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provigil side effects

I am a 23 year old student and have had multiple sclerosis for nearly 3 years now.
I have recently been prescribed Provigil to help with chronic fatigue during the day. I have been taking it for about a month now but lately I have noticed increased levels of anxiety. It is coming to the end of the semester and there are obviously deadlines looming etc and I am a naturally anxious person but I have never had this kind of anxiety. My heart feels like it's thudding all the time in my chest at night and it feels faster. Last night I only managed 3 and a half hours of sleep even though I was absolutely shattered because my heart was thudding so much and I was extremely anxious. I'm pretty sure this is to do with the provigil. I can't function without the provigil though as i tried on saturday. Is there anything I can do to cease the anxiety. I do not feel that it is productive for my degree.
Thank you for your help.
Tara Martin
2 Responses
292349 tn?1201481643
MEDICAL PROFESSIONAL
Hi tarmarti,

Yes, provigil can cause all of your symptoms.  

5% anxiety
5% insomnia
2% palpitation
2% tachycardia

I copied below the side effect profile of provigil.  You can take the tablet in the morning, so it will have less effect on your sleep.  I would recommend to cut down the dosage since you have anxiety and insomnia that are potentially disabling.

ADVERSE REACTIONS SIGNIFICANT
>10%:
  Central nervous system: Headache (34%, dose related)
  Gastrointestinal: Nausea (11%)

1% to 10%:
  Cardiovascular: Chest pain (3%), hypertension (3%), palpitation (2%), tachycardia (2%), vasodilation (2%), edema (1%)
  Central nervous system: Nervousness (7%), dizziness (5%), depression (2%), anxiety (5%; dose related), insomnia (5%), somnolence (2%), chills (1%), agitation (1%), confusion (1%), emotional lability (1%), vertigo (1%)
  Gastrointestinal: Diarrhea (6%), dyspepsia (5%), xerostomia (4%), anorexia (4%), constipation (2%), flatulence (1%), mouth ulceration (1%), taste perversion (1%)
  Genitourinary: Abnormal urine (1%), hematuria (1%), pyuria (1%)
  Hematologic: Eosinophilia (1%)
  Hepatic: LFTs abnormal (2%)
  Neuromuscular & skeletal: Back pain (6%), paresthesia (2%), dyskinesia (1%), hyperkinesia (1%), hypertonia (1%), neck rigidity (1%), tremor (1%)
  Ocular: Amblyopia (1%), eye pain (1%), vision abnormal (1%)
  Respiratory: Pharyngitis (4%), rhinitis (7%), lung disorder (2%), asthma (1%), epistaxis (1%)
  Miscellaneous: Diaphoresis

Postmarketing and/or case reports: Agranulocytosis, mania, psychosis

CONTRAINDICATIONS — Hypersensitivity to modafinil or any component of the formulation

WARNINGS / PRECAUTIONS
Concerns related to adverse effects:

CNS effects: May impair the ability to engage in potentially hazardous activities.
Disease-related concerns:

Cardiovascular disease: Use is not recommended in patients with a history of angina, cardiac ischemia, recent history of myocardial infarction, left ventricular hypertrophy, or patients with mitral valve prolapse who have developed mitral valve prolapse syndrome with previous CNS stimulant use.
Hepatic impairment: Use with caution in patients with hepatic impairment.
Psychiatric disorders: Use with caution in patients with pre-existing psychosis or bipolar disorder (may induce mixed/manic episode). May exacerbate symptoms of behavior and thought disorder in psychotic patients; new onset psychosis or mania may occur with stimulant use; observe for symptoms of aggression and/or hostility.
Renal impairment: Use with caution in patients with renal impairment.
Sleep disorders: Appropriate use: For use following complete evaluation of sleepiness and in conjunction with other standard treatments (eg, CPAP). The degree of sleepiness should be reassessed frequently; some patients may not return to a normal level of wakefulness.
Tourette's syndrome: Use with caution in patients with Tourette's syndrome; stimulants may unmask tics.
Special populations:

Pediatrics: Safety and efficacy have not been established in children 16 years of age.
RESTRICTIONS — C-IV

DRUG INTERACTIONS — Substrate of CYP3A4 (major); Inhibits CYP1A2 (weak), 2A6 (weak), 2C9 (weak), 2C19 (strong), 2E1 (weak), 3A4 (weak); Induces CYP1A2 (weak), 2B6 (weak), 3A4 (weak)

(For additional information: Launch Lexi-Interact™ Drug Interactions Program )

Cyclosporine: Metabolism of cyclosporine may be increased; monitor serum levels.

CYP2C19 substrates: Modafinil may increase the levels/effects of CYP2C19 substrates. Example substrates include citalopram, diazepam, methsuximide, phenytoin, propranolol, and sertraline.

CYP3A4 inducers: CYP3A4 inducers may decrease the levels/effects of modafinil. Example inducers include aminoglutethimide, carbamazepine, nafcillin, nevirapine, phenobarbital, phenytoin, and rifamycins.

CYP3A4 inhibitors: May increase the levels/effects of modafinil. Example inhibitors include azole antifungals, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid, nefazodone, nicardipine, propofol, protease inhibitors, quinidine, telithromycin, and verapamil.

Oral contraceptives; Serum concentrations may be reduced (enzyme induction); contraceptive failure may result; alternative contraceptive measures are recommended during therapy and for 1 month after modafinil is discontinued.

Phenytoin: Serum concentrations may be increased by modafinil (enzyme inhibition); modafinil concentrations may be reduced by phenytoin (enzyme induction)

SSRIs: In populations genetically deficient in the CYP2D6 isoenzyme, where CYP2C19 acts as a secondary metabolic pathway, concentrations of selective serotonin reuptake inhibitors may be increased during coadministration

Tricyclic antidepressants: In populations genetically deficient in the CYP2D6 isoenzyme, where CYP2C19 acts as a secondary metabolic pathway, concentrations of tricyclic antidepressants may be increased during coadministration

Warfarin: Serum concentrations/effect may be increased by modafinil

ETHANOL / NUTRITION / HERB INTERACTIONS
Ethanol: Avoid or limit ethanol.

Food: Delays absorption, but does not affect bioavailability.

PREGNANCY RISK FACTOR — C (show table)

PREGNANCY IMPLICATIONS — Embryotoxic effects have been observed in some, but not all animal studies. There are no adequate and well-controlled studies in pregnant women; use only when the potential risk of drug therapy is outweighed by the drug's benefits. Efficacy of steroidal contraceptives may be decreased; alternate means of contraception should be considered during therapy and for 1 month after modafinil is discontinued.

LACTATION — Excretion in breast milk unknown/use caution

TOXICOLOGY / OVERDOSE COMPREHENSIVE — Signs and symptoms of overdose include agitation, irritability, aggressiveness, confusion, nervousness, tremor, sleep disturbance, palpitations, decreased prothrombin time, and slight-to-moderate elevations of hemodynamic parameters. Treatment is symptomatic and supportive. There is no data to suggest the utility of dialysis or urinary pH alteration in enhancing elimination. Cardiac monitoring is warranted.



HIS INFORMATION IS PROVIDED FOR GENERAL MEDICAL EDUCATION PURPOSE ONLY.  PLEASE CONTACT YOUR PHYSICIAN FOR DIAGNOSTIC AND TREATMENT OPTIONS OF YOUR SPECIFIC MEDICAL CONDITIONS.
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