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Insomnia consequences and market research insights

A common condition with major consequences

Approximately 70 million Americans have insomnia according to the National Sleep Foundation (NSF).1 Nearly 7 out of 10 Americans say that they experience frequent sleep problems, although most remain undiagnosed.1 Patients with insomnia report a variety of sleep difficulties. In a recent national survey by the NSF, specific sleep issues included waking feeling unrefreshed, waking up frequently during the night, waking too early and difficulty falling asleep.2 One of the most prevalent complaints reported were difficulty maintaining sleep (as seen in the chart below).3 On average, it is recommended that adults need 7-8 hours of sleep daily.4

It is established that insufficient sleep leads to deterioration of mood, lack of motivation, fatigue, malaise and decrease in energy, attention and concentration.2 In addition to the decrease in feelings of well-being, chronic insomnia can have serious health consequences as it has been associated with, and may even lead to, the development of anxiety, depression, obesity and diabetes and even some types of cardiovascular disease.1

In market research, insomnia patients reported a significant degree of concern with the safety profile of currently available sleep medications. The strongest concern voiced by patients was the potential for addiction and/or habituation with current prescription treatments. Today, many Americans are not getting the sleep they need. Coupled with the limitations of the currently available treatment options, insomnia remains an under-diagnosed and under-treated disorder.5

Click on one of the links below to learn more about the serious health effects of insomnia, consequences and patient insights:

Health consequences of insomnia

Proper, restorative sleep is essential to proper mind and body function.6-9 The long term consequences of insomnia may lead to serious health problems. Excessive sleepiness may cause concentration deficits, memory impairments, loss of energy, and emotional problems.6-9 Serious consequences include accidents on the road or in the workplace, poor performance at work or school, and difficulty with personal relationships.10

Poor sleep can aggravate medical conditions and predispose individuals to the development of psychiatric and medical disorders. For example, people with insomnia are 34 times more likely to develop a new psychiatric disorder (usually major depression).11 Heart disease patients who sleep less than 5 hours a night have a threefold increase in myocardial infarction.11

Insomnia can also be brought on by different disorders or factors:12

  • Advancing age
  • Emotional distress
  • Anxiety
  • Major life change
  • Acute or chronic pain
  • Obesity
  • Chronic obstructive pulmonary disease (COPD)
  • Obstructive sleep apnea
  • Depression
  • Restless leg syndrome and periodic limb movement (PLM) disorder

Anxiety and depression
Chronic insomnia is a marker of both anxiety disorder and depression, and the relationship among them extends beyond co-existence — there appears to be a cause-effect relationship.7,13-15 Studies have documented that insomnia can come before or after anxiety and depression. In other words, insomnia may predispose patients to anxiety and depression and, likewise, anxiety and depression may predispose patients to insomnia.7,13-15 People with insomnia have a statistically elevated risk of developing depression and anxiety over time.7

Diabetes, obesity and cardiovascular disease
The interaction among sleeping, feeding, glucose metabolism and other metabolic processes has been well documented, which has led to further research into the correlation between insomnia, cardiovascular health, diabetes and obesity. Recent studies reveal that sleep restriction exerts negative effects on glucose metabolism, such as decreased glucose tolerance and insulin sensitivity.16-18

Missed sleep is also correlated with increased hunger and appetite, which may lead to overeating and obesity.16 Furthermore, an increase in cardiovascular events and cardiovascular morbidity is associated with reduced sleep duration.6,16-18

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Accidents and injuries from drowsiness

Poor-quality sleep may pose a significant health risk for not only the patient, but society in general. Accidents in the home and on the job from fatigue-related errors can be injurious or even fatal.9 Drowsy driving is a potentially lethal activity for patients, and a common one. It is to blame in nearly 20% of all serious injuries from car accidents.19

The National Sleep Foundation reported in 2007 that 100,000 police-reported crashes, 71,000 injuries and 1,550 deaths occur due to drowsy driving each year in the U.S. These reports are believed to be underestimated due to lack of police recording of drowsiness in reports.20 A 22-year follow-up study concluded that getting less than 7 hours of sleep a night increases the risk of death by up to 26%.21

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Consumer insights

All patients do not experience insomnia the same way. A nationwide survey study of insomnia patients revealed the following22:

42% reported that they spend considerable time awake during the night 49% reported that they do not feel refreshed in the morning
26% have trouble falling asleep at least a few nights a week 29% awaken too early in the morning and cannot fall back asleep

Sleep facts:

  • 40 million people in the U.S. report having sleep problems23
  • Insomnia affects about 25% of patients seen in primary care practices7
  • More than 60% of adults have never been asked about the quality of their sleep by their physicians23
  • Fewer than 20% of adults have initiated a discussion about their sleep with their healthcare providers23
  • 60% of adults said they drove while drowsy in the past year, with 37% admitting they dozed off behind the wheel24
  • 10% to 20% of shift workers fall asleep on the job23
  • Approximately 1 out of every 4 shift and night workers reports insomnia7
  • 75% of older adults report frequent sleep problems, but only 29% said their doctors never asked about their sleep problems24
  • People with any medical condition have a higher prevalence of chronic insomnia than those without medical conditions7
  • Insomnia affects about 90% of patients seen in psychiatric practices7

This data suggests that the consequences of insomnia are significant. It's important to talk to your patients about their sleep.

Silenor is indicated for the treatment of sleep maintenance insomnia and has not been approved to treat any other condition.

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Talking with your patients

Patients don't always bring up the fact that they are having problems with sleep, even if it's becoming a chronic issue.22 In some cases, they don't know how to approach the subject during an office visit. Therefore, it is important for healthcare professionals to proactively ask their patients how they're sleeping.

If the patient is having sleep issues, it is crucial to ask the right kinds of questions to find out more so that you can make a diagnosis. Therefore, it is valuable to have a formal criterion for the identification of insomnia when evaluating sleep problems in patients.

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Here are some important sleep questions to ask patients:

  1. Do you have trouble falling asleep or maintaining sleep?
  2. Do you wake up too early or feel unrefreshed after sleeping?
  3. Does this occur even though you have the opportunity and the time to get a good night's sleep?
  4. Have you been experiencing this sleep problem for more than a month?
  5. Have you found yourself dozing off during the day or doing things to keep yourself from falling asleep during the daytime?
  6. Do you experience any of the following issues?
    • Daytime sleepiness
    • Frustration or worry about your sleep
    • Low energy
    • Lack of motivation
    • Attention, concentration or memory problems
    • Poor performance at school or work

Silenor is indicated for the treatment of sleep maintenance insomnia and has not been approved to treat any other condition.

Silenor is approved for use at 3 mg and 6 mg. Do not substitute: There is no generic Silenor.

References:

  1. National Sleep Foundation. Sleep Studies. Available at: http://www.sleepfoundation.org/article/sleep-topics/sleep-studies. Accessed August 8, 2010.
  2. National Sleep Foundation. Can’t Sleep? What to Know About Insomnia. Available at: http://www.sleepfoundation.org/article/sleep-related-problems/insomnia-and-sleep. Accessed August 8, 2010.
  3. Littner M, Hirshkowitz M, Kramer M, et al. Sleep. 2003;26(6):754-760.
  4. National Sleep Foundation. How much Sleep Do We Really Need? Available at: http://www.sleepfoundation.org/article/how-sleep-works/how-much-sleep-do-we-really-need. Accessed August 8, 2011.
  5. Leger D, Poursain. An international survey of insomnia: under-recognition and under-treatment of a polysymptomatic condition. Curr Med Res Opin. 2005;21(11):1785-92.
  6. Banks S, Dinges DF. Behavioral and physiological consequences of sleep restriction. J Clin Sleep Med. 2007;3(5);519-528.
  7. Lamberg L. Insomnia Shows Strong Link To Psychiatric Disorders. Psychiatr News. 2005;40(11):22.
  8. Terzano MG, Parrino L, Bonanni E, et al. Insomnia in general practice: a consensus report produced by sleep specialists and primary-care physicians in Italy. Clin Drug Investig. 2005;25(12):745-764.
  9. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders - 4th ed. DSM-IV. 1996. p.551-573.
  10. National Institutes of Health. Teacher's guide: Information about sleep. 2003. Available at: http://science.education.nih.gov/supplements/nih3/sleep/guide/info-sleep.htm. Accessed May 21, 2010.
  11. Hamblin JE. Insomnia: an ignored health problem. Prim Care Clin Office Pract. 2007;34(3):659-674.
  12. Roth T, Culpepper L. Insomnia management in primary care. Clin Symp. 2008;58(1):3-32.
  13. Chang PP, Ford DE, Mead LA, et al. Insomnia in young men and subsequent depression. The Johns Hopkins Precursors Study. Am J Epidemiol. 1997;146(2):105-114.
  14. Perlis ML, Giles DE, Buysse DJ, et al. Self-reported sleep disturbance as a prodromal symptom in recurrent depression. J Affect Disord. 1997;42(2-3):209-212.
  15. Neckelmann D, Mykletun A, Dahl AA. Chronic insomnia as a risk factor for developing anxiety and depression. Sleep. 2007;30(7):873-880.
  16. Spiegel K, Knutson K, Leproult R, et al. Sleep loss: a novel risk factor for insulin resistance and Type 2 diabetes. J Appl Physiol. 2005;99(5):2008-2019.
  17. González-Ortiz M, Martínez-Abundis E, Balcázar-Muñoz BR, et al. Effect of sleep deprivation on insulin sensitivity and cortisol concentration in healthy subjects. Diabetes Nutr Metab. 2000;13(2):80-83.
  18. Ferrie JE, Shipley MJ, Cappuccio FP, et al. A prospective study of change in sleep duration: associations with mortality in the Whitehall II cohort. Sleep. 2007;30(12):1659-1666.
  19. Institute of Medicine (IOM). Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem. April 2006 Report Brief. National Academies Press, 500 Fifth St, NW, Lockbox 285, Washington. p.1-2.
  20. National Sleep Foundation. 2007 State of the States Report on Drowsy Driving. November 2007. Available at: http://www.drowsydriving.org/stateofthestatesreport. Accessed August 2008.
  21. Hublin C, Partinen M, Koskenvuo M, et al. Sleep and mortality: a population-based 22-year follow-up study. Sleep. 2007;30(10):1245-1253.
  22. National Sleep Foundation. 2008 Sleep in America Poll: Summary of Findings. Available at: http://www.sleepfoundation.org/atf/cf/%7Bf6bf2668-a1b4-4fe8-8d1a-a5d39340d9cb%7D/2008%20POLL%20SOF.PDF. Accessed August 2008.
  23. National Sleep Foundation. Sleep-Wake Cycle: Its Physiology and Impact on Health. Available at: http://www.sleepfoundation.org/atf/cf/%7BF6BF2668-A1B4-4FE8-8D1A-A5D39340D9CB%7D/Sleep-Wake_Cycle.pdf. Accessed October 2010.
  24. National Sleep Foundation. 2005 Sleep in America Poll: Summary of Findings. Available: http://www.sleepfoundation.org/sites/default/files/2005_summary_of_findings.pdf Accessed October 2010.

