MANAGING CHRONIC INSOMNIA IN PRIMARY CARE OFFICE

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1 MANAGING CHRONIC INSOMNIA IN PRIMARY CARE OFFICE Purti Papneja, MD CCFP Clinical Associate at Ellesmere Sleep Lab and Woodbine Sleep Clinic Clinical faculty at Dept of Community and Family Medicine, Sunnybrook Health Sciences Assistant Professor at University of Toronto

2 DISCLOSURE OF COMMERCIAL SUPPORT This program has not received external financial support Potential for conflict(s) of interest: none

3 OBJECTIVES 1. To develop an approach for evaluating patients with chronic Insomnia 2. To review evidence-based treatment for chronic Insomnia a. Non-pharmacological b. Pharmacological

4 WHO GETS INSOMNIA: EPIDEMIOLOGY Prevalence of insomnia symptoms in adults: 35-50% Prevalence of Insomnia disorder: 12-20% Female Middle age and older adults Co-morbidities: Higher risk of depression, anxiety and substance abuse Higher risk of chronic pain, obesity, diabetes and cardiovascular disorder

5 WHY IS IT SO COMMON High Homeostatic Drive Balanced Circadian Rhythm Low Arousal Sleep

6 INSOMNIA: PREDISOPING, PRECIPITATING AND PERPECTUATING FACTORS Behavioral Factors Age Circadian Factors Primary sleep disorder INSOMNIA Acute Stress Medications Substances Psychiatric Disorders Medical Disorders

7 CASE 1: WORKING WILLIAM 43 year previously healthy male with difficulty falling asleep for 6 months. Has tried many over the counter sleeping aids without success. He recently tried Zoplicone that worked well. It given by his friend and is requesting a prescription from you. Recently, was promoted to senior position at work and reports difficulty concentrating due to sleep deprivation

8 HOW CAN YOU STRUCTURE INSOMNIA HISTORY? Primary complaint: Characterization of Complaint(s): Difficulty falling asleep Awakenings Poor or unrefreshing sleep Onset Duration Frequency Severity and course Perpetuating factors Past and current treatments and responses

9 INSOMNIA HISTORY Sleep-Wake Schedule (average, variability): Bedtime: Time to fall asleep Factors prolonging sleep onset Factors shortening sleep Awakenings number, characterization, duration associated symptoms associated behaviors Final awakening (natural or alarm) versus Time out of bed Amount of sleep obtained

10 INSOMNIA HISTORY Before getting to Bed Exercise, smoking, alcohol, caffeine Environment Evening mental status In Bed Bed partner s behaviour Snoring, witnessed apnea Restless legs, teeth grinding, dream enactments, sleep walking, sleep paralysis, seizures Awakenings in night Cough, pain, reflux, nocturia After Awakening Identify sleepiness vs fatigue Napping Daytime Consequences: mood disturbance, cognitive dysfunction Other Factors contributing to sleep: Psychological Disorder Medical Condition Medications

11 MEDICATIONS AFFECTING SLEEP Drugs may cause fragmented sleep, nightmares, nocturia, or stimulation. These include: Antidepressants Cardiovascular Decongestants Bupropion, MAOIs (phenelzine, tranylcypromine), SNRIs (desvenlafaxine, duloxetine, venlafaxine), SSRIs (citalopram, escitalopram, fluoxetine, paroxetine, sertraline) α-blockers (e.g., tamsulosin), β-blockers (e.g., propranolol, metoprolol), diuretics (e.g., furosemide, hydrochlorothiazide), statins Phenylephrine, pseudoephedrine Opioids In combination with caffeine (e.g., Tylenol #1, #2, #3) Respiratory Stimulants Others β2-agonists (e.g., salbutamol, salmeterol, formoterol, terbutaline, indacaterol, olodaterol), theophylline Amphetamine, caffeine, cocaine, ephedrine, methylphenidate, modafinil Acetylcholinesterase inhibitors (e.g., donepezil), alcohol (fragmented sleep), antineoplastics, corticosteroids (e.g., prednisone), dopamine receptor agonists (e.g., levodopa, rotigotine), nicotine, medroxyprogesterone, phenytoin, thyroid supplement

