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presented by Teresa D. Valerio, D.N.P. APN, FNP-BC Illinois State University Normal, Illinois Presentation 12.3.54 5/25/2017 1 At the end of this presentation, the learner will be able to: 1. Identify key components of a diagnosis of chronic insomnia in adults 2. Describe effective behavioral management of chronic insomnia 3. Describe effective pharmacologic management of chronic insomnia Presentation 11.5.22 5/25/2017 2 Teresa D. Valerio has no financial relationship or interests to disclose related to this topic. Presentation 11.5.22 5/25/2017 3 1. Complaint (> 3 times a week, > 1 month) Difficulty falling (initiating) asleep Difficulty staying (maintaining) asleep Waking too early Poor quality (non-restorative) of sleep 2. Above occurs despite adequate sleep opportunity 3. One or more daytime impairments Sleepiness, fatigue Attention, concentration, memory, mood, motivation, energy Work/school or social performance Worry about sleep, headaches or GI distress INSOMNIA=symptom Presentation 11.5.22 5/25/2017 4 30% of general population, 10% chronic problem, 50% in clinical setting1 ↑ in chronic illness2 ◦ 75-90% with insomnia have comorbid medical disorder (hypoxemia, dyspnea, pain syndromes, gastroesophageal reflux, neurodegenerative disease) ◦ 40% with insomnia have psychiatric condition ↑ in primary sleep disorders2 (restless leg syndrome, periodic limb movement disorder, snoring, obstructive sleep apnea, circadian rhythm disorders, shift work disorder) Presentation 11.5.22 5/25/2017 5 ↑ in women (onset of menses & menopause) ↑ older adults Divorced, separated, or widowed Lower education and income Cigarette smoking Alcohol and caffeine consumption Certain prescription drugs Presentation 11.5.22 5/25/2017 6 Frequency of Sleep Problem in Past Month (N=1000) Net: Any 44% Woke up feeling unrefreshed 28% Awake a lot during the night 25% Woke up too early and couldn’t get back to sleep 11% Difficulty falling asleep 14% 18% 12% 21% 21% 17% 20% 16% 19% 14% Every night/Almost every night A few nights a week A few nights a month 12% 26% 26% 28% 20% <1% 16% 26% 32% 1% <1% <1% Rarely Never Don’t know/Refused Presentation 11.5.22 5/25/2017 7 Sleep Problem in Past Month At Least a Few Nights/Week 26% Difficulty Falling Asleep 65% 35% 29% Early Awakenings 42% Frequent Awakenings 49% Woke Unrefreshed Rarely, Never, Don't Know/Refused Any Sleep Problem 4% diagnosed (told by physician that they had a sleep problem) 2% currently receiving treatment for sleep problem Presentation 11.5.22 5/25/2017 8 • ↓ Quality of life • Greater dysfunction than CHF (pain, emotional & mental health)4 • Health problems; developing evidence of increased hypertension, AMI17, diabetes and obesity • Psychiatric disorders; depression, anxiety • ↑Health care expenditures5 • + $1,253 for 6 months; age 18-64 • + $1,143 for 6 months; age 65 and older • Risk of accidents; motor vehicle crashes Presentation 11.5.22 5/25/2017 9 How much sleep do you get at night? ◦ <6h, >8 h are “red flags” Do you have trouble falling or staying asleep? Do you have uncomfortable leg feelings in the evening? Do you feel unrefreshed after a night’s sleep? Do you feel tired or sleepy during the day? Do you snore (does your partner say you snore)? Do you have breathing pauses (gasp, snort)? Do you have any unwanted behaviors in your sleep? Presentation 11.5.22 5/25/2017 10 Identify the sleep complaints ◦ ◦ ◦ ◦ Difficulty initiating sleep (onset) Difficulty maintaining sleep (maintenance) Early morning awakenings Non-restorative sleep Adequate sleep opportunity? What are the associated impairments? ◦ ◦ ◦ ◦ ◦ Excessive sleepiness, fatigue Reduced attention, concentration, memory, motivation, mood Errors/accidents Concerns/worries about sleep Symptoms in response to sleep loss – tension, headaches, gastrointestinal distress Presentation 11.5.22 