The Medical Letter. on Drugs and Therapeutics. Usual Adult Hypnotic Dose 1,2 Some Adverse Effects Comments Cost 3

Size: px
Start display at page:

Download "The Medical Letter. on Drugs and Therapeutics. Usual Adult Hypnotic Dose 1,2 Some Adverse Effects Comments Cost 3"

Transcription

1 The Medical Letter publications are protected by US and international copyright laws. Forwarding, copying or any other distribution of this material is strictly prohibited. For further information call: Last updated: December 17, 2018 The Medical Letter on s and Therapeutics Expanded Table: Some Hypnotics for Chronic Insomnia Some Hypnotics for Chronic Insomnia Benzodiazepine Receptor Agonists Eszopiclone generic Lunesta (Sunovion) Zaleplon generic Sonata (Pfizer) Zolpidem immediate-release generic Ambien (Sanofi) extended-release generic Ambien CR spray Zolpimist (Atyu Bioscience) Sleep-onset 1, 2, 3 mg <30 min intermediate 1-3 mg elderly: 1-2 mg 5, 10 mg caps <30 min ultra-short mg Sleep-onset 5, 10 mg <30 min short men: 5-10 mg 6.25, 12.5 mg ER <30 min intermediate men: mg women: 6.25 mg elderly: 6.25 mg Sleep-onset 5 mg/actuation 20 min short men: 5-10 mg sublingual Edluar (Meda) Sleep-onset 5, 10 mg SL Intermezzo (Purdue) generic Insomnia following middle-of-the-night awakening 1.75, 3.5 mg SL <30 min short men: 5-10 mg 20 min ultra-short men: 3.5 mg women: 1.75 mg elderly: 1.75 mg Headache and dizziness are common possible increased risk of cancer and death Increased risk of adverse cognitive effects and falls in elderly Withdrawal, dependence, and abuse can occur Eszopiclone has an unpleasant aftertaste Decrease sleep latency Zaleplon has been used off-label for following middle-of-the-night awakening Risk factors for complex sleep-related behaviors include use of the drug in high doses, with other sedating drugs, or while still active Observational cohort studies have found an increased risk of cancer and death with use of hypnotics; a causal relationship has not been established eszopiclone and all formulations of zolpidem may be slower if taken with or immediately after a meal Zaleplon should not be taken with or immediately after a high-fat meal Zolpimist and Intermezzo should only be taken if 4 hours remain before waking Classified as schedule IV controlled substances Interactions: Metabolized by CYP3A4 (zaleplon to a lesser extent); concurrent use of CYP3A4 inducers could decrease their effectiveness and is not recommended and concurrent use of CYP3A4 inhibitors could increase their serum concentrations and the risk of adverse effects Preterm birth and low birth weight have been reported Third-trimester use of zolpidem has caused respiratory depression and sedation in neonates Zaleplon and zolpidem have been detected in human breast milk Excess sedation has been reported in breastfed infants of mothers who took zolpidem $ e209

2 Some Hypnotics for Chronic Insomnia (continued) Benzodiazepines Estazolam generic Flurazepam generic Lorazepam generic Ativan (Valeant) Quazepam generic Doral (Galt) Temazepam generic Restoril (Mallinckrodt) Triazolam generic Halcion (Pfizer) Not FDA-approved for treatment of Sleep-onset 1, 2 mg min intermediate 1-2 mg elderly: mg 15, 30 mg caps min long mg elderly: 15 mg 0.5, 1, 2 mg min intermediate mg elderly: mg 15 mg 30 min long mg elderly: 7.5 mg 7.5, 15, 22.5, 30 mg caps 0.125, 0.25 mg 0.25 mg min intermediate mg elderly: mg min short mg elderly: mg anterograde amnesia (particularly triazolam), aggressive behavior I ncreased risk of adverse cognitive effects and falls in elderly Dependence, tolerance, abuse, and rebound can occur Withdrawal, which may be life-threatening, can occur with rapid dosage reductions or abrupt discontinuation Decrease sleep latency and prolong the first two stages of sleep Tolerance to their sedative effects develops rapidly; they are not recommended for longterm use Classified as schedule IV controlled substances Interactions: Metabolized to some extent by CYP3A4 (except lorazepam, oxazepam, and temazepam); concurrent use of inducers could decrease their serum concentrations and their effectiveness and concurrent use of inhibitors could increase their serum concentrations and the risk of adverse effects Concurrent use of an opioid and benzodiazepine has been associated with a significant increase in the risk of overdose compared to use of an opioid alone $ Increase the risk of fetal malformations and should not be used during pregnancy American College of Obstetricians and Gynecologists (ACOG) considers benzodiazepines moderately safe for use during breastfeeding e210