12 EVALUATING TOOLS: CONSENSUS SLEEP DIARY Sample ID/Name Today s date 4/5/11 1. What time did you get into bed? 10:15 p.m. 2. What time did you try to go to sleep? 3. How long did it take you to fall asleep? 4. How many times did you wake up, not counting your final awakening? 11:30 p.m. 55 min. 3 times 5. In total, how long did these awakenings last? 1 hour 10 min. 6. What time was your final awakening? 6:35 a.m. 7. What time did you get out of bed for the day? 7:20 a.m. 8. How would you rate the quality of your sleep? q Very poor q Poor q Fair q Good q Very good q Very poor q Poor q Fair q Good q Very good q Very poor q Poor q Fair q Good q Very good q Very poor q Poor q Fair q Good q Very good q Very poor q Poor q Fair q Good q Very good q Very poor q Poor q Fair q Good q Very good q Very poor q Poor q Fair q Good q Very good q Very poor q Poor q Fair q Good q Very good 9. Comments (if applicable) I have a cold lcarney CE, Buysse DJ, Ancoli-Israel S, et al. The consensus sleep diary: standardizing prospective sleep selfmonitoring. Sleep. 2012;35(2): Sleep Societies, LLC.

13 EVALUATING TOOL: INSOMNIA SEVERITY INDEX For each question below, please circle the number corresponding most accurately to your sleep patterns in the LAST MONTH. For the first three questions, please rate the SEVERITY of your sleep difficulties. 1. Difficulty falling asleep: None Mild Moderate Severe Very Severe Difficulty staying asleep: None Mild Moderate Severe Very Severe Problem waking up too early in the morning: None Mild Moderate Severe Very Severe How SATISFIED/dissatisfied are you with your current sleep pattern? Very Satisfied Satisfied Neutral Dissatisfied Very Dissatisfied Copyright Morin, C.M. (1993, 1996, 2000, 2006). Bastien CH, Vallières A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001;2(4):

14 INSOMNIA SEVERITY INDEX (CONT.) 5. To what extent do you consider your sleep problem to INTERFERE with your daily functioning (eg, daytime fatigue, ability to function at work/daily chores, concentration, memory, mood)? Not at all A little Somewhat Much Very much How NOTICEABLE to others do you think your sleeping problem is in terms of impairing the quality of your life? Not at all A little Somewhat Much Very much How WORRIED/distressed are you about your current sleep problem? Not at all A little Somewhat Much Very much Guidelines for Scoring/Interpretation: Add scores for all seven items (Total score ranges from 0-28) 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21= Clinical insomnia (moderate severity) = Clinical insomnia (severe)

15 CASE 1: WORKING WILLIAM Bedtime 10:30-6:30 am, taking up to 30 min 90 minutes to fall asleep most nights, once asleep, has 1-4 awakenings that lasts upto minutes each Comes home around 7 pm and then uses treadmill for 30 minutes Caffeine: 1 cup in AM Etoh:1-2 drinks/night Often finds himself planning the next day when he can t fall asleep Denies snoring or restlessness Screens negative for mood disorder No prescription medications ISI score: 17 (moderate severity)

16 WHAT IS YOUR NEXT STEP? A. Order an overnight polysomnogram B. Order an actigraphy for 14 days C. Diagnose him with Insomnia Disorder D. Prescribe Zoplicone and discuss sleep hygiene

17 INSOMNIA DISORDER: DIAGNOSTIC CRITERIA DSM-5 Main complaint: dissatisfaction with sleep quantity/quality ( 1 of the following symptoms): Difficulty initiating sleep Difficulty maintaining sleep (i.e., frequent awakenings or trouble returning to sleep) Early morning awakening with inability to return to sleep Non-restorative sleep Sleep complaint is accompanied by great distress or impairment in daytime functioning ( 1 of the following): Fatigue or low energy Daytime sleepiness Cognitive impairments Mood disturbance Behavioural difficulties Impaired occupational or academic function Impaired interpersonal/social function Occurs for 3 nights/week, for 3 months, despite adequate opportunity for sleep Symptoms are not explained by co-existing sleep disorder, mental disorder or medical conditions

