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Anxiety Disorders: A Focus on Sleep and Improving Patient Outcomes

Anxiety Disorders: A Focus on Sleep and Improving Patient Outcomes. Thursday, March 6, 2008 Savannah, Georgia. Introductions and Program Objectives. Mark H. Pollack, MD Director, Center for Anxiety and Traumatic Stress Disorders Massachusetts General Hospital

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Anxiety Disorders: A Focus on Sleep and Improving Patient Outcomes

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  1. Anxiety Disorders:A Focus on Sleep and Improving Patient Outcomes Thursday, March 6, 2008 Savannah, Georgia Presented at the 28th Annual Conference Anxiety Disorders Association of America

  2. Introductions and Program Objectives Mark H. Pollack, MD Director, Center for Anxiety and Traumatic Stress DisordersMassachusetts General Hospital Professor of PsychiatryHarvard Medical School Presented at the 28th Annual Conference Anxiety Disorders Association of America

  3. Mark H. Pollack, MD Center for Anxiety and Traumatic Stress DisordersMassachusetts General HospitalHarvard Medical SchoolBoston, Massachusetts Michael W. Otto, PhDCenter for Anxiety and Related DisordersBoston UniversityBoston, Massachusetts Daniel S. Lewin, PhD, D.ABSMChildren’s National Medical CenterGeorge Washington University School of Medicine Naomi M. Simon, MD, MScCenter for Anxiety and Traumatic Stress DisordersMassachusetts General HospitalHarvard Medical SchoolBoston, Massachusetts W. Vaughn McCall, MD, MSWake Forest University School of MedicineWinston-Salem, North Carolina Program Faculty Presented at the 28th Annual Conference Anxiety Disorders Association of America

  4. Program Agenda

  5. Learning Objectives • After participating in this educational activity, the participant should be better able to: • Discuss and relate both naturally occurring sleep compared to the effect of sleep disorders in the various patient populations • Improve the ability to differentially diagnose patients with anxiety disorders and to understand the interplay with sleep, particularly insomnia • Engage patients and develop a management plan for those with sleep and anxiety disorders • Identify which patients to refer to other providers based on differential diagnosis Presented at the 28th Annual Conference Anxiety Disorders Association of America

  6. Disclosures • Dr. Mark H. Pollack has received grants or research support from AstraZeneca, Bristol-Myers Squibb, Cephalon, Cyberonics, Forest, GlaxoSmithKline, Janssen, Lilly, NARSAD, NIDA, NIMH, Pfizer, Roche, Sepracor, UCB, and Wyeth. He has been a consultant for AstraZeneca, Brain Cells, Bristol-Myers Squibb, Cephalon, Dov, Forest, GlaxoSmithKline, Janssen, Jazz, Lilly, Medavante, Neurocrine, Neurogen, Novartis, Otsuka, Pfizer, Predix, Roche, sanofi-aventis, Sepracor, Solvay, Tikvah, Transcept, UCB, and Wyeth. He has been a speakers bureau member for Bristol-Myers Squibb, Forest, GlaxoSmithKline, Janssen, Lilly, Pfizer, Solvay, and Wyeth, and has equity in Medavante and Mensante. • Dr. Michael W. Otto has been a consultant for Jazz and Organon. Presented at the 28th Annual Conference Anxiety Disorders Association of America

  7. Disclosures • Dr. Daniel S. Lewin has no financial relationships over the past 12 months with any commercial organizations having a direct or indirect interest in the subject matter of his presentation. • Dr. Naomi M. Simon has received grants or research support from AstraZeneca, Bristol-Myers Squibb, Cephalon, Forest, GlaxoSmithKline, Janssen, Lilly, NARSAD, NIMH, Pfizer, Sepracor, and UCB. She has received honoraria for speaking from Forest, Janssen, Lilly, Pfizer, Sepracor, and UCB, and has been a consultant for Paramount Biosciences and Solvay. • Dr. W. Vaughn McCall has received grants or research support from GlaxoSmithKline, sanofi-aventis, and Sepracor. He has been a consultant for Sepracor and a speakers bureau member for GlaxoSmithKline and Sepracor. Presented at the 28th Annual Conference Anxiety Disorders Association of America

