Opioid Therapy How can opioid analgesic efficacy be assessed? Is there a rationale for concurrently prescribing multiple long-acting opioid analgesics? Are patient agreements helpful when initiating long-term opioid therapy? Addiction Topics How is opioid addiction different from dependence or tolerance? What evidence supports neurological dysfunction in addiction? Non-Opioid TherapiesNon-Opioid Therapies Is shockwave therapy a valid alternative for treating plantar fasciitis? Are epidural steroid injections helpful for chronic low back pain? Pain DisordersPain Disorders & Complications How can sleep disturbances in patients with pain be managed? Opioid Therapy Opioid Therapy How can opioid analgesic efficacy be assessed? The assessment of opioid analgesic efficacy should begin when therapy is first considered and continue at each visit. Many clinicians follow the “4 A’s” developed by Passik and Weinreb (2000), which consider the main domains for evaluating pain treatment outcomes. Current opioid guidelines also recommend routine assessment of the “4 A’s” (ASIPP 2006). Ideally, every interaction with a patient complaining of pain will include a review of the opioid-therapy regimen and the “4 A’s,” along with documentation of patient responses. * Analgesia – Measure pain relief as reported by the patient. Multiple assessment tools exist and the most commonly used are: a four-category verbal rating scale (VRS-4), an 11-point numeric rating scale (NRS-11), or a 100-mm visual analog scale (VAS). Consistency in using the same instrument to measure pain relief at each visit is more important than the actual choice of scale. In patients with low literacy, the numeric scale has been reported as more reliable than the VAS (Ferraz et al. 1990). * ADL’s (Activities of Daily Living) – Assess level of physical and psychosocial functioning, including: bathing, walking, dressing, sexual function, ability to work, mood, sleep, family/social interactions, and recreational or leisure activities (ASIPP 2006, NGC 2005). Consider goals expressed by the patient and how much has been achieved against those goals. * Adverse Effects – Document all adverse effects due to opioid therapy. Consider those that either are not effectively managed or prevent function (e.g., constipation, cognitive impairment), or those that may be minimal (e.g., occasional itching). Determine appropriate strategies to avoid or minimize side effects; for example, reducing opioid dose or frequency, changing the drug formulation, or opioid rotation. * Abuse Issues – Evaluate the patient for any signs suggestive of dependency or drug-seeking behavior. Some suggested criteria to evaluate potential opioid abuse or misuse include: early or frequent prescription refills, inappropriate focus on opioid-medication issues at each visit, escalating opioid use in the absence of an acute or related change in medical condition, multiple telephone calls or visits requesting more opioids, and lost/stolen medications (ASIPP 2006). Also be alert to any signs of potential drug diversion, such as doctor shopping or prescription forgery. However, keep in mind that, rather than an actual addiction/dependency disorder, these behaviors may represent “pseudoaddiction” (which relates to aberrant behaviors associated with a patient’s attempts to overcome the undertreatment of pain). References ASIPP (American Society of Interventional Pain Physicians). Trescot AM, Boswell MV, Sairam LA, et al. Opioid guidelines in the management of chronic non-cancer pain. Pain Physician. 2006;9:1-40. Available online at: http://www.asipp.org/documents/1-40-OpioidGuidelines.pdf. Access checked 5/31/06. Ferraz MB, Quaresma MR, et al. Reliability of pain scales in the assessment of literate and illiterate patients with rheumatoid arthritis. J Rheumatol. 1990;17:1022-1024. NGC (National Guideline Clearinghouse). Sanders SH, Harden RN, Vicente PJ. Evidence-based clinical practice guideline for interdisciplinary rehabilitation of chronic non-malignant pain syndrome patients. Chattanooga (TN): Siskin Hospital for Physical Rehabilitation; 2005. Available online at: http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=8014&nbr=4500. Access checked 5/31/06. Passik SD, Weinreb HJ. Managing chronic nonmalignant pain: overcoming obstacles to the use of opioids. Adv Ther. 2000;17(2):70-83. Researcher/Writers: Stewart B. Leavitt, MA, PhD; Sandra E. Checri, RPh. Medical Reviewers: Lee A. Kral, PharmD, BCPS; Paul W. Lofholm, PharmD, FACA; James D. Toombs, MD; Steven J. Tucker, MD. – Posted June 2006. < Back to Question List > Is there a rationale for concurrently prescribing multiple long-acting opioid analgesics? Presently, evidence does