Chapter 11: Antianxiety Agents Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. DHY 1330 - Therapeutics Chapter 11 Outline Antianxiety Agents Definitions Benzodiazepines Barbiturates Nonbenzodiazepine-nonbarbiturate sedativehypnotics Nonbenzodiazepine benzodiazepine receptor agonists Melatonin receptor agonist Centrally acting muscle relaxants Miscellaneous agents General comments about antianxiety agents Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 2 Antianxiety Agents Objectively assessing the patient’s anxiety is necessary on both the first and subsequent visits Haveles (pp. 136-137) (Fig. 11-1) The dental team will most commonly use orally administered drugs to provide relaxation for an anxious patient Intravenous (IV) administration is used infrequently; most states require a separate certificate to administer IV agents or provide conscious sedation The dosing of a particular antianxiety agent is vastly variable, involving intrapatient and interpatient variation Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 3 Definitions Haveles (p. 137) (Fig. 11-2) Sedative-hypnotic agents can produce varying degrees of central nervous system (CNS) depression, depending on the dose administered A small dose will produce mild CNS depression described as sedation—reduction of activity and simple anxiety • This level has some anxiolytic effects A larger dose of the same drug, the hypnotic dose, will produce greater CNS depression In even larger doses, sedative-hypnotics may produce anesthesia and finally death Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 4 Benzodiazepines Haveles (pp. 137-142) Chemistry Pharmacokinetics Mechanism of action Pharmacologic effects Adverse reactions Abuse and tolerance Drug interactions Medical uses Management of the dental patient taking benzodiazepines Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 5 Chemistry Named according to their structure—a 1, 4— benzodiazepine nucleus Haveles (pp. 137-138) (Table 11-1) chlordiazepoxide (Librium) was synthesized in 1955 diazepam (Valium) was synthesized in 1959 and marketed in 1963 When an additional ring was added, triazolam was synthesized Next, midazolam and flumazenil were synthesized Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 6 Pharmacokinetics Benzodiazepines are well absorbed when administered by the oral route The onset of action is related to their lipid solubility Benzodiazepines are available as tablets, capsules, oral solution, rectal gel, and injectable form Haveles (pp. 138-139) For benzodiazepines available in parenteral form the IV route produces a rapid, predictable response; ideal for conscious sedation Benzodiazepines cross the blood-brain and placental barriers to produce an effect on the CNS and the fetus cont’d… Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 7 Pharmacokinetics Haveles (pp. 138-139) Benzodiazepines are metabolized by phase II metabolism alone or by phase I metabolism followed by phase II metabolism Phase I metabolism involves oxidation, reduction, hydrolysis, dealkylation, and hydroxylation • It is hard metabolism; it is affected by external factors such as other drugs and hepatic disease Phase II involves glucuronidation • It is easy metabolism; unaffected by external factors Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 8 Mechanism of Action Haveles (p. 139) Benzodiazepines enhance or facilitate the action of the neurotransmitter by exerting their effects in the CNS mediated by γaminobutyric acid (GABA), a major inhibitory neurotransmitter The inhibitor effect of GABA is enhanced Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 9 Pharmacologic Effects Behavioral effects Clinical effects in humans are anxiety and panic reduction at low doses and drowsiness and even sleep at higher doses Antiseizure effects Haveles (p. 139) Increase the seizure threshold Muscle relaxation Can produce relaxation of skeletal muscles Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 10 Adverse Reactions of Benzodiazepines Haveles (p. 139) In general, benzodiazepines, used alone, have a wide margin of safety They all have similar adverse effects but differ in their frequency cont’d… Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 11 Adverse Reactions of Benzodiazepines CNS effects The most common side effect is depression manifested as fatigue, drowsiness, muscle weakness, and ataxia • The use of parenteral benzodiazepines during a dental appointment reduces anxiety and alters perception of time Diazepam’s long half-life and metabolism to an active metabolite prolongs its duration of action Midazolam is metabolized primarily to inactive metabolites • flunitrazepam (Rohypnol) is available in Europe cont’d… Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 12 Adverse Reactions of Benzodiazepines Anterograde amnesia Respiratory effects Produced beginning when the drug is taken Doses of diazepam have occasionally been reported to produce respiratory depression Cardiovascular effects Relief of anxiety may result in a fall in blood pressure and pulse rate cont’d… Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 13 Adverse Reactions of Benzodiazepines Visual