sign in sign up
<<
Home , Chloral hydrate, Estazolam, Eszopiclone, Quazepam, Temazepam, Zaleplon

Santa Clare County Mental health Department Practice Guideline

SEDATIVE- AGENTS

Documentation A. FDA approved indications Required 1. 2. Sedation for an agitated patient in an inpatient setting

Documentation B. Non-FDA approved, commonly used indications Required 1. EPS (Benadryl)

For non-FDA approved use, please refer to Anti- section (Section G).

Documentation C. Minimal documentation Required 1. All standard outpatient and inpatient requirements 2. For Inpatient: Document rationale when making more than 3 changes in any 7-day period. 3. In patients with substance use, may be provided in accordance to Section P of medication practice guideline, Guidelines for Prescribing Controlled Psychotropic to Patients with Substance Use.

Documentation D. Maximum dosage – see Maximum Daily Dose (MDD): Required Medication Summary (Section B)

Documentation E. Duration Required 1. For Outpatient: Document rationale when making any medication change. 2. Lunesta () and Rozerem () are the only hypnotic agents approved for insomnia without a specified time limit. The other agents are approved for short term use.

Documentation F. Polypharmacy

1. Prior to consideration of polypharmacy; individual medications should be prescribed at adequate dose, duration and response documented. 2. Polypharmacy (Refer to Purpose Section for exceptions): The following combinations are considered to be polypharmacy and require the appropriate documentation of rationale including clinical response:

Section P, Revised: 5/2014 Page 1 of 6

Santa Clare County Mental health Department Medication Practice Guideline

- ≥2 benzodiazepines - ≥2 non-benzodiazepines - A benzodiazepine plus a non-benzodiazepine

3. Refer to section E2 for duration of use

G. -Drug Interactions

Due to the heterogeneity of this class, refer to appropriate references for drug-drug interactions of individual agents.

Document H. Adverse Reactions Assessment of Following 1. and angiodema can occur as early as the first time the medication is taken. 2. Complex -related behaviors, which may include sleep- driving, making phone calls, and preparing and eating food (while asleep or with no of event) 3. Respiratory 4. Agranulocytosis (Seconal, Luminal) 5. Granulocytopenic disorder (rare), Leukopenia (rare) (Dalmane) 6. Hepatotoxity 7. CNS effects (Cognitive impairment, lack of motor coordination)

Documentation I. Standard laboratory and examination requirements Required 1. Inpatient: Basic laboratory studies on admission

Documentation J. Contraindications Required 1. History of allergy to any drug in the same class 2. History of or 3. History of 4. (Dalmane, Doral) 5. Severe hepatic impairment (Halcion, , Luminal) 6. Severe renal impairment () 7. Severe respiratory disease (Luminal) 8. and Nursing Mothers: See Table 2 Pregnancy & Categories 9. Newborns or premature infants (Benadryl) 10. Narrow angle (Ativan, Valium) 11. History of manifest or latent porphyria ()

Section P, Revised 5/2014 Page 2 of 6 Santa Clare County Mental health Department Medication Practice Guideline

K. Precautions

1. Withdrawal reactions/symptoms, such as convulsions, , rebound anxiety, insomnia, , behavioral disorders, , abdominal and muscle , 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 and insomnia, have been reported following abrupt discontinuation of benzodiazepines taken continuously at therapeutic doses over several months. Therefore, to minimize discontinuation symptoms after extended exposure, gradual taper from benzodiazepine is recommended.

2. History of alcohol abuse or substance abuse (See Section: P) 3. May cause physical and psychological dependence, tolerance, and withdrawal symptoms 4. Risk of abuse 5. Severe cardiac disease (Chloral Hydrate) 6. Mentally depressed patients 7. Elderly and debilitated patients 8. History of gastritis, esophagitis, or gastric or duodenal ulcers (Chloral Hydrate) 9. Patients with acute or chronic pain (Butisol) 10. Tartrazine (FD&C Yellow No. 5) sensitivity with increase in patients with concomitant aspirin allergy; increased risk of allergic reactions including bronchial asthma in susceptible patients (Butisol in tartrazine preparation, Sonata, Serax) 11. History of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease or hypertension (Benadryl) 12. Asthma (Atarax, Vistaril)

Recent Findings (3/19/14):

A retrospective cohort study of more than 100,000 age- and sex-matched patients showed that those who used and/or were 3 times more likely to die prematurely during the 7- year follow-up period than those who did not use these . The study included benzodiazepines and the “z-drugs” – , , and . Please refer to large study, published in BMJ in March 19, 2014.