not support the concurrent and continued use of more than one long-acting opioid analgesic. And, depending on the half-lives and dosing intervals of multiple long-acting opoids, there is a potential for harmful drug accumulation and additive adverse effects over time. In certain cases, a patient might receive two long-acting opioids concurrently for a brief time when the intent is to wean the patient off one agent and onto the other. The dose of one is appropriately tapered while the other agent is titrated upward. In clinical practice, it is more common to use a long-acting analgesic dosed appropriately to control baseline chronic pain, and to add a short-acting analgesic as a rescue medication taken for episodes of breakthrough pain. Guideline recommendations include the following points: * Rational polypharmacy could include the use of two or more drugs with complementary mechanisms of action, and this may provide greater pain relief at lower doses of each drug and with less toxicity. However, prescribing two drugs in the same class, at the same time, and at larger quantities for an extended period is generally not advised. * Be alert for possible interactions with other medications the patient is taking and for additive side effects. * Titrate doses to achieve optimal balance between analgesic benefit, side effects, and functional improvement. * Optimize administration of analgesics. Generally better pain control is obtained with regularly scheduled doses and supplemented with as-needed (PRN) doses, up to prespecified limits, for breakthrough pain. Resources: Kral LA. Opioid Tapering: Safely Discontinuing Opioid Analgesics 2006. Available online at: http://www.pain-topics.org/pdf/Safely_Tapering_Opioids.pdf. Access checked 5/31/06. Nelson B. Combining methadone with other long-acting and short-acting opioids for pain management. Medscape Pharmacists. 2006. Available at: http://www.medscape.com/viewarticle/523729. Access checked 6/6/06. Researcher/Writers: Stewart B. Leavitt, MA, PhD; Sandra E. Checri, RPh. Medical Reviewers: Lee A. Kral, PharmD, BCPS; Paul W. Lofholm, PharmD, FACA; James D. Toombs, MD; Steven J. Tucker, MD. – Posted June 2006; Reviewed/Updated September 2007. < Back to Question List > Are patient agreements helpful when initiating long-term opioid therapy? A patient opioid-medication contract, sometimes called a controlled-substances agreement, is not required by federal regulations; yet, many pain management practitioners employ them for some or all patients receiving long-term opioid therapy. In a nationwide survey of more than 2,500 board-certified pain specialists, 85% reported using an opioid agreement (Breuer et al. 2006). Although the evidence favoring the efficacy of these agreements in curbing drug abuse is limited, proponents of patient agreements believe they can serve as a communication tool between physician and patient by clarifying the patient’s (and healthcare provider’s) responsibilities. Agreements seem to be most helpful in patients with a history of substance abuse, or if the healthcare provider determines that a patient is at high risk for medication abuse. Carefully worded patient agreements may help with the following: * explaining the goals of therapy; * educating patients and caregivers about benefits, side effects, and concerns related to opioid therapy; * outlining consequences of not adhering to the agreement, such as drug discontinuation; and * addressing potential behavioral concerns, for example, when patients repeatedly “lose” medication, are unable or unwilling to store the medication in a safe place, repeatedly run short and ask for early refills, or obtain medication from more than one physician or pharmacy. Those critical of patient agreements cite the following reasons: * there is limited evidence that such agreements significantly reduce opioid abuse; * there are ethical concerns about their equitable implementation and enforcement; * the objectives can be overly complex and ill-defined; and * their implementation can add time/cost to healthcare delivery. Although patient agreements seem to vary substantially in their content, the American Academy of Pain Medicine (AAPM 2001) has samples available online for clinicians to download and use (see below). Aside from some dissenters citing a lack of clear evidence and the need for further research, there can be advantages for healthcare providers and patients, and the use of opioid-management agreements in certain patients, such as those with substance-abuse potential, may be helpful as a preventive measure. Resources: AAPM: American Academy of Pain Medicine. Long-term Controlled Substances Therapy for Chronic Pain - Sample Agreement. 