3 Some Hypnotics for Chronic Insomnia (continued) Melatonin Receptor Agonist Ramelteon Rozerem (Takeda) Sleep-onset 8 mg min short 8 mg Somnolence, dizziness, fatigue, and nausea are common Hallucinations, agitation, mania, complex sleeprelated increased serum prolactin concentrations, decreased serum testosterone concentrations Efficacy is modest at best Should be taken with or immediately after a high-fat meal Not classified as a controlled substance Interactions: Metabolized by CYP1A2 and to a lesser extent by CYP3A4 and CYP2C isozymes Concurrent use of the strong CYP1A2 inhibitor fluvoxamine increased ramelteon serum concentrations and is contraindicated; other strong CYP1A2 inhibitors may have a similar effect Concurrent use of CYP1A2 or 2C9 inhibitors could increase ramelteon serum concentrations and the risk of adverse effects Concurrent use of rifampin decreased ramelteon serum concentrations by 80% No adequate studies in pregnant women Developmental toxicity and teratogenic effects have occurred in the offspring of pregnant rats given doses higher than the recommended human dose No data on the presence of ramelteon in human breast milk or on its effects on the breastfed infant or milk production Excreted in milk of lactating rats $ e211

4 Some Hypnotics for Chronic Insomnia (continued) Tricyclic Antidepressant Doxepin Silenor (Pernix) Sleep-maintenance 3, 6 mg 30 min long 3-6 min elderly: 3 mg Residual next-day somnolence reported with 6-mg dose In low doses, it is claimed to have a hypnotic effect without anticholinergic or other typical tricyclic adverse effects Should not be taken within 3 hours of a meal Not classified as a controlled substance Interactions: Coadministration with cimetidine, a CYP2C19, 2D6, and 1A2 inhibitor, can double doxepin serum concentrations; maximum doxepin dose of 3 mg is recommended Contraindicated for use with a monoamine oxidase inhibitor (MAOI) or within two weeks of stopping one No adequate studies of low-dose doxepin in pregnant women Administration of doxepin doses 6 mg/day to pregnant rats resulted in adverse effects on fetal development Excreted in human breast milk Apnea and drowsiness reported in an infant whose mother was taking doxepin in doses used to treat depression Effect on milk production is unknown $ e212

5 Some Hypnotics for Chronic Insomnia (continued) Orexin Receptor Antagonist Suvorexant Belsomra (Merck) 5, 10, 15, 20 mg 30 min intermediate mg Somnolence, fatigue, and abnormal dreams are common cataplexy-like symptoms Has been associated with narcolepsy; contraindicated for use in patients with narcolepsy Should be administered with caution in patients with compromised respiratory function; it appears to be safe for use in mild to moderate COPD Classified as a schedule IV controlled substance Interactions: Metabolized by CYP3A4; should not be administered with strong CYP3A4 inhibitors or inducers Recommended dose is 5 mg when taken concurrently with moderate CYP3A4 inhibitors Suvorexant is a P-glycoprotein inhibitor and can increase digoxin serum concentrations if taken concomitantly No adequate studies in pregnant women Administration of higher-than-recommended doses to pregnant rats resulted in reduced fetal weight in offspring No data on the presence of suvorexant in human breast milk or on its effects on the breastfed infant or milk production Excreted in milk of lactating rats ER = extended-release; SL = sublingual 1. Treatment should be started with the lowest dose, especially in patients who have a low body weight, are debilitated, or are receiving opioids or other CNS or cardiorespiratory depressants. 2. Dosage adjustment may be required for renal or hepatic impairment. 3. Approximate WAC for 30 days treatment at the lowest usual adult hypnotic dosage. WAC = wholesaler acquisition cost or manufacturer s published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource Monthly. December 5, Reprinted with permission by First Databank, Inc. All rights reserved drug-pricing-policy. 4. Cost of a 7.7-mL bottle that contains 60 5-mg actuations after 5 initial priming actuations. 5. Cost of mg tablets. 6. Cost of mg tablets. $ e213

