone; Ethinyl Estradiol; Levomefolate
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- Elbasvir; Grazoprevir
- Elvitegravir
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- Empagliflozin; Linagliptin
- Empagliflozin; Linagliptin; Metformin
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- Encorafenib
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- Erlotinib
- Erythromycin
- Erythromycin; Sulfisoxazole
- Escitalopram
- Esketamine
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- Estropipate
- Ethanol
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- Ethinyl Estradiol; Desogestrel
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- Ethinyl Estradiol; Levonorgestrel; Ferrous bisglycinate
- Ethinyl Estradiol; Levonorgestrel; Folic Acid; Levomefolate
- Ethinyl Estradiol; Norelgestromin
- Ethinyl Estradiol; Norethindrone
- Ethinyl Estradiol; Norethindrone Acetate
- Ethinyl Estradiol; Norethindrone Acetate; Ferrous fumarate
- Ethinyl Estradiol; Norethindrone; Ferrous fumarate
- Ethinyl Estradiol; Norgestimate
- Ethinyl Estradiol; Norgestrel
- Etonogestrel
- Fedratinib
- Fentanyl
- Flibanserin
- Fluconazole
- Fluoxetine
- Fluoxetine; Olanzapine
- food
- Fosamprenavir
- Glasdegib
- grapefruit juice
- Green Tea
- Guaifenesin; Hydrocodone
- Guaifenesin; Hydrocodone; Pseudoephedrine
- Homatropine; Hydrocodone
- Hydantoins
- Hydrochlorothiazide, HCTZ; Propranolol
- Hydrocodone
- Hydrocodone; Ibuprofen
- Hydrocodone; Phenylephrine
- Hydrocodone; Potassium Guaiacolsulfonate
- Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine
- Hydrocodone; Pseudoephedrine
- Hydroxyprogesterone
- Ibrutinib
- Ibuprofen; Oxycodone
- Idelalisib
- Ifosfamide
- Imipramine
- Isavuconazonium
- Isocarboxazid
- Isoniazid, INH; Pyrazinamide, PZA; Rifampin
- Isoniazid, INH; Rifampin
- Itraconazole
- Ivabradine
- Ixabepilone
- Ketoconazole
- Lefamulin
- Lemborexant
- Letermovir
- Leuprolide; Norethindrone
- Levonorgestrel
- Lidocaine
- Lidocaine; Prilocaine
- Linagliptin
- Linagliptin; Metformin
- Linezolid
- Lisdexamfetamine
- Loperamide
- Loperamide; Simethicone
- Lopinavir; Ritonavir
- Lorlatinib
- Lumateperone
- Lurasidone
- Macimorelin
- Maraviroc
- Medroxyprogesterone
- Meloxicam
- Mestranol; Norethindrone
- Methamphetamine
- Methylphenidate
- Mitotane
- Monoamine oxidase inhibitors
- Nanoparticle Albumin-Bound Paclitaxel
- Nefazodone
- Neratinib
- Nisoldipine
- Norethindrone
- Norgestrel
- Olaparib
- Ombitasvir; Paritaprevir; Ritonavir
- Omeprazole; Amoxicillin; Rifabutin
- Oritavancin
- Oxycodone
- Pazopanib
- Pemigatinib
- Pemoline
- Perampanel
- Perindopril; Amlodipine
- Phenelzine
- Pimavanserin
- Posaconazole
- Praziquantel
- Progesterone
- Progestins
- Propranolol
- Ribociclib
- Ribociclib; Letrozole
- Rifabutin
- Rifampin
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- Riluzole
- Rimegepant
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- Rivaroxaban
- Roflumilast
- Romidepsin
- Ruxolitinib
- Segesterone Acetate; Ethinyl Estradiol
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- Selumetinib
- Sertraline
- Simeprevir
- Siponimod
- Sofosbuvir; Velpatasvir
- Sofosbuvir; Velpatasvir; Voxilaprevir
- Solriamfetol
- Sonidegib
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- St. John’s Wort, Hypericum perforatum
- Sufentanil
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- Tasimelteon
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- Telithromycin
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- Theophylline, Aminophylline
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- Triazolam
- Tucatinib
- Ubrogepant
- Ulipristal
- Vemurafenib
- Venetoclax
- Vincristine
- Vincristine Liposomal
- Vorapaxar
- Voriconazole
- Voxelotor
- Warfarin
- Zanubrutinib
- Zolpidem