  8. Unlabeled Uses • Please note that these presentations may discuss unapproved or unlabeled uses of drugs or devices. Any product mentioned in the presentations should be used in accordance with the prescribing information provided by the manufacturer. Presented at the 28th Annual Conference Anxiety Disorders Association of America

  9. Using your ResponseCard • Questions will be displayed along with the available answers • When the ten (10) second countdown clock appears, press and release the button that best represents your answer • A green light indicates your answer was received • Your last answer will be recorded • There is no need to press “GO” or “?” • Please leave the ResponseCard on the table at the end of this session. - Thank You. Presented at the 28th Annual Conference Anxiety Disorders Association of America

  10. Sleep-Wake Cycle Disturbancesand Anxiety Mark H. Pollack, MD Director, Center for Anxiety and Traumatic Stress DisordersMassachusetts General Hospital Professor of PsychiatryHarvard Medical School Presented at the 28th Annual Conference Anxiety Disorders Association of America

  11. Disclosure • Dr. Mark H. Pollack has received grants or research support from AstraZeneca, Bristol-Myers Squibb, Cephalon, Cyberonics, Forest, GlaxoSmithKline, Janssen, Lilly, NARSAD, NIDA, NIMH, Pfizer, Roche, Sepracor, UCB, and Wyeth. He has been a consultant for AstraZeneca, Brain Cells, Bristol-Myers Squibb, Cephalon, Dov, Forest, GlaxoSmithKline, Janssen, Jazz, Lilly, Medavante, Neurocrine, Neurogen, Novartis, Otsuka, Pfizer, Predix, Roche, sanofi-aventis, Sepracor, Solvay, Tikvah, Transcept, UCB, and Wyeth. He has been a speakers bureau member for Bristol-Myers Squibb, Forest, GlaxoSmithKline, Janssen, Lilly, Pfizer, Solvay, and Wyeth, and has equity in Medavante and Mensante. Presented at the 28th Annual Conference Anxiety Disorders Association of America

  12. Objectives Review prevalence and public health impact of insomnia Describe relationship between anxiety disorders and insomnia Discuss issues related to treatment of sleep and anxiety Presented at the 28th Annual Conference Anxiety Disorders Association of America

  13. What Is “Insomnia”? Insomnia is a subjective complaint (symptom) of one or more of the following: Inadequate sleep quality Insufficient amount of sleep Dissatisfaction with sleep timing Not feeling rested after habitual sleep episode Presented at the 28th Annual Conference Anxiety Disorders Association of America Kupfer DJ, Reynolds CF. N Engl J Med. 1997;336:341-346.

  14. Insomnia Prevalence and Impact Prevalence of chronic insomnia in adults is 10%-15%1,2 With varying degrees of severity Another 20%-30% have transient or occasional sleep problems Chronic insomnia is associated with3-5: Absenteeism Accidents Memory impairment Greater health care utilization 1. Léger D, et al. J Sleep Res. 2000;9:35-42. 2. Ohayon MM, Roth MT. J Psychiatr Res. 2003;37:9-15.3. Simon G, VonKorff M. Am J Psychiatry. 1997;154:1417-1423.4. Benca RM. Psychiatr Serv. 2005;56:332-343. 5. Kim K, et al. Sleep. 2000;23:41-47. Presented at the 28th Annual Conference Anxiety Disorders Association of America

  15. Consequences of Chronic Insomnia Societal and Clinical Impact of Insomnia Societal High direct and indirect costs Increased utilization of inpatient and outpatient healthcare resources Increased use of sleep-promoting medication Reduced quality of life Reduced daily functioning Personal Increased daytime sleepiness with consequent psychomotor impairment Increased risk of depression or anxiety Increased risk of alcohol/drug abuse or dependence Poorer outcomes in medical and psychiatric illnesses Presented at the 28th Annual Conference Anxiety Disorders Association of America Thase ME. Gen Hosp Psychiatry. 2005; 27:100-112.