effects Dental effects Contraindicated in angle-closure (narrow-angle) glaucoma and can produce diplopia (single object viewed as two), nystagmus (rhythmic oscillation of the eyeballs), and blurred vision Have been reported to produce xerostomia, increased salivation, swollen tongue, and a bitter or metallic taste Thrombophlebitis Parenteral diazepam may cause thrombophlebitis because propylene glycol is used to solubilize it cont’d… Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 14 Adverse Reactions of Benzodiazepines Other effects Can produce cramps or pain, difficulty in urination, allergic reactions Pregnancy and lactation considerations Increased risk of congenital malformations if taken in the first trimester of pregnancy has been reported Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 15 Abuse and Tolerance Haveles (p. 140) Overview Benzodiazepines can be abused; physical dependence and tolerance have been documented • Their abuse and addiction potential is less than that of the other sedative-hypnotic agents such as barbiturates • Benzodiazepines have a wider TI than barbiturates • Combining with other CNS depressants can reduce the safety cont’d… Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 16 Abuse and Tolerance Haveles (p. 140) Treatment of overdose With recent ingestion, emesis may be induced • Activated charcoal and a saline cathartic To reduce some of the effects of a benzodiazepine, flumazenil (Romazicon), a benzodiazepine antagonist for IV administration may be used Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 17 Drug Interactions Benzodiazepines will interact in an additive fashion with other CNS depressants Haveles (pp. 140-141) Drugs that inhibit oxidative metabolism (phase I metabolism) may increase the effect of benzodiazepines that undergo phase I metabolism Selective serotonin uptake inhibitors alter clearance of diazepam May reduce the effectiveness of levodopa May increase the effect of digoxin, phenytoin, and probenecid Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 18 Medical Uses Haveles (p. 141) Useful in short-term treatment of anxiety, panic attacks, insomnia, and alcohol withdrawal Used for acute treatment of seizures Used for conscious sedation, general anesthesia, or during surgery cont’d… Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 19 Medical Uses Anxiety control Insomnia management Generalized anxiety disorders and panic disorder; manifestations of anxiety include restlessness, tension, tachycardia, and dyspnea If a manifestation of anxiety Treatment of epilepsy (seizures) Diazepam or lorazepam is the drug of choice cont’d… Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 20 Medical Uses Treatment of alcoholism Used in treatment of alcohol withdrawal syndrome Control of muscle spasms Used to control muscle spasticity that accompanies diseases such as multiple sclerosis and cerebral palsy Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 21 Management of the Dental Patient Taking Benzodiazepines Dental procedures Orally administered diazepam to allay apprehension Premedication Haveles (pp. 141-142) (Box 11-2) Used before surgical procedures to allay anxiety Conscious sedation Usually accompanied by IV administration • Muscle relaxation and anterograde amnesia (events after the injection) cont’d… Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 22 Management of the Dental Patient Taking Benzodiazepines Conscious sedation Parenteral benzodiazepines have been associated with respiratory depression and arrest when used for conscious sedation • Require continuous monitoring of respiratory and cardiac function • Dentists without additional training cannot use conscious sedation Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 23 Benzodiazepines Haveles (p. 138) (Table 11-1) alprazolam chlordiazepoxide (Librium) clonazepam (Klonopin) chlorazepate (Tranxene) diazepam (Valium) estazolam (ProSom) flurazepam (Dalmane) cont’d… Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 24 Benzodiazepines Haveles (p. 138) (Table 11-1) halazepam (Paxipam) lorazepam (Ativan) midazolam (Versed) oxazepam (Serax) quazepam (Doral) temazepam (Restoril) triazolam (Halcion) Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 25 Barbiturates Haveles (pp. 142-144) Chemistry Pharmacokinetics Mechanism of action Pharmacologic effects Adverse reactions Chronic long-term use Contraindications Drug interactions Uses cont’d… Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 26 Barbiturates The original sedative-hypnotic agents Haveles (p. 142) Problems with their use are well documented Associated with a high rate of abuse and complete cardiovascular and respiratory depression with overdose Benzodiazepines have almost completely replaced barbiturates for treating anxiety and insomnia Barbiturates are still used as anticonvulsants and to induce general anesthesia Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 27 Chemistry of Barbiturates Haveles (p. 142) Formed by substitution of R groups on the barbiturate nucleus sites A and B The oxygen atom may be replaced with a sulfur atom site C Compounds with S substitution are effective as IV agents