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Current Treatment Strategies for Insomnia Objectives Sleep States

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									                                                                                                          Objectives
                                                                                Identify various causes and classifications of
Current Treatment Strategies                                                    insomnia.
        for Insomnia                                                            Understand the importance of sleep hygiene
                                                                                and other non-pharmacologic therapies to help
    Devon Sherwood, Pharm.D.                                                    counsel patients with insomnia.
   Psychopharmacology Resident                                                  Review current pharmacologic therapies
                                                                                available for insomnia.
   Nova Southeastern University
                                                                                Recognize the adverse effect profiles and
        sdevon@nova.edu
                                                                                interactions of treatment strategies presented.
                                                                            1                                                                                    2




    Sleep States in Adults                                                                         Types of Sleep
                                                                                Nonrapid Eye Movement (NREM)
                                                                                   Stage I - Theta waves
             Wake                                                                    Lightest sleep, easy to rouse
            ~2/3 of                                                                Stage II – More theta waves, sleep spindles
              life                                                                   Deeper level of sleep
                                                                                   Stage III – Increase in delta waves (20%)
                                        NREM                                         Deeper sleep
                                                                                   Stage IV – Delta waves (50%)
                          REM                                                        Deep sleep, difficult to rouse
                                                                                        Kaplan V, Kaplan & Sadock’s Comprehensive Textbook of Psychiatry, 8th
                                                                            3                               edition 2003; ch 1.20: 280-295                       4




               Types of Sleep                                                                           Sleep Cycle

Rapid Eye Movement (REM)
  Frequent bursts of eye movement
  activity that occur
  Brain waves resemble Stage 1 (fast,
  low)
  Harder to wake than Stage 1


    Kaplan V, Kaplan & Sadock’s Comprehensive Textbook of Psychiatry, 8th               Butkov N. Atlas of Clinical polysomonography. Medford, Oregon: Synapse
                        edition 2003; ch 1.20: 280-295                      5                                          Media; 1996                               6




                                                                                                                                                                     1
     Effects of Age on Sleep                                                                   Circadian Rhythm
                                                                                     Develops within the first 2 years of life
                                                                                     Involves a 24.2 – 25 hour internal clock
                                                                                       Reset by external stimuli




        American Academy of Sleep Medicine - NIH Sleep Academic Award          7                                                                                  8




 Categories of Sleep Disorders                                                                              Insomnia
Primary – Conditions inherent to the                                               Definition: Difficulty falling asleep,
mechanisms by which sleep is regulated                                             maintaining sleep, or not feeling rested
  Parasomnia                                                                       despite a sufficient opportunity to sleep
  Dyssomnia
    Insomnia
                                                                                   Epidemiology: 1/3 of US population
    Hypersomnia
                                                                                   reports insomnia, and 17% reported the
Secondary – Sleep disturbances                                                     symptoms to be serious
consequently due to some other disorder
      Kaplan V, Kaplan & Sadock’s Comprehensive Textbook of Psychiatry, 8th              Dipiro JT, Pharmacotherapy – A Pathophysiologic Approach, 5th edition
                         edition 2003; ch 20: 2022-2034                        9                                2002; ch 73: 1323-1333                           10




Common Etiologies of Insomnia                                                                  Primary Insomnia
 Situational – stress, conflicts, jet lag
 Medical – cardiovascular, pain,                                                     Inadequate Sleep Hygiene
 respiratory, endocrine disorders, GI,                                               Psychophysiological Insomnia
 neurologic, pregnancy
 Psychiatric – mood disorders, anxiety,                                              Sleep State Misperception
 substance abuse                                                                     Idiopathic Insomnia
 Pharmacologically Induced –
 anticonvulsants, central adrenergic
 blockers, diuretics, SSRI’s, steroids,
 stimulants
      Dipiro JT, Pharmacotherapy – A Pathophysiologic Approach, 5th edition              Kaplan V, Kaplan & Sadock’s Comprehensive Textbook of Psychiatry, 8th
                             2002; ch 73: 1323-1333                           11                            edition 2003; ch 20: 2022-2034                       12




                                                                                                                                                                      2
  Nonpharmacologic Therapy                                                                     Sleep Hygiene
 *Sleep hygiene*
                                                                               Maintain regular hours of bedtime
 Cognitive therapy
 Relaxation therapy                                                            and arising
 Stimulus control                                                              Do not eat heavy meals before
 Light therapy                                                                 bedtime
 Sleep deprivation
                                                                               Avoid napping during the daytime
 Between 70-80% of people with insomnia                                        Exercise daily
 treated nonpharmacologically have a positive
 response.
                                                                                    Table 20-1: Kaplan V, Kaplan & Sadock’s Comprehensive Textbook of
                                                                          13                      Psychiatry, 8th edition 2003; ch 20: 2025                 14




                Sleep Hygiene                                                               Herbal Products
Minimize cigarette smoking and                                                 Valerian Root
caffeine before bedtime
Avoid “clock watching”                                                         Melatonin
Release worrisome thoughts before
bedtime                                                                        Kava Kava (not recommended)
Make the bedroom comfortable
Avoid alcohol as a sleep aid
      Table 20-1: Kaplan V, Kaplan & Sadock’s Comprehensive Textbook of
                    Psychiatry, 8th edition 2003; ch 20: 2025             15                                                                                16




