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INSOMNIA & Sleep Disorders

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Presentation on theme: "INSOMNIA & Sleep Disorders"— Presentation transcript:

1 INSOMNIA & Sleep Disorders
W. Klugh Kennedy, PharmD, BCPP, FASHP, FCCP Professor of Pharmacy Practice and Psychiatry Mercer University (Savannah Campus) Memorial University Medical Center 2015

2 OBJECTIVES Describe the types of insomnia and associated symptoms
Recognize social situations, medications and medical conditions that may lead to insomnia Define treatment plans for insomnia Be able to select an appropriate pharmacologic agent for different types of insomnia Understand and define treatment plans for other sleep disorders such as Circadian Rhythm Disorders and Narcolepsy

3 BACKGROUND We spend about one-third of our lives asleep.
Sleep-Wake Cycle Usually lasts 25 hours, so there is some internal “resetting” required. The reticular activating system maintains wakefulness and when activity here declines, sleep occurs.

4 CIRCADIAN RHYTHM

5 SLEEP CYCLE Non-Rapid Eye Movement (NREM) -- 75% Stage 1 Drowsiness
Light sleep, mild muscle relaxation Heart rate slows, body temperature decreases Stage 3 & 4 Deepest sleep (delta-sleep) Rapid Eye Movement (REM) % REM Sleep Slow-wave state of sleep Brain becomes electrically and metabolically activated Increase in cerebral blood-flow Generalized muscle atonia, vivid dreams, fluctuations in respiratory and cardiac rate

6 How much sleep do we need?
AGE Amount Infants ~16 hours per day Babies and Toddlers (6 months to 3 years) 10-14 hours per day Children 9-12 hours per day (decreases an hour every 3 years from 6 to 12) Teenagers ~9 hours per night Adults 7-8 hours per night Older Adults 7-8 hours per day Pregnant Women Usually require ~3 hours more sleep than usual

7 SLEEP & WAKE DISORDERS DSM-5 Categorizations Insomnia Disorder
Hypersomnolence Disorder Narcolepsy Breathing-Related Disorders Obstructive Sleep Apnea Hypopnea Central Sleep Apnea Sleep-Related Hypoventilation Circadian Rhythm Disorders Parasomnias Non-REM Sleep Arousal Disorders Nightmare Disorder REM Sleep Behavior Disorder Restless-Legs Syndrome Substance/Medication-Induced Sleep Disorder Other Specified Insomnia Disorders Unspecified Insomnia Disorders Other Specified Hypersomnolence Disorders Unspecified Hypersomnolence Disorders Other Specified Sleep-Wake Disorders

8 How do we measure sleep? Subjective Questioning Objective Studies
But not too subjective Objective Studies Polysomnography (PSG) Multiple Sleep Latency Test (MSLT) Maintenance of Wakefulness Test (MWT)

9 INSOMNIA

10 INSOMNIA “Difficulty falling asleep, maintaining sleep, arising, or not feeling rested despite a sufficient opportunity to sleep.”

11 Prevalence In the United States, people report:
>50% experienced insomnia during their lifetime 40% get less than 7 hrs of sleep every night 15% report some type of daytime impairment Elderly: up to 80% Chronic insomnia make up 6-15% of cases

12 INSOMNIA Cost Diagnosis $35 billion per year
Physicians detect insomnia in only about 50% of those experiencing it Primary Providers often rate their knowledge regarding as insomnia as fair or poor

13 Complications from Insomnia

14 Associated Factors Gender Age Situational Stressors Environmental
Poor Sleep Hygiene Psychiatric Conditions General Medical Conditions Substances and Medications Unemployment Lower Socioeconomic Status

15 Insomnia Classification
Transient Lasts a few days, usually associated with stressful situation Examples: jet lag, a stressful event, change in work schedule Short-Term Lasts up to 4 weeks and is usually associated with acute or situational stress Examples: death of loved one, medical illness, surgery recovery Long-Term Lasts more than 4 weeks Examples: caffeine misuse, chronic stress, secondary to underlying condition

16 Causes of Insomnia Medical Illnesses Mental Illnesses
Cancer Chronic Pain Restless Leg Syndrome (RLS) Sleep Apnea Incontinence Allergies Menopause/Hot Flashes Asthma and Chronic Obstructive Pulmonary Disease (COPD) Dementia Fibromyalgia Irritable Bowel Syndrome (IBS) Arthritis Seizure Disorders Mental Illnesses Depression Generalized Anxiety Disorder Panic Disorder PTSD Substance Abuse Somatoform Disorders Adjustment Disorders Personality Disorders Inadequate Sleep Hygiene Daytime napping Inconsistent sleep schedule Eating, exercise, caffeine and/or nicotine Etc.

17 Causes of Insomnia Medication Induced Insomnia Decongestants
Appetite Suppressants Stimulants Steroids Antidepressants Beta-agonists Beta-blockers Diuretics Dopamine agonists/replacement Hypoglycemics Thyroid Hormones CNS Depressant Withdrawal

18 TREATMENT OF INSOMNIA

19 Pharmacotherapy of Insomnia
Part of an overall plan to deal with the causes and used for well-defined time Should only be considered adjunctive therapy for short-term and chronic insomnia Used SHORT-TERM for managing symptoms NOT a permanent solution!

20 BENZODIAZEPINES

21 Benzodiazepines (BZDs)
Class IV Substances Used when: Immediate response needed Non-pharmacologic measures do not work Short-term use FDA-Approved for Insomnia: Half-Life Onset of Action Triazolam (Halcion®) SHORT 15 – 30 minutes Estazolam (ProSom®) INTERMEDIATE 30 minutes Temezepam (Restoril®) INTERMEDIATE 45 minutes Quazepam (Doral®) LONG 30 minutes Flurazepam (Dalmane®) VERY LONG 30 minutes Effect: Increase sleep time and reduce time to onset of sleep Benzo Pearls: Estazolam – Concurrent administration of azole antifungals is contraindicated; no active metabolites Flurazepam – Avoid in elderly, high potential for daytime drowsiness Quazepam – Should be avoided in elderly – long half life and active metabolite Temezepam – no CYP interactions; preferred in liver impairment Triazolam – Concurrent administration with efavirenz, delavirdine, azole antifungals or protease inhibitors is contraindicated; tolerance develops sooner than with other benzos

22 BZDs Use LOWEST effective dose
Avoid residual daytime sedation Use for a SHORT DURATION (only 2-4 weeks) and intermittently Not indicated for chronic use, may develop tolerance AVOID in substance abuse and respiratory impairment Monitor for escalating doses or early refill requests Anterograde amnesia Can worsen depression Use caution in elderly (Beers List – pretty much all hypnotics) Pregnancy: Category X Withdrawal: Anxiety, depression, nightmares, rebound insomnia TAPER DOSE prior to discontinuing to avoid

23 NON-BZDs Pharmacologic Options

24 Non-BZDs Class Drugs NBRAs (“Z”-Drugs) Zolpidem (Ambien®)
Zaleplon (Sonata®) Eszopiclone (Lunesta®) Melatonin Agonist Ramelteon (Rozerem®) All FDA approved

25 Zolpidem (Ambien®) Drug (Trade) What you need to know: Zolpidem
Ambien CR® Intermezzo® Usual dose: 5-10mg PO 30 min before HS Duration: IR: 5 hours (fall asleep) CR: Released over longer period of time (stay asleep) Onset: minutes Lacks anticonvulsant action, muscle-relaxant properties, and respiratory depressant effects Lower risk of tolerance and withdrawal Avoid in obstructive sleep apnea Must be hepatically adjusted (half dose) Controlled release formulation available (Ambien CR®) as well as SL tablets and Oral Spray (Edluar® and Zolpimist®) and the SL Intermezzo® which may be taken during nighttime awakenings Women clear zolpidem slower than men Adverse Effects may include HA, dizziness, daytime somnolence, GI complaints Psychotic symptoms, sensory distortions, parasomnias, amnesia...

26 Zaleplon (Sonata®) Drug (Trade) What you need to know: Zaleplon
Usual dose: 5-20mg PO before HS Duration: <4 hours Onset: min FDA Approved for Short-Term Treatment of Insomnia to improve sleep onset May cause fewer problems in AM due to 1 hour half-life No apparent rebound insomnia, withdrawal symptoms, daytime anxiety, sedation, or impairment Can be given late and preserves all sleep stages Low risk of dependence Food can delay onset and dose should be reduced in elderly, liver disease, concomitant cimetidine use Side Effects: dizziness, headache, somnolence, nausea

27 Eszopiclone (Lunesta®)
Drug (Trade) What you need to know: Eszopiclone (Lunesta®) Usual Dose: 2-3mg adults, 1-2mg elderly Duration: 8 hours, longer in elderly Onset: 30 min 3mg for sleep maintenance 1mg for elderly having trouble falling asleep Morning effects possible if taken late Can be used for chronic insomnia Food causes delayed onset Less tolerance risk Metallic aftertaste (34%) HA, dizziness, unpleasant dreams What the…?

28 Ramelteon (Rozerem®) Drug (Trade) What you need to know: Ramelteon
Melatonin Agonist Usual Dose: 8mg Duration: 8 hours Onset: 20 minutes? Not a controlled substance! No dependence/tolerance May use long-term Do not take with high-fat meal Avoid in liver dysfunction AE: HA, fatigue, dizziness, nausea, increased prolactin levels Your dreams miss you!

29 OTHER agents

30 Other Agents Class Drugs Sedating Antidepressants
Mirtazapine (Remeron®) 15mg Trazodone (Desyrel®) 50 – 150mg Doxepin (Silenor®) mg Antihistamines Diphenhydramine (Benadryl®) 25 – 50mg Doxylamine (Unisom®) 25 – 50mg Hydroxyzine (Atarax®, Vistaril®) 25 – 50mg Atypical Antipsychotics* Quetiapine (Seroquel®) mg Olanzapine (Zyprexa®) 5 – 10mg Antihypertensive Prazosin 1- 6mg/day

31 Mirtazapine (Remeron®)
Drug (Trade) What you need to know: Mirtazapine (Remeron®) Class: Antidepressant DOSING: 15mg adult 15mg elderly Renal/Hepatic dose adjustments required HALF-LIFE: hours NOT FDA-Approved for Insomnia Increases risks of RLS and periodic limb movements May be useful for insomnia in depression Available in 15mg tablets May cause increased appetite and weight gain along with constipation and asthenia Lower doses tend to be more sedating

32 Trazodone (Desyrel®) Drug (Trade) What you need to know: Trazodone
Class: Antidepressant DOSING: mg adult 25-50mg elderly ONSET: hour HALF-LIFE: hours NOT FDA-Approved for Insomnia Often used with SSRIs if patient is experiencing insomnia related to their use Limited efficacy data for insomnia Little anticholinergic activity Long-term use is acceptable Adverse Effects: priapism (<0.1%), orthostatic hypotension nausea, xerostomia, blurry vision

33 Antihistamines Medications What you need to know:
Diphenhydramine Benadryl® OTC Doxylamine Unisom® OTC Hydroxyzine Atarax® Rx Vistaril® Rx Adverse Effects: Dizziness, headache, blurry vision, hypotension, photosensitivity, constipation, dry mouth, increased liver enzymes Often a hangover effect is experienced Avoid in patients with urinary retention problems and closed angle glaucoma Inappropriate for use in elderly (Beers Criteria) Not effective for chronic insomnia because tolerance develops after 1-2 weeks of continued use; consider “off night” after 3 days use Counsel patients not to use Tylenol PM for sleep. Benadryl – 25mg elderly, 25-50mg adult / min onset, hour half-life Doxylamine dose – 25mg, onset min, 10 hour half-life

34 ALTERNATIVE/HERBAL TREATMENT

35 Alternative/Herbal Treatment
Class Drug Herbal/Alternative Valerian Melatonin Kava-Kava* (illegal in the USA) *Kava-Kava not recommended due to hepatotoxicity

36 Valerian Valerian Root Therapy What it Does: What you need to know:
(valeriana officinalis) sedative, anxiolytic, antidepressant, anticonvulsant, hypotensive and antispasmodic effects One of the most common OTCs used for sleep Evidence Grade C (conflicting) Causes CNS depression and muscle relaxation Safe for short-term use, long-term safety not determined Does not work until 2-3 weeks after initiation Usually well-tolerated, may have GI distress, morning sedation, headache Avoid in patients with hepatic disease and in pregnancy Do not take with EtOH, benzos, other hypnotics Interacts with drugs metabolized by CYP3A4 Valerian Flower

37 Melatonin Melatonin Therapy About What you need to know:
(N-acetyl-5-methoxytryptamine) Hormone produced from tryptophan which is secreted by pineal gland. Exogenous OTC Melatonin is synthetically produced to mimic the natural hormone. DOSE: 5mg PO 3-4 hours prior to HS May be useful in treating abnormalities of the circadian clock (i.e. shift work, jet lag, blind) Adverse Effects: sedation, headache, depression, tachycardia, pruritus Avoid in pregnancy

38 Sleep Apnea Circadian Rhythm Disorder Narcolepsy
OTHER SLEEP DISORDERS Sleep Apnea Circadian Rhythm Disorder Narcolepsy

39 Sleep apnea

40 SLEEP APNEA Neurological condition that results in periods of breathing cessation about times per hour Brain will respond and patient awakens usually with no memory of the episode Types: Obstructive Sleep Apnea (OSA) Most common Usually due to physical blocking (obesity, tonsils, tongue, thyroid) Central Sleep Apnea (CSA) 10% of all apneas Due to delay of brain signal for breathing Idiopathic Requires O2 as treatment Diagnosis: Polysomnography (PSG)

41 Treatment: Obstructive Sleep Apnea
Weight Loss Smoking Cessation Positional changes CPAP (face-mask) Oral Appliances Avoid CNS depressants Modafanil and Armodafanil (Provigil® and Nuvigil®) to improve daytime sleepiness Methylphenidate or stimulants classically used Surgical

42 Modafanil (Provigil®) & Armodafanil (Nuvigil®)
Drug (Trade) What you need to know: Modafanil and Armodafanil (Provigil® and Nuvigil®) CNS Activating; exact MOA unknown DOSING: Modafanil 200mg qAM Armodafanil mg qAM Hepatic adjustment required Schedule IV Less abuse potential than stimulants May reduce effectiveness of oral birth control Onset: ~2 hours AE: Headache (34%), insomnia, anxiety, SJS (rare)

43 Circadian rhythm disorders

44 CIRCADIAN RHYTHM DISORDERS
Examples: Shift Work and Jet Lag Non-Pharmacologic Interventions Adjusting sleep schedule prior to event Avoid naps, EtOH, stimulants Pharmacologic Interventions Melatonin Zolpidem for 3 nights

45 Narcolepsy

46 NARCOLEPSY Chronic, incurable disorder characterized by irrepressible sleep attacks and cataplexy Patient moves directly into REM sleep without NREM period Symptoms: Excessive Daytime Sleepiness Cataplexy Loss of muscle tone in face or limb muscles induced by emotions or laughter May be subtle (limp) or dramatic (drops to the floor) Hallucinations Hypnagogic Hypnopompic Sleep paralysis Genetic link

47 NARCOLEPSY: Treatment
Schedule naps, approximately one to two lasting ~20 min/day No EtOH, caffeine, nicotine For EDS 1st line: Wake Promoting Agents Modafinil (Provigil®) and R-enantiomer armodafinil (Nuvigil®) 2nd line: Stimulants Methlyphenidate (Ritalin®) and Amphetamines SSRIs/SNRIs (last line)

48 NARCOLEPSY: Treatment
For Cataplexy Sodium Oxybate (Xyrem®) Scheduled Substance: C-III (medical use) and C-I (illicit use) FDA approved for cataplexy in patients with narcolepsy Changes sleep architecture by decreasing night-time awakenings and increasing REM sleep Prescribers MUST be enrolled in Xyrem Success Program Must enroll in post-marketing surveillance program First Rx can only be written for a ONE MONTH supply and following Rxs for only THREE month supply at a time Dosing: Initial: 4.5/day in two divided doses (one at HS and second in 2.5 to 4 hours) Maximum: May increase up to 9mg/day Taken on empty stomach

49 SLEEP HYGIENE Counseling

50 SLEEP HYGIENE STRATEGIES
Maintain regular hours of going to bed and arising Do not eat heavy meals 2-3 hours before bedtime but do not go to bed hungry – try a light snack. Avoid napping during the daytime. Only use the bed for sleep, sexual activity or pillow fights – Don’t watch TV in bed. Exercise daily but NOT within 2 hours of sleep Minimize cigarette smoking and caffeine intake – none after noon!

51 SLEEP HYGIENE STRATEGIES
Avoid “clock-watching” – try facing clock AWAY Release worrisome thoughts before bedtime Do not stay in bed if unable to sleep – get up for 30 minutes and then try again Make the bedroom as comfortable and dark as possible (black out curtains, blinds, etc.) Avoid alcohol as a sleep aid IF YOU SNORE frequently, see your doctor!

52

53 Conclusion The physiologic process of sleep is essential to normal restorative functioning in humans Untreated sleep deprivation increases risk for multiple medical disorders and makes underlying medical problems difficult to treat -- it may also increase mortality When non-pharmacologic options do not offer optimal benefit, drug therapy may be utilized Benzodiazepines, Non-Benzodiazepine Hypnotics, Sedating Antidepressants, Antihistamines or Alternative Therapies may be viable options for sleep aid Other sleep disorders include sleep apnea, circadian rhythm disorders and narcolepsy and all require different approaches to treatment Pharmacotherapy should be used for the shortest periods possible to alleviate symptoms -- they are NOT a cure -- always consider there may be more to the problem than just the inability to sleep

54 References Diagnostic and Statistical Manual of Mental Disorders: DSM-5. Washington, D.C.: American Psychiatric Association, Print. Erman MK. Therapeutic options in the treatment of insomnia. J Clin Psychiatry. 2005;66 (suppl9);18-23. Lande RG, Gragnani C. Nonpharmacologic approaches to the management of insomnia. J Am Osteopath Assoc. 2010;110(12): Stahl, Stephen M. Stahl's Essential Psychopharmacology: Prescriber's Guide. 5th ed. New York: Cambridge, Print.


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