5/25/2017 11 Routine physical examination vital signs heart lungs oropharynx neurological screening Consider screening for anxiety and depression If memory concerns, Mini Mental Exam Presentation 11.5.22 5/25/2017 12 Determined primarily by physical exam ◦ Chem 20 ◦ Thyroid panel ◦ CBC If indicated ◦ polysomnogram if other sleep disorders are suspected ◦ FE/TIBC/Ferritin/B12/Folate Presentation 11.5.22 5/25/2017 13 Presentation 11.5.22 5/25/2017 14 5/25/2017 1. Use ↓ to mark the time you get in bed and ↑ to mark the time you get out of bed. 2. Mark any time you sleep (including naps) by filling the spaces with a line or shade. The hour starts at the beginning of each square. 3. Place a "C" any time you consume caffeine 4. Fill in this log after you get up. Don't look at the clock during the night. Just estimate the time. MONTH/YEAR:_June__2012 Time 6/ 20 6/21 1 PM 2 3 4 5 6 7 8 c c ↓ - ↑ c c c ↓ ↑ c c 9 10 11 12 AM 1 2 3 4 10 11 -- - ↑ ↓ - - ↑ ↓ - - -↑ ↓ ↓ ↓ 5 6 7 8 9 12 PM ↑ c c c ↑ 15 Presentation 11.5.22 Look for: ◦ ◦ ◦ ◦ ◦ ◦ ◦ ◦ ◦ Patterns (differences between weekend/weekdays) How patient rates sleep quality Time patient goes to bed and awakens Time in bed awake Total sleep time Number of awakenings/why How patient feels in the morning/day Caffeine/alcohol intake and medication schedule Napping patterns Use to determine if treatment is helping patient’s insomnia or to refer Presentation 11.5.22 5/25/2017 16 Situation Chance of dozing (0-3) Sitting and reading 0 1 2 3 Watching television 0 1 2 3 Sitting inactive in a public place for example, a theater or meeting 0 1 2 3 As a passenger in a car for an hour without a break 0 1 2 3 Lying down to rest in the afternoon 0 1 2 3 Sitting and talking to someone 0 1 2 3 Sitting quietly after lunch (when you’ve had no alcohol) 0 1 2 3 In a car, while stopped in traffic 0 1 2 3 Total Score 0 = would never doze 1 = slight chance of dozing 5/25/2017 2 = moderate chance of dozing 3 = high chance of dozing Presentation 11.5.22 17 Primary insomnia is a DSM-IV-TR® classification: • >1 month duration Impaired next-day functioning Independent of another sleep or mental disorder Not due to a substance, medication, or medical condition Cormorbid insomnia is described by DSM-IV-TR® as insomnia: • psychiatric disorder • medical condition • substance use Presentation 11.5.22 5/25/2017 18 Primary insomnias ◦ ◦ ◦ ◦ ◦ Adjustment (acute) Psychophysiological Inadequate sleep hygiene Idiopathic Paradoxical Comorbid insomnia ◦ Mental disorder ◦ Medical condition ◦ Drug or substance Presentation 11.5.22 5/25/2017 19 Psychosocial stressors – work, family, home Mental disorders – anxiety, somatoform, depression, dysthymia, bipolar, cyclothymic Prescription drugs – antidepressants, antihypertensives, hypolipidemics, corticosteroids, antiparkinsonian, theophylline, anorectic, decongestants, stimulants Drug or substance abuse – nicotine, alcohol, caffeine, food allergen Medical disorders – pain, fibromyalgia, COPD, asthma, Parkinson’s, dementia, “hot flashes”, pregnancy, gastroesophageal reflux, hyperthyroidism, anemia Other sleep disorders – circadian rhythm, restless legs syndrome, periodic leg movements, obstructive sleep apnea Presentation 11.5.22 5/25/2017 20 Behavioral techniques Effective, particularly in chronic insomnia; time consuming and some require specialists Adherence Patient preference Time limitations (provider and patient) Pharmacological therapy Sleep maintenance problems with generic drugs Side effects; residual sleepiness, amnesia, sleep behaviors Tolerance Dependence concern and issues in discontinuation Scheduled drugs; limited NPs prescribing in some states Costs Health insurer coverage issues; short-term vs. long-term use Presentation 11.5.22 5/25/2017 21 Viable treatment options for the management Most are compatible with one another and can be combined to optimize outcome Benefits