such as thiopental Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 28 Pharmacokinetics of Barbiturates Haveles (p. 142) Absorption: barbiturates are well absorbed orally and rectally; used intravenously but not intramuscularly Distribution: IV agents are inactivated by redistribution from site of action in the CNS, to muscles, and adipose tissue Metabolism: short- and intermediate-acting barbiturates are rapidly and almost completely metabolized by the liver Excretion: long-acting barbiturates are largely excreted through the kidneys as a free drug Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 29 Mechanism of Action Barbiturates produce their effect by enhancing GABA receptor binding and prolong the opening of chloride channels Haveles (p. 142) In higher dose may also act directly on chloride channels Mechanism is less specific than benzodiazepines; may account for ability to induce surgical anesthesia and pronounced generalized CNS depression effects Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 30 Pharmacologic Effects Haveles (pp. 142-143) CNS depression With normal doses, relaxation occurs • With larger doses, inhibitory fibers of the CNS are depressed, resulting in disinhibition and euphoria • When higher doses are administered, hypnosis can be produced • Even higher doses, can result in anesthesia, with respiratory and cardiovascular depression and finally arrest cont’d… Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 31 Pharmacologic Effects Analgesia Haveles (p. 143) Barbiturates have no significant analgesic effect Anticonvulsant effect Barbiturates have anticonvulsant action • Long-acting agents are used to treat epilepsy Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 32 Adverse Reactions Haveles (p. 143) Sedative or hypnotic doses In usual doses, barbiturates are relatively safe • CNS depression may be exaggerated in elderly and debilitated patients or those with liver or kidney impairment Anesthetic doses With higher doses, concentrations in the blood can be lethal Acute poisoning Although a lethal dose can only be approximated, severe poisoning will follow ingestion of 10 times the hypnotic dose; life may be threatened when more than 15 times the hypnotic dose is consumed Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 33 Chronic Long-Term Use Chronic use of barbiturates can lead to physical and psychologic dependence Haveles (p. 143) The addict becomes progressively depressed and is unable to function Tolerance develops to most effects but not to the lethal dose A larger and larger dose must be used to produce an effect, and this dose can approximate the lethal dose Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 34 Contraindications Barbiturates are absolutely contraindicated in patients with intermittent porphyria or a positive family history of porphyria Haveles (p. 143) Porphyria: a group of disorders involving heme biosynthesis Barbiturates can stimulate and increase the synthesis of porphyrins which are already at an excessive level in this disease Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 35 Drug Interactions Haveles (pp. 143-144) (Box 11-3) Barbiturates are stimulators of liver microsomal enzyme production These enzymes are responsible for the metabolism of many drugs An increase in these enzymes could increase the rate of drug destruction and decrease the duration of action Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 36 Uses of Barbiturates Haveles (pp. 143-144) (Table 11-2) Therapeutic uses are determined by duration of action Ultrashort-acting barbiturates are used intravenously for induction of general anesthesia Short- and intermediate-acting barbiturates: little medical use; replaced by benzodiazepines Long-acting barbiturates: used for treatment of epilepsy Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 37 Nonbenzodiazepine-Nonbarbiturate Sedative-Hypnotics Haveles (p. 144) chloral hydrate (Noctec) buspirone (BuSpar) Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 38 chloral hydrate (Noctec) An inexpensive, orally effective sedativehypnotic drug with a rapid onset and short duration of action Haveles (p. 144) Therapeutic doses do not produce pronounced respiratory or cardiovascular depression Gastric irritation can be minimized by taking with milk or food Used in dentistry for preoperative sedation of children The dose is 50 mg/kg, up to a maximum of 1 g Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 39 buspirone (BuSpar) Unique in structure and action Haveles (p. 144) Mechanism of action is unknown; believed to be related to interactions with neurotransmitters in the CNS Anxioselective because of its selective anxiolytic action without hypnotic, anticonvulsant, or muscle-relaxant properties Most patients prefer the benzodiazepines Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 40 Nonbenzodiazepine-Benzodiazepine Receptor Agonists Haveles (p. 144) Zolpidem, zaleplon, and eszopiclone comprise a new class of drugs that are not benzodiazepines but appear to bind to benzodiazepine receptors and decrease sleep latency with little effect on sleep stages All are thought to have agonist effects on GABA