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Provigil (Modafinil) - Summary



PROVIGIL (modafinil) is a wakefulness-promoting agent for oral administration. Modafinil is a racemic compound.

PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work disorder.

In OSA, PROVIGIL is indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating PROVIGIL. If PROVIGIL is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary.

In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness.

The effectiveness of modafinil in long-term use (greater than 9 weeks in Narcolepsy clinical trials and 12 weeks in OSA and SWD clinical trials) has not been systematically evaluated in placebo-controlled trials. The physician who elects to prescribe PROVIGIL for an extended time in patients with Narcolepsy, OSA, or SWD should periodically reevaluate long-term usefulness for the individual patient.

See all Provigil indications & dosage >>


Media Articles Related to Provigil (Modafinil)

Source: MedicineNet amphetamine and dextroamphetamine Specialty [2016.10.06]
Title: Narcolepsy
Category: Diseases and Conditions
Created: 3/4/2002 12:00:00 AM
Last Editorial Review: 10/6/2016 12:00:00 AM

more news >>

Published Studies Related to Provigil (Modafinil)

Modafinil for the treatment of fatigue in lung cancer: results of a placebo-controlled, double-blind, randomized trial. [2014]
fatigue in patients with non-small-cell lung cancer (NSCLC)... CONCLUSION: Modafinil had no effect on cancer-related fatigue and should not be

Modafinil augmentation therapy in unipolar and bipolar depression: a systematic review and meta-analysis of randomized controlled trials. [2013]
CONCLUSIONS: Modafinil is an effective augmentation strategy for acute depressive

Association of a deficit of arousal with fatigue in multiple sclerosis: effect of modafinil. [2013]
Multiple sclerosis (MS) is a multifocal demyelinating disease of the central nervous system, leading to chronic disability. Fatigue is a common and distressing symptom of MS which is unrelated to its clinical form, stage of development, the degree of disability, or the lesion load on magnetic resonance imaging...

Neurophysiological effects of modafinil on cue-exposure in cocaine dependence: a randomized placebo-controlled cross-over study using pharmacological fMRI. [2013]
modafinil and placebo conditions... CONCLUSIONS: Enhanced cue reactivity in the cocaine dependent group compared to

Armodafinil and modafinil in patients with excessive sleepiness associated with shift work disorder: a pharmacokinetic/pharmacodynamic model for predicting and comparing their concentration-effect relationships. [2012]
Armodafinil, the longer lasting R-isomer of racemic modafinil, improves wakefulness in patients with excessive sleepiness associated with shift work disorder (SWD). Pharmacokinetic studies suggest that armodafinil achieves higher plasma concentrations than modafinil late in a dose interval following equal oral doses...

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Clinical Trials Related to Provigil (Modafinil)

Modafinil - Escitalopram Study for Cocaine Dependence [Completed]

A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia [Completed]
This pilot study is an eight-week, randomized, double-blind, placebo-controlled, escalating dose trial of the novel vigilance-promoting drug, modafinil, added to a stable dose of clozapine in 40 patients with schizophrenia or schizoaffective disorder. Modafinil will be initiated at 100 mg/d. After 2 weeks, the study drug may be increased to 200 mg/d and after 4 weeks, study drug may be increased to a maximum of 300 mg/d. Dose escalation will be based upon persistence of sedation versus emergence of side effects.

Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL [Completed]
The purpose of the study is to compare the overnight efficacy and plasma concentration-time profiles of armodafinil and PROVIGIL, after multiple doses, in patients with excessive sleepiness associated with chronic Shift Work Sleep Disorder (SWSD).

Evaluate the Efficacy of Armodafinil for Patients With B-cell Lymphoma and Severe Fatigue [Withdrawn]
To determine whether armodafinil is more effective than placebo in reducing fatigue.