Insomnia Agents (Sherwood Employer Group)

Insomnia Agents (Sherwood Employer Group) Insomnia Agents (Sherwood Employer Group) BCBSKS will review Prior Authorization requests Prior Authorization Form: https://www.bcbsks.com/customerservice/forms/pdf/priorauth-6058ks-st-ippi.pdf Link to

More information

See Important Reminder at the end of this policy for important regulatory and legal information.

See Important Reminder at the end of this policy for important regulatory and legal information. Clinical Policy: Non-Benzodiazepine Insomnia Medications Reference Number: CP.HNMC.265 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Medicaid Medi-Cal Revision Log See Important Reminder

More information

See Important Reminder at the end of this policy for important regulatory and legal information.

See Important Reminder at the end of this policy for important regulatory and legal information. Clinical Policy: Non-Benzodiazepine Insomnia Reference Number: CP.PMA_10.11.23 Effective Date: 07.16 Last Review Date: 04.18 Line of Business: Medicaid- Arizona (AHCS, CIC) Revision Log See Important Reminder

More information

See Important Reminder at the end of this policy for important regulatory and legal information.

See Important Reminder at the end of this policy for important regulatory and legal information. Clinical Policy: Non-Benzodiazepine Insomnia Medications Reference Number: CP.CPA.265 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Commercial Revision Log See Important Reminder at

More information

SEDATIVE-HYPNOTIC AGENTS

SEDATIVE-HYPNOTIC AGENTS 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.

More information

HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES. SEDATIVE HYPNOTIC AGENTS Generic Brand HICL GCN Exception/Other ZOLPIDEM

HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES. SEDATIVE HYPNOTIC AGENTS Generic Brand HICL GCN Exception/Other ZOLPIDEM Generic Brand HICL GCN Exception/Other ZOLPIDEM AMBIEN 07842 GENERIC IS UNRESTRICTED TARTRATE AMBIEN CR EDLUAR INTERMEZZO ZOLPIMIST ESZOPICLONE LUNESTA 26791 GENERIC IS UNRESTRICTED RAMELTEON ROZEREM 33126

More information

Insomnia. Arturo Meade MD

Insomnia. Arturo Meade MD Insomnia Arturo Meade MD Goals Definition Prevalence Pathophysiology The role of Orexin Orexin receptor blockers Consequences: Daily Functioning Insomnia: Consequences Decreased quality of life

More information

Insomnia: Updates in Medical Management. Michael Newnam M.D.

Insomnia: Updates in Medical Management. Michael Newnam M.D. Insomnia: Updates in Medical Management Michael Newnam M.D. Sleep Neurobiology Delicate balance of excitatory and inhibitory neurotransmitters that control the switch between wakefulness and sleep Circadian

More information

Sedative Hypnotics. Description

Sedative Hypnotics. Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.60.11 Subject: Sedative Hypnotics Page: 1 of 7 Last Review Date: December 8, 2017 Sedative Hypnotics

More information

Sedative Hypnotics. Description

Sedative Hypnotics. Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.60.11 Subject: Sedative Hypnotics Page: 1 of 8 Last Review Date: September 15, 2016 Sedative Hypnotics

More information

Comparison of Insomnia Treatments

Comparison of Insomnia Treatments PL Detail-Document #280504 This PL Detail-Document gives subscribers additional insight related to the Recommendations published in PHARMACIST S LETTER / PRESCRIBER S LETTER May 2012 Comparison of Insomnia

More information

Information for Vermont Prescribers of Prescription Drugs. Lunesta (eszopiclone tablets)

Information for Vermont Prescribers of Prescription Drugs. Lunesta (eszopiclone tablets) Information for Vermont Prescribers of Prescription Drugs Lunesta (eszopiclone tablets) This list does not imply that the products on this chart are interchangeable or have the same efficacy or safety.

