DSM-5 INSOMNIA. Maintaining. Maintaining Sleep. Difficulty Falling Asleep: Difficulty. Early AM awakenings: (> 30 minutes before desired wake time)

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DSM-5 INSOMNIA 3 nights/wk 3 months Difficulty Falling Asleep: > 30 minutes Difficulty Maintaining Sleep Next Day Consequences Early AM awakenings: (> 30 minutes before desired wake time) Initiation

earlier than desired Insomnia Is a Distinct Disorder That Should Be Treated NIH (1983) 1 NIH (2005) 2 Definition Treatment Other Insomnia is a symptom, not a disorder Insomnia is secondary to a

2 DSM-5 INSOMNIA 3 nights/wk 3 months Difficulty Falling Asleep: > 30 minutes Difficulty Maintaining Sleep Next Day Consequences Early AM awakenings: (> 30 minutes before desired wake time) Initiation Trouble falling asleep APA Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition: DSM-5 Maintaining Frequent awakening or trouble returning to sleep after awakening Waking early Waking earlier than desired Insomnia Is a Distinct Disorder That Should Be Treated NIH (1983) 1 NIH (2005) 2 Definition Treatment Other Insomnia is a symptom, not a disorder Insomnia is secondary to a primary disorder Important to treat the primary disorder; insomnia may or may not receive attention Hypnotics should generally be used in the lowest doses and for the shortest period of time Chronic insomnia occurs in the context of medical and psychiatric disorders Insomnia is a disorder Insomnia is a disorder that typically is comorbid with other disorders Treat insomnia as well as other disorders; improvements in insomnia may result in improvements in other disorders Chronic insomnia exists and merits treatment Insomnia itself is associated with significant impairment in function and quality of life Percent Prevalence of Insomnia by Age Group Age Group 1. National Institutes of Health. Drugs and Insomnia: The Use of Medications to Promote Sleep. NIH Consensus Statement. 1983;4:1-19; 2. National Institutes of Health. State-of-the-Science Conference Statement. Manifestations and Management of Chronic Insomnia in Adults. 2005:1-18. Mellinger GD et al. Arch Gen Psychiatry. 1985;42: Longitudinal Patterns of Insomnia Transient Short Term Chronic Few Days Few days-month >3 month Exam Traumatic event Depression Clinical Symposia 56(1), 2006 Slide courtesy, Tom Roth

Neuroimaging Evidence for Hyperarousal in Insomnia Insomnia is associated with greater brain metabolism.

Impact of Co-morbidity on Insomnia Prevalence in Adults Without Percent Other Disease OAD Obesity Arthritis CVD During sleep, there was a smaller decline observed in relative metabolism in brainstem,

28 Causes of Insomnia Primary / psychophysiologic 20% Periodic limb movement 10% Treatment Goals for Insomnia Psychiatric 40% Circadian rhythm ( DSPS / shift ) 10% Other 10% Breathing related 5%

3 Neuroimaging Evidence for Hyperarousal in Insomnia Insomnia is associated with greater brain metabolism. The inability to fall asleep may be related to failure of arousal mechanisms to decline in activity from waking to sleep states. Impact of Co-morbidity on Insomnia Prevalence in Adults Without Percent Other Disease OAD Obesity Arthritis CVD During sleep, there was a smaller decline observed in relative metabolism in brainstem, hypothalamic/basal forebrain, and limbic networks in insomnia patients vs. healthy subjects With Klink, et al. Arch Intern Med. 1992;152: Causes of Insomnia Primary / psychophysiologic 20% Periodic limb movement 10% Treatment Goals for Insomnia Psychiatric 40% Circadian rhythm ( DSPS / shift ) 10% Other 10% Breathing related 5% Substances 5% Restore and improve sleep quality and duration Prevent progression from acute to chronic insomnia Reduce impact on comorbid conditions 1. Nadolski N. Plast Surg Nurs. 2005;25(4): Roth T, Culpepper L. Clin Symp. 2008;58(1): Ohayon MM. Sleep Med Rev. 2002;6: Approach to the Management of Insomnia Cognitive & Behavioral Therapy This technique Targets these symptoms Diagnosis 1,2 Sleep restriction Excessive time spent in bed; fragmented sleep Education, including good sleep practices 1,2 Stimulus control Relaxation Techniques Associating bed with wakefulness High physiologic, cognitive, or emotional arousal Nonpharmacologic and/or pharmacologic therapy 1,2 Cognitive Misconceptions about sleep and insomnia Sleep hygiene education Behaviors that undermine good quality sleep Referral to sleep specialist (in cases of treatment failure) 1 1. Kupfer DJ, Reynolds CF III. N Engl J Med. 1997;336: [Evidence Level C]; 2. Consensus Conference. Drugs and insomnia. JAMA ;251: [Evidence Level C] 1. Spielman AJ et al. Psychiatr Clin North Am. 1987;10: ; 10: Walsh JK et al. NIH Publication No Morin CM. Principles and Practice of Sleep Medicine. 2005: Ringdahl EN et al. J Am Board Fam Pract. 2004;17:

4 3 Lippmann S et al. South Med J. 2001;94: Sleep Hygiene 101 What Do People Take to Try to Improve Their Sleep? Do s: Enhance sleep environment: dark, quiet, cool temperature Increase exposure to bright light during the day Practice relaxing routine Reduce time in bed; regular sleep/wake cycle Incorporate regular exercise in the morning and/or afternoon Dont's: watch the clock Use stimulants (e.g, caffeine, nicotine, particularly near bedtime) Consume a heavy meals or drink alcohol within 3 hours of bed Use bright light during the night, avoid TV/computers e-gadgets. 1 NHLBI Working Group on Insomnia NIH Publication Kupfer DJ, Reynolds CF. N Engl J Med. 1997;336: Alcohol 1,2,3 Herbals 3,4 Dietary supplements 1,4 Homeopathic preparations 4 Melatonin 1,3,4 OTC sleep aids 2 Sedating antidepressants 1 Sedative-hypnotics 1,5 Melatonin receptor agonist Hypocretin Receptor Antagonist 1. Neubauer DN. Clinical Cornerstone. 2003;5: Ancoli-Israel S, Roth T. Sleep. 1999;22(suppl 2):S347-S Wagner J et al. Neuro 4. Larzelere MM, Wiseman P.Prim Care Clin Office Pract. 2002;29: Mitler MM. Sleep. 2000;23(suppl 1):S39-S47. What Do People Take to Try to Improve Their Sleep? Ideal insomnia medicine ASLEEP ASLEEP 28% use alcohol AWAKE AWAKE Take medicine Time to wake up Characteristics of the Ideal Hypnotic No memory deficits Rapid absorption Address underlying pathophysiology Drug classes No respiratory depression No interaction with ethanol Ideal Hypnotic Rapid sleep induction Minimal adverse effect on sleep physiology Histamine Receptor Antagonist BZA Receptor Agonists Melatonin Receptor Agonist Hypocretin Receptor Antagonist No tolerance No physical dependence No rebound insomnia No residual effects Optimal duration of action No formation of active metabolites Doxepin Zolpidem Eszopiclone Zaleplon Triazolam Ramelteon Suvorexant Adapted from Mendelson et al. Sleep Med Rev 2004;8:

5 Agent Initiates Sleep Maintains Sleep Sleep with limited opportunity Required Inactivity (hr) Dose (mg) Eszopiclone 8+ 1,2,3 Zaleplon 4 5,10 Zolpidem 7-8 5,10 Extended release , 12.5 Intermezzo (Sublingual) (4 hrs) , , 10 Zolpimist (oral spray) Elduar (Sublingual) 4 5, 10 Silenor 7-8 3, 6 Ramelteon - 8 Suvorexant 7 5, 10, 15, AASM Chronic Insomnia Clinical Guideline Consensus Recommendations Hypnotic treatment should be combined with CBTi when possible. OTC antihistamine as well as herbal and nutritional substances are not recommended in the Tx of chronic insomnia due to the relative lack of efficacy and safety data. Older approved drugs for insomnia including barbiturates, barbiturate-type drugs and chloral hydrate are not recommended for the Tx of insomnia AASM Chronic Insomnia Clinical Guideline Consensus Recommendations Efforts should be made to employ the lowest effective maintenance dosage of medication and to taper medication when conditions allow. Chronic hypnotic medication may be indicated for long-term use in those with severe or refractory insomnia or chronic comorbid illness Long-term use may be nightly, intermittent, or as needed in an on demand pattern. The Sleepless Patient: Summary Insomnia is an extremely common problem Assessment requires careful inventory of potential confounders CBTi is an ideal ideal option Numerous medications are available: Risk analysis: evaluate cost benefit Rx has variable benefit profiles Insomnia therapy needs to be tailored to meet patient s expectations. Comorbidity Hypnotic Outcome Rheumatoid Eszopiclone Improved pain Arthritis Menopausal Insomnia Eszopiclone decreased awaking due to hot flashes Fibromyalgia Zolpidem sleep and energy Major Depression Eszopiclone, BZA Improve MDD along with sleep GAD Eszopiclone Improved Hamilton Anxiety Scale (HAMA) Post-Alcohol Discontinuation Trazodone Improves sleep time PTSD Eszopiclone (Prazosin) Improved Sleep & daytime PTSD Sx. References: 1Nolen et al. J Affect Disord Jul;28(3):179-88; 2Londborg PD et al. J Affect Disord Dec;61(1-2):73-9; 3Fava M et al. Biol Psychiatry Jun 1;59(11): ; 4Krystal AD. J Clin Sleep Med Feb 15;3(1):63-72; 5Pollack M et al. Arch Gen Psychiatry May;65(5):551-62; 6Le Bon O et al. J Clin Psychopharmacol Aug;23(4): Fava et al., J Clin Psychopharm.2009 Jun;29(3):222-30; 8Fava et al.j Clin Psych 2011.,9Germain et al, J Psychosom Res. 72(2):89-96:2012; 10Taylor et al., Biol Psych. 2008;63(6): Raskind et al., Biol Psych. 2008;61(8):928-34; 11Raskind et al., Am J Psych. 2003;160(2): Pollack et al., J Clin Psych. 2011;72(7): Limited evidence shows no benefit compared with placebo. The FDA does not regulate valerian, and thus different preparations vary in valerian content. Safety data are minimal, but there have been case reports of hepatotoxicity in persons taking herbal products containing valerian. Other herbal remedies have also been promoted, but efficacy evidence is lacking.