2001. Available on line at: http://www.painmed.org/pdf/controlled_substances_sample_agrmt.pdf. Access checked 6/5/06. Breuer B, Pappagallo M, et al. A national survey on pain management practices in the United States. Poster presented at the 2006 Annual Meeting of the American Pain Society.. Fishman SM, et al. The opioid contract in the management of chronic pain. J Pain Symptom Manage. 1999;18(1):27-37. Researcher/Writers: Stewart B. Leavitt, MA, PhD; Sandra E. Checri, RPh. Medical Reviewers: Lee A. Kral, PharmD, BCPS; Paul W. Lofholm, PharmD, FACA; James D. Toombs, MD; Steven J. Tucker, MD. – Posted June 2006. Reviewed/updated November 15, 2010. < Back to Question List > Addiction Topics Addiction Topics How is opioid addiction different from dependence or tolerance? Many of the concerns regarding opioid use originate from misconceptions or confusion regarding the terminology describing the risks of addiction, tolerance, and dependence. Numerous authorities – including the American Academy of Pain Medicine, American Pain Society, and the American Society of Addiction Medicine – have addressed these concerns. An appreciation of more concise definitions can help dispel misunderstandings, which otherwise might lead to inadequate pain management therapy. Addiction (Substance Dependence) – is a disorder in which patients exhibit compulsive use of the drug, cravings, and loss of control (use of the drug continues despite harm to themselves or to others). Addiction is not a pharmacological side effect but rather a cluster of behavioral symptoms. While patients with a history of substance abuse may be at higher risk for developing addiction to opioids, the risk for most patients is very small. A commonly used reference from the American Psychiatric Association (APA 2000) – the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) – does not use the term addiction at all; rather, it uses “substance dependence.” And, to be more precise, the particular drug involved is specified: for example, heroin dependence or alcohol dependence. However, for the general public, the term “addiction” is generally synonymous with “substance dependence.” The>DSM defines dependence (addiction) as a maladaptive pattern of substance use leading to significant impairment or distress in 3 or more of the following 7 areas during a 12-month period: * Tolerance – defined by either: a) a need for increased amounts of substance to achieve intoxication or desired effects, b) diminished effect with continued use of the same amount of substance. * Withdrawal – evident by either: a) characteristic, uncomfortable abstinence signs/symptoms for the particular substance, b) the same (or closely related) substance is taken to relieve or avoid the withdrawal syndrome. * The substance is used in greater quantities or for longer periods than intended. * There is a persistent desire or unsuccessful efforts to cut down or control substance use. * Considerable time and effort are spent in obtaining or using the substance or in recovering from its effects. * Important social, employment, and/or recreational activities are given up or reduced because of an intense preoccupation with substance acquisition and use. * Substance use is continued despite knowledge of having a persistent or recurrent physical or psychological problem that is likely caused or exacerbated by the misuse of the substance. Addiction may occur with or without tolerance and withdrawal. A key issue in addiction is the patient’s complete failure or inability to abstain from using a substance that serves no bona fide medical purpose –– that is, loss of control. In many cases, excessive (compulsive) use, loss of control, and neglect of activities/obligations are best confirmed by those close to the patient. Furthermore, no single event or criteria is diagnostic of an addiction disorder; rather, addiction becomes evident via a pattern of behavior that takes place over time. In that regard, opioid addiction is not solely associated with opioid-induced euphoria (feelings of well-being), craving, or physical withdrawal (hyperexcitability, tremors, seizures, etc.). Nor are persons who merely use opioids too often and/or in larger quantities than prescribed necessarily addicted, at least not according to commonly accepted definitions. Physical/Physiological dependence – occurs when withdrawal symptoms are precipitated upon abrupt withdrawal of the opioid, rapid dose reduction, and/or administration of an antagonist. Physical dependence is not necessarily indicative of addiction; rather, it is an expected consequence of long-term therapy with opioids, just as it is with some antihypertensive medications or with corticosteroid