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Provigil (Modafinil) - Summary

 
 



PROVIGIL SUMMARY

PROVIGIL (modafinil) is a wakefulness-promoting agent for oral administration. Modafinil is a racemic compound. The chemical name for modafinil is 2-[(diphenylmethyl)sulfinyl]acetamide.

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

In OSAHS, 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.


See all Provigil indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Provigil (Modafinil)

Health Tip: Dealing With Narcolepsy When Driving
Source: MedicineNet Narcolepsy Specialty [2014.07.01]
Title: Health Tip: Dealing With Narcolepsy When Driving
Category: Health News
Created: 7/1/2014 7:35:00 AM
Last Editorial Review: 7/1/2014 12:00:00 AM

Narcolepsy
Source: MedicineNet Interstitial Cystitis Specialty [2014.02.06]
Title: Narcolepsy
Category: Diseases and Conditions
Created: 3/4/2002 12:00:00 AM
Last Editorial Review: 2/6/2014 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...

more studies >>

Clinical Trials Related to Provigil (Modafinil)

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.

Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy [Completed]
This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be required to make 5 visits over up to 14 weeks to a participating expert physician practitioner for various sleep and narcolepsy evaluations and diaries will also be collected. Participants will take assigned medications during the course of the trial. Subjects will have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All subject volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness. Patients will not incur any personal medical expenses due to participation in this trial. The sponsor is covering all visit costs not covered by insurance and there are some funds for patient expenses such as travel.

Modafinil Treatment for Cocaine-Dependent Individuals [Active, not recruiting]

Fasting Study of Modafinil Tablets 200 mg and ProvigilŽ Tablets 200 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan modafinil 200 mg tablets to Cephalon ProvigilŽ 200 mg tablets following a single, oral 200 mg (1 x 200 mg) dose administration under fasting conditions.

Food Study of Modafinil Tablets 200 mg to ProvigilŽ Tablets 200 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan modafinil 200 mg tablets to Cephalon ProvigilŽ 200 mg tablets following a single, oral 200 mg (1 x 200 mg) dose administration under fed conditions.

more trials >>

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 >>


PATIENT REVIEWS / RATINGS / COMMENTS

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

  Rating
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

  Rating
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

  Rating
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: 2014-12-01

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