Don’t Lose Sleep Over Insomnia...88TH ANNUAL POSTGRADUATE CONVENTION | LLU HOMECOMING ALUMNI...

88TH ANNUAL POSTGRADUATE CONVENTION | LLU HOMECOMING

ALUMNI ASSOCIATION, SCHOOL OF MEDICINE OF LOMA LINDA UNIVERSITY

Don’t Lose Sleep Over Insomnia

88th Annual Postgraduate Convention

Ramiz A. Fargo MD

Loma Linda University Medical CenterSleep Disorders Center.



Insomnia

• Definition & Scope

• Predisposing Factors

• Diagnosis

• Treatment



Case 1

• Jim 45 y/o, presents with difficulty falling asleep and staying asleep.

• The problem started after the death of his brother 2 months previously.

• He is unable to fall sleep until at least an hour after going to bed.

• He has no previous sleep problems.



Case 1

• His physician prescribed a low-dose tricyclic antidepressant for sedation, but he was unable to tolerate the morning drowsiness and dry mouth.

• He consumes 4 cups of coffee during the day and lately has been using alcohol at night to aid sleep.

• He does not snore and has no limb movements during sleep per his wife.



Case 2

• Judy, 40 y/o schoolteacher complains of inability to sleep well for more than 2 years.

• She regularly goes to bed at 10 pm but is unable to fall sleep until 1 am.

• She experiences about 3 awakenings every night and with each awakening requires about 30 minutes to fall asleep again.

• Has daytime fatigue and is unable to concentrate on her work.

• She sometimes takes a nap during the day after lunch.



Case 2

• She vaguely recalls being involved in a stressful family property dispute just prior to onset of her sleep difficulty.

• As bedtime approaches, she becomes very tense and worries about the prospect of another sleepless night.

• She does not take any sleeping pills and has no symptoms of depression.

• She surprisingly admits that she sleeps well while on vacations.



Diagnoses

• Case 1 Jim: Short-term Insomnia Disorder

• Case 2 Judy: Chronic Insomnia Disorder



Insomnia Defined

• Difficulty initiating sleep, maintaining sleep, waking up too early, or sleep that is chronically non-restorative or poor in quality.

• Occurs despite adequate opportunity and circumstances for sleep.

• At least one of the following forms of daytime impairment related to the nighttime sleep difficulty.

International Classification of Sleep Disorders – Third Edition (ICSD-3)



Insomnia DefinedCompromised Daytime Function

• Fatigue or malaise

• Attention, concentration, or memory impairment

• Social or vocational dysfunction or poor school performance

• Mood disturbance or irritability

• Daytime sleepiness

• Motivation, energy, or initiative reduction

• Proneness for errors/accidents at work or while driving

• Headaches, tension, or gastrointestinal symptoms in response to sleep loss

• Concerns or worries about sleep




Short-Term InsomniaAcute Insomnia, Adjustment Insomnia

• Lasts a few days or weeks (less than 3 months)

• In response to an identifiable stressor. • Acute stress, conflict, or recent environmental change

• Symptoms usually resolve when the stressor is eliminated, or the individual adapts




Chronic Insomnia

• Duration of at least 3 months

• Occurs at least 3 times per week

• Usually begins following a stressful life event

• The precipitating event many times resolves but the insomnia takes a chronic course.

• Learned sleep-preventing associations at bedtime result in agitation, arousal and increased muscle tone.


Diagnostic and Statistical Manual of Mental disorders, DSM-5



Chronic Insomnia

• Commonly coexists with psychiatric or medical disorders.

• Depression, anxiety, stroke, DM, CAD, HTN

• In many cases it is difficult to discern which condition came first – bidirectional.

• Its imperative we identify insomnia patients even if they don’t complain.

• Successful treatment requires attention to both insomnia and comorbidities.



The Scope of Insomnia

• 1/3 of American adults develop insomnia each year.

SLEEP 2018, the 32nd Annual Meeting of the Associated Professional Sleep Societies

National Sleep Foundation Poll 2005

• 15 to 20% of Americans have a short-term insomnia disorder (lasting less than 3 months).

The American Academy of Sleep Medicine. (2008) Insomnia

• Up to 10% of American adults are likely to have chronic insomnia.

The American Academy of Sleep Medicine. (2008) Insomnia



The Scope of Insomnia

• Insomnia costs the US Government more than $15 billion per year in healthcare costs.