6 Because melatonin is not regulated by the FDA, preparations containing it vary in strength, making comparisons across studies difficult. Although melatonin appears to be effective for the treatment of circadian rhythm disorders (e.g., jet-lag), little evidence exists for efficacy in the treatment of insomnia or its appropriate dosage. In short-term use, melatonin is thought to be safe, but there is no information about the safety of long-term use. (H1 receptor antagonists i.e diphenhydramine) are the most commonly used OTC treatments for chronic insomnia, but there is no systematic evidence for efficacy and there are significant concerns about risks of these medications. Adverse effects include residual daytime sedation, diminished cognitive function, and delirium, the latter being of particular concern in the elderly. Other adverse effects include dry mouth, blurred vision, urinary retention, constipation, and risk of increased intraocular pressure in individuals with narrow angle glaucoma. Diphenhydramine* Use As a Sedative- Hypnotic in Older Adults % Use Over 10 Years OTC Diphenhydramine Prescription Sedative-Hypnotics (primarily benzodiazepines) All antidepressants have potentially significant adverse effects, raising concerns about the risk benefit ratio. There is a need to establish doseresponse relationships for all of these agents and communicate them to prescribers *Diphenhydramine-containing products include: generic dyphenhydramine, Benadryl, Benylin, Nervine, Aid-To-Sleep, Nytol, Robitussin PM, Tylenol PM, Motrin PM, acetaminophen PM, Excedrin PM, Legatrin PM. 1. Basu R et al. Am J Geriatr Psychiatry. 2003;11: Rickels K et al. J Clin Pharmacol. 1983;23: Kudo Y and Kurihara M. J Clin Pharmacol. 1990;30: Winkelman J et al. Ann Clin Psychiatry. 2005;17: Richardson G et al. J Clin Pharmacol. 2002:22: ) Adverse Events Associated with Trazodone Adverse events raise concerns, especially in older adults: 1 Dizziness 1 Oversedation 1,2 Priapism 3,4 Atrial and ventricular arrhythmias 3 Alpha-adrenergic blockade, including orthostatic hypotension 2 potential for falls A number of other sedating medications have been used in the treatment of insomnia. These include barbiturates (e.g., phenobarbital) and antipsychotics (e.g., quetiapine and olanzepine). Studies demonstrating the usefulness of these medications for either short- or long-term management of insomnia are lacking. Furthermore, all of these agents have significant risks. Thus, their use in the treatment of chronic insomnia cannot be recommended. 1. Mendelson WB. J Clin Psychiatry. 2005;66: Lippmann S et al. South Med J. 2001;94: Mendelson WB et al. Sleep Med Rev. 2004;8: Winkelman J and Pies R. Ann Clin Psychiatry. 2005;17:31-40.

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Definitions. Prevalence. Chronic Insomnia DSM-5 INSOMNIA. Insomnia Is a Distinct Disorder That Should Be Treated ~10% 3 nights/wk 3 months

Definitions. Prevalence. Chronic Insomnia DSM-5 INSOMNIA. Insomnia Is a Distinct Disorder That Should Be Treated ~10% 3 nights/wk 3 months Chronic Definitions Alon Y. Avidan, M.D., M.P.H UCLA Sleep Disorders Center Is a Distinct Disorder That Should Be Treated NIH (1983) 1 NIH (2005) 2 is a symptom, is a disorder not a disorder DSM-5 INSOMNIA