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Millions of Americans may suffer from shift work disorder (SWD)1-3

SWD is a circadian rhythm sleep disorder that occurs when a patient's internal sleep-wake clock is out of sync with his or her work schedule.4-6

The sleep-wake cycle is regulated by a complex interaction between the endogenous circadian rhythm and the normal homeostatic drive for sleep.7 SWD is defined as a clinically meaningful impairment in wakefulness and/or sleep associated with required work schedules outside of the traditional daytime hours (eg, night and early morning shifts).5,6 SWD is triggered by a sleep-wake pattern that is misaligned with the normal endogenous circadian rhythm.2

Shift work results in a misalignment of both the sleep and wake drives.8,9


Diagram: The Sleep-Wake Cycle: Circadian Misalignment (eg, SWD)

The drive for wakefulness increases throughout the day, with a midafternoon dip, until about 9 pm or 10 pm when it drops during the normal sleep time.

The exact disruption experienced by patients with SWD depends on their work schedules. Rotating schedules, evening shifts, and early morning shifts4 can all run counter to the circadian rhythm.6 Patients who work an early morning shift may have to be awake at 4 am, for example, when the circadian rhythm is still calling for sleep. For shift workers who need to sleep during the day, the drive for wakefulness can result in difficulties: falling asleep, maintaining sleep, and fragmented sleep. When the normal circadian drive for wakefulness decreases at 9 pm or 10 pm, the night shift worker is awake and at work.8,9

The normal circadian rhythm can contribute to excessive sleepiness (ES) while the shift worker is at work and/or insomnia during the hours when the shift worker is trying to sleep.4

SWD can have consequences.

The potential consequences of SWD include2,4:

  • Trouble focusing
  • Sleepiness-related accidents
  • Reduced work performance
  • Missed family and social activities
  • Increased irritability
  • Exacerbation of cardiovascular and gastrointestinal disorders

While NUVIGIL® (armodafinil) Tablets [C-IV] are indicated to treat ES associated with SWD, they are not indicated to treat SWD or its other associated symptoms and sequelae.

Risk factors for more severe impairment

While SWD can affect men and women of all ages,2 some factors may cause even greater problems coping with symptoms.10

  • Age greater than 50 years
  • History of sleep disorders
  • History of gastrointestinal complaints
  • Diabetes
  • Cardiovascular disease

The prevalence of SWD is 10% to 25% in night and/or rotating shift workers.2,3,11

It is estimated that up to 20% of US workers are involved in some form of shift work, including permanent or intermittent night work, early morning work, and rotating schedules.2,5

Up to 45% of shift workers report ES and may be at risk for SWD.2

These 3 screening questions can help identify a patient who needs further evaluation for SWD.6

1) Do you work shifts or a nontraditional work schedule?
2) Do you struggle to stay awake when you should be awake, or do you have trouble falling asleep or staying asleep when you should be asleep?
3) Is your work, home, or social life negatively affected?

If the patient answers yes to all 3 questions, consider the full diagnostic criteria determined by the American Psychiatric Association in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR)6 or the American Academy of Sleep Medicine in The International Classification of Sleep Disorders: Diagnostic and Coding Manual, 2nd Edition (ICSD-2).4

There are specific evidence-based diagnostic criteria for SWD according to the DSM-IV-TR6 and the ICSD-2.4

A patient should meet all diagnostic criteria for one of these assessment tools.

Diagnostic Criteria for Shift Work Disorder

DSM-IV-TR: Circadian Rhythm Sleep Disorder—Shift Work Type6

  1. A persistent or recurrent pattern of sleep disruption leading to excessive sleepiness or insomnia that is due to a mismatch between the sleep-wake schedule required by a person’s environment and his or her circadian sleep-wake pattern.

  2. The sleep disturbance causes clinically significant distress or impairment in social, occupational, or other important areas of functioning.

  3. The disturbance does not occur exclusively during the course of another sleep disorder or other mental disorder.

  4. The disturbance is not due to the direct physiologic effects of a substance (eg, a drug of abuse or a medication) or a general medical condition.

