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Obstructive sleep apnea (OSA) is an underdiagnosed medical condition with potentially serious sequelae

Patients with OSA experience repeated arousals from sleep.

OSA is characterized by recurrent episodes of partial or complete collapse of the upper airway during sleep, despite continued respiratory effort.1 The reduction in airflow can result in repetitive arousals and fragmented sleep, oxyhemoglobin desaturations (hypoxemia), and fluctuations in blood pressure and heart rate.1-3

An estimated 20% of US adults have at least mild OSA.

The prevalence of OSA in men and women aged 30 to 60 years in the United States has been estimated to be 24% and 9%, respectively.4 An estimated 1 in 5 US adults has at least mild OSA, and about 1 in 15 has at least moderate OSA.3

OSA is underdiagnosed.4 In the Wisconsin Sleep Cohort Study, it was estimated that 93% of women and 82% of men with moderate to severe OSA were not clinically diagnosed. For mild OSA, 98% of women and 90% of men were not diagnosed.5

OSA is associated with significant mortality and health consequences.

OSA increases risk of stroke, death, and multiple medical comorbidities, including hypertension and diabetes3,6-9

Lower survival rates are associated with lower compliance with treatment (such as continuous positive airway pressure [CPAP], discussed below).6 In one study, all-cause mortality was approximately 4 times higher in patients with moderate to severe sleep apnea compared with patients without.7

Patients with OSA are at increased risk for the following:

  • Hypertension10
  • Cardiovascular disease10
  • Stroke11
  • Diabetes3
  • Depression12
  • Mortality7

About 50% of patients with OSA have hypertension, and an estimated 30% of patients with hypertension also have OSA, often undiagnosed.13 In 2 large case studies, OSA was observed in up to 37% of patients with heart failure; the prevalence of OSA in heart failure is greater in men.13 Several studies have noted a high prevalence of OSA in patients shortly after the occurrence of stroke.13 Nocturnal arrhythmias have been shown to occur in up to 50% of patients with OSA; they increase with the number of apneic episodes and the severity of the associated hypoxemia.13

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

For these reasons, it is important to evaluate your patients for OSA.

Patients with established risk factors should be screened for OSA.

Obesity is an important predisposing factor for OSA. Increasing neck circumference also predicts for OSA, and smoking is associated with OSA as well. Menopause is also a risk factor for OSA in women.

Various abnormalities of the bony and soft tissue structures of the head and neck may predispose your patient to having OSA. Anatomic risk factors include mandibular size, mandibular position, palatal height, enlarged adenoids and enlarged tonsils.1

Screening and Diagnosis for OSA

The most common nighttime symptom of OSA is loud snoring accompanied by gasping or choking during sleep.1,14 These symptoms are frequently diagnosed by the patient's bed partner rather than the patient.1,14 The most common daytime symptom is lack of energy or fatigue, often accompanied by morning headaches, poor memory, reduced concentration, or impaired coordination.1,14

The STOP Screener is a concise and easy-to-use screening tool for OSA. The questionnaire contains 4 yes/no questions (regarding snoring, tiredness during daytime, observed apnea during sleep, and high blood pressure).15 It can be administered in a primary care setting. Other screening tools used in clinical practice include a longer version of the STOP screener called STOP-Bang, the Berlin questionnaire, and the American Society of Anesthesiologists checklist.

Click here to see an example of the STOP Screener.

The American Academy of Sleep Medicine recommends that patients with the following risk factors should be evaluated for OSA symptoms15,16:

  • Obesity (BMI >35)
  • Congestive heart failure
  • Atrial fibrillation
  • Treatment refractory hypertension
  • Type 2 diabetes
  • Nocturnal dysrhythmias
  • Stroke
  • Pulmonary hypertension
  • High-risk driving populations
  • Preoperative for bariatric surgery

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

Diagnosis of OSA is made by polysomnography.16

CPAP is the standard treatment for most patients with OSA.

CPAP is an effective treatment for most patients with OSA. It delivers pressurized air through a nasal mask or nasal pillow, allowing air to flow.17

Diagram: obstructed airway   Diagram: airway treated using a CPAP device
An obstructed airway, as seen in patients with OSA. Note the enlarged tonsils and tongue as well as the nasal congestion.   An airway treated using a CPAP device.
 

Other treatment options for OSA include18:

  • Weight loss
  • Therapies for nasal congestion or rhinitis
  • Upper airway surgery
  • Oral appliances
  • Maxillofacial surgery

Patients with OSA treated with CPAP may still experience residual ES.

CPAP is an effective treatment for most patients with OSA, improving ES and mood. In many patients, however, CPAP does not eliminate the symptom of ES. A number of patients continue to complain about persistent sleepiness after CPAP.19

In a clinical study by Weaver et al, many patients experienced residual ES as shown in both objective and subjective measures, despite regular CPAP use19*

Patients with ES at baseline: percentage with normal and abnormal value after 3 months of CPAP treatment as measured by the Multiple Sleep Latency Test (MSLT)† and the Epworth Sleepiness Scale (ESS)‡§

Diagram: pie charts

Many patients still experienced functional impairment as measured by the Functional Outcomes of Sleep Questionnaire (FOSQ), despite regular CPAP use19 †† ¶

Patients with functional impairment at baseline: percentage with normal and abnormal functional status after 3 months of CPAP treatment¶ #

Diagram: pie chart

* Average CPAP use was 4.7 hours per night.

† MSLT is an objective measure of a patient's underlying propensity for sleep.