are sustained over time Adverse effects are minimal Require more clinical time and patient motivation than using pharmacologic therapies Presentation 11.5.22 5/25/2017 22 Therapy Description Stimulus control Set of instructions designed to reassociate the bedbedroom with sleep and to re-establish a consistent sleep-wake schedule Sleep restriction Method designed to curtail time in bed to the actual amount of sleep time Relaxation training Clinical procedures aimed at reducing somatic tension Cognitive therapy Psychological methods aimed at challenging and changing misconceptions about sleep and insomnia Sleep hygiene education Guidelines about health practices such as diet, exercise, and substance abuse and environmental factors such as light, noise and temperature related to sleep Cognitive-behavior therapy (CBT) Combination of any of the above. Addresses behavioral mechanisms underlying insomnia. Refer to psychologist or professional trained in CBT. Presentation 11.5.22 5/25/2017 23 Definition: education for patients about behaviors that will help them sleep ◦ Limit use of stimulants (caffeine, decongestants, tobacco, some SSRIs) ◦ No checking the time ◦ Do not use alcohol as a sleep aid ◦ Do not exercise 3 hours before bedtime ◦ Establish a conducive sleep environment (quiet, cool, dark) ◦ Reduce napping and time in bed not sleeping Insufficient evidence for use as monotherapy Presentation 11.5.22 5/25/2017 24 Go to bed when sleepy Get up at the same time every day Sleep only in bed Use the bedroom only for sleeping and sex If you cannot fall asleep, do not lie in bed and “try harder” No nap Cover the clock or turn it around No caffeine use Don’t take worries to bed Limit sounds Moderate room temperature Limit light exposure Tobacco and alcohol use disturbs sleep Presentation 11.5.22 5/25/2017 25 Caution – Consider other sleep disorders first Determine usual total hours of sleep ◦ Example; 5-6 hours by patient history Set regular wake up time – 7 days a week ◦ Example; 0530 for work at 0700, and 0700 on days off! Determine the usual time sleep begins ◦ Example; often asleep by 0000 (in bed at 2200) Set an initial sleep schedule = to total hours ◦ Example; 0000 to 0530, daily for 1 week Advance bedtime 30 minutes/week if insomnia improved up to 7-8 hours total ◦ Example; after 1 week of falling asleep easily at 0000 with 1-2 brief awakenings then progress to 2 nd week 2330-0530, 3rd week 2300-0530, etc. Presentation 11.5.22 5/25/2017 26 Nonbenzodiazepines (nonBZD) Benzodiazepines (BZD) Melatonin receptor agonist Selective H1 antagonist “Off-label” (Not FDA approved) ◦ Sedating antidepressants ◦ Atypical antipsychotics Under study for fibromyalgia – Sodium Oxybate Over-the-counter (OTC) ◦ Antihistamines ◦ Herbals ◦ Alcohol Presentation 11.5.22 5/25/2017 27 Thalamus Cortical activation Sleep spindles EEG synchronization Cortex Hypothalamus Pineal gland Sleep-wake switch SCN Circadian clock Brain Stem Ascending cortical activation REM/SWS switch EEG=electroencephalography; REM=rapid eye movement; SCN=suprachiasmatic nucleus; SWS=slow-wave sleep. Presentation 11.5.22 5/25/2017 28 Acetylcholine (BF) Acetylcholine (PPT; LDT) Norepinephrine (LC) Histamine (TMN) Dopamine (VTA) Serotonin (raphe) Motor neurons Reticular formation BF=basal forebrain; LC=locus coeruleus; LDT=laterodorsal tegmental nucleus; PPT=pedunculopontine nucleus; TMN=tuberomammillary nucleus; VTA=ventral tegmental area. Presentation 11.5.22 5/25/2017 29 GABA Sleep GABA (ventrolateral preoptic area) – – – Norepinephrine Histamine Dopamine Serotonin Acetylcholine Wake Norepinephrine, Serotonin Presentation 11.5.22 5/25/2017 30 Process S: Homeostatic sleep drive Work Sleep propensity Sleep Process C: Circadian drive for wakefulness 09.00 15.00 21.00 03.00 09.00 Time of day Presentation 11.5.22 5/25/2017 31 Nearly all agents promote sleep by broadly enhancing