therapy. In these scenarios, the patient will experience withdrawal symptoms if therapy is abruptly discontinued rather than gradually tapered. Symptoms commonly associated with opioid withdrawal include tremor, anxiety, abdominal pain, increase in blood pressure, and sweating (diaphoresis). Tolerance – is the most common response to repetitive use of the same drug. It can be defined as a state of adaptation where a higher dose is required to produce the same effect previously obtained at a lower dose. Tolerance to some drug effects develops more rapidly than to others. With opioids, for example, tolerance to sedation, euphoria, and depressed respiration develops faster than tolerance to analgesia or to the constipating side effects of these drugs. Pseudoaddiction – has been used to describe aberrant patient behaviors that may occur when pain is undertreated (AAPM 2001). Although this diagnosis is not supported by rigorous investigation, it has been widely observed that patients with unrelieved pain may become very focused on obtaining opioid medications, and may be erroneously perceived as “drug seeking.” Pseudoaddiction can be distinguished from true addiction in that the behaviors resolve when the pain is effectively treated. Along with this, two related phenomena have been described in the literature (Alford et al. 2006): Therapeutic dependence – sometimes patients exhibit what is considered drug-seeking because they fear the reemergence of pain and/or withdrawal symptoms from lack of adequate medication; their ongoing quest for more analgesics is in the hopes of insuring a tolerable level of comfort. Pseudo-opioid-resistance – other patients, with adequate pain control, may continue to report pain or exaggerate its presence, as if their opioid analgesics are not working, to prevent reductions in their currently effective doses of medication. Patient anxieties about receiving inadequate pain control can be profound, resulting in demanding or aggressive behaviors that are misunderstood by healthcare practitioners and ultimately detract from the provision of adequate pain relief. Resources: AAPM. Definitions Related to the Use of Opioids for the Treatment of Pain. Consensus Statement by American Academy of Pain Medicine (AAPM), American Pain Society (APS) and American Society of Addiction Medicine (ASAM). Approved 2001. Alford DP, Comptom P, Samet JH. Acute pain management for patients receiving maintenance methadone or buprenorphine therapy. Ann Intern Med. 2006;144:127-134. APA (American Psychiatric Association). Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Text Revision (DSM IV-TR). Washington, DC: American Psychiatric Association; 2000. Dahl JL, Portenoy RK. Myths about controlling pain. JPPCP. 2004;18(3),55-58. Jaffe JH. Current concepts on addiction. In: O’Brien CP, Jaffe JH. Addictive States. New York: Raven Press;1992:1-21. Leshner AI. Understanding drug addiction: Insights from the research. In: Graham AW, et al. (eds). Principles of Addiction Medicine. 3 rd ed. Chevy Chase, MD: American Society of Addiction Medicine; 2003: 47-56. Nestler EJ, Malenka RC. The addicted brain. Scientific American. 2004 (March). Researcher/Writers: Stewart B. Leavitt, MA, PhD; Sandra E. Checri, RPh. Medical Reviewers: Lee A. Kral, PharmD, BCPS; Paul W. Lofholm, PharmD, FACA; James D. Toombs, MD; Steven J. Tucker, MD. – Posted June 2006. < Back to Question List > What evidence supports neurobiological dysfunction in addiction? SPECT ScansThrough the years, some commentators have asserted that drug addiction is not a neurobiological disease process; rather, detractors say, it relates solely to poor choices people make based on a distorted value system. This is an old and outdated argument viewing persons who develop addictions as being weak-willed, morally corrupt, and irresponsible. Such perspectives ignore the evidence-based findings of modern neuroscience. That is, although that initial abuse of an addictive substance may be voluntary, it can result in neurobiological dysfunctions that are beyond individual control. Using advanced brain-imaging techniques, researchers have been able to conclusively demonstrate that there are chemical, anatomical, and functional changes in the brains of substance-addicted persons, similar to the changes in other neurobiological disease processes. For example, the colorful images here depict SPECT scans (from Amen 2001) demonstrating that addictions (to heroin or alcohol, in this case), as well as mental disorders, affect brain function similarly to a neurological impairment such as stroke. Single-photon emission computed tomography (SPECT) uses small doses of radioisotope tracers to study regional cerebral