                 OTC Products                                                              Hypnotic Agents
Diphenhydramine and Doxylamine                                                 Barbiturates
 Branded as several products                                                   Chloral Hydrate
   Diphenhydramine: Benadryl, Diphenhist,                                      Antidepressants
   Unisom Gelcaps, Nytol, Simply Sleep,
                                                                                 Trazodone
   Sleepinal, Sominex, Twilite, Tylenol PM
   Doxylamine: Good Sense Sleep Aid, Unisom                                      Mirtazapine
   Sleep Tabs                                                                    Amitryptiline
 MOA – competes with histamine for H1-                                           Doxepin
 receptor sites; also Ach effects
                                                                                    Dipiro JT, Pharmacotherapy – A Pathophysiologic Approach, 5th edition
                            LexiComp Drug 2005                            17                               2002; ch 73: 1323-1333                           18




                                                                                                                                                                 3
Nonbenzodiazepine Agents                             Zolpidem (Ambien)
                                              As effective as BZD hypnotics with little
Zolipidem (Ambien)                            effect on sleep stage
Zaleplon (Sonata)                             Not associated with tolerance or
                                              rebound after 35 days of use
Eszopiclone (Lunesta)
                                              Due to MOA which selectively acts on
                                              BZD1 receptor:
 All have same MOA: Selectively act on          Minimal anxiolytic effects
 BZD1 receptor                                  No muscle relaxant or anticholenergic
                                                effects
                                         19                                                                             20




            Zolpidem                                   Zaleplon (Sonata)
Dose:                                         No significant rebound insomnia,
 10 mg qhs (max dose 20 mg qhs)               withdrawl symptoms, daytime
 Elderly and hepatically impaired patients    anxiety or daytime sedation
 - 5 mg qhs                                   No psychomotor impairment, or
PK:                                           memory impairment
 T½ = 2.5h     Duration = 6-8 h               Most common SE are dizziness, HA,
 NO active metabolites                        and somnolence


                                         21                                                                             22




             Zaleplon                              Eszopiclone (Lunesta)
Dose:
 10 mg nonelderly adults
                                               FDA approved for long term use
 5 mg elderly                                  No evidence of tolerance
                                               throughout 6 months of nightly use
PK:
 Rapid onset, short duration of effects        Most common side effects are
 T½ = 1 hour
                                               unpleasant taste, headache and
                                               somnolence
  Duration = 3 hours

                                                                      1.) Lunesta Drug Monograph
                                         23         2.) Krystal AD, Walsh JK, Laska E, et al. SLEEP. 2003;26:793-799.   24




                                                                                                                             4
                              Eszopiclone                                                          Ramelteon (Rozerem)
  Dosing:                                                                                     Shows NO evidence of abuse or
     2 mg qhs in nonelderly patients, then                                                    dependance
     increase to 3 mg if necessary                                                            MOA:
     1 mg qhs in elderly, severely hepatic                                                      Melatonin receptor agonist with high
     impairment, or concurrently                                                                affinity for MT1 and MT2 and
     administered potent CYP 3A4 inhibitors                                                     selectivity over the MT3 receptor
  PK:                                                                                           No affinity for GABA receptors
     T½ = 6 h                                                                                 Side effects include fatigue,
     Duration = 7-8 hours                                                                     dizziness, drowsiness
                                    Lunesta Drug Monograph                            25                                Rozerem Drug Monograph                             26




                               Ramelteon                                                                  Benzodiazepines
                                                                                            Five BZD are FDA approved for insomnia:
  Dose:                                                                                        Estazolam, Flurazepam, Quazepam,
     8 mg qhs                                                                                  Temazepam, Triazolam

  PK:                                                                                       MOA of BZD:
                                                                                               Nonselectively binds to BZD receptors
     T½ = 1-2.6 h
                                                                                               Increase stage 2 sleep, decrease stage 1 and 4
        2-5 hours (active metabolite)
                                                                                               sleep – Do not decrease REM sleep
     Quick onset and duration of action                                                        Increase total sleep time
        Median peak concentration occurs at 0.75 h                                             Decrease latency to sleep onset and number of
                                                                                               awakenings
                                                                                                   Dipiro JT, Pharmacotherapy – A Pathophysiologic Approach, 5th edition
                                   Rozerem Drug Monograph                             27                                  2002; ch 73: 1323-1333                           28




                                                                                                         Pharmacist’s Role
                                          Daily
                      Parent              Dose                  Clinically Significant
Generic Name
                      T½ h                Range                      Metabolites
                                          (mg)                                             Assist in diagnosis
                                                                                             Insomnia has a high prevalence – Usually an
                                                                                             underlying problem, not a primary disorder
 Estazolam           12-15 h               1-2                                  -

                                                             Hydroxyethylflurazepam,       SLEEP HYGIENE!!
 Flurazepam               8               15-30               Flurazepam aldehyde,
                                                              N-desalkylflurazepam           Nonpharmacologic treatment first, then
                                                                                             pharmacologic therapies
                                                                                           Appropriate Drug Selection
 Quazepam                39              7.5-15                    2-Oxo-quazepam

Temazepam             10-15               15-30                                 -            Pharmacokinetics
 Triazolam                2
                                         0.125-
                                                                                -
                                                                                             Drug-drug interactions
                                          0.25                                               Drug-disease interactions
              Dipiro JT, Pharmacotherapy – A Pathophysiologic Approach, 5th edition
                                     2002; ch 73: 1323-1333                           29                                                                                   30




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