18 WHAT BEHAVIOUR FACTORS MIGHT BE AMENABLE TO CHANGE? Sleep Hygiene Regular sleep schedule Avoid stimulants near bedtime (smoke, caffeine, alcohol) Avoid stimulating activity near bedtime Quiet sleep environment Avoid daytime napping Exercise regularly, but more than 4 to 5 hours prior to bedtime

19 COGNITIVE BEHAVIOUR THERAPY FOR INSOMNIA Full CBT-I 3 components Education Sleep scheduling (builds homeostatic drive and re-establish circadian rhythm) Stimulus Control Therapy and Sleep Restriction What to do with your mind (decreases arousals) Cognitive restructuring Progressive relaxation, visualization 6-8 sessions each minutes

20 STIMULUS CONTROL THERAPY Goal: Extinguish negative association of bed with undesirable outcomes such as wakefulness, fear and worry Use bed only for sleep (not for reading, watching television, eating, or worrying) Not go to bed until sleepy No more than 20 minutes in bed awake if awake, leave room and do a relaxing or boring activity, no rewarding activity (TV, eating) Repeat process if not sleepy Maintain regular sleep schedule (regardless of bedtime)

21 SLEEP RESTRICTION THERAPY Goal: Improve sleep continuity by using sleep restriction to enhance sleep drive Step 1: Maintain a sleep log for 2 weeks Step 2: Calculate the average total sleep time (TST) Step 3: Prescribe initial time-in-bed (TIB) at the average TST plus 30 (time normally required to fall asleep) If after 1 week, sleep efficiency (Total sleep time/total time spent in bed)<85%, further restrict bedtime by min If sleep efficiency >85%, increase bedtime by minutes

22 BACK TO CASE: WILLIAM S DIARY Today s date Sample Mon Tues Wed Thurs Friday Sat Sunday 1. What time did you get into bed? 10:15 p.m. 10:30 pm 11:00 pm 11:10 pm 10:30 pm 12:00 12:30 10:45 pm 2. What time did you try to go to sleep? 3. How long did it take you to fall asleep? 4. How many times did you wake up, not counting your final awakening? 5. In total, how long did these awakenings last? 6. What time was your final awakening? 7. What time did you get out of bed for the day? 8. Total Time in Bed 9. Total sleep time Comments 11:30 p.m. 11: 00 pm 11:00 pm 11:10pm 11:00 pm 12:00 12:30 11:00 pm 55 min min times 2 times 1 time 3 times 2 times 3 times 4 times 1 time 1 hour 10 min. 30 min 25 min 1 hour 40 min 40 min 30 min 25 min 6:35 a.m. 6:30 am 6:30 am 6:30 am 6:30 am 6:30 am 7:00 am 7:00 am 7:20 a.m. 6:35 am 6:35 am 6:35 am 6:35 am 6:35am 8:00 am 6:35 am 8:05 7:35 7:25 8:05 6:35 7:30 7:50 6:00 5:50 5:30 5:45 5:20 6:30 5:35 Reproduced with permission from Carney CE et al. Sleep. 2012;35(2): Copyright 2012, Associated Professional Sleep Societies, LLC.

23 WILLIAM S PRESCRIPTION Average Total time in bed: 7:35 minutes Average Total sleep time: 5:47 minutes Sleep efficiency: 76% Prescription for Total time in Bed: 5:47+30 minutes = 6:20 Prescribed bedtime: 12:10 am -6:30 am

24 RELAXATION THERAPY Goal: Lower somatic and cognitive arousal state which interferes with sleep Progressive Relaxation Guided Imagery

25 BRIEF BEHAVIOURAL TREATMENT OF INSOMNIA Core techniques from stimulus control and sleep restriction therapy Limit time in bed to actual sleep time plus 30 minute Establish regular wake time everyday, regardless of prior night s sleep duration Do not got bed until sleepy Do not stay in bed if awake

26 CBT-I: WEB-BASED EVIDENCE

27 CBT-I: ONLINE RESOURCES FOR PATIENTS

28 CBT-I: BOOKS FOR PATIENTS

29 CASE 2: BENZO BOB 78 y male, a new patient to your practice, comes to the clinic for refill of his Temazepam. He s been using it for more than 10 years for sleep initiation and maintenance. He was initially taking 15 mg qhs and now requires 30 mg qhs. Although he has no issues with memory, he does state he is not as sharp as he was before.