  16. Sleep and Psychiatric Illness: Bidirectional Relationship? Insomnia adversely affects quality of life in anxiety disorders Treatment of chronic insomnia may prevent the development and persistence of mood and anxiety disorders ? Anxiety/Mood Insomnia Disorders Mellinger GD, et al. Arch Gen Psychiatry. 1985;42:225-232. Lustberg L, Reynolds CF. Sleep Med Rev. 2000;4:253-262. Stein MB, Barrett-Connor E. Am J Geriatr Psychiatry. 2002;10:568-574.(after Stein, 2005) Presented at the 28th Annual Conference Anxiety Disorders Association of America

  17. Prevalence of Psychiatric Disorders in Insomnia Sufferers Drug Abuse 4.2 Other Psychiatric Disorder 5.1 Alcohol Abuse 7.0 Dysthymia 8.6 Major Depression 14.0 Anxiety Disorders 23.9 No Psychiatric Disorder 59.5 0 10 20 30 40 50 60 % of Respondents Presented at the 28th Annual Conference Anxiety Disorders Association of America Ford DE, Kamerow DB. JAMA. 1989;262:1479-1484.

  18. Insomnia Is a Risk Factor for Psychiatric Disorders Incidence (%) Over 3.5 years 18 * 16 Insomnia, n=240 * 14 No Insomnia, n=739 12 Incidence (%) 10 8 6 * 4 2 0 Depression Anxiety Alcohol Abuse Drug Abuse *95% CI for odds ratio excludes 1.0. Presented at the 28th Annual Conference Anxiety Disorders Association of America Breslau N, et al. Biol Psychiatry. 1996;39:411-418.

  19. Insomnia and Mental Disorder Trajectory Insomnia Depressive Disorder 40% 22% Insomnia-Depressive Disorder Anxiety Disorder Insomnia 34% Insomnia-Anxiety Disorder 38% Presented at the 28th Annual Conference Anxiety Disorders Association of America Ohayon MM, Roth MT. J Psychiatr Res. 2003;37:9-15.

  20. Causes of Chronic Insomnia In Psychiatric Illness Is the underlying psychiatric disorder adequately treated? A comorbid psychiatric disorder? Substance use/abuse? Medical illness? Medication side-effect? Primary sleep disorders? Presented at the 28th Annual Conference Anxiety Disorders Association of America Thase ME. Gen Hosp Psychiatry. 2005; 27:100-112.

  21. GAD and Sleep Disturbance Sleep disturbance is one of the criteria for the diagnosis of GAD Fatigue and irritability (two other criteria), may be consequences of sleep loss Excessive and uncontrollable worry (the core cognitive symptom of GAD) at bedtime may generate and maintain insomnia by interfering with ability to fall asleep Presented at the 28th Annual Conference Anxiety Disorders Association of America Mellman TA. Psychiatr Clin N Am. 2006;29:1047-1058.

  22. Characteristics of Sleep Disturbance in Generalized Anxiety Disorder 90 77.3 80 70 63.6 56.8 60 47.4 50 % with Sleep Disturbance 40 30 20 10 0 At least one type Initial insomnia Sleep Maintenance Early morningawakening Note: Insomnia severity was not associated with GAD severity. Total N=44.Belanger L, et al. JAnxiety Disord.2004;18:561-571. Presented at the 28th Annual Conference Anxiety Disorders Association of America

  23. GAD and Sleep Parameters By PSG patients with GAD have: Increased sleep latency Increased wake time after sleep onset Reduced total sleep time and lower sleep efficiency1 Presented at the 28th Annual Conference Anxiety Disorders Association of America Monti JM, Monti D. Sleep Med Rev. 2000;4:263-276.