• Lost productivity related to insomnia costs the US economy about $63 billion annually.Hussain, M. T. & Shea, S. A. Wake up to insomnia: future approaches to the management of

insomnia. Nat Sci Sleep. 2011; 3: 33–35.

• 30% of overdoses involve medications commonly prescribed for insomnia.National Institute on Drug Abuse. (2018) Benzodiazepines and Opioids. [Online] Available

from: https://www.drugabuse.gov/drugs-abuse/opioids/benzodiazepines-opioids



National Sleep Foundation, 2016

Recommended Sleep Duration



Evaluation

• History

• Physical examination• Body habitus, clues to other medical problems

• Medication and substance review• Caffeine, tobacco, alcohol, prescription and herbal medications

• Screening tools• Insomnia (Pittsburgh Sleep Quality Index, Insomnia Severity Index)

• Depression (PHQ-2, PHQ-9)

• Anxiety (GAD-7)

• OSA (STOP-BANG)

• Sleep diary

• Actigraphy



Sleep History

• Predisposing factors• Older age, female sex, psychological disorders (depression,

anxiety), substance abuse, smoking, living alone, shift-work

• Precipitating factors• Chronic pain, comorbid medical conditions, shift work,

stressful life events (divorce, unemployment)

• Perpetuating factors• Cognitive issues (worry about sleep loss)

• Behavioral (excessive time spent in bed, napping, chronic sleep medication use)

Psychiatr Clin North Am. 1987; 10(4):541-553



Sleep History• Primary Insomnia Complaint:

• Characterization of Complaint(s)• Difficulty falling asleep• Awakenings• Poor or unrefreshing sleep

• Onset• Duration• Frequency • Severity• Course• Perpetuating factors• Past and current treatments and responses

• Pre-Sleep Conditions• Pre-bedtime activities• Bedroom environment • Evening physical and mental status

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



Sleep 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 vs. Time Out of Bed

• Amount of sleep obtained




Sleep History

• Daytime Activities and Function• Identify sleepiness versus fatigue

• Napping

• Work

• Lifestyle

• Travel

• Daytime consequences - quality of life, mood disturbance, cognitive dysfunction, exacerbation of comorbid conditions




Common Medications May Cause Insomnia

• Antihypertensives

• Clonidine

• Beta-blockers

• CCBs

• Methyldopa

• Reserpine

• Antiarrhythmics

• Amiodarone

• Bronchodilators

• Beta agonists

• Ipratropium

• Theophylline

• Decongestants

– Pseudoephedrine

• Hormones

– Oral contraceptive

– Thyroid replacement

– Corticosteroids

– Progesterone

• Antibiotics

– Ciprofloxacin

– Levofloxacin

– Amphotericin B

– Amantadine

• Antidepressants

– Bupropion

– Buspirone

– MAO inhibitors

– SSRI

– TCA

• CNS Stimulants

– Methylphenidate

• Anticonvulsants

– Phenytoin



Sleep Diary

American Family Physician vol 92, Number 12, Dec 15, 2015.



Actigraphy

• Wristwatch-sized device

• Worn on non-dominant hand

• Measures wrist movements



PSG for Insomnia

• Polysomnography is not generally indicated, except in the following circumstances:

• Clinical suspicion for a sleep disorder including sleep apnea, periodic limb movements of sleep, or abnormal sleep behaviors.

• Chronic insomnia that is refractory to multiple standard treatments.



Treatment

• Pharmacologic therapy

• Cognitive-behavioral therapy for insomnia (CBT-I)



Short-Term Insomnia Treatment

• Note: Many patient try remedies including over-the-counter sleep aids and alcohol before seeing a doctor.

• Sleep hygiene counseling

• Consider a non-benzodiazepine hypnotic for 2-4 weeks if necessary.

• Depressive symptoms may warrant the use of counseling and/or an antidepressant medication.



Short-Term Insomnia Treatment

• Goal of treatment is to minimize the additional psychological or physical stress that sleepiness produces.

• Follow-up every 2-4 weeks to reassess.

• If causes for insomnia are not improving or the patient is developing increasing anxiety about sleep, evaluate for treatment of chronic insomnia.



