ANTIANXIETY AGENTS (non-ssris)
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1 Santa Clara County Mental Health Department Santa Clara County Mental Health Department Medication Practice Guidelines Medication Practice Guidelines ANTIANXIETY AGENTS (non-ssris) Documentation A. FDA Approved Indications in Psychiatry (Note: The FDA approved indications for specific benzodiazepines vary considerably; e.g. only lorazepam is FDA-approved for both anxiety and insomnia (see Table 1) 1. Anxiety disorder 2. Panic disorder (Alprazolam, alprazolam XR & clonazepam) 3. Insomnia (lorazepam ONLY) Documentation B. Non-FDA approved indications commonly used in Psychiatry 1. All Anxiety Disorders 2. Sleep Disorders 3. Abnormal movements associated with medications 4. Catatonia 5. Tourette s syndrome (Clonazepam) 6. Delirium; delirium tremens 7. Agitation Documentation C. Minimal Documentation 1. All standard outpatient & inpatient requirements Documentation D. Maximum Dosage see Medication Summary for MDD Documentation E. Duration 1. For Outpatient: Document rationale when making any medication change. 2. For Inpatient: Document rationale when making more than 3 changes in any 7-day period. 3. Drug Abuse and Dependence: For patients with substance use refer to Section P: medication guidelines for prescribing controlled psychotropic medications to patients with substance use. Psychological dependence is a risk with all benzodiazepines (Schedule IV). The risk may increase at higher doses and with longer term usage. This risk is further increased in patients with a Section G, Page 1 of 6, Revised: 8/23/13
2 Santa Clara County Mental Health Department Medication Practice Guidelines history of alcohol or drug abuse. Periodic reassessment of drug usefulness for the individual patient must be done to avoid creating physiological abuse and dependence. Withdrawal reactions/symptoms, such as convulsions, psychosis, rebound anxiety, insomnia, hallucinations, behavioral disorders, tremor, abdominal and muscle cramps, may occur following abrupt discontinuation. The more severe withdrawal symptoms GENERALLY OCCUR FOR those patient receiving HIGHER doses over an extended period of time. HOWEVER, milder withdrawal symptoms, such as dysphoria and insomnia, have been reported following abrupt DISCONTINUATION of benzodiazepines taken continuously at therapeutic doses over several months. Therfore, to minimize discontinuation symptoms after extended exposure, gradual taper from benzodiazepine is recommended. Documentation F. Polypharmacy (Refer to Purpose Section for exceptions) If using >1 anti-anxiety agents with the same mechanism of action (i.e. 2 benzodiazepines) clear documentation of rational including clinical response to monotherapy is required. For the purposes of this guideline, concurrent use of a benzodiazepine and a nonbenzodiazepine hypnotic i.e. zolpidem, zaleplon and eszopiclone is considered poly-pharmacy, requiring the appropriate documentation of rational including clinical response to benzodiazepine is required. G. Drug-Drug Interactions Refer to Concomitant treatment with other medications with anticholinergic properties (including Alcohol) may increase risk of CNS depression, psychomotor impairment (additive effects). Document H. Black Box Warning Assessment of Following: Dementia-Related Psychosis PProchlorperazine Prochlorperezine: not (Compazine) approved for is associated dementia-related with dementia- psychosis; increaincrea. Increased mortality It can risk increase elderly mortality dementia risk in patients elderly on dementia convpatients conventional on or atypical conventional antipsychotics; or atypical most antipsychotics. deaths due to Most are cardiovascular due to cardiovascular or infectious or infectious events; extent events. to which It is not clear to the increasedextent to which prochlorperazine increases mortality Section G, Page 2 of 6, Revised: 8/23/13