  24. GAD and Sleep Parameters Sleep in “pure” GAD differentiated from major depression Reduction in REM latency seen in endogenous major depression is generally not seen in non-depressed patients with GAD1-3 However, differences in sleep of uncertain clinical diagnostic utility given high rates of depressive comorbidity in practice 1. Saletu-Zyhlarz G, et al. Neuropsychobiology. 1997;36:117-29. 2. Arriaga F, Paiva T. Neuropsychobiology. 1990-1991;24(3):109-14.3. Papadimitriou GN, et al. J Affect Disord. 1988;15:113-8. Presented at the 28th Annual Conference Anxiety Disorders Association of America

  25. Disordered Sleep in PTSD Difficulty falling asleep — greater onset latency Difficulty with sleep maintenance REM-related awakenings and nightmares Changes in REM More total REM or higher REM density Fragmented (more frequent short duration) Reduced heart-rate variability (NE-related) Sleep disturbances at one-month post-trauma may predict PTSD evolution and ultimate chronicity Mellman TA, et al. Am J Psychiatry. 1995;152:110-115. Mellman TA, et al. Sleep. 1997;20:46-51. Mellman TA, et al. Am J Psychiatry. 2002;159:1696-1701. DeViva JC, et al. Behav Sleep Med. 2004;2:162-176. Hurwitz TD, et al. Biol Psychiatry. 1998;44:1066-1073. Ross RJ, et al. Sleep. 1994;17:723-732. Ross RJ, et al. Biol Psychiatry. 1999;45:938-941. Koren D, et al. Am J Psychiatry. 2002;159:855-857. Presented at the 28th Annual Conference Anxiety Disorders Association of America

  26. How Might the Pathophysiology of Anxiety Disorders Impair Sleep? “Hyperarousal” theory Increased arousal (amygdala? brain stem?) Increased cortical activity due to ruminations Comorbid conditions and drugs Affective disorders Substance abuse Prescribed Rx (e.g., antidepressants) Presented at the 28th Annual Conference Anxiety Disorders Association of America

  27. How Might Disturbed Sleep Influence Pathogenesis and Treatment of Anxiety Disorders? • Disturbed sleep the night before an event • Effects on emotional learning • Shifts bias towards negativeemotional learning Presented at the 28th Annual Conference Anxiety Disorders Association of America

  28. Encoding Results: Behavioral Sleep Deprivation Sleep Control * ** 1.6 1.2 n.s. 1.4 1.0 1.2 0.8 n.s. 1.0 Memory Retention (d-prime) Memory Retention (d-prime) 0.8 0.6 0.6 0.4 0.4 0.2 0.2 0.0 0.0 Positive Negative Neutral ALL MEMORY TYPES MEMORY TYPES SEPARATED *p≤0.05, **p≤0.01 Presented at the 28th Annual Conference Anxiety Disorders Association of America Walker MP, Stickgold, R. Annu Rev Psychol. 2006;57:139:166.

  29. Animal Studies of Sleep Deprivation Effects on Fear Conditioning and Extinction Sleep (REM and NREM) deprivation before conditioning in rats (Ruskin et al, 2004) No change in amygdala-based fear conditioning Deficits in hippocampal-based contextual memory REM deprivation in rats after conditioning (Silvestri, 2005) Normal retention of conditioned fear Impaired extinction consolidation Presented at the 28th Annual Conference Anxiety Disorders Association of America Ruskin DN, et al. Eur J Neurosci. 2004;19:3121-3124. Silvestri AJ. Physiol Behav. 2005;84:343-349.

  30. Sleep Disturbance and Anxiety: Moderating Factors Poor sleep shifts the bias toward negative emotional learning and may disrupt extinction consolidation and recall Thus, poor sleep quality may: Contribute to the pathogenesis of anxiety disorders and/or: Undermine the effectiveness of treatment Presented at the 28th Annual Conference Anxiety Disorders Association of America

  31. Treatment Goals for Anxiety and Insomnia Improve anxiety and the associated symptomatology Improve sleep Reduce time it takes to fall asleep Increase sleep time to levels that support daytime functioning Reduce awakenings during the night Eliminate nightmares and/or unwanted sleep behavior Enhance subjective sleep quality Restore confidence in the patient’s ability to sleep and to handle sleeplessness Presented at the 28th Annual Conference Anxiety Disorders Association of America Mellman TA. Psychiatr Clin N Am. 2006;29:1047-1058.

  32. General Principles in theManagement of Insomnia Treat underlying cause(s) Promote good sleep habits Initiate behavioral intervention Prescribe sedatives, hypnotics: use in combination with behavioral management Presented at the 28th Annual Conference Anxiety Disorders Association of America Kupfer DJ, Reynolds CF. N Engl J Med. 1997;336:341-346.