More information

Addressing Pharmacologic Issues in. DSM-5 Sleep-Wake. Insomnia. Disorders. DSM-5 Insomnia Disorder. Insomnia. Disorder

Addressing Pharmacologic Issues in. DSM-5 Sleep-Wake. Insomnia. Disorders. DSM-5 Insomnia Disorder. Insomnia. Disorder Addressing Pharmacologic Issues in David N. Neubauer, MD Associate Professor of Psychiatry and Behavioral Sciences Johns Hopkins School of Medicine Baltimore, Maryland Restless Legs Syndrome Substance/

More information

Insomnia treatment. Sleep hygiene education sleep hygiene teaches good sleeping habits. This includes:

Insomnia treatment. Sleep hygiene education sleep hygiene teaches good sleeping habits. This includes: Insomnia treatment INSOMNIA OVERVIEW insomnia is defined as difficulty falling asleep, difficulty staying asleep, or waking up early in the morning and not being able to return to sleep. In general, people

More information

Managing Insomnia Disorder A Review of the Research for Adults

Managing Insomnia Disorder A Review of the Research for Adults Managing Insomnia Disorder A Review of the Research for Adults e Is This Information Right for Me? This information is right for you if: Your health care professional said you have insomnia disorder (said

More information

Drug Review Rozerem (ramelteon)

Drug Review Rozerem (ramelteon) Drug Review Rozerem (ramelteon) Introduction 1 Ramelteon is a melatonin receptor agonist with affinity for MT 1 and MT 2 and selectivity over the MT 3 receptor. The activity at the MT 1 and MT 2 receptors

More information

Anxiolytic and Hypnotic drugs

Anxiolytic and Hypnotic drugs Anxiolytic and Hypnotic drugs Anxiolytic and Hypnotic drugs Anxiety is unpleasant state of tension and fear that seems to arise from unknown source. The symptoms of severe anxiety are similar to those

More information

Pharmacological Help for a Good Night s s Sleep. Thomas Owens, MD

Pharmacological Help for a Good Night s s Sleep. Thomas Owens, MD Pharmacological Help for a Good Night s s Sleep Thomas Owens, MD Objectives 1. Define insomnia and characterize the symptoms and array of causes. 2. Describe traditional and new pharmacologic approaches

More information

DRUGS THAT ACT IN THE CNS

DRUGS THAT ACT IN THE CNS DRUGS THAT ACT IN THE CNS Anxiolytic and Hypnotic Drugs Dr Karamallah S. Mahmood PhD Clinical Pharmacology 1 OTHER ANXIOLYTIC AGENTS/ A. Antidepressants Many antidepressants are effective in the treatment

More information

14. Percent Mellinger GD et al. Arch Gen Psychiatry. 1985;42: ICSD III

14. Percent Mellinger GD et al. Arch Gen Psychiatry. 1985;42: ICSD III 4:45 5:45 pm Management of Insomnia and Other Disorders Presenter Disclosure Information The following relationships exist related to this presentation: Alon Y. Avidan, MD, MPH, FAAN, FAASM: Speakers Bureau

More information

Pharmacy Medical Necessity Guidelines: Insomnia Treatments

Pharmacy Medical Necessity Guidelines: Insomnia Treatments Pharmacy Medical Necessity Guidelines: Effective: January 1, 2019 Prior Authorization Required Type of Review Care Management Not Covered Type of Review Clinical Review Pharmacy (RX) or Medical (MED) Benefit

More information

Anxiolytic, Sedative and Hypnotic Drugs. Assistant Prof. Dr. Najlaa Saadi PhD Pharmacology Faculty of Pharmacy University of Philadelphia

