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Five Biggest Blunders in the Use of Sedatives and Hypnotics

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Five Biggest Blunders in the Use of Sedatives and Hypnotics Five Biggest Blunders in the use of sedatives and hypnotics Lisa A. Whims-Squires, DO, FCCP, FAASM, FACOI Director, Morton Plant Mease Sleep Disorders Centers Insomnia Treatment ⦿ Insomnia is often a condition with multiple etiologies. • Treatment depends on the etiology and is tailored to the case • No two patients are alike. ⦿ Prescribing a medication for insomnia should be taken seriously • Take a good history • Have a pre-prescription discussion with the patient. AMERICAN ACADEMY OF SLEEP MEDICINE, Practice Parameters, 2008 Clinical Guideline for the Evaluation and Management of Chronic Insomnia in Adults •Consensus on Pharmacological Treatment: • Short-term hypnotic treatment should be supplemented with behavioral and cognitive therapies. Long-term treatment for comorbid insomnia. • When pharmacotherapy is utilized, the choice of a specific pharmacological agent within a class, should be directed by: (1) symptom pattern; (2) treatment goals; (3) past treatment responses; (4) patient preference; (5) cost; (6) availability of other treatments; (7) comorbid conditions; (8) contraindications; (9) concurrent medication interactions; and (10) side effects. Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 AMERICAN ACADEMY OF SLEEP MEDICINE, Practice Parameters, 2008 Clinical Guideline for the Evaluation and Management of Chronic Insomnia in Adults • Standard: Initial behavioral intervention such as sleep restriction, stimulus control or relaxation, or combination of cognitive behavioral therapy for insomnia (CBT-I).) • Guideline: Multicomponent therapy (without cognitive therapy). Other therapies: paradoxical intention, biofeedback therapy. • Consensus on sleep hygiene: Insufficient evidence to indicate that sleep hygiene alone is effective in the treatment of chronic insomnia. Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Journal of Clinical Sleep Medicine, Vol. 4, No. 5, 2008 6 P’s + M Evaluation of Chronic Insomnia Precipitating Predisposing Factors Perpetuating Factors factors Insomni Pharmacolo Psychologica gy a l/ /substances Psychiatric Causes Medical/Sleep Periodicit Disorders y (circadian ) Sateia MJ et al. Lancet. 2004;364:1959-1973. Blunder One ⦿ Not considering the insomnia pattern. Presenting Complaints for Insomnia ⦿ Not enough sleep ⦿ Trouble falling asleep ⦿ Difficulty staying asleep ⦿ Early AM awakenings ⦿ Light or unrefreshing sleep ⦿ Perpetuating event. Blunder Two ⦿ Not considering other underlying diseases or other medications Causes of Chronic Insomnia (at sleep center) Coleman et al. JAMA 1983 Prevalence of Insomnia Symptoms by Disorder Major Depression 65-90% Generalized Anxiety 60-80% Restless Legs Syndrome 30-70% Sleep Apnea 25-50% Medications Causing Insomnia ⦿ Selective serotonin reuptake inhibitors ⦿ Dopamine agonists ⦿ Psychostimulants and amphetamines ⦿ Anticonvulsants ⦿ Cold medicines and decongestants ⦿ Steroids ⦿ Beta agonists ⦿ Theophylline ⦿ Medications for hypertension (alpha agonists, beta blockers) ⦿ Diuretics ⦿ Appetite suppressants ⦿ Caffeine ⦿ Niacin Treatment Emergent Side Effects of Common Anti-depressants PDR.net Blunder Three ⦿ One size fits all. Considerations ⦿ Age of patient ⦿ Chronicity of insomnia ⦿ Pattern of insomnia ⦿ Patient expectations, motivation • Risks and benefits ⦿ Addiction history Blunder Four ⦿ Not considering clearance or half life of drug • Kidney disease • Liver disease Am Fam Physician. 2017;96(1):29-35. Blunder Five ⦿ No plan for medication cessation or not adding nonmedicinal therapies Insomnia-Treatment ⦿ Emphasize it is for a time limited period ⦿ Detail plans to use behavioral approaches Pharmacologic Considerations ⦿ Safety ⦿ Potential complications ⦿ Potential adverse effects ⦿ Dosage escalation ⦿ Rebound insomnia ⦿ Use the lowest effective dosage and taper medication when conditions allow. ⚫ Medication tapering and discontinuation are facilitated by CBT-I. Sedative Hypnotics ⦿ BZDZ ⦿ BZRA ⦿ Melatonin Receptor Agonist ⦿ Histamine H1 receptor antagonist ⦿ Orexin Antagonists Benzodiazepines ⦿ Rapid onset-short action • Triazolam • Flunitrazepam ⦿ Delayed onset, intermediate action • Temazepam • Estazolam ⦿ Rapid onset, long action • Flurazepam • Quazepam Benzodiazepines Used in the Treatment of Insomnia Agent Dosage Peak Action Half Life Estazolam 1 to 2 mg 2 hrs 10 – 24 hours (ProSom) Flurazepam 15 to 30 mg 0.5-1 hr 2 to 3 hours (Dalmane) (47 to 100 hrs of metabolite) Oxazepam 10 to 15 mg 3 hrs 5 to 10 hours (Serax) Quazepam 7.5 to 15 mg 2 hrs 41 hours (Doral) (47 to 100 hrs of metabolite) Temazepam 7.5 to 30 mg 1.2-1.6 hrs 3.5 to 18.4 hours (Restoril) (9 to 15 hours for metabolite) Triazolam .125 to .5 1-2 hrs 1.5 to 5.5 hours (Halcion) mg Am Fam Physician. 