‡ Excessive sleepiness was defined as an ESS score >10 or an MSLT value <7.5 minutes. Of the 137 patients with an ESS assessment at baseline, 106 had an ESS score >10. Of the 136 patients with an MSLT assessment at baseline, 85 had an MSLT value <7.5 minutes.

§ The ESS is a questionnaire that helps physicians screen for ES. Patients are asked to rate the chances of dozing off or falling asleep during different daytime routine situations. A total score of 10 or more suggests the need for further evaluation.

†† FOSQ is a quality-of-life questionnaire designed specifically to evaluate the impact of disorders of ES on activities of daily living.

Functional impairment is defined as a FOSQ total score <17.9.

# Of the 147 patients with a FOSQ assessment at baseline, 120 had a FOSQ score <17.9.


Recognition of ES associated with OSA is often difficult because patients may not report being sleepy. Most patients use different words to describe their symptoms, including11:

  • Tiredness
  • Fatigue
  • Problems with attention
  • Lack of energy
  • Mood disturbances

When a patient treated with CPAP presents with ES, another clinical history should be taken. It is important to confirm the diagnosis of OSA, to check CPAP pressure and compliance, and to exclude associated conditions such as poor sleep hygiene, use of medications that promote ES, or a coexisting sleep disorder such as narcolepsy.20

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

The ESS is a simple tool for assessing ES.

The Epworth Sleepiness Scale (ESS) is a validated questionnaire that can be used to screen for ES.21 It can be a useful tool to identify ES associated with treated OSA. It can also be used to establish a baseline measure of ES and assess response to therapy over time.21,22 The maximum score on this scale is 24, with higher scores indicating greater sleepiness. A score of 10 or more suggests the need for further evaluation.21,22

Click here to view and download the ESS

Residual ES associated with treated OSA can be treated.

CPAP treatment for the underlying OSA should not be discontinued. Nevertheless, residual ES can be treated.

NUVIGIL is indicated to improve wakefulness in patients with ES associated with treated OSA.

Click here to learn more about Significant Improvements in Patients With Treated OSA

While NUVIGIL is indicated to treat ES associated with treated OSA, it is not indicated to treat OSA 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. 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. 2. Malhotra A, White DP. Obstructive sleep apnoea. Lancet. 2002;360(9238):237-245. 3. Young T, Skatrud J, Peppard PE. Risk factors for obstructive sleep apnea in adults. JAMA. 2004;291(16):2013-2016. 4. Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993;328(17):1230-1235. 5. Young T, Evans L, Finn L, Palta M. Estimation of the clinically diagnosed proportion of sleep apnea syndrome in middle-aged men and women. Sleep. 1997;20(9):705-706. 6. Campos-Rodriguez F, Peña-Griñan N, Reyes-Nuñez N, et al. Mortality in obstructive sleep apnea-hypopnea patients treated with positive airway pressure. Chest. 2005;128(2):624-633. 7. Marshall NS, Wong KKH, Liu PY, Cullen SRJ, Knuiman MW, Grunstein RR. Sleep apnea as an independent risk factor for all-cause mortality: the Busselton Health Study. Sleep. 2008;31(8):1079-1085. 8. Marin JM, Carrizo SJ, Vicente E, Agusti AGN. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005;365(9464):1046-1053. 9. Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005:353(19):2034-2041. 10. Naughton MT. The link between obstructive sleep apnea and heart failure: underappreciated opportunity for treatment. Curr Heart Fail Rep. 2006;3(4):183-188. 11. Aldrich MS. Sleep Medicine. New York, NY: Oxford University Press, Inc.; 1999. 12. Peppard PE, Szklo-Coxe M, Hla KM, Young T. Longitudinal association of sleep-related breathing disorder and depression. Arch Intern Med. 2006;166(16):1709-1715. 13. Somers VK, White DP, Amin R, et al. Sleep apnea and cardiovascular disease. J Am Coll Cardiol. 2008;52(8):686-717. 14. Guilleminault C, Bassiri A. 87 clinical features and evaluation of obstructive sleep apnea-hypopnea syndrome and upper airway resistance syndrome. In: Kryger MH, Roth T, Dement WC, eds. Principles and Practice of Sleep Medicine. 4th ed. Philadelphia, PA: Elsevier Saunders; 2005:1043-1052. 15. Chung F, Yegneswaran B, Liao P, et al. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008;108(5):812-821. 16. Epstein LJ, Kristo D, Strollo PJ Jr, et al. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009;5(3):263-276. 17. Kushida CA, Littner MR, Hirshkowitz M, et al. Practice parameters for the use of continuous and bilevel positive airway pressure devices to treat adult patients with sleep-related breathing disorders. Sleep. 2006;29(3):375-380. 18. Sanders MH, Givelber RJ. Overview of obstructive sleep apnea in adults. In: Lee-Chiong T, ed. Sleep: A Comprehensive Handbook. Hoboken, NJ: John Wiley & Sons, Inc.; 2006:231-240. 19. Weaver TE, Maislin G, Dinges DF, et al. Relationship between hours of CPAP use and achieving normal levels of sleepiness and daily functioning. Sleep. 2007;30(6):711-719. 20. Santamaria J, Iranzo A, Montserrat J, de Pablo J. Persistent sleepiness in CPAP treated obstructive sleep apnea patients: evaluation and treatment. Sleep Med Rev. 2007;11(3):195-207. 21. Johns MW. A new method for measuring daytime sleepiness: the Epworth Sleepiness Scale. Sleep. 1991;14(6):540-545. 22. Johns MW. Reliability and factor analysis of the Epworth Sleepiness Scale. Sleep. 1992;15(4):376-381.

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