Anxiolytic, Sedative and Hypnotic Drugs. Assistant Prof. Dr. Najlaa Saadi PhD Pharmacology Faculty of Pharmacy University of Philadelphia Anxiolytic, Sedative and Hypnotic Drugs Assistant Prof. Dr. Najlaa Saadi PhD Pharmacology Faculty of Pharmacy University of Philadelphia Anxiolytics: reduce anxiety Sedatives: decrease activity, calming

More information

Temazepam 30 mg sleeping pills

Temazepam 30 mg sleeping pills Temazepam 30 mg sleeping pills The sedative effects of temazepam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling

More information

EU Core Safety Profile

EU Core Safety Profile EU Core Safety Profile Active Substance: Triazolam Brand Names: HALCION, SOMESE Pharmaceutical form(s)/strength: Tablets RMS: Finland Date: 9 th Dec 2013 Supersedes: 24 th May 2010 4.3. Contraindications

More information

How to Manage Insomnia with and without medications

How to Manage Insomnia with and without medications How to Manage Insomnia with and without medications Tatyana Gurvich, Pharm.D. USC School of Pharmacy UC Irvine SeniorHealth Center Insomnia: How common is it? 26-50% of adult population complain of insomnia

More information

Restful Sleep or Getting Up to Eat? Suvorexant (Belsomra )

Restful Sleep or Getting Up to Eat? Suvorexant (Belsomra ) Restful Sleep or Getting Up to Eat? Suvorexant (Belsomra ) Alyssa Penick, PharmD PGY1 Pharmacy Resident UC Health- University of Cincinnati Medical Center Insomnia Most common sleep disorder Defined as

More information

Kentucky Department for Medicaid Services Drug Review and Options for Consideration

Kentucky Department for Medicaid Services Drug Review and Options for Consideration The following tables list the Agenda items as well as the that are scheduled to be presented and reviewed at the November 16, 2017 meeting of the Pharmacy and Therapeutics Advisory Committee. Maximum Duration

More information

M0BCore Safety Profile. Active substance: Bromazepam Pharmaceutical form(s)/strength: Tablets 6 mg FR/H/PSUR/0066/001 Date of FAR:

M0BCore Safety Profile. Active substance: Bromazepam Pharmaceutical form(s)/strength: Tablets 6 mg FR/H/PSUR/0066/001 Date of FAR: M0BCore Safety Profile Active substance: Bromazepam Pharmaceutical form(s)/strength: Tablets 6 mg P-RMS: FR/H/PSUR/0066/001 Date of FAR: 26.11.2013 4.3 Contraindications Bromazepam must not be administered

More information

Ambien vs Rozerem There are people out there who have trouble falling asleep at night. Â Often, this would be considered as a disease that

Ambien vs Rozerem There are people out there who have trouble falling asleep at night. Â Often, this would be considered as a disease that 22-10-2013 Ambien vs Rozerem There are people out there who have trouble falling asleep at night. Â Often, this would be considered as a disease that can be treated with Ambien vs Rozerem. Ambien:. Ramelteon

More information

11/1/2010. Psychology 472 Pharmacology of Psychoactive Drugs. Listen to the audio lecture while viewing these slides

11/1/2010. Psychology 472 Pharmacology of Psychoactive Drugs. Listen to the audio lecture while viewing these slides Treatment for Anxiety Disorders Benzodiazepines and Other Anxiolytics Psychology 472 Pharmacology of Psychoactive Drugs Listen to the audio lecture while viewing these slides Ethanol Barbiturates and related

More information

DOD PHARMACY AND THERAPEUTICS COMMITTEE RECOMMENDATIONS INFORMATION FOR THE UNIFORM FORMULARY BENEFICIARY ADVISORY PANEL

DOD PHARMACY AND THERAPEUTICS COMMITTEE RECOMMENDATIONS INFORMATION FOR THE UNIFORM FORMULARY BENEFICIARY ADVISORY PANEL DOD PHARMACY AND THERAPEUTICS COMMITTEE RECOMMENDATIONS INFORMATION FOR THE UNIFORM FORMULARY BENEFICIARY ADVISORY PANEL I. UNIFORM FORMULARY REVIEW PROCESS Under 10 United States Code 1074g, as implemented