Sleep MechanismsPromote Wakefulness

• Reticular formation• Acetylcholine

• Norepinephrine

• Histamine

• Serotonin

• Dopamine

• Orexin/Hypocretin• Neurotransmitter in the hypothalamus

• Discovered in 1998 by two different laboratories

• Missing in patients with narcolepsy-cataplexy

• Also involved with appetite regulation

JCSM 2006;2(2):S19-S26



Sleep MechanismsPromote Sleep

• Gamma-Aminobutyric Acid (GABA)• Most widely distributed inhibitory

neurotransmitter

• GABAA complex is stimulated by benzodiazepines and non-benzodiazepine receptor agonists

• Melatonin • Secreted by the pineal gland soon after onset

of darkness

• Has a hypnotic effect

JCSM 2006;2(2):S7-S11

NEJM 1997; 336:185-195



FDA Approved for Insomnia

Int. J. Mol. Sci. 2016, 17, 50

Lemborexant Dayvigo, approved by FDA Dec 23, 2019 SOI, SMI



Zolpidem Formulations

• High blood levels, 8 hours after ingestion, have been found in women (15%) vs men (3%)

• The FDA mandated a lower starting dose in women.

Int. J. Mol. Sci. 2016, 17, 50



Off-label Medications

• Off-label hypnotics may be considered:• When FDA approved drugs are not efficacious

• Co-morbid conditions• Sedating antidepressants – depression

• Quetiapine – schizophrenia or bipolar disorder

• Gabapentin – seizure disorder

• Antihistamines – severe seasonal allergies

Int. J. Mol. Sci. 2016, 17, 50



Chronic Insomnia TreatmentCognitive Behavioral Therapy for Insomnia (CBT-I)

• Structural treatment utilizing behavioral strategies usually by a “Sleep Coach”.

• Administered usually over 45 min – 1 hr weekly for 6-8 weeks.

• Monthly maintenance treatments may be required for some patients.

• Currently used in only about 1% of patients with chronic insomnia.

• Benefits appear sustained >2 years.

Int. J. Mol. Sci. 2016, 17, 50



CBT-I

• Primary Interventions• Sleep Hygiene Education

• Stimulus Control Therapy

• Sleep Restriction Therapy

• Adjunctive Treatments• Cognitive Therapy

• Relaxation Training• Progressive muscle relaxation

• Biofeedback

• Guided imagery



CBT-ISleep Hygiene Instructions

• Recommendations relating to environmental factors, behaviors, and habits that promote sound sleep.

• Sleep only as much as you need to feel refreshed

• Get up at the same time each day, 7 days a week

• Exercise regularly (not within 3 hrs of bedtime)

• Maintain a comfortable bedroom (noise, light, temperature)



CBT-ISleep Hygiene Instructions

• Avoid heavy meals, but also don’t go to bed hungry

• Avoid excessive liquids in the evening

• Cut down on all caffeine products

• Avoid alcohol and smoking

• Avoid naps

• Don’t take your problems to bed. Set a time prior to bed to plan the next day’s activities and review events that occurred during the day.

• Turn the clock away, so that you can’t see it from bed



CBT-IStimulus-Control Therapy

• Behavioral instructions aimed at strengthening the association between the bed and sleep

• Go to bed only when sleepy

• Use the bed only for sleep and sex

• If unable to sleep within 15-20 minutes, go to another room, read or engage in other quiet activities, and return to bed only when sleepy; repeat if necessary

• Have a regular wake time, regardless of the duration of sleep, all days of the week

• Avoid daytime napping



CBT-ISleep Restriction Therapy

• Behavioral instructions to reduce time in bed to estimated total sleep time (sleep efficiency) as shown by sleep logs (no less than 5 hrs)

• Rising time is fixed. Bedtime is manipulated based on the patient’s self-reported sleep efficiency (ratio of time asleep to time in bed).

• If the sleep efficiency for the prior week reaches >85%, then the patient is allowed to go to bed 15 minutes earlier.

• Bedtime is gradually increased.



CBT-IRelaxation Therapy & Cognitive Therapy

• Relaxation Therapy• Any relaxation technique that the patient finds effective to limit

cognitive arousal and reduce muscular tension.

• May include meditation, mindfulness, progressive muscle relaxation, guided imagery, breathing techniques.

• Cognitive Therapy• Aims to identify, challenge, and replace faulty or dysfunctional

beliefs about sleep and insomnia.

• Examples include unrealistic expectations of sleep, fear of missing sleep, overestimation of the consequences of poor sleep.