inhibition of brain regions Clinical effects of neural inhibition ◦ Sleep promotion, reduction of anxiety, amnesia, muscle relaxation, incoordination, antiseizure effect Effects proportional to blood level ◦ Independent of time of day, activity level, other neural systems Presentation 11.5.22 5/25/2017 32 Generic Name Adult Dose Geriatric Dose t1/2 Eszopiclone 2-3 mg 1-2 mg ~6h/9h Zaleplon 10-20 mg 5 mg ~1h Zolpidem 10 mg 5 mg ~2.5h/2.9h Zolpidem Extendedrelease 12.5 mg 6.25 mg ~2.8h Act on GABA receptors, nonselective depressants Side effects: Residual next-day sedation, cognitive impairment, motor incoordination, dependence, rebound insomnia Presentation 11.5.22 5/25/2017 33 Generic Name Adult Dose Geriatric Dose T1/2 Estazolam 0.5-2 mg 0.5 mg ~8-25h Flurazepam 15-30 mg 15 mg ~47-100h Quazepam 15-50 mg 7.5 mg ~39-73h Temazepam 7.5-30 mg 7.5 mg ~3.5-18h 0.125-0.25 mg 0.125 mg ~1.5-5.5h Triazolam Act on GABA receptors, nonselective depressants Side effects: Residual next-day sedation, cognitive impairment, motor incoordination, dependence, rebound insomnia Presentation 11.5.22 5/25/2017 34 Ramelteon (Rozerem®) 9 Melatonin Receptor Agonist FDA approved; nonscheduled, onset insomnia indication Dose: 8 mg Side effects - headache, somnolence, dizziness, and fatigue; no abuse or rebound insomnia Doxepin (Silenor®)15 Selective H1 antagonist that decreases wakefulness FDA approved; nonscheduled, maintenance insomnia indication - efficacy throughout the night, no next day sedation Dose; 3 mg, 6 mg Side effects - headache, sedation, GI; no sleep behaviors, amnesia, anticholinergic effects Presentation 11.5.22 5/25/2017 35 Sedating Antidepressants10 No established dose-response relationship Significant adverse effects, risk-benefit ratio? Trazodone ◦ Widely used; sedating, risk of serious adverse effects ◦ limited research; use for 2 weeks studied in treating insomnia Amitriptyline and others – lacking data for insomnia use Atypical Antipsychotics10 ◦ Quetiapine (Seroquel®), Risperidone (Risperdal®), Olanzapine (Zyprexa®) Presentation 11.5.22 5/25/2017 36 Sodium Oxybate (Xyrem) AKA GHB Currently FDA-approved for treatment of cataplexy and sleepiness in Narcolepsy Controlled substance schedule III; made in 1 pharmacy in the U.S. and shipped to patients home CNS depressant ↑ Slow Wave Sleep (Stage IV) Trials reported reduces insomnia, fatigue and myalgias in fibromyalgia patients Dosed 2 times a night; bedtime and 2-4 hours later Salt added to provide taste Presentation 11.5.22 5/25/2017 37 Antihistamines ◦ No systematic evidence for efficacy ◦ May be effective for mild, transient insomnia for 3-4 days ◦ Side effects: Next-day sedation, cognitive impairment, anticholinergic effects Herbals – melatonin, valerian ◦ Variability in quality of preparations ◦ Little to no evidence of efficacy and safety ◦ Side effects: Next-day sedation, headache, excitability Alcohol Presentation 11.5.22 5/25/2017 38 Medication Indication Sleep Maint Sleep Onset Flurazepam X Quazepam X Estazolam X Temazepam X Triazolam X Doxepin (low-dose) X Eszopiclone X X Ramelteon X Zaleplon X Zolpidem Ext-Rel X X Zolpidem X Presentation 11.5.22 5/25/2017 39 With BZDs and nonBZD medications, discontinuation effects are minimal and transient Gradually decrease the dose when concerns about dependence ◦ To minimize any discontinuation symptoms ◦ To minimize the potential for recurrence of insomnia Ensure stimulus control and sleep hygiene measures are in place and continue Presentation 11.5.22 5/25/2017 40 Plan for regular follow-up until improved and then periodically Insomnia is often a chronic problem See patient in 1 month If improved, then schedule for 2-3 months After 3 months of improved sleep, consider discontinuing or long-term therapy Treatment improves perceived health, qualityof-life and function16 Presentation 11.5.22 5/25/2017 41 5/25/2017 Discuss “normal” sleep