Shift Work Type: insomnia during the major sleep period or excessive sleepiness during the major awake period associated with night shift work or frequently changing shift work

ICSD-2: General Criteria for Circadian Rhythm Sleep Disorder4

  1. There is a persistent or recurrent pattern of sleep disturbance due primarily to one of the following:

    1. Alternations of the circadian timekeeping system

    2. Misalignment between the endogenous circadian rhythm and exogenous factors that affect the timing or duration of sleep

  2. The circadian-related sleep disruption leads to insomnia, excessive daytime sleepiness, or both.

  3. The sleep disturbance is associated with impairment of social, occupational, or other areas of functioning.

Circadian Rhythm Sleep Disorder, Shift Work Type (Shift Work Disorder)4

  1. There is a complaint of insomnia or excessive sleepiness that is temporally associated with a recurring work schedule that overlaps the usual time for sleep.

  2. The symptoms are associated with the shift-work schedule over the course of at least one month.

  3. Sleep log or actigraphy monitoring (with sleep diaries) for at least seven days demonstrates disturbed circadian and sleep-time misalignment.

  4. The sleep disturbance is not better explained by another current sleep disorder, medical or neurological disorder, mental disorder, medication use, or substance use disorder.

Consider SWD when a patient who works shifts or a nontraditional work schedule presents with ES.

Screening tools like the Epworth Sleepiness Scale (ESS) can help identify ES associated with SWD.11,12

Click here to learn more about Significant Improvements in Patients With SWD.

While NUVIGIL is indicated to treat ES associated with SWD, it is not indicated to treat SWD or its other associated symptoms and sequelae.

Also of interest:

For patient assessment, download the Epworth Sleepiness Scale.

Could snoring be something more serious? Download the STOP Screener, the OSA patient screener.


IMPORTANT INFORMATION FOR PHYSICIANS

INDICATIONS

NUVIGIL® (armodafinil) is indicated to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea (OSA), shift work disorder (SWD) and narcolepsy.

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

IMPORTANT SAFETY INFORMATION

Serious rash, including Stevens-Johnson Syndrome (SJS), requiring hospitalization and discontinuation of treatment, has been reported in adults in association with the use of armodafinil and modafinil, and in children in association with use of modafinil.

NUVIGIL has not been studied in pediatric patients in any setting and is not approved for use in pediatric patients for any indication.

In pediatric clinical trials of modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil), cases of serious rash including possible SJS and apparent multi-organ hypersensitivity reaction have been reported. Several of the cases were associated with fever and other abnormalities (e.g., vomiting, leukopenia). No serious skin rashes have been reported in adult clinical trials of modafinil. Rare cases of serious or life-threatening rash, including SJS, Toxic Epidermal Necrolysis (TEN) and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported in adults and children in postmarketing experience with modafinil.

No serious skin rashes were reported in adult clinical trials of armodafinil. However, cases of serious rash similar to those observed with modafinil including skin and mouth blistering have been reported in adults in postmarketing experience.

There are no factors, including duration of therapy, that are known to predict the risk of occurrence or the severity of rash. Although benign rashes occur with NUVIGIL, it is not possible to reliably predict which rashes will prove to be serious. NUVIGIL should ordinarily be discontinued at the first sign of rash unless the rash is clearly not drug-related.

Cases of angioedema and hypersensitivity (with rash, dysphagia, and bronchospasm) were observed among patients treated with NUVIGIL. Multi-organ hypersensitivity reactions, including at least one fatality postmarketing, have occurred in close temporal association to the initiation of modafinil. Patients should be advised to discontinue NUVIGIL and immediately report to their physician any signs or symptoms suggesting multi-organ hypersensitivity, angioedema or anaphylaxis.

Patients should be advised that their level of wakefulness may not return to normal. Although NUVIGIL has not been shown to produce functional impairment, any drug affecting the CNS may alter judgment, thinking or motor skills. Patients should be frequently reassessed for their degree of sleepiness and functional impairment and, if appropriate, advised to avoid driving or any other potentially dangerous activity.