Silenor is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.

IMPORTANT SAFETY INFORMATION

Silenor is contraindicated in individuals who have shown hypersensitivity to doxepin HCl, any of its inactive ingredients, or other dibenzoxepines. Serious side effects and even death have been reported following the concomitant use of certain drugs with MAO inhibitors (MAOIs). Do not administer Silenor if patient is currently on MAOIs or has used MAOIs within the past two weeks. The exact length of time may vary depending on the particular MAOI dosage and duration of treatment.

Silenor is contraindicated in individuals with untreated narrow angle glaucoma or severe urinary retention.

The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.

Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a hypnotic, with amnesia for the event) have been reported with hypnotics. These events can occur in hypnotic-naive as well as in hypnotic-experienced persons. Although behaviors such as "sleep-driving" may occur with hypnotics alone at therapeutic doses, the use of alcohol or other central nervous system depressants with hypnotics appears to increase the risk of such behaviors, as does the use of hypnotics at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of Silenor should be strongly considered for patients who report a "sleep-driving" episode. Other complex behaviors (i.e., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a hypnotic. As with "sleep-driving", patients usually do not remember these events. Amnesia, anxiety and other neuro-psychiatric symptoms may occur unpredictably.

Patients should not consume alcohol with Silenor. Patients should be cautioned about potential additive effects of Silenor used in combination with CNS depressants or sedating antihistamines.

In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides), has been reported in association with the use of hypnotics. Doxepin, the active ingredient in Silenor, is an antidepressant at doses 10- to 100-fold higher than in Silenor. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Risk from the lower dose of doxepin in Silenor can not be excluded.

Patients should not take Silenor unless they are prepared to get a full night’s sleep. After taking Silenor, patients should confine their activities to those necessary to prepare for bed. Patients should avoid engaging in hazardous activities, such as operating a motor vehicle or heavy machinery, at night after taking Silenor, and should be cautioned about potential impairment in the performance of such activities that may occur the day following ingestion.

For faster onset and to minimize the potential for next day effects, Silenor should not be taken within 3 hours of a meal.

In clinical trials, the most common treatment-emergent adverse reaction was somnolence/sedation.

Silenor has not been studied in pregnant women. Silenor is excreted in human milk after oral administration. Silenor is not approved for use in children.

Please see complete Prescribing Information before prescribing Silenor.