More information

Drug Class Update: Sedatives

Drug Class Update: Sedatives Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119

More information

14. Percent

14. Percent 4:30 5:45 pm Management of Insomnia and Other Disorders Presenter Disclosure Information The following relationships exist related to this presentation: Alon Y. Avidan, MD, MPH, FAAN, FAASM: Speakers Bureau

More information

INSOMNIA IN THE GERIATRIC POPULATION. Shannon Bush, MS4

INSOMNIA IN THE GERIATRIC POPULATION. Shannon Bush, MS4 INSOMNIA IN THE GERIATRIC POPULATION Shannon Bush, MS4 CHANGES IN SLEEP ARCHITECTURE 2 Reduction in slow wave sleep (stage 3 and 4) Increase in lighter stages of sleep (stage 1 and 2) Decrease in REM sleep

More information

Can you take ambien with doxepin

Can you take ambien with doxepin Can you take ambien with doxepin Any Bad Experiences with Taking Ambien and Doxepin : I have been taking these 2 meds along with a great deal of others. I am taking these meds for my 19-2-2018 Can you

More information

CPT David Shaha, MC US Army

CPT David Shaha, MC US Army CPT David Shaha, MC US Army None Thoughts and comments are my own and do not represent the official policy of the Department of the Army, Department of Defense, or United States Government. Clinical Case

More information

Question #1. Disclosures. CAPA 2015 Annual Conference. All of the following occur as we get older EXCEPT: Evaluating Patients with Insomnia

Question #1. Disclosures. CAPA 2015 Annual Conference. All of the following occur as we get older EXCEPT: Evaluating Patients with Insomnia Evaluating Patients with Roger D. Seheult, M.D. Pulmonary Critical Care Physician - Beaver Medical Group, Redlands California Assistant Clinical Professor of Medicine - Loma Linda University School of

More information

P-RMS: FR/H/PSUR/0036/001

P-RMS: FR/H/PSUR/0036/001 Core Safety Profile Active substance: Alprazolam Pharmaceutical form(s)/strength: Tablet uncoated, sugar coated, film coated, 0.25mg Tablet uncoated, 0.4 mg Tablet uncoated, sugar coated, film coated,

More information

Ramelteon to ambien The Borg System is 100 % Retrievable & Reusable Ramelteon to ambien

Ramelteon to ambien The Borg System is 100 % Retrievable & Reusable Ramelteon to ambien Ramelteon to ambien The Borg System is 100 % Ramelteon to ambien Learn about how ROZEREM (ramelteon ) works, its side effects, and clinical studies in adults and older patients. See Important Safety Information

More information

Available Strengths Limits. 200 mg tablets PA. 50 mg, 150 mg, 200 mg, 250 mg tablets. 500 mg/ml solution PA

Available Strengths Limits. 200 mg tablets PA. 50 mg, 150 mg, 200 mg, 250 mg tablets. 500 mg/ml solution PA MEDICATION COVERAGE POLICY PHARMACY AND THERAPEUTICS ADVISORY COMMITTEE POLICY Sleeping Disorders P&T DATE: 12/14/2016 THERAPEUTIC CLASS Psychiatric Disorders REVIEW HISTORY: 2/16, 5/15, 2/12 LOB AFFECTED

More information

European PSUR Work Sharing Project CORE SAFETY PROFILE. Lendormin, 0.25mg, tablets Brotizolam

European PSUR Work Sharing Project CORE SAFETY PROFILE. Lendormin, 0.25mg, tablets Brotizolam European PSUR Work Sharing Project CORE SAFETY PROFILE Lendormin, 0.25mg, tablets Brotizolam 4.2 Posology and method of administration Unless otherwise prescribed by the physician, the following dosages

More information

continuing education for pharmacists

continuing education for pharmacists continuing education for pharmacists General Insomnia Disorder in Adults and Treatment Guidelines Amanda R. Kriesen, R.Ph., PharmD Volume XXXV, No. 9 Dr. Amanda Kriesen has no relevant financial relationships

More information

SANDOMIGRAN (pizotifen malate)

SANDOMIGRAN (pizotifen malate) SANDOMIGRAN (pizotifen malate) S N CH 3 Pizotifen. COOH CH OH CH 2 COOH MALATE DESCRIPTION Pizotifen is a cycloheptathiophene derivative structurally related to cyproheptadine and the tricyclic antidepressants.

More information

Anxiolytic & Hypnotic Drugs. Asst Prof Dr Inam S Arif

Anxiolytic & Hypnotic Drugs. Asst Prof Dr Inam S Arif Anxiolytic & Hypnotic Drugs Asst Prof Dr Inam S Arif isamalhaj@yahoo.com Anxiolytic & Hpnotic Agents Anxiety: unpleasant state of tension, apprehension or uneasiness, characterised by, tachycardia, sweating,

More information

Insomnia. Learning Objectives. Disclosure 6/7/11. Research funding: NIH, Respironics, Embla Consulting: Elsevier

Insomnia. Learning Objectives. Disclosure 6/7/11. Research funding: NIH, Respironics, Embla Consulting: Elsevier Insomnia Teofilo Lee-Chiong MD Professor of Medicine National Jewish Health University of Colorado Denver School of Medicine Learning Objectives Learn about the causes of transient and chronic Learn how

More information

3/24/2016 DISCLOSURE STATEMENT PHARMACIST OBJECTIVES OVERVIEW TECHNICIAN OBJECTIVES PREVALENCE OF INSOMNIA THE WRONG SIDE OF THE BED: CHRONIC INSOMNIA

3/24/2016 DISCLOSURE STATEMENT PHARMACIST OBJECTIVES OVERVIEW TECHNICIAN OBJECTIVES PREVALENCE OF INSOMNIA THE WRONG SIDE OF THE BED: CHRONIC INSOMNIA DISCLOSURE STATEMENT I do not have any actual or potential conflict of interest in relation to this presentation THE WRONG SIDE OF THE BED: CHRONIC INSOMNIA DANIELLE ROWAN, PHARMD, MBA PGY1 PHARMACY PRACTICE

More information

SUMMARY OF PRODUCT CHARACTERISTICS FOR BENZODIAZEPINES AS ANXIOLYTICS OR HYPNOTICS

SUMMARY OF PRODUCT CHARACTERISTICS FOR BENZODIAZEPINES AS ANXIOLYTICS OR HYPNOTICS SUMMARY OF PRODUCT CHARACTERISTICS FOR BENZODIAZEPINES AS ANXIOLYTICS OR HYPNOTICS Guideline Title Summary of Product Characteristics for Benzodiazepines as Anxiolytics or Hypnotics Legislative basis Directive

More information

Sleep Disorders and Insomnia

Sleep Disorders and Insomnia 7:45 8:45 am Management of Insomnia and Other Disorders SPEAKER Alon Y. Avidan, MD, MPH, FAAN, FAASM Presenter Disclosure Information The following relationships exist related to this presentation: Alon

More information

SLEEP-WAKE DISORDERS: INSOMNIA. Prof. Paz Gía-Portilla

SLEEP-WAKE DISORDERS: INSOMNIA. Prof. Paz Gía-Portilla SLEEP-WAKE DISORDERS: INSOMNIA Prof. Paz Gía-Portilla SLEEP-WAKE DISORDERS AND ICD-10 Chapter V: Mental and Behavioural Disorders F51. Non-organic sleep disorders Chapter VI: Nervous System Illnesses G47.

More information

The safety concerns defined with the reference product apply to Buprenorphine-Naloxone 2/0.5 mg, 8/2 mg, sublingual tablets.

The safety concerns defined with the reference product apply to Buprenorphine-Naloxone 2/0.5 mg, 8/2 mg, sublingual tablets. These products are indicated in the substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter

More information

Anxiety& Depression in Primary Care- a Pharmacology Primer. Lisa Deloris Slade, DNP, MSN, FNP-BC North Carolina NP Spring Symposium