CBT-I vs. Hypnotics

• CBT-I Advantages• Equally effective to

hypnotics in short-term treatment

• Superior in long-term management to hypnotics

• Minimal side effects• Some patients prefer a

non-drug option when given a choice

• Provides lifelong skills

• CBT-I Disadvantages• Insurance

reimbursement barriers• Qualified providers are

in short supply

• Delay in therapeutic response compared with medications

• Requires discipline, perseverance

JCSM 2006;1(2):120-128



CBT-I vs. Hypnotics

• Hypnotic Advantages

• Speed of response

• Easily available in clinical practice

• Minimal patient burden for behavioral change

• Hypnotic Disadvantages

• Risk of dependence

• Less risk with newer non-benzodiazepine medications

JCSM 2006;1(2):120-128



Combination Therapy

• Investigations have been mixed and inconsistent. No clear advantage of combined treatment over CBT-I alone.

• Consider if rapid response is needed • Deterioration in daytime function

• Excessive anxiety regarding sleeplessness

• Can be used initially, with a plan to taper the medication over time (six to eight weeks)



Cognitive Behavioral Therapy for Chronic Insomnia, A Systematic Review and Meta-analysisAnn Intern Med. 2015;163(3):191-204.

• Review of 20 randomized, controlled trials

• 4 Main outcome measures using sleep diary• SOL – Sleep Onset Latency

• Time required to enter sleep after lights out

• WASO – Wake After Sleep Onset

• Time spent awake, after entering sleep

• TST – Total Sleep Time

• Total time spent in sleep

• SE% - Sleep Efficiency

• TST/Time in Bed

• Measures assessed at 3 time points• Immediately after CBT-I

• Early follow-up (4 weeks - 6 months)

• Late follow-up (6 - 12 months)



Ann Intern Med. 2015;163(3):191-204.

Effect of CBT-I on SOL (sleep onset latency) Effect of CBT-I on WASO (wake after sleep onset)



Ann Intern Med. 2015;163(3):191-204.

Effect of CBT-I on TST (total sleep time) Effect of CBT-I on SE% (sleep efficiency)



CBT-ISleep Parameter Improvements

• Sleep onset latency (SOL)

• Wake after sleep onset (WASO)

• Total sleep time (TST)

• Sleep efficiency (SE%)

Normal Insomnia Post CBT-i

SOL 35 58 min 39 min (-19)

WASO 40 76 min 50 min (-26)

TST 439 344 min 352 min (-8)

SE% 80-90% 72% 82% (-10)

Ann Intern Med. 2015;163(3):191-204.



Internet-based CTB-I• 15 RCTs

• 1013 + 591 experimental and wait list group participants

• SOL (-18.41 min)

• TST (+22.30 min)

• SE% (+9.58%)

• WASO (-22.31 min)

BMJ Open. 2016 Nov 30;6(11)



Mobile Phone Interventions

Mobile Phone Interventions for Sleep Disorders and Sleep Quality: Systematic Review

• Mobile phones are a useful tool due to their portability

• 16 studies between 1983-2016 (12 RCTs)

• Two intervention methods• Conventional therapy supported by telephone calls and texts• Phone apps

• 14/16 studies demonstrated improvement• Traditional therapy given via phone• Telephone-supported traditional interventions

• Patients on a waitlist, awaiting conventional therapy

JMIR Mhealth Uhealth. 2017 Sep; 5(9): e131.



CBT-I Coach AppCollaboration between

• Veterans Administration

• Stanford University

• DOD’s National Center for Tele-health

Free for Apple and Android devices



CBT-I Coach App

CBT-I Coach: A Description and Clinician Perceptions of a Mobile App for Cognitive Behavioral Therapy for Insomnia

• Surveyed VA CBT-I clinicians regarding patient adherence issues (dropout, homework, non-compliance).

• 59% of clinicians reported using the app with patients within 2 years of app release and had a favorable impression toward improving patient adherence.

J Clin Sleep Med. 2016 Apr 15; 12(4): 597–606.



CBT-I Online vs Attended

Pros

• Available to anyone with an internet connection

• Patients can work on the therapy on their own schedules

• Can be just as effective as traditional therapy for self-motivated individuals

• Less expensive

Cons

• Higher dropout rate than traditional therapy (33% vs 22%)

• Unable to detect other comorbid medical problems



Summary

• Insomnia is common in our society

• Often associated with and exacerbates other medical and psychological conditions

• Associated with increased accidents and mortality

• Short-term insomnia may require pharmacologic therapy and close follow-up

• Chronic insomnia is due to maladaptive behaviors that develop

• CBT-I offers an effective and long-lasting effect for chronic insomnia

Don’t Lose Sleep Over Insomnia...88TH ANNUAL POSTGRADUATE CONVENTION | LLU HOMECOMING ALUMNI...

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