30 PRINCIPLES OF PHARMACOLOGICAL TREATMENT FOR INSOMNIA Considered an adjunct to cognitive and behavioral therapies in the comprehensive management of primary insomnia Generally recommended at the lowest effective dose for short term Long-term use of hypnotic agents is discouraged due to the potential for tolerance and dependence Specific situations and circumstances under which long term use of hypnotics may be appropriate. CMA Clinical Practice Guidelines Adult Insomnia, 2010

31 MEDICATIONS INDICATED FOR PRIMARY INSOMNIA IN CANADA: BENZODIAZEPINES Drug Name Doses Half-life Primary Indication & Effect Additional Consideration Flurazepam (Dalmane) 15, 30 mg (75 mean) Sleep onset and Maintenance Insomnia Caution with Alcohol Potential for Abuse SE: Dizziness Nirtazepam 5, 10 mg (28.8 mean) Falls Headaches Fatigue Memory Impairment Temazepam (Restoril) 15, 30 mg 4-18 (8.8 mean) Improves sleep onset latency(~30min), Total sleep time(~60 min) Triazolam (Halcion) 0.125, 0.25 mg (2 mean)

32 MEDICATIONS INDICATED FOR INSOMNIA IN CANADA: BENZODIAZEPINE RECEPTOR AGONIST Drug Name Doses Half-life Primary Indication & Effect Zoplicone (Imovane) 5, 7.5 mg 5-6 Sleep onset & maintenance Insomnia Improves sleep onset latency(~19min), Total sleep time(~45 min), wake after sleep onset (~11 min) Additional Consideration SE: Headache Unpleasant taste Health Canada 2014: lower initiation dose Warn re: driving 12 hours post medication Zoplidem (Sublinox) SL 5, 10 mg 2-3 Sleep onset Insomnia Improves sleep onset latency(~15min), total sleep time(~23min) Drowsiness Dizziness Diarrhea Health Canada 2014: lower dose for women Warn re: driving 7 hours post medication

33 MEDICATIONS INDICATED FOR INSOMNIA IN CANADA: LOW DOSE ANTIDEPRESSANT Drug Name Doses Half-life Primary Indication & Effect Doxepin (Silenor) 3, 6 mg 15.3 Sleep Maintenance Insomnia Improve total sleep time (~12-17 min), wake after sleep onset (~10-14 min) Trazodone 25-50mg 3-8 Sleep onset & maintenance Insomnia Additional Consideration SE: Nausea, URTI Take within 30 minutes before bedtime Should not be taken within 3 hours of meal Cost $$ Limited-evidence for Insomnia Lower risk of hang over SE: orthostatic hypotension, priapism in men(rare)

34 HERBAL OPTIONS: VARIABLE EVIDENCE Agent Recommended Dose Comments L-Tryptrophan 500mg-2g Evidence supporting efficacy is variable and Melatonin Valerian 0.3-5mg mg insufficient. May be requested by individual patients looking for a natural source agent. Taken 60 minutes before bedtime CMA Clinical Practice Guidelines Adult Insomnia, 2010

35 NON-PRESCRIPTION OPTIONS Agent Usual Dose Comments Diphenhydramine Benadryl Sleep Eze Simply Sleep Nytol Unisom Dimenhydrinate Gravol Doxylamine Unisom mg hs Potential for serious side effects arising from anticholinergic properties (especially in elderly); residual daytime sleepiness, diminished cognitive function, dry mouth, blurred vision, constipation, urinary retention, etc mg hs mg hs These products are not intended for long term use and tolerance to sedative effects likely develops rapidly (3 days) Gravol not approved in Canada as a sleep aid CMA Clinical Practice Guidelines Adult Insomnia, 2010

