Modafinil

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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

  1. attention-deficit hyperactivity disorder (ADHD)
  2. depression
  3. fatigue
  4. narcolepsy
  5. obstructive sleep apnea
  6. shift work sleep disorder

For the treatment of narcolepsy to improve wakefulness in patients with excessive sleepiness

Side Effects

  1. agitation
  2. agranulocytosis
  3. anaphylactoid reactions
  4. angioedema
  5. anorexia
  6. anxiety
  7. asystole
  8. back pain
  9. bronchospasm
  10. chest pain (unspecified)
  11. chills
  12. confusion
  13. constipation
  14. depression
  15. diarrhea
  16. dizziness
  17. drowsiness
  18. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
  19. dysgeusia
  20. dyskinesia
  21. dysmenorrhea
  22. dyspepsia
  23. dyspnea
  24. edema
  25. elevated hepatic enzymes
  26. emotional lability
  27. eosinophilia
  28. epistaxis
  29. erythema multiforme
  30. euphoria
  31. fever
  32. flatulence
  33. hallucinations
  34. headache
  35. hostility
  36. hyperhidrosis
  37. hyperkinesis
  38. hypertension
  39. hypertonia
  40. insomnia
  41. irritability
  42. leukopenia
  43. mania
  44. nausea
  45. oral ulceration
  46. palpitations
  47. paresthesias
  48. peripheral vasodilation
  49. pharyngitis
  50. polydipsia
  51. pruritus
  52. psychological dependence
  53. psychosis
  54. rash
  55. rhinitis
  56. sinus tachycardia
  57. Stevens-Johnson syndrome
  58. suicidal ideation
  59. Tourette’s syndrome
  60. toxic epidermal necrolysis
  61. tremor
  62. vertigo
  63. visual impairment
  64. 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
  • Bedaquiline
  • Benzhydrocodone; Acetaminophen
  • Benzphetamine
  • Boceprevir
  • Brexpiprazole
  • Brigatinib
  • Bromocriptine
  • Brompheniramine; Guaifenesin; Hydrocodone
  • Brompheniramine; Hydrocodone; Pseudoephedrine
  • Budesonide
  • Budesonide; Formoterol
  • 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
  • Conjugated Estrogens
  • Conjugated Estrogens; Bazedoxifene
  • Conjugated Estrogens; Medroxyprogesterone
  • Cyclophosphamide
  • Cyclosporine
  • Daclatasvir
  • Dapsone
  • Darunavir
  • Darunavir; Cobicistat
  • Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
  • Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
  • Deflazacort
  • Desipramine
  • Dexamethasone
  • Dexmethylphenidate
  • Dextroamphetamine
  • Diazepam
  • Diclofenac
  • Diclofenac; Misoprostol
  • Dienogest; Estradiol valerate
  • Dihydrocodeine; Guaifenesin; Pseudoephedrine
  • Diphenhydramine; Hydrocodone; Phenylephrine
  • Dolutegravir
  • Dolutegravir; Lamivudine
  • Dolutegravir; Rilpivirine
  • Donepezil
  • Donepezil; Memantine
  • Doravirine
  • Doravirine; Lamivudine; Tenofovir disoproxil fumarate
  • Doxepin
  • Doxercalciferol
  • Doxorubicin
  • Dronabinol
  • Drospirenone
  • Drospirenone; Estradiol
  • Drospirenone; Ethinyl Estradiol
  • Drospirenone; Ethinyl Estradiol; Levomefolate
  • Elagolix; Estradiol; Norethindrone acetate
  • Elbasvir; Grazoprevir
  • Elvitegravir
  • Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
  • Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
  • Empagliflozin; Linagliptin
  • Empagliflozin; Linagliptin; Metformin
  • Emtricitabine; Rilpivirine; Tenofovir alafenamide
  • Emtricitabine; Rilpivirine; Tenofovir disoproxil fumarate
  • Encorafenib
  • Entrectinib
  • Enzalutamide
  • Erdafitinib
  • Erlotinib
  • Erythromycin
  • Erythromycin; Sulfisoxazole
  • Escitalopram
  • Esketamine
  • Esterified Estrogens
  • Esterified Estrogens; Methyltestosterone
  • Estradiol
  • Estradiol Cypionate; Medroxyprogesterone
  • Estradiol; Levonorgestrel
  • Estradiol; Norethindrone
  • Estradiol; Norgestimate
  • Estradiol; Progesterone
  • Estropipate
  • Ethanol
  • Ethinyl Estradiol
  • Ethinyl Estradiol; Desogestrel
  • Ethinyl Estradiol; Ethynodiol Diacetate
  • Ethinyl Estradiol; Etonogestrel
  • Ethinyl Estradiol; Levonorgestrel
  • 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
  • Rifapentine
  • Rilpivirine
  • Riluzole
  • Rimegepant
  • Ritonavir
  • Rivaroxaban
  • Roflumilast
  • Romidepsin
  • Ruxolitinib
  • Segesterone Acetate; Ethinyl Estradiol
  • Selegiline
  • Selpercatinib
  • Selumetinib
  • Sertraline
  • Simeprevir
  • Siponimod
  • Sofosbuvir; Velpatasvir
  • Sofosbuvir; Velpatasvir; Voxilaprevir
  • Solriamfetol
  • Sonidegib
  • Sorafenib
  • St. John’s Wort, Hypericum perforatum
  • Sufentanil
  • Sunitinib
  • Tasimelteon
  • Tazemetostat
  • Telaprevir
  • Telithromycin
  • Telotristat Ethyl
  • Temsirolimus
  • Terbinafine
  • Theophylline, Aminophylline
  • Tolvaptan
  • Tranylcypromine
  • Triazolam
  • Tucatinib
  • Ubrogepant
  • Ulipristal
  • Vemurafenib
  • Venetoclax
  • Vincristine
  • Vincristine Liposomal
  • Vorapaxar
  • Voriconazole
  • Voxelotor
  • Warfarin
  • Zanubrutinib
  • Zolpidem

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