  33. CBT Approaches to Insomnia May Be Helpful in Setting Anxiety Disorders Presented at the 28th Annual Conference Anxiety Disorders Association of America Morin, CM. J Clin Psychiatry. 2004;65(suppl 16):33-40.

  34. Treatment of Anxiety and Insomnia Pharmacologic and cognitive-behavioral therapy of anxiety improves associated sleep disturbance Belanger L, et al. J Anxiety Disord. 2004;18:561-571.Morin CM, et al. JAMA. 1999;281:991-999.Rosenthal M. J Clin Psychiatry. 2003;64:1245-1249. Presented at the 28th Annual Conference Anxiety Disorders Association of America

  35. Reduction in Sleep Disturbance During Treatment for GAD with Paroxetine and Tiagabine 14 12 * 10 * * 8 * Mean (SEM) PSQI Global Score 6 4 2 0 Baseline Wk 4 Wk 10 Baseline Wk 4 Wk 10 Tiagabine (n=20) Paroxetine (n=20) *p<0.05 relative to baseline.No significant difference between treatments. Presented at the 28th Annual Conference Anxiety Disorders Association of America Rosenthal M. J Clin Psychiatry. 2003;64:1245-1249.

  36. Impact of Worry-Focused CBT for GAD vs. Waitlist on Concomitant Insomnia 14 Baseline Endpoint 12 10 8 Insomnia Severity Index Score 6 4 2 0 CBT for GAD Waitlist Control p<0.01; N=44.Belanger L, et al. JAnxiety Disord.2004;18:561-571. Presented at the 28th Annual Conference Anxiety Disorders Association of America

  37. Treatment of Anxiety and Insomnia Does targeted treatment of insomnia improves anxiety? Presented at the 28th Annual Conference Anxiety Disorders Association of America

  38. Targeted Insomnia Treatment in GAD: Escitalopram (ESC) plus Eszopiclone or Placebo – Effect on Sleep Latency 70 Placebo + ESC 60 Eszopiclone + ESC 50 40 Minutes (median) 30 * * * * * 20 10 0 0 1 2 3 4 5 6 7 8 9 10 Double-Blind Treatment Period SB Run-Out *p<0.0005 vs. placebo Pollack MH, et al. Arch Gen Psych (in press). Presented at the 28th Annual Conference Anxiety Disorders Association of America This information concerns a use that has not been approved by the US FDA.

  39. Targeted Insomnia Treatment in GAD: Escitalopram (ESC) plus Eszopiclone or Placebo – Effect on Anxiety (HAM-A) Placebo + ESC 30 Eszopiclone + ESC 25 * * * 20 * * * Mean Score 15 10 5 0 BL 1 2 4 6 8 10 Week *p<0.05 vs. placebo; Week 10 = end of single-blind placebo run-out period. Pollack MH, et al. Arch Gen Psych (in press). Presented at the 28th Annual Conference Anxiety Disorders Association of America This information concerns a use that has not been approved by the US FDA.

  40. Targeted Insomnia Treatment in GAD: Escitalopram (ESC) Plus Eszopiclone or Placebo – Effect on Anxiety (HAM-A excluding insomnia item) Placebo + ESC 30 Eszopiclone + ESC 25 * 20 * * * Mean Score 15 10 5 0 BL 1 2 4 6 8 10 Week *p<0.05 vs. placebo; Week 10 = end of single-blind placebo run-out period. Pollack MH, et al. Arch Gen Psych (in press). Presented at the 28th Annual Conference Anxiety Disorders Association of America This information concerns a use that has not been approved by the US FDA.

  41. Therapeutic Approach to Nocturnal Panic (NP) Attacks May occur as part of panic disorder(44%-71% at least once) or PTSD Non-REM event in Stage II-III transition Not clear difference in sleep architecture orinsomnia severity Some support for CBT specific to NP Lack data on pharmacotherapy approaches May improve with treatment of primary disorder Presented at the 28th Annual Conference Anxiety Disorders Association of America Craske MG, Tsao JC. Sleep Med Rev. 2005;9:173-184.

  42. Limited Pharmacotherapy Data for PTSD-Related Sleep Disturbance SSRIs may have negative effects on sleep physiology with  REM and  arousals But data support improved subjective sleep quality Negative single-blind crossover of clonazepam 2 mg HS vs. placebo in combat PTSD No effect on nightmares Only one person continued clonazepam after trial Open support for trazodone (survey n=74) Helpful for nightmares, sleep initiation, and maintenance in veterans with chronic PTSD Dosed 50-150 mg HS 12% reported priapism Cates ME, et al. Ann Pharmacother. 2004:38:1395-1399.Singareddy RK, Balon R. Ann Clin Psychiatry. 2002:14:183-190. Presented at the 28th Annual Conference Anxiety Disorders Association of America This information concerns a use that has not been approved by the US FDA.

  43. Hypnotic Medication in Aftermath of Trauma Admitted to medical trauma center and manifesting early PTSD symptoms (N=22) Recalled incident and at least moderate impairment of sleep initiation or maintenance Treated 14.3  10 days post-trauma Randomized to receive temazepam x 7 days(i.e., 30 mg x 5 nights and 15 mg x 2 nights)vs. placebo Mellman TA, et al. J Clin Psychiatry. 2002;63:1183-1184. Presented at the 28th Annual Conference Anxiety Disorders Association of America This information concerns a use that has not been approved by the US FDA.

  44. Potential Impact of Early Benzodiazepine on Recovery in PTSD 80 70 55 60 50 % with PTSD at 6-Week Follow-Up 40 27 30 20 10 0 Temazepam Control Acute improvement in sleep in temazepam group but no difference upon discontinuation. Mellman TA, et al. J Clin Psychiatry. 2002;63:1183-1184. Presented at the 28th Annual Conference Anxiety Disorders Association of America This information concerns a use that has not been approved by the US FDA.

  45. Alpha1 Adrenergic Antagonist for Nightmares and Insomnia in Chronic Combat PTSD: Prazosin vs. Placebo 4 Prazosin (mean 9.5 mg HS) 3.5 Placebo 3 2.5 Change in Score 2 1.5 1 0.5 0 CAPS Nightmares CAPS Insomnia p<0.01; N=10. CAPS: Clinician-Administered PTSD Scale. Raskind MA, et al. Am J Psychiatry. 2003;160:371-373. Presented at the 28th Annual Conference Anxiety Disorders Association of America This information concerns a use that has not been approved by the US FDA.

  46. Improved Sleep in Open-Label Quetiapine for PTSD (N=20) 9 ** 8 7 6 PSQI Change Score 5 4 3 ** 2 ** ** 1 0 Global score Quality Latency Duration **p<0.01; PSQI = Pittsburgh Sleep Quality Index. Robert S, et al. J Clin Psychopharmacol. 2005;25:387-388. Presented at the 28th Annual Conference Anxiety Disorders Association of America This information concerns a use that has not been approved by the US FDA.

  47. Summary • Sleep disturbance may resolve with treatment of primary anxiety disorder, but not always • Treatment approaches for primary insomnia are likely useful in setting anxiety • May provide more rapid relief and improve overall outcomes • All patients should be educated about sleep hygiene rules • Both CBT and pharmacologic approaches to insomnia appear to be effective Presented at the 28th Annual Conference Anxiety Disorders Association of America

  48. Using your ResponseCard • Questions will be displayed along with the available answers • When the ten (10) second countdown clock appears, press and release the button that best represents your answer • A green light indicates your answer was received • Your last answer will be recorded • There is no need to press “GO” or “?” • Please leave the ResponseCard on the table at the end of this session. - Thank You. Presented at the 28th Annual Conference Anxiety Disorders Association of America

  49. Psychosocial Interventions for Insomnia: Methods, Outcomes, and Applicationsto Patients with Anxiety and Mood Disorders Michael W. Otto, PhD Director, Center for Anxiety and Related DisordersProfessor of Psychology Boston University Presented at the 28th Annual Conference Anxiety Disorders Association of America

  50. Disclosure • Dr. Michael W. Otto has been a consultant for Jazz Pharmaceuticals and Organon. Presented at the 28th Annual Conference Anxiety Disorders Association of America

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