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Praveen Kambam, PGY-2 EBM Seminar 10/27/2005

Treatment of Chronic Insomnia: A Literature Search of Practice Guidelines, Meta-Analyses, and Review Articles. Praveen Kambam, PGY-2 EBM Seminar 10/27/2005. What would you recommend for treatment?. 45 year-old man with primary insomnia and difficulty initiating sleep

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Praveen Kambam, PGY-2 EBM Seminar 10/27/2005

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  1. Treatment of Chronic Insomnia:A Literature Search of Practice Guidelines, Meta-Analyses, and Review Articles Praveen Kambam, PGY-2 EBM Seminar 10/27/2005

  2. What would you recommend for treatment? • 45 year-old man with primary insomnia and difficulty initiating sleep • 83 year-old woman with depression treated with fluoxetine and complaints of repeated awakenings throughout the night • 25 year-old man with anxiety and difficulty initiating sleep • 12 year-old girl with early morning awakening

  3. Searching the Literature • Online resources able to be accessed from UM Clinical Home Page or internet only • Searches on PubMed, Medline, Up To Date, MD Consult • Keywords: • “Insomnia” and “treatment” • “Soporific” • “Trazodone” and “quetiapine”

  4. Pharmacological Treatments • Trials for continuous use do not exceed 6 months for eszopiclone, 12 weeks for temazepam, 6 weeks for trazodone, 5 weeks for zolpidem (12 weeks for intermittent use2), and 4 weeks for zapelon1,6

  5. Diphenhydramine • RCT’s suggest improved sleep subjectively but limited by small numbers, short duration, lack of objective measurements2 • No recent data of efficacy over 3 weeks; tolerance within a few days1 • Considerations: next day neurocognitive effects, anticholinergic effect, orthostasis, increased liver enzymes

  6. Melatonin • Conflicting results • Studies limited by small numbers, short periods, various dosages and formulations2 • Considerations: not regulated by FDA so unknown formulation and dosage

  7. Trazodone • Limited data, and especially limited on primary insomnia (only 2 studies) • Lack of objective efficacy measures • Short duration of trials (longest is 6 weeks) • Consideration for side effects (sedation, dizziness, orthostasis, psychomotor impairment, priapism, etc.) • Some evidence of tolerance (after 1-2 weeks) especially for primary insomnia _________________________________________________________________________________________________________ 6. Mendelson WB. A review of the evidence for the efficacy and safety of trazodone in insomnia. J Clin Psychiatry. 2005 Apr;66(4):469-76.

  8. Trazodone vs. zolpidem • 14 day, placebo controlled, primary insomnia • Subjective sleep latency and duration showed significant improvement with both trazodone and zolpidem vs. placebo • Effect was greater with zolpidem __________________________________________________________________________________________________________ 2. Silber MH. Clinical practice. Chronic insomnia. N Engl J Med. 2005 Aug 25;353(8):803-10.

  9. Benzodiazepines • Subjective and objective improvements in sleep maintenance measures (WTSO, number of awakenings) greater for longer-acting agents (flurazepam, quazepam, estazolam) vs. triazolam • However next-day sedation as well as cognitive and psychomotor function impairment worse. • Objective sleep lab data on temazepam to improve number of awakenings is equivocal _________________________________________________________________________________________________________ 1. Benca RM. Diagnosis and treatment of chronic insomnia: a review. Psychiatr Serv. 2005 Mar;56(3):332-43.

  10. Benzodiazepines and non-benzodiazepine agonists • Reduction in sleep onset latency greater than that for antidepressants and melatonin by indirect comparisons • Risk for harm greater for benzodiazepines vs. non-benzodiazepines based on indirect comparisons • Strong evidence of publication bias __________________________________________________________________________________________________________ 3. Buscemi N et al. Manifestations and Management of Chronic Insomnia in Adults. Evidence Report/Technology Assessment. Agency for Healthcare Research and Quality. 2005 Jun;125:1-11.

  11. Benzodiazepines and non-benzodiazepine agonists • Less evidence of subjective and objective next-day residual effects associated with zolpidem vs. benzos • Less evidence of subjective next-day impairment with zaleplon, even if given in the middle of the night • Efficacy for sleep-onset, not for maintenance • Less drug-drug interactions _________________________________________________________________________________________________________ 1. Benca RM. Diagnosis and treatment of chronic insomnia: a review. Psychiatr Serv. 2005 Mar;56(3):332-43.

  12. Non-benzodiazepine agonists • Next day benefits of zolpidem not clearly defined (only improvement in somatic complaints over placebo) _________________________________________________________________________________________________________ 1. Benca RM. Diagnosis and treatment of chronic insomnia: a review. Psychiatr Serv. 2005 Mar;56(3):332-43.

  13. Quetiapine • ??? • Emerging case reports for PTSD and anxiety • Consideration of cost, metabolic side effects, tardive dyskinesia

  14. Behavioral Treatments • Well-established treatments: • Stimulus Control • Paradoxical Intention • Progressive Muscle Relaxation • Probably efficacious treatments: • Sleep Restriction • Sleep Hygiene education • Cognitive Therapy • Biofeedback _________________________________________________________________________________________________________ 4. Chesson AL et al. Practice Parameters for the Nonpharmacologic Treatment of Chronic Insomnia. Standards of Practice Committee of the American Academy of Sleep Medicine. Sleep. 1999;22(8):1128-1133.

  15. Considerations - Behavioral • Cost • Lack of availability • Potential problems with patient motivation and adherence • Training • Limited if any side effects • Differences in insomnia and outcome measures make comparison of study results difficult3

  16. Pharmacologic vs. Behavioral Treatments • Evidence favoring pharmacologic therapy over behavioral therapy or vice versa was inconclusive1 • Hypnotic drugs may result in more rapid improvements in the first 1-4 weeks • Clinical benefit not as well maintained over time (6-24 months) after discontinuation of treatment • Combined treatments did worse than behavioral therapy alone

  17. Pharmacological Treatment vs. CBT vs. Combo • CBT>combo after treatment termination (10-24 month follow-up)1,2 • Pharmacological therapy tended to be superior in the first 2 weeks

  18. Conclusions • No prospective studies demonstrating treatment of insomnia improves outcomes of its associated comorbid conditions1 • Limited duration of studies • No conclusive evidence to favor pharmacological vs. behavioral therapy but limited evidence to guide specific treatment goals and settings • In the absence of evidence, need to match nature of sleep problem with treatment, availability, cost tolerance, side effect tolerance, and co-morbid conditions

  19. Selected Articles • Benca RM. Diagnosis and treatment of chronic insomnia: a review. Psychiatr Serv. 2005 Mar;56(3):332-43. • Silber MH. Clinical practice. Chronic insomnia. N Engl J Med. 2005 Aug 25;353(8):803-10. • Buscemi N et al. Manifestations and Management of Chronic Insomnia in Adults. Evidence Report/Technology Assessment. Agency for Healthcare Research and Quality. 2005 Jun;125:1-11. • Chesson AL et al. Practice Parameters for the Nonpharmacologic Treatment of Chronic Insomnia. Standards of Practice Committee of the American Academy of Sleep Medicine. Sleep. 1999;22(8):1128-1133. • Nowell PD et al. Benzodiazepines and Zolpidem for Chronic Insomnia: A Meta-analysis of Treatment Efficacy. JAMA. 1997 Dec;278(24):2170-2177. • Mendelson WB. A review of the evidence for the efficacy and safety of trazodone in insomnia. J Clin Psychiatry. 2005 Apr;66(4):469-76.

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