Psychiatric adverse experiences have been reported in patients treated with modafinil. Postmarketing adverse events associated with the use of modafinil have included mania, delusions, hallucinations, suicidal ideation and aggression, some resulting in hospitalization. In controlled trials in adults administered NUVIGIL, psychiatric symptoms resulting in treatment discontinuation were anxiety, agitation, nervousness, and irritability. Caution should be exercised when NUVIGIL is given to patients with a history of psychosis, depression, or mania. Consider discontinuing NUVIGIL if psychiatric symptoms develop.

Patients with a recent history of myocardial infarction or unstable angina should be treated with caution. NUVIGIL should not be used in patients with a history of left ventricular hypertrophy or in patients with mitral valve prolapse who have experienced mitral valve prolapse syndrome when previously receiving CNS stimulants. There were also a greater proportion of patients on NUVIGIL requiring new or increased use of antihypertensive medications compared to patients on placebo. Increased monitoring of blood pressure may be appropriate in patients on NUVIGIL.

NUVIGIL may interact with drugs that inhibit, induce, or are metabolized by cytochrome P450 isoenzymes. The effectiveness of steroidal contraceptives may be reduced when used with NUVIGIL and for one month after discontinuation of therapy. The concomitant use of NUVIGIL and alcohol has not been studied and should be avoided.

In clinical trials, the most commonly reported adverse events (≥5%) were headache, nausea, dizziness, and insomnia. Most adverse experiences were rated as mild to moderate.

NUVIGIL is a Schedule IV controlled substance because it has the potential to be abused or lead to dependence. Physicians should follow patients closely, especially those with a history of drug and/or stimulant abuse.

Physicians should be aware and inform their patients of the availability of a Medication Guide for NUVIGIL.

Please see Full Prescribing Information for NUVIGIL.

 

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References: 1. US Department of Labor, Bureau of Labor Statistics. Workers on flexible and shift schedules. Bureau of Labor Statistics Web site. http://www.bls.gov/news.release/pdf/flex.pdf. Accessed January 18, 2011. 2. Schwartz JRL, Roth T. Shift work sleep disorder: burden of illness and approaches to management. Drugs. 2006;66(18):2357-2370. 3. Waage S, Moen BE, Pallesen S, et al. Shift work disorder among oil rig workers in the North Sea. Sleep. 2009;32(4):558-565. 4. American Academy of Sleep Medicine. The International Classification of Sleep Disorders: Diagnostic and Coding Manual. 2nd ed. Westchester, IL: American Academy of Sleep Medicine; 2005. 5. Morgenthaler TI, Lee-Chiong T, Alessi C, et al. Practice parameters for the clinical evaluation and treatment of circadian rhythm sleep disorders. Sleep. 2007;30(11):1445-1459. 6. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed, text revision. Washington, DC: American Psychiatric Association; 2000. 7. Reid KJ, Burgess HJ. Circadian rhythm sleep disorders. Prim Care Clin Office Pract. 2005;32(2):449-473. 8. Czeisler CA, Buxton OM, Khalsa SBR. The human circadian timing system and sleep-wake regulation. In: Kryger MH, Roth T, Dement WC, eds. Principles and Practice of Sleep Medicine. 4th ed. Philadelphia, PA: Elsevier Saunders; 2005:384-385. 9. Van Dungen HPA, Dinges DF. Circadian rhythms in sleepiness, alertness, and performance. In: Kryger MH, Roth T, Dement WC, eds. Principles and Practice of Sleep Medicine. 4th ed. Philadelphia, PA: Elsevier Saunders; 2005:435-441. 10. Monk TH. Shift work: basic principles. In: Kryger MH, Roth T, Dement WC, eds. Principles and Practice of Sleep Medicine. 4th ed. Philadelphia, PA: Elsevier Saunders; 2005:673-679. 11. Drake CL, Roehrs T, Richardson G, Walsh JK, Roth T. Shift work sleep disorder: prevalence and consequences beyond that of symptomatic day workers. Sleep. 2004;27(8):1453-1462. 12. Johns MW. A new method for measuring daytime sleepiness: the Epworth Sleepiness Scale. Sleep. 1991;14(6):540-545.

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