blood flow and thus, indirectly, brain function during health and disease states. The images graphically show the cerebral regions of different patients. As can be seen, compared with a normal subject, there are multiple disruptions in the brains of these patients –– the Swiss cheese appearance indicates defects in blood circulation and, hence, abnormal cerebral activity. Portions of the cerebral cortex are responsible for executive functions of cognition, judgement, and impulse control, which become critically dysfunctional in many mental and addictive disorders. Other types of imaging studies (e.g., PET, fMRI) have demonstrated that deeper structures in the brain also may be adversely affected during addiction. And, substances of abuse also selectively alter neurochemical and receptor systems (such as the mesolimbic dopamine “reward” pathways). Thus, substance addiction may best be understood to a great extent as a neurobiological disease process. With effective medical and psychosocial treatments, patients may benefit from at least partial “normalization” of brain activity in the affected regions. Whether or not the long-term use of opioid analgesics – many of which have abuse potential – might adversely affect neurobiological function has not been adequately investigated. Available evidence suggests that appropriate use of these agents, as properly prescribed, does not incur permanent dysfunction during short- or long-term application. For example, a favorable safety profile, including unaffected mental functioning, has been demonstrated in patients receiving long-term methadone therapy; some of whom have been maintained on the drug for 20 years or more. Resources: Amen DG. Why don’t psychiatrists look at the brain? The case for greater use of SPECT imaging in neuropsychiatry. Neuropsychiatry Rev. 2001;2(1). Andreasen NC. Linking mind and brain in the study of mental illnesses: a project for scientific psychopathology. Science. 1997;275:1586-1593. Dolan RJ. Emotion, cognition, and behavior. Science. 2002;298:1191-1194. Gordon NB. The functional potential of the methadone maintained person. CDRWG Monograph #2. Chemical Dependency Research Working Group: The New York State Office of Alcoholism and Substance Abuse Services. December 1994:43-46. NIH (National Institutes of Health). Effective Medical Treatment of Opiate Addiction. NIH Consensus Statement. Bethesda, MD: National Institutes of Health; 1997;15(6):1-38. (See also: JAMA. 1998;280:1936-1943.) Novick DM, Richman BL, Friedman JM, et al. The medical status of methadone maintenance patients in treatment for 11-18 years. Drug Alcohol Dep. 1993;33:235-245. Researcher/Writer: Stewart B. Leavitt, MA, PhD. Medical Reviewers: Lee A. Kral, PharmD, BCPS; Paul W. Lofholm, PharmD, FACA; James D. Toombs, MD; Steven J. Tucker, MD. – Posted June 2006. < Back to Question List > Non-Opioid Therapies Non-Opioid Therapies Is shockwave therapy a valid alternative for treating plantar fasciitis? Extracorporeal shockwave treatment (ESWT) may be an alternative therapy for plantar fasciitis that is unresponsive to other measures. Plantar fasciitis is a painful condition that can lead to functional limitations, and it sometimes responds poorly to treatments like rest, physical therapy, orthotics, NSAIDs, and/or corticosteroid injections. Wang et al. (2006) reported positive long-term results using ESWT in a prospective randomized clinical trial evaluating 149 patients with a diagnosis of chronic plantar fasciitis. After the treatment intervention, patients were evaluated at 60-72 months for the study group (ESWT), and at 34-64 months for the control group. Clinical outcomes assessed were improvements in pain and function rated as excellent, good, fair, or poor. Patients in the study group (n=79) received one shockwave therapy session; 69.1% of them reported excellent results and 13.6% reported good results. Control group patients (n=70) received standard conservative treatment; 0% reported excellent results and 55% good results. A more cautious viewpoint has been expressed by the Technology Evaluation Center (TEC) of the Blue Cross Blue Shield Association. Published in March 2005, the TEC assessment looked at 8 double-blind randomized clinical trials to determine if ESWT for plantar fascitis improved health outcomes (pain and functional limitations). The TEC review concluded that ESWT improved morning pain as measured on a 0-10 point score Visual Analog Scale; however, it was uncertain from the available evidence whether the treatment effect was clinically significant. Overall, the evidence was not sufficient to permit definitive conclusions on the health outcome benefits of ESWT for plantar