These drugs are used to treat insomnia only Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 41 zolpidem (Ambien) Recently developed hypnotic indicated for short-term management of insomnia Haveles (pp. 144-145) Has hypnotic and anxiolytic effects, but receptor specificity produces less muscle-relaxant and anticonvulsant effects Likely to be useful in dentistry when an oral anxiolytic agent is desired for relaxing an anxious dental patient Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 42 zaleplon (Sonata) Haveles (p. 145) A rapid-acting hypnotic that is less potent and has a shorter duration of action than zolpidem Appears to have a lower risk of next-day residual effects, even with use in the middle of the night Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 43 eszopiclone (Lunesta) Haveles (p. 145) The newest agent of this class available in the United States Anterograde amnesia has been reported Some patients report an unpleasant taste Eszopiclone could impair driving the morning after nighttime administration Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 44 Melatonin Receptor Agonist Haveles (p. 145) ramelteon (Rozeram) has been approved for treatment of insomnia characterized by difficulty falling asleep An indenofuran derivative highly selective for melatonin type 1 (MT1) and melatonin type 2 (MT2) receptors Animal studies indicate that the MT1 receptor regulates sleep, and the MT2 receptor may mediate the phase-shifting effects of melatonin on a 24-hour biologic clock Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 45 Centrally Acting Muscle Relaxants Haveles (p. 145) Exert their effects on the CNS to produce skeletal muscle relaxation cont’d… Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 46 Centrally Acting Muscle Relaxants Haveles (p. 145) Pharmacologic effects All CNS muscle relaxants produce some degree of sedative effect because their action is on the CNS • The sedative effects dominate over the “selective” muscle-relaxant activity • Useful in treating muscle spasms and back and neck pain cont’d… Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 47 Centrally Acting Muscle Relaxants Haveles (pp. 145-146) Individual centrally acting muscle relaxants Overview • Exert their muscle-relaxing properties indirectly by producing CNS depression Have no direct effect on striated muscle; do not directly relax tense skeletal muscles Use • An adjunct to rest and physical therapy for relief of muscle spasm associated with acute painful musculoskeletal conditions May be used for symptomatic relief of temporomandibular joint disorder Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 48 Examples of Centrally Acting Skeletal Muscle Relaxants Haveles (p. 145) (Table 11-3) carisoprodol (Soma) chlorzoxazone (Parafon Forte DSC) methocarbanol (Robaxin) orphenadrine (Norflex) cyclobenzapine (Flexeril) diazepam (Valium) Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 49 Miscellaneous Agents Haveles (p. 146) baclofen (Lioresal) Inhibits both monosynaptic and polysynaptic reflexes at the spinal level • Indicated for spasticity from multiple sclerosis or spinal cord injuries or diseases tizanidine (Zanaflex) A short-acting muscle relaxant • Centrally acting α-adrenergic receptor agonist dantrolene (Dantrium) Affects contractile response of skeletal muscle by acting on the muscle itself • Indicated for treatment of spasticity from upper motor neuron disorders Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 50 General Comments About Antianxiety Agents Haveles (pp. 146-147) Analgesic-sedative combinations Special considerations Precautions Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 51 Analgesic-Sedative Combinations Haveles (p. 146) (Box 11-4) Both sedation and analgesia can be obtained from opioid analgesics alone Prescribing an opioid to add sedation to analgesia is undesirable unless the analgesic potency is required In cases in which anxiety is an important component in pain relief, either a nonopioid or an opioid can be used concomitantly with a sedative Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 52 Special Considerations Haveles (p. 146) Patients who are to use antianxiety agents should be driven to and from the dental appointment Drugs are not a substitute for patient management Drugs should not be substituted for patient education or for the proper psychologic approach to patient care Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 53 Precautions Haveles (p. 147) Patients with impaired elimination may experience exaggerated effects of these medications Depression caused by all sedative-hypnotics will add to depression caused by other CNS depressants The patient should be accompanied by a responsible adult who can drive the patient home Psychic and physical dependence has been observed with almost all drugs used to allay anxiety Suicide may be attempted by taking sedative-hypnotic drugs These drugs should never be administered to pregnant women or to those who may be pregnant unless the potential benefit to the mother outweighs the risk to the fetus Sedatives do not provide analgesia Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved. 54