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.
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NEWS HIGHLIGHTSMedia Articles Related to Provigil (Modafinil)
Is Provigil Addictive?
Source: MedicineNet Narcolepsy Specialty [2009.03.18]
Title: Is Provigil Addictive?
Category: Health News
Created: 3/18/2009
Last Editorial Review: 3/18/2009
Researcher IDs Narcolepsy as Autoimmune Disease
Source: MedicineNet Narcolepsy Specialty [2009.05.04]
Title: Researcher IDs Narcolepsy as Autoimmune Disease
Category: Health News
Created: 5/4/2009 10:38:00 AM
Last Editorial Review: 5/4/2009
Narcolepsy
Source: MedicineNet modafinil Specialty [2008.08.05]
Title: Narcolepsy
Category: Diseases and Conditions
Created: 3/4/2002
Last Editorial Review: 8/5/2008
Published Studies Related to Provigil (Modafinil)
Modafinil for the treatment of cocaine dependence. [2009.09.01]
AIM: Modafinil was tested for efficacy in facilitating abstinence in cocaine-dependent patients, compared to placebo... CONCLUSIONS: These data suggest that modafinil, in combination with individual behavioral therapy, was effective for increasing cocaine non-use days in participants without co-morbid alcohol dependence, and in reducing cocaine craving.
A randomized, double-blind and placebo-controlled trial of modafinil in children and adolescents with attention deficit and hyperactivity disorder. [2009.08.15]
Attention-deficit/hyperactivity disorder (ADHD) is the most common behavioral disorder in childhood, with an estimated prevalence worldwide of 7%-17% among school-aged children... The results of this study indicate that modafinil significantly improved symptoms of ADHD, was well tolerated, and may open a new window in the treatment of children with ADHD.
Modafinil for the treatment of hypersomnia associated with myotonic muscular dystrophy in adults: a multicenter, prospective, randomized, double-blind, placebo-controlled, 4-week trial. [2009.08]
BACKGROUND: Myotonic muscular dystrophy type 1 (MMD1) is the most common form of adult MD, with a mean prevalence of 1 in 8000. Excessive daytime sleepiness (ie, hypersomnia) is a common complication of MMD1. OBJECTIVE: The aim of this study was to evaluate the efficacy and tolerability of modafinil for the treatment of hypersomnia in adults with MMD1... CONCLUSION: In this small study conducted in an adult population with MMD1 and a high prevalence of hyper-somnia, modafinil had no significant effects on daytime somnolence measured using objective MWTs.
Modafinil as a potential motion sickness countermeasure. [2009.08]
INTRODUCTION: Motion sickness adversely affects military air and sea operations. Medications help prevent motion sickness but are frequently associated with side effects. Better medications or combinations of medications are needed. Dextroamphetamine has documented anti-motion sickness effects but also has a potential for abuse. Modafinil is a relatively new central nervous system stimulant that has none of the drawbacks of dextroamphetamine, but has not been evaluated for the treatment of motion sickness... CONCLUSION: Modafinil was not found to be more effective than placebo. Further testing is recommended to determine whether the potentially promising combination of modafinil and scopolamine provides better efficacy or fewer side effects than scopolamine administered alone.
Effects of the atypical stimulant modafinil on a brief gambling episode in pathological gamblers with high vs. low impulsivity. [2009.08]
Pathological gambling (PG) is a serious psychiatric disorder afflicting 1-3% of the general population.
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 Provigil® Tablets 200 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan modafinil 200 mg
tablets to Cephalon Provigil® 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 Provigil® Tablets 200 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan modafinil 200 mg
tablets to Cephalon Provigil® 200 mg tablets following a single, oral 200 mg (1 x 200 mg)
dose administration under fed conditions.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 20 ratings/reviews, Provigil has an overall score of 7.55. The effectiveness score is 7.90 and the side effect score is 8.20. 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. |
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| | Provigil review by 51 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | MS-related fatigue |
| Dosage & duration: | | 100-200 mg. daily taken daily for the period of 7 months |
| Other conditions: | | GERD |
| Other drugs taken: | | Copaxone, prontonix | | |
Reported Results |
| Benefits: | | Taking the provigil has allowed me to keep working fulltime; otherwise I wouldn't be able to function well due to the extreme constant fatigue I experience related to MS. My neurologist suggested I try this. It has helped considerably during the daytime with my concentration level and also has helped me to stay focused. |
| Side effects: | | Provigil works well for an approximate 3 hr. period, but wears off shortly after that. I do experience slight rapid heartbeat initially and feel jittery for a short time but it goes away quickly. I currently take 100 mg. and if needed, another 100 mg. in the afternoon. I don't take this any time after 2 pm as I'll be up all night. I do need to take a prescribed sleeping pill in order to get to sleep since I've been on Provigil. |
| Comments: | | I initially started on 200 mg. daily and have cut back as I do have trouble getting to sleep and staying asleep. I have been on this for 7 months and the effectiveness of Provigil is at the same level today as it was when I began. |
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| | 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. |
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Page last updated: 2009-10-20
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