patterns Completing sleep logs/diary Completing Epworth Sleepiness Scale Behavioral therapy implementation: ◦ ◦ ◦ ◦ Stimulus control Good sleep hygiene Sleep restriction Relaxation techniques ◦ ◦ ◦ ◦ When to take Frequency; nightly for 2-3 months, then . . . Side effects Discontinuation plan Drug therapy Presentation 11.5.22 42 5/25/2017 Uncomfortable with diagnosing and managing insomnia Do not have the time to manage insomnia Suspect other sleep disorders Obstructive Sleep Apnea Restless leg syndrome Narcolepsy or hypersomnia Unusual behaviors in sleep Patient not improving with treatment or dangerous symptoms (excessive sleepiness) 43 Presentation 11.5.22 Insomnia is a symptom, not a diagnosis Diagnosis is made by history Significant health and safety issues Behavioral therapy is most effective; adherence issues Pharmacologic therapy alone less effective than behavioral therapy Combination therapy most effective NPs in any setting can effectively evaluate and manage insomnia Presentation 11.5.22 5/25/2017 44 1. American Academy of Sleep Medicine. (2005). The international classification of sleep disorders : diagnostic and coding manual (2nd ed.). Westchester, Ill.: American Academy of Sleep Medicine. 2. National Institutes of Health State-of-the-Science Conference Statement on Manifestations and Management of Chronic Insomnia in Adults. Sleep. 2005;28:1049-1057. 3. National Sleep Foundation. (2008). 2008 Sleep in America Poll. Retrieved from http://www.sleepfoundation.org/sites/default/files/2008%20POLL%20SOF.PDF 4. Katz, D. A., & McHorney, C. A. (2002). The relationship between insomnia and health-related quality of life in patients with chronic illness. J Fam Pract, 51(3), 229-235. doi: jfp_0302_ [pii] 5. Ozminkowski, R. J., Wang, S., & Walsh, J. K. (2007). The direct and indirect costs of untreated insomnia in adults in the United States. Sleep, 30(3), 263-273. 6. National Sleep Foundation. (2010). Sleep Diary. Retrieved from http://www.sleepfoundation.org 7. Johns, M. W. (1991). A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep, 14(6), 540-545. 8. American Psychological Association, (2000). Diagnostic and Statistical Manual of Mental Disorders-IV-TR (Fourth Edition ed.). Washington, D.C.: American Psychiatric Association. 9. Schutte-Rodin, S., Broch, L., Buysse, D., Dorsey, C., & Sateia, M. (2008). Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med, 4(5), 487-504. 10. National Institutes of Health State of the Science Conference statement on Manifestations and Management of Chronic Insomnia in Adults, June 13-15, 2005. (2005). Sleep, 28(9), 1049-1057. 11. Espana, R. A., & Scammell, T. E. (2004). Sleep neurobiology for the clinician. Sleep, 27(4), 811-820. 12. Saper, C. B., Scammell, T. E., & Lu, J. (2005). Hypothalamic regulation of sleep and circadian rhythms. Nature, 437(7063), 1257-1263. doi: nature04284 [pii] 10.1038/nature04284 13. Edgar, D. M., Dement, W. C., & Fuller, C. A. (1993). Effect of SCN lesions on sleep in squirrel monkeys: evidence for opponent processes in sleep-wake regulation. J Neurosci, 13(3), 1065-1079. 14. Lu, J., & Greco, M. A. (2006). Sleep circuitry and the hypnotic mechanism of GABAA drugs. J Clin Sleep Med, 2(2), S19-26. 15. Weber, J., Siddiqui, M. A., Wagstaff, A. J., & McCormack, P. L. (2010). Low-dose doxepin: in the treatment of insomnia. CNS Drugs, 24(8), 713-720. doi: 6 [pii]10.2165/11200810-000000000-00000 16. Krystal, A. D. (2007). Treating the health, quality of life, and functional impairments in insomnia. J Clin Sleep Med, 3(1), 63-72. 17. Laugsand, L.E., Vatten, L.J., Platou, C., & Jansky, I. (2011). Insomia and the risk of acute myocardial infarction: a population study. Circulation, 124:2073-2081. doi: 10.1161/CIRCULATIONAHA.111.025858. 18. Staud, R. (2010). Pharmacological treatment of fibromyalgia syndrome. Drugs 2010: 70(1), 1-14. Presentation 11.5.22 5/25/2017 45