fasciitis. Therefore, ESWT studies published to date appear to offer mixed results. Until more studies are published, currently available evidence suggests that extracorporeal shock wave treatment (ESWT) may improve pain scores and functionality in some, but not all, patients. References: Wang CJ, Wang FS, Yang KD, et al. Long-term results of extracorporeal shockwave treatment for plantar fasciitis. Am J Sports Med. 2006;34(4):592-596. Extracorporeal Shock Wave Treatment for Chronic Plantar Fasciitis. Blue Cross Blue Shield Association TEC (Technology Assessment Center). Assessment Program, Volume 19, No. 18, March 2005. Researcher/Writers: Stewart B. Leavitt, MA, PhD; Sandra E. Checri, RPh. Medical Reviewers: Lee A. Kral, PharmD, BCPS; Paul W. Lofholm, PharmD, FACA; James D. Toombs, MD; Steven J. Tucker, MD. – Posted June 2006. < Back to Question List > Are epidural steroid injections helpful for chronic low back pain? Although significant questions remain in the management of chronic low back pain, clinical data suggest that patients with unresolved low back pain lasting more than 3 months may be candidates for epidural steroid injections. The pain should be severe enough that it significantly limits function and quality of life, and has not responded to oral analgesic medications and/or conservative care measures. For pain control, epidural steroid injections might be considered as an adjunct to conservative treatment and/or as an alternative to surgery in conditions causing chronic low back and/or leg pain, such as: — degenerative disc disease, — lumbar disc herniation, — lumbar spinal stenosis, and/or — recurrence of pain post-laminectomy. Contraindications include: — history of allergic reactions to any of the injected solutions (e.g., local anesthetic, steroids), — systemic or local infection in the area where the injection is planned, — bleeding disorders, and/or, — anticoagulant therapy. In terms of efficacy, review articles present variable results and published data show an even mix of positive and negative outcomes. Some authors have noted methodological and/or research-design limitations as the reasons for this variability. At this time, research results fail to demonstrate conclusively that epidural injection therapy is either effective or ineffective. Patient response and overall effectiveness often depend on the etiology and duration of the nerve root irritation, with a better response in conditions lasting less than one year. Furthermore, injected steroids could be relatively contraindicated in diabetes, since they may increase blood sugars for up to a few weeks. Although the evidence is ambivalent, epidural steroid injections seem beneficial in some patients for at least decreasing pain on a short-term basis (e.g., for up to 3 weeks post-injection), and possibly much longer. Additional strategies include an overall multidisciplinary rehabilitation program to help reduce pain and improve function. Patient education and participation in the overall treatment plan are important as well. Resources: Adult low back pain. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2005 Sep. Available online at: http://icsi.org/knowledge/detail.asp?catID=29&itemID=149. Access checked 5/31/06. Koes BW, Scholten RJPM, Mens JMA, et al. Efficacy of epidural steroid injections for low-back pain and sciatica: a systematic review of randomized clinical trials. Pain. 63 (1995) 279-288. Samanta A, Kendall J. Is epidural injection of steroids effective for low back pain? Editorial. BMJ. 2004;328:1509-1510. Available online at: http://bmj.bmjjournals.com/cgi/content/extract/328/7455/1509. Access checked 5/31/06. Patient Resource Available at Pain-Topics.org: Handout on Health: Back Pain (Booklet by the U.S. Department of Health and Human Services National Institutes of Health, National Institute of Arthritis and Musculoskeletal and Skin Diseases). See: http://www.pain-topics.org/patient_resources/index2.php#handoutback. Access checked 5/31/06. Researcher/Writers: Stewart B. Leavitt, MA, PhD; Sandra E. Checri, RPh. Medical Reviewers: Lee A. Kral, PharmD, BCPS; Paul W. Lofholm, PharmD, FACA; James D. Toombs, MD; Steven J. Tucker, MD. – Posted June 2006. < Back to Question List > Pain Disorders & Complications Pain Disorders How can sleep disturbances in patients with pain be managed? The National Institutes of Health (NIH) has defined insomnia as complaints of disturbed sleep in the presence of adequate opportunity and circumstance for sleep. The disturbances may including one or more of the following: 1) difficulty initiating sleep; 2) difficulty maintaining sleep; or 3) waking up too early. Lack of restorative, REM sleep also is frequently associated with