SEDATIVE-HYPNOTIC AGENTS Documentation A. FDA approved indications 1. Insomnia 2. Sedation for an agitated patient in an inpatient setting Documentation B. Non-FDA approved, commonly used indications 1. EPS (Benadryl) For Benzodiazepine non-fda approved use, please refer to Anti-Anxiety section (Section G). Documentation C. Minimal documentation 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, benzodiazepines may be provided in accordance to Section P of medication practice guideline, Guidelines for Prescribing Controlled Psychotropic Medications to Patients with Substance Use. Documentation D. Maximum dosage see Maximum Daily Dose (MDD): Medication Summary (Section B) Documentation E. Duration 1. For Outpatient: Document rationale when making any medication change. 2. 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. 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
- 2 benzodiazepines - 2 non-benzodiazepines - A benzodiazepine plus a non-benzodiazepine 3. Refer to section E2 for duration of use G. Drug-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. Anaphylaxis and angiodema can occur as early as the first time the medication is taken. 2. Complex sleep-related behaviors, which may include sleepdriving, making phone calls, and preparing and eating food (while asleep or with no memory of event) 3. Respiratory depression 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 1. Inpatient: Basic laboratory studies on admission Documentation J. Contraindications 1. History of allergy to any drug in the same class 2. History of alcohol abuse or substance abuse 3. History of addiction 4. Sleep Apnea (Dalmane, Doral) 5. Severe hepatic impairment (Halcion, Chloral Hydrate, Luminal) 6. Severe renal impairment (Chloral Hydrate) 7. Severe respiratory disease (Luminal) 8. Pregnancy and Nursing Mothers: See Table 2 Pregnancy & Breastfeeding Categories 9. Newborns or premature infants (Benadryl) 10. Narrow angle glaucoma (Ativan, Valium) 11. History of manifest or latent porphyria (Barbiturate) Section P, Revised 5/2014 Page 2 of 6
Recent Findings (3/19/14): K. Precautions 1. 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. 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) A retrospective cohort study of more than 100,000 age- and sex-matched patients showed that those who used anxiolytics and/or hypnotics were 3 times more likely to die prematurely during the 7- year follow-up period than those who did not use these drugs. The study included benzodiazepines and the z-drugs Zaleplon, zolpidem, and zopiclone. Please refer to large study, published in BMJ in March 19, 2014. Attachments: Section P, Revised: 5/2014 Page 3 of 6
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 s Table 1: FDA-approved Indications & MDD Generic Brand MDD Insomnia Sedation Adult Benzodiazepine Children Diazepam Valium 40mg 10mg (>6mo) X Estazolam Prosom 2mg Non FDA X Flurazepam Dalmane 30mg Non FDA X Lorazepam Ativan 10mg 4mg (>12yo) X Oxazepam Serax 120mg 120mg (>12yo) Quazepam Doral 30mg Non FDA X Temazepam Restoril 30mg Non FDA X Triazolam Halcion.5mg Non FDA X non-benzodiazepine Butabarbital Butisol 120mg Non FDA X X Chloral Hydrate Aquachloral, Somnote 2000mg 50mg/kg X X Diphenhydramine Benadryl 400mg Eszopiclone* Lunesta 1 2mg Non FDA X Atarax (HCl), Vistaril (Pamoate) Non- Controlled 1mg/kg (2-12yo); 50mg (>12yo) X X 50mg (<6yo); 100mg (>6yo) X X Hydroxyzine 400mg Phenobarbital Luminal 320mg 6mg/kg X X Ramelteon Rozerem 1 8mg Non FDA X X Secobartibal Seconal 100mg 5mg/kg or 100mg X Zaleplon Sonata 20mg Non FDA X Zolpidem Ambien, CR 10mg (CR 12.5) X Females:1.75mg SL, Zolpidem Intermezzo 2 Males: 3.5 SL X 1. 2. 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. 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. Section Sedative-Hypnotics, P, Page 5 of 6 Revised 1-145/2014
Santa Clara County Mental Health Department s Table 2: Pregnancy and Breastfeeding Categories Generic Brand Pregnancy Category Breastfeeding Category Benzodiazepine Diazepam Valium D Estazolam Prosom X Thomson: Infant risk cannot be ruled out. Flurazepam Dalmane X Thomson: Infant risk cannot be ruled out. Lorazepam Ativan D Oxazepam Serax C Thomson: Infant risk cannot be ruled out. Quazepam Doral X Temazepam Restoril X Triazolam Halcion X Thomson: Infant risk cannot be ruled out. non-benzodiazepine Butabarbital Butisol C Thomson: Infant risk cannot be ruled out. Chloral Hydrate Aquachloral, Somnote A AAP: Maternal medication usually compatible with breastfeeding. Diphenhydramine Benadryl B Thomson: Milk effects are possible. Eszopiclone Lunesta C Thomson: Infant risk cannot be ruled out. Hydroxyzine Atarax (HCl), Vistaril (Pamoate) C Thomson: Infant risk cannot be ruled out. Phenobarbital Luminal D AAP: Drugs that have been associated with significant effects on some nursing infants and should be given to nursing mother with caution. Ramelteon Rozerem C Thomson: Infant risk cannot be ruled out. Secobartibal Seconal D AAP: Maternal medication usually compatible with breastfeeding. Zaleplon Sonata C Thomson: Infant risk is minimal. Zolpidem Ambien, CR* C AAP: Maternal medication usually compatible with breastfeeding. *Bolded RXs are non-formulary for SCVH&HS. Section P, Page 6 of 6 Revised 5/2014 Sedative Hypnotic, 1-14