Attachments: Section P, Revised: 5/2014 Page 3 of 6

Santa Clare County Mental health Department Medication Practice Guideline

Table 1 FDA approved Ind & MDD Table 2: Table 2 Preg & breastfeed categories

References:

- Prescriber’s Package Insert for each medication - Epocrates - Micromedix - http://www.bmj.com/content/348/bmj.g1996#alternate

Section P, Revised: 5/2014 Page 4 of 6

Santa Clara County Mental Health Department Medication Practice Guidelines Table 1: FDA-approved Indications & MDD

Non- Generic Brand MDD Insomnia Sedation Controlled Adult Children Benzodiazepine 10mg Valium 40mg (>6mo) X Prosom 2mg Non FDA X Dalmane 30mg Non FDA X Ativan 10mg 4mg (>12yo) X 120mg Serax 120mg (>12yo) Doral 30mg Non FDA X Restoril 30mg Non FDA X Halcion .5mg Non FDA X non-Benzodiazepine Butisol 120mg Non FDA X X Aquachloral, Chloral Hydrate Somnote 2000mg 50mg/kg X X 1mg/kg (2- 12yo); 50mg Benadryl 400mg (>12yo) X X Eszopiclone* Lunesta1 2mg Non FDA X 50mg Atarax (HCl), (<6yo); Vistaril 100mg Hydroxyzine (Pamoate) 400mg (>6yo) X X Luminal 320mg 6mg/kg X X Ramelteon Rozerem1 8mg Non FDA X X 5mg/kg or Secobartibal Seconal 100mg 100mg X Zaleplon Sonata 20mg Non FDA X Zolpidem Ambien, CR 10mg (CR 12.5) X Females:1.75mg SL , Males: 3.5 SL Zolpidem Intermezzo2 X

1. Lunesta (eszopiclone) and Rozerem (ramelteon) are the only sedative hypnotic agents approved for insomnia without a specified time limit. The other agents are approved for short term use. 2. For middle-of-the-night waking with difficulty returning to sleep; give only if>4h before planned time of waking; reevaluate if insomnia persists after 7-10 days of tx.

SectionSedative P, Page-Hypnotics 5 of 6 Revised, 1-14 5/2014

Santa Clara County Mental Health Department Medication Practice Guidelines Table 2: Pregnancy and Breastfeeding Categories

Pregnancy Generic Brand Category Breastfeeding Category Benzodiazepine AAP: Drugs for which the effect on nursing Diazepam Valium D infants is unknown but may be of concern Estazolam Prosom X Thomson: Infant risk cannot be ruled out. Flurazepam Dalmane X Thomson: Infant risk cannot be ruled out. AAP: Drugs for which the effect on nursing Lorazepam Ativan D infants is unknown but may be of concern Oxazepam Serax C Thomson: Infant risk cannot be ruled out. AAP: Drugs for which the effect on nursing Quazepam Doral X infants is unknown but may be of concern AAP: Drugs for which the effect on nursing Temazepam Restoril X infants is unknown but may be of concern Triazolam Halcion X Thomson: Infant risk cannot be ruled out. non-Benzodiazepine Butabarbital Butisol C Thomson: Infant risk cannot be ruled out. Aquachloral, AAP: Maternal medication usually compatible Chloral Hydrate Somnote A with breastfeeding. Diphenhydramine Benadryl B Thomson: Milk effects are possible. Eszopiclone Lunesta C Thomson: Infant risk cannot be ruled out. Atarax (HCl), Vistaril (Pamoate) C Thomson: Infant risk cannot be ruled out. AAP: Drugs that have been associated with significant effects on some nursing infants and Phenobarbital Luminal D should be given to nursing mother with caution. Ramelteon Rozerem C Thomson: Infant risk cannot be ruled out. AAP: Maternal medication usually compatible Secobartibal Seconal D with breastfeeding. Zaleplon Sonata C Thomson: Infant risk is minimal. AAP: Maternal medication usually compatible Zolpidem Ambien, CR* C with breastfeeding. *Bolded RXs are non-Formulary for SCVH&HS.

Section P, Page 6 of 6 Revised 5/2014 Sedative Hypnotic, 1-14