insomnia (NIH 2005). Patients with unresolved pain frequently have disturbed sleep, including nighttime awakenings, difficulty falling back to sleep after awakenings, and less time spent in restorative rapid eye movement (REM) sleep. Research has shown that losing as little as 4 hours of sleep in one night may result in a significant lowering of the pain threshold (Roehrs et al. 2006). In the patient with chronic pain, treating insomnia can present some challenges: 1) comorbid physical and psychiatric conditions may also be present (e.g., depression, anxiety), either as a cause of insomnia or a contributory factor; 2) opioid analgesics are known to be REM suppressants and lack of restorative sleep, as noted earlier, may contribute to hyperalgesia; 3) pharmacologic therapies may be limited for insomnia in patients receiving long-term opioids or adjunctive medications due to potential drug interactions, side effects, or additive effects (e.g., respiratory depression). Depending on the patient’s particular situation, several strategies might be considered (NIH 2006; Moldofsky 2004): Problem Assessment: * Evaluate current therapy – If medication interactions are present and they are causing the insomnia, a change may be warranted. Conversely, current analgesic therapy may not adequately provide pain relief through the night. In either case, consultation with a clinical pharmacist may be helpful. * Ask the Patient – Patients may fail to report sleep disturbances. Although there are a number of insomnia questionnaires (e.g., Insomnia Severity Index), the best approach is to ask the patient if he/she is having problems with falling or staying asleep, or with staying awake during the day. Non-pharmacologic Strategies: * Sleep hygiene – Patients should be advised about practicing good “sleep hygiene,” such as: using the bed only for sleeping; relaxing before bedtime; avoiding caffeine, nicotine, and alcohol; daily exercise to the extent possible; controlling noise and light in the bedroom; and, setting a regular schedule for sleeping and waking. * Stress reduction or biofeedback may help in the long-term management of insomnia, and in stressed or depressed patients. * Alternative activities like tai chi, yoga, acupuncture, and light therapy might be useful in the treatment of insomnia; however, these have not been adequately evaluated at this time. Pharmacologic Approaches: In general, lower doses of sleep medications may be necessary in patients taking opioid analgesics due to potentially additive CNS-depressant effects –– clinical discretion is advised. Also consider that the elderly are usually more sensitive to the effects of these agents. * Over-the-Counter (OTC) products include medications such as Nytol®, Sleep-Eze®, Sominex®, and others. Most of these products contain antihistamines, such as diphenhydramine that act as a sedative and provide the relaxation needed for falling asleep. However, patients should be cautioned against their routine use. * Benzodiazepines like flurazepam (Dalmane®), quazepam (Doral®), triazolam (Halcion®), and temazepam (Restoril®) are useful in treating co-existing anxiety conditions or sleep disorders. Consider their half-lives; those with longer half-lives can cause daytime sleepiness and impair waking cognitive and motor function, while those with shorter half-lives may wear off before desired or scheduled wake-up times. Some benzodiazepines may disturb sleep architecture, and there can be uncomfortable withdrawal following cessation after long-term use. * Non-benzodiazepine hypnotics like zolpidem (Ambien®), zaleplon (Sonata®), and others seem to have better side-effect profiles than the benzodiazepines. They help patients fall asleep, but may not be as helpful in those frequently waking after falling asleep. * Antidepressants can have sedative side effects and two commonly used for this purpose include trazodone (Desyrel®) and doxepin (Sinequan®).These medications can be associated with more troubling adverse effects (e.g., anticholinergic side effects) than prescription sedative-hypnotic medications; however, clinicians may find them useful when insomnia occurs in the context of depression. Note: These antidepressants are currently not FDA approved for insomnia and their value in the treatment of insomnia has been questioned. * Herbal remedies may have been considered or used by some patients before talking to their physicians. Melatonin, the most commonly used, seems to help some patients fall asleep but not all patients stay asleep. Others promoted for insomnia include valerian, chamomile, and L-tryptophan. The effectiveness and safety of these products for this application have not been established.