Insomnia Update: How To Avoid Over-‐Prescribing Hypnotics
Dragos Manta, MDMedical Director, Upstate Sleep Center
Division Of Pulmonary, Critical Care and Sleep MedicineSUNY Upstate Medical University
Disclosures
• No financial conflict of interest• I am not a Behavioral Sleep Medicine therapist
Objectives
1. Understand how to diagnose insomnia.2. Discuss mimics and associated conditions of insomnia. 3. Review recommendations for pharmacological therapy.4. Explore non-‐pharmacological interventions for insomnia.
Case• JS is 38 y.o female with a BMI of 22 who was referred to the
Upstate Sleep Clinic for insomnia• H/o anxiety and depression for which she is on desvenlafaxine
and she is seeing a counselor • H/o chronic low back pain since age 18, s/p back surgery and
takes oxycodone every day• Takes zolpidem, melatonin and diphenhydramine every night
for sleep for at least 5 years• She has been on zolpidem “for too long” and would like to
come off
Case-‐Sleep History• Going into the bedroom around 11PM• Has pain, cannot turn off her mind and she is very
anxious and fidgety as she is trying to fall asleep• Takes her more than an hour to fall asleep• Once asleep, still wakes up 3-‐4 times a night and takes a
long time to go back to sleep • Restless sleeper, sweaty and cold, sleep talks, snores and
has apneic episodes• Wakes up at 7AM and is never rested• Works part-‐time in sales and she cannot focus at work
due to her poor sleep
ICSD-‐3rd Edition• Chronic Insomnia Disorder
– >3 months• Short-‐Term Insomnia
Disorder – <3 months
• Other Insomnia Disorder– Need more history
• With or without co-‐morbidities, weather or not those are sleep disruptive
Chronic Insomnia DisorderDefinition
• 3 components– Persistent sleep difficulties• >3 nights per week, >3 months
– Despite adequate opportunity and circumstances– Leading to daytime impairment
ICSD-‐3rd Edition
Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008
Co-‐Morbidities Associated with Insomnia
• Medical disorders• Sleep disorders• Psychiatric disorders• Substance use, misuse or abuse
• When the insomnia is a prominent symptom, a separate insomnia diagnosis is made
Comorbid Medical Disorders
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Comorbid Psychiatric Disorders
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Medications and Substances
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Epidemiology
• High prevalence– Chronic 5-‐10% – Short-‐Term 10-‐30%
• Risk factors– Females– Lower socio-‐economic class
– Elderly– African-‐American race– Patients with comorbid medical, mental and substance abuse disorders
– Shift work
Pathophysiology
• Physiologic hyper-‐arousal due to increased sympathetic and HT-‐pituitary-‐adrenal axis activity– Increased HR, decreased heart rate variability– Increased metabolic rate and temperature– Increased cortisol, ACTH and CRF– Increased high frequency EEG during NREM sleep
• No structural brain pathology
Obstructive Sleep Apnea– Is very common– Can present with sleep onset or maintenance insomnia
– Can overlap with insomnia
– There is no anxiety and excessive worry about being able to sleep
– Patients are sleepy during the day
Delayed Sleep Phase Disorder – Teenagers and young adults
– Sleep difficulties when trying to fall asleep at the usual sleep times
– They go to sleep later than usual
– Normal total sleep time (as long as they coordinate with endogenous circadian rhythm)
– No impairment during the day
– No night to night variability
Advanced Sleep Phase Disorder
– Elderly– They wake up early
– They go to bed early– No daytime impairment
Shift Work Syndrome
– Insomnia related to sleep during non-‐habitual times
– It is very common for shift workers to have insomnia complaints
Chronic Volitional Sleep Restriction/ Insufficient Sleep Syndrome
– Patients do not allow themselves sufficient sleep time due to work or family constraints
– Have EDS or un-‐intentional daytime sleep episodes
– Can have normal sleep if allow themselves enough time
Complications
• Hypertension, diabetes, metabolic syndrome and coronary artery disease
• Absenteeism and work disability• Increased health-‐care expenditures• Prolonged use of prescription and OTC sleep aids
Sleep Diary
Polysomnography• Abnormal
– SO>30 min– WASO>30 min– TST <6 hours– Increased N1, decreased
N3– Some patients do not sleep
at all!
• Normal– Night to night variability– “psychophysiological
insomnia– “paradoxical insomnia”
Not generally indicated unless sleep co-‐morbidities are
suspected
Treatment Goals
Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008
Pharmacologic TreatmentAASM 2016
J Clin Sleep Med. 2017;13(2):307–349.
PICO Question
J Clin Sleep Med. 2017;13(2):307–349.
Weak Recommendations( or Suggestions)
J Clin Sleep Med. 2017;13(2):307–349.