3 increased mortality attributed to antipsychotic vs. some patient characteristic(s) not clears. Documentation H. Standard laboratory and examination requirements 1. For inpatient: Basic laboratory studies on admission 2. For outpatient: Not Applicable 3. Additional monitoring should be considered depending on the clinical situation and whenever there is a change in the patient s status. Documentation I. Pregnancy and Lactation (Table 3) All benzodiazepines used in psychiatry are pregnancy category D (except Tranxene which is category C). Use of benzodiazepines during pregnancy requires documentation of the risk vs. benefit analysis. Attachments: able 1: FDA Approved Indication for Anti-Anxiety Agents Table 2: Maximum Daily Dose Table 3: Pregnancy and Nursing Mother Category References: 1. Epocrates 2. Micromedex 3. Physician s Package Inserts for Xanax, Klonopin, Tranxene, Ativan, and Ambien 4. Rudolph U, Knoflach F. Beyond classical benzodiazepines: Novel therapeutic potential of GABAA receptor subtypes. Nat Rev Drug Discov.; 10(9): Doi: /nrd Morin A, Jarvis C, Lynch A. Therapeutic Options for Sleep-Maintenance and Sleep- Onset Insomnia. Pharmacotherapy. 2007;27(1): Estivill E and et. Al. Consensus on Drug Treatment, Definition and Diagnosis for Insomnia. Clin Drug Invest. 2003;23(6) 7. Pigeon W, Cribbet M. The pathophysiology of Insomnia, From Models to Molecules (and back). Curr Opin Pulm Med. 2012; 18(6); Section G, Page 3 of 6, Revised: 8/23/13
4 Table: 1 ANTIANXIETY AGENTS FDA-Approved Indications For SSRI, refer to Antidepressant Section Agents Brand Ax. Disorder PD Insomnia Alc. W/D Sz. Disorder Benzodiazepines Alprazolam Xanax X X Alprazolam Xanax XR X Chlordiazepoxide Librium X X Clonazepam Klonopin X X Clorazepate Tranxene X X X Diazepam Valium X X X Lorazepam* Ativan X X X (Status Epilepticus Oxazepam* Serax X X Non-Benzodiazepines Buspirone Buspar X Hydroxyzine 1 Atarax/Vistaril X Prochlorperazine Compazine X Meprobamate 1 X 1 Only available as generic References: EPOCRATES, MICROMEDIX, PPIs * Oxazepam & Lorazepam may be preferred agents in patients with liver disease. Section G, Page 4 of 6, Revised: 8/23/13
5 ANTI-ANXIETY AGENTS Maximum Daily Dose For SSRI, refer to Antidepressant Section Table 2: Agents Brand Adult Children & Adolescent Benzodiazepines Alprazolam Xanax 4 mg non-fda approved Alprazolam Xanax XR 6 mg non-fda approved Chlordiazepoxide Librium 100 mg >6 y.o mg/day in divided doses. Tapper to DC Clonazepam Klonopin 4 mg non-fda gradually approved Clorazepate Tranxene T-Tab 60 mg non-fda approved Tranxene SD 90 mg non-fda approved Diazepam Valium 40 mg mg/kg (6 mo-12 yo); Lorazepam Ativan 10 mg non-fda approved Oxazepam Serax 120 mg non-fda approved non-benzodiazepines Buspirone Buspar 60 mg non-fda approved Hydroxyzine 1 Atarax/Vistaril 600 mg 2mg/kg (<6 yo); Prochlorperazine Compazine 20 mg non-fda approved Meprobamate mg 600 mg (6-12 yo) 1 Only available as generic References: EPOCRATES, MICROMEDEX, PPIs Section G, Page 5 of 6, Revised: 8/23/13
6 Guidelines Table 3: Pregnancy Categories & Nursing Mother Alprazolam Agents Brand Pregnancy Category Benzodiazepines Xanax; Xanax XR Nursing Mother D AAP: Drugs for which the effect on nursing infants is unknown but may be of concern. Thomson: Infant risk has been demonstrated. Chlordiazepoxide Librium D Thomson: Infant risk cannot be ruled out. Clonazepam Klonopin D Thomson: Infant risk cannot be ruled out. Clorazepate Tranxene T-Tab; C 1 WHO: Compatible with breastfeeding. Monitor infant for side effects. Tranxene SD Thomson: Infant risk cannot be ruled out. Diazepam Valium D AAP: Drugs for which the effect on nursing infants is unknown but may be of concern. WHO: Compatible with breastfeeding. Monitor infant for side effects. Thomson: Infant risk has been demonstrated. Lorazepam Ativan D Oxazepam Serax D WHO: Compatible with breastfeeding. Thomson: Infant risk cannot be ruled out. non-benzodiazepines Buspirone Buspar B Thomson: Infant risk cannot be ruled out. Hydroxyzine Atarax/Vistaril C Prochlorperazine Compazine C Meprobamate 2 D 1 Caution in 1 st trimester or population specific, i.e. elderly 2 Only available as generic References: EPOCRATES, MICROMEDEX Section G, Page 6 of 6, Revised: 8/23/13
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