Modafinil vs Placebo for the Treatment of Methamphetamine Dependence [Completed]
Modafinil is a non-amphetamine type stimulant that acts as a wakefulness-promoting drug, and is approved for managing symptoms of narcolepsy (i. e., daytime somnolence). Its precise mechanism of action in promoting wakefulness remains unclear. This trial is a placebo-controlled double-blind trial of modafinil, on a platform of contingency management (CM) and individual cognitive-behavioral (CBT) counseling, for the treatment of methamphetamine dependence. Participants in this study will complete a 2-week baseline screening period during which they will provide urine samples and complete physical and psychological assessments to establish their eligibility for the study. In addition, participants will be asked to provide a blood or saliva specimen for genetic testing in order to identify genetic variations that influence response to methamphetamine and to treatment with modafinil. Upon successful completion of screening, participants will be randomly assigned to receive either modafinil (400mg qd) or placebo during the 12 weeks of the study. Neither the participants nor study staff will know who is receiving active medication or placebo. Regardless of medication condition, all participants will receive CM and weekly individual CBT counseling sessions to help them stop using methamphetamine and prevent relapse. They will attend the clinical research site (either at the UCLA Hollywood Clinic, or the Rancho Cucamonga site) three times per week, providing urine samples at each visit, completing data measures, and receiving individual CBT counseling on one visit each week. At the end of the 12-week study, the medication or placebo will be discontinued. Participants will return to the research site approximately 30 days following medication discontinuation for a brief health check to assess any possible lingering side effects and complete brief data measures.

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Reports of Suspected Provigil (Modafinil) Side Effects

Depression (23)Suicidal Ideation (22)Drug Ineffective (19)Maternal Exposure During Pregnancy (18)Headache (17)Mania (16)Hallucination (16)Anxiety (14)Drug Interaction (13)Nausea (13)more >>


Based on a total of 30 ratings/reviews, Provigil has an overall score of 7.63. The effectiveness score is 7.87 and the side effect score is 8.27. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Provigil review by 38 year old female patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   Fatigue from Rheumatoid Arthiritis
Dosage & duration:   200mg Qam and 100mg Qnoon prn taken once to twice a day for the period of 8 months and counting
Other conditions:   rheumatoid arthritis, MTHFR, PAI-4g, Insulin resistant
Other drugs taken:   Folbic, Effexor, Aspirin, metformin, Celebrex, hydroxycloroquin
Reported Results
Benefits:   I was able to function until later in the day, without needing a nap
Side effects:   none, but since it is a brand name drug, my copay is $50
Comments:   I was diagnosed with RA in April 07 after 2 years of different doctors. The fatigue was overwhelming. The Provigil is helping.


Provigil review by 37 year old male patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   Central sleep apnea related fatigue
Dosage & duration:   200mg taken 6:30 am and 9:30 am for the period of 9+ months
Other conditions:   Hypertension, ­Premature ventri­cular contractio­ns, seasonal allergies
Other drugs taken:   Lisinopril, Prilosec, Zyrtec, Pepcid, Cialis
Reported Results
Benefits:   Provided increased alertness and perceived cognitive enhancement. Helped me maintain focus and motivation at work. I still drank coffee throughout the day but it was significantly less with Provigil. Prior to Provigil I was prescribed Adderall XR 20 mg. which really had a negative effect on my duty performance. I had TOO much energy and jitters and could not focus on anything for more than 5 minutes. The opposite of what it was prescribed for.
Side effects:   I began having stomach troubles with this drug. I now take Prilosec and Pepcid to counter this. Worth it? Sometimes. Like other reviews here, I found that the positive effects did wear off by the end of the day and dosing again is not smart if you want to get any sleep at all. In addition, I notice increased heart rate at times and seems to exacerbate the frequency and strength of my PVCs.
Comments:   I do like the increased alertness and cognitive enhancement but not sure how Provigil is effecting my heart in the long term.


Provigil review by 33 year old female patient

Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
Treatment Info
Condition / reason:   shift work insomnia
Dosage & duration:   unsure (dosage frequency: once a day) for the period of 3 times
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   I couldn't tolerate the side effects, so I was unable to experience the benefits.
Side effects:   I experienced severe flew like symptoms and severe headaches that worsened with each dose.
Comments:   I was only on this medication for a very short time because after 3 days my doctor took me off of it.

See all Provigil reviews / ratings >>

Page last updated: 2016-10-06

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