Suggested Pharmacologic Agents
Sleep Onset Insomnia• Eszopiclone• Zolpidem• Zaleplon• Temazepam• Triazolam• Ramelteon
Sleep Maintenance Insomnia• Eszopiclone• Zolpidem• Temazepam• Sovorexant• Doxepin
J Clin Sleep Med. 2017;13(2):307–349.
Agents Suggested Not to Be Used
• Melatonin • Trazodone• Diphenhydramine• Valerian
• Tiagabine• L-‐tryptophan
J Clin Sleep Med. 2017;13(2):307–349.
Issues with 2016 AASM Guidelines
• The clinical improvement thresholds were determined based on task force judgment
• Physicians treat patients with insomnia based of patient’s reported distress, not by objective measures of sleep parameters
• Insomnia is not classified as sleep onset or maintenance anymore
• Evidence for/against is poor, so recs are weakJ Clin Sleep Med. 2017;13(2):307–349.
• We do not know how the clinically significant change in SOL, WASO and TST
• Absolute mean effect versus placebo was small
• Most patients in trials were white, middle-‐age females without co-‐morbidities
Ann Intern Med. 2016;165(2):103-‐112.
Pharmacotherapy Harms
• Most studies are not adequately powered to detect rare but serious side effects– falls, fractures – car accidents– sleep walking, sleep driving
– dementia– cancer– increased mortality.
• Hypnotics only approved for 4-‐5 weeks by FDA and PRN basis.
• Decreased dosages are recommended in elderly, debilitated and women
Ann Intern Med. 2016;165(2):103-112.
UK Retrospective Cohort Study from 273 primary care practices enrolled in in General Practice Research Database
Ann Intern Med. 2016;165(2):103-112.
Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008
Psychological and Behavioral Interventions
South Med J. 2018 Feb;;111(2):75-80.
Sleep Hygiene ( SH)
Ann Intern Med. 2016;165(2):113-‐124.
Sleep Restriction (SR)
Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008
Ann Intern Med. 2016;165(2):113-‐124.
Stimulus Control (SC)
Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008
Ann Intern Med. 2016;165(2):113-‐124.
Relaxation Training (RT)
Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008
Ann Intern Med. 2016;165(2):113-‐124.
Other Behavioral Therapies
• Paradoxical Intention– patient is trained to confront their fear of staying awake and its potential effects in order to decrease anxiety about sleep performance
• Biofeedback– patient is trained to control some physiologic variable through visual or auditory feedback in order to reduce somatic arousal
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Cognitive Therapy (CT)
Ann Intern Med. 2016;165(2):113-‐124.
Cognitive Behavioral Therapy for Insomnia (CBT-‐I)
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Ann Intern Med. 2016;165(2):113-‐124.
Evidence
Ann Intern Med. 2016;165(2):113-‐124.
Cautions
• SR is contraindicated in patients with seizure disorder
• SR and SC in patients with bipolar disorder has been associated with hypomania and mania– patients should be closely monitored
• SR can cause EDS in patient with OSA– patient should be monitored with Epworth Sleepiness Scale(ESS)
– But…insomnia due to PAP can be treated with CBT-‐I!South Med J. 2018 Feb;;111(2):75-80.
CBT-‐I in the Elderly• Adults over 65 have twice
the insomnia rates of younger adults
• Sedative-‐hypnotic have been associated with a 22% increase in falls in the elderly
• Comorbidities are common and treatment helps the insomnia symptoms too
• CBT-‐I is similar in older adults except– For SC, patients do not
have to leave bedroom to prevent falls
– For SH, napping is allowed to improve fatigue and allow for later bedtime for SC
– For RT active muscle contractions is eliminated for the frail elderly patients
South Med J. 2018 Feb;;111(2):75-80.
Online CBT-‐I
• Insomnia is not seen as a primary problem• Physicians have bias against psychological interventions
• CBT-‐I trained professionals are limited• CBT-‐I is not delivered in health care setting, but behavioral care setting
• It’s time intensive for the practitioner and patient (7-‐8 customized sessions)
• eCBT-‐I is not reimbursed and has less evidence
Ann Intern Med. 2016; 165(2):149-‐150.
https://www.behavioralsleep.orgaccessed 4/18/2018
Key Points
• Insomnia is classified as short-‐term or chronic• “Secondary” insomnia requires specific treatment• Consider other sleep disorders in the differential– Refer to sleep specialist if necessary
• Use a sleep diary to aid in diagnosis and follow up• Avoid pharmacological therapy as initial treatment• Use cognitive-‐behavioral interventions as the first line– Refer to behavioral sleep therapist for CBT-‐I if necessary
Case
• Home Sleep Apnea test was negative for obstructive sleep apnea
• Advised to follow up with her mental health and pain medicine providers
• Counseled about risk of long term hypnotics• Discussed stimulus control measures• Plan to refer for CBT-‐I if not improved
Objectives
1. Understand how to diagnose insomnia.2. Discuss mimics and associated conditions of insomnia. 3. Review recommendations for pharmacological therapy.4. Explore non-‐pharmacological interventions for insomnia.