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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

Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008

Comorbid Psychiatric Disorders

Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008

Medications and Substances

Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008

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

Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008

Cognitive Therapy (CT)

Ann Intern Med. 2016;165(2):113-­‐124.

Cognitive Behavioral Therapy for Insomnia (CBT-­‐I)

Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008

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.

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