36 NOT RECOMMENDED FOR PRIMARY INSOMNIA Agent Antidepressants - mirtazapine, fluvoxamine Comments Relative lack of evidence Amitriptyline Benzodiazepines (Intermediate and Long- Acting)- diazepam, clonazepam, lorazepam,, alprazolam, oxazepam Antipsychotics (Conventional or 1 st Generation) - chlorpromazine, methotrimeprazine, loxapine Antipsychotics (Atypical or 2nd-Generation) - risperidone, olanzapine, quetiapine Relative lack of evidence and serious adverse events Excessive risk of daytime sedation and psychomotor impairment. No longer recommended due to unacceptable risk of memory disturbances abnormal thinking and psychotic behaviours. Relative lack of evidence and unacceptable risk of anticholinergic and neurological toxicity Relative lack of evidence and unacceptable cost and risk of metabolic toxicity CMA Clinical Practice Guidelines Adult Insomnia, 2010

37 EFFECT OF HYPNOTICS ON SLEEP ARCHITECTURE Benzo Zopiclone Zolpidem Silenor Trazodone S1 S2 SWS REM

38 CANNABIS AND SLEEP Short-term use: Subjective: Improves sleep onset latency, decreases wake time after sleep Objective data inconsistent Chronic use: Tolerance Reduced sleep efficiency, poor sleep quality and insomnia Insomnia and strange dreams (1-43 days after discontinuation),

39 LONG-TERM PHARMACOTHERAPY May be necessary Severe or Refractory Insomnia Co-morbid illness Requires consistent follow up, ongoing assessment of effectiveness and monitoring of side effects Should receive adequate trial of CBT-I when possible

40 IS HIS SUBJECTIVE COGNITIVE DEFICIENCY RELATED TO SLEEP AIDS? Meta-analysis (24 randomized trials, 2417 patients) evaluated the impact of pharmacotherapy in adults older than 60 years with insomnia Improvement of sleep onset latency (~10 min), total sleep time (~25 min), and frequency of nighttime awakening However, the magnitude of these benefits was relatively small compared to two-to fivefold increase in adverse cognitive or psychomotor events Buscemi N, Vandermeer B, Friesen C, et al. The efficacy and safety of drug treatments for chronic insomnia in adults: a meta-analysis of RCTs. J Gen Intern Med. 2007;22:1335 Glass J et. al, Sedative hypnotics in older people with insomnia: meta-analysis of risks and BMJ. 2005;331(7526):1169.

41 WHAT CAN YOU RECOMMEND FOR HIM? Adequate sleep hygiene and brief behavioural therapy Screen underlying medical causes of disturbed sleep Pain Reflux Nocturia Breathing problems (Asthma, COPD) Eliminate Underlying Sleep Disorder Discuss weaning off

42 WEANING OFF Weaning can be accomplished by Gradually reducing the nightly dose (smallest increment possible) over weeks-months Not taking hypnotic for one night of the week (typically starting with the weekend), and then gradually increasing the number of drug-free nights The hypnotic should not be taken PRN Once the dose or frequency of the hypnotic has been reduced, there is no going back Some rebound insomnia may occur Continue to apply principles of behavioural sleep techniques/ hygiene during the weaning process and record with a sleep diary

43 PRACTICAL TIPS First Visit: Detailed sleep history and set expectations about treatment Prescribe behavioral techniques Provide sleep education and online resource handouts Encourage them to do 2 week sleep logs Consider pharmacotherapy based on the patient s sense of urgency, need for relief and willingness to follow the behavioral and cognitive recommendations Second Visit (2-4 weeks) Evaluate sleep efficiency and daytime symptoms Reinforce behavioral interventions Review or reconsider pharmacotherapy Follow up (2-4 weeks) If there is no progress or limited improvement referral to sleep medicine program or psychologist may be warranted

44 FURTHER RESOURCES For you: Center for Effective Practice -Clinical tool guide for providers: Sleep Diary: Insomnia Severity Index * For your Patients: Online CBT-I and Books: Top Ten Sleep Tips (patient handout)

45 CLINICAL CONUNDRUM 73 y F with history of depression/anxiety, chronic insomnia, Osteoporesis, PMR seen for early medication refill. Started treatment for depression/anxiety 3 months ago Medications: Citalopram 20 mg (increased 4 weeks ago from 10 mg due to depressive symptoms, now reports more anxiety on it) Imovane -7.5 mg qhs (longstanding, now using 1.5 tabs as finds otherwise wakes up around 3-4 am x 1 week) Prednisone 4 mg od (tapering down) Alendronate 35 mg q weekly No sleep hygiene issues Doing meditation course (one more session left) Current sleep habits: 9-10 pm Citalopram 20 mg 11:00 pm- Meditation audio tape 11:30- pm- Zoplicone 7.5 mg tab Sleeps from 12 am-7:30 with no awakenings

46 CLINICAL CONUNDRUM Is this treatment-emergent Insomnia? -consider switching to another SSRI (eg Mirtazepine) Is this untreated Depression/Anxiety? -consider increasing dose of Citalopram or switching to another SSRI or augmenting Is she developing tolerance to Zoplicone? -consider switching to another agent like Doxepin

47 REFERENCES 1. Tobaldini E, Costantino G, Solbiati M, Cogliati C, Kara T, Nobili L, Montano N. Sleep, sleep deprivation, autonomic nervous system and cardiovascular diseases. Neurosci Biobehav Rev Mar;74( 2. Tobaldini E, Fiorelli EM, Solbiati M, Costantino G, Nobili L, Montano N. Short sleep duration and cardiometabolic risk: from pathophysiology to clinical evidence. Nat Rev Cardiol Nov Aili K, Andersson M, Bremander A, Haglund E, Larsson I, Bergman S. Sleep problems and fatigue as predictors for the onset of chronic widespread pain over a 5- and 18-year perspective Zachariae R, Lyby MS, Ritterband LM, O'Toole MS. Efficacy of internet-delivered cognitive-behavioral therapy for insomnia - A systematic review and meta-analysis of randomized controlled trials. Sleep Med Rev Ritterband LM, Thorndike FP, Ingersoll KS, Lord HR, Gonder-Frederick L, Frederick C, Quigg MS, Cohn WF, Morin CM. Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial. JAMA Psychiatry Emsley R, Kyle SD, Gordon C, Drake CL, Siriwardena AN, Cape J, Ong JC, Sheaves B, Foster R, Freeman D, Costa- Font J, Marsden A, Luik AI. Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. JAMA Psychiatry Sep The efficacy and safety of drug treatments for chronic insomnia in adults: a meta-analysis of RCTs. Buscemi N; Vandermeer B; Friesen C; Bialy L; Tubman M; Ospina M; Klassen TP; Witmans M; J Gen Intern Med Sep;22(9): Meta-analysis of benzodiazepine use in the treatment of insomnia. Holbrook AM; Crowther R; Lotter A; Cheng C; King D ; CMAJ 2000 Jan 25;162(2): Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. Glass J et al BMJ Nov 19;331(7526): Clinical Guideline for the Evaluation and Management of Chronic Insomnia in Adults Sharon Schutte-Rodin, M.D. Lauren Broch, Ph.D, Daniel Buysse, M.D, Cynthia Dorsey, Ph.D,; Michael Sateia, M.D. C. Journal of Clinical Sleep Medicine Oct 15;4(5): Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline. Michael J. Sateia, MD1; Daniel J. Buysse, MD2; Andrew D. Krystal, MD, MS3; David N. Neubauer, MD4; Jonathan L. Heald, MA5 12. Bastien CH, Vallières A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001;2(4):

48 THANK YOU

Guideline for Adult Insomnia

Guideline for Adult Insomnia Exclusions This guideline does not apply to: Children under the age of 18 Pregnant and lactating women Geriatric patients: While the general principles of the diagnosis and