2017;96(1):29-35. Nowell PD et al. JAMA. 1997;278:2170-2177.. Benzodiazepines Acute Effects: Decrease in: SL,WASO,REM, SWS Increase in: Stage 2 sleep, spindles, TST Withdrawal: Decrease in TST and increase in SL, WASO Sleep Medicine Clinics Volume 5, Issue 4, December 2010, Pages 559-570 Advantages of Benzodiazepines ⦿ Effective in promoting sleep – All benzodiazepine hypnotics reduce sleep latency ⦿ Longer-acting agents maintain sleep – May decrease wakefulness during sleep – Increase total sleep time • Does not produce sleep-eating, sleep-driving, sleep-sex Charney DS et al. In: Hardman JG, Limbird LE, eds. Goodman & Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. 2001: 399-427 Disadvantages of Benzodiazepine Use ● Potential adverse effects – Residual sedation ● Related to dose and elimination half-life ● Potential impairment of psychomotor skills/memory – Tolerance ● Some require progressively larger doses to achieve same results ● Risk of symptoms on withdrawal – Potential for abuse ● Especially in those with history of drug abuse Charney DS et al. In: Hardman JG, Limbird LE, eds. Goodman & Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. 2001: 399-427 Nonbenzodiazepines/ BZRA Agonists ⦿ Zaleplon • 5-10 mg ⦿ Zolpidem • IR: 5-10 mg • ER: 6.25-12.5 mg ⦿ Eszopiclone • 1-3 mg PDR.net BZRA Hypnotics ⦿ GABA receptor agonists • Zolpidem tartarate (Ambien) t ½: 2.5 hrs • Zolpidem ER (Ambien CR) t ½: 2.8 hrs • Zaleplon (Sonata) t ½: 1 hr • Eszopiclone (Lunesta) t ½ :6 hrs PDR.net BZRA Hypnotics Acute Effects: Decrease in SL, increase in TST, no significant change in REM or SWS Withdrawal: Some increase in SL and WASO Sleep Medicine Clinics Volume 5, Issue 4, December 2010, Pages 559-570 Advantages of BZRA ● Receptor selectivity and shorter half-life may lead to: – Reduced side effects – Reduced withdrawal symptom – Preserved sleep architecture ● Rapid onset of action Mitler MM. Sleep. 2000; 23 (suppl): S39-S47; MICROMEDEX, http://www.micromedex.com Disadvantages of BzRAs ● May have adverse evens similar to benzodiazepines – Headache, drowsiness, dizziness, nausea, amnesia ● Dose reduction needed in elderly ● Sleep walking; sleep eating; sexsomnia ● Potential for dependence in vulnerable populations Mitler MM. Sleep. 2000; 23 (suppl): S39-S47; MICROMEDEX, http://www.micromedex.com Am Fam Physician. 2017;96(1):29-35. Melatonin Agonists ⦿ MT Receptor agonists: Ramelteon (Rozerem) 8 mg (MT1 & MT2, not MT 3) Tasimelteon (Hetlioz) 20 mg MT2>MT1 t ½ 1.3-3.7 hrs for “Non-24 hour S-W schedule PDR.net Melatonin-Receptor Agonist: Ramelteon ● Selective agonist of MT1, MT2 receptors – MT1, MT2 found in brain, associated with regulation of sleepiness and circadian rhythms – No affinity for other receptors involved in sleep and wakefulness (e.g., GABA, norepinephrine, serotonin, dopamine, acetylcholine) Kato K, et al. Neruopharmacol. 2005; 48: 301-310. Melatonin-Receptor Agonist: Ramelteon ● Not classified as a controlled substance ● Primarily useful for sleep onset ● Indication does not limit length of use ● No dose adjustment across clinical populations Kato K, et al. Neruopharmacol. 2005; 48: 301-310. Adverse Events with Ramelteon ● Headache, fatigue, somnolence, dizziness, nausea most common ● Use with caution in those with severe hepatic impairment ● Drug interaction with fluvoxamine (Luvox®) • Greatly increases ramelteon level Ramelteon NDA 021782 approved labeling text 7/22/2005. Roth T, et al. Sleep. 2005; 28: 303-307 Orexin Receptor Antagonists ⦿ Suvorexant (Belsomra) • Doses: 5,10,15,20 mg • t max: 2 hrs, t ½: 12 hours • Contraindicated in Narcolepsy • Useful for sleep maintenance insomnia PDR.net Journal of Clinical Sleep Medicine 2017, 13(2): 307-349 Orexin Antagonists ⦿ Suvorexant (Belsomra) • Elimination pathway: CYP3A ⚫ Avoid with strong CYP3A inhibitors (ketoconazole, clarithromycin, etc.) ⚫ Decrease dosage to 5 mg with moderate CYP3A inhibitors (Cipro, fluconazole, diltiazem, etc.) • Can slightly increase digoxin. • Main concern: EDS PDR.net Journal of Clinical Sleep Medicine 2017, 13(2): 307-349 Doxepin (Silenor) ⦿ Histamine H1 receptor antagonist ⦿ Dose: 3 and 6 mg ⦿ t ½: 15.3 hours, t max 3.5 hours PDR.net Doxepin (Silenor) ⦿ Advantage • Low potential for abuse • No addiction, no withdrawal • Useful for sleep maintenance ⦿ Disadvantage – May be less effective than BzRAs – May cause daytime sedation Primary Care Companion for CNS Disorders 2016; 18 (10). Summary of Hypnotics for Insomnia: AASM practice recommendations and GRADE components of decision-making. AGENT Dose Onset Maintain Strength Benefit/ Quality Harm Suvorexant 10-20 mg N YES Weak Benefit Low Eszopiclone 2 & 3 mg YES YES Weak Benefit Very Low Zaleplon 10 mg YES N Weak Benefit Low Zolpidem 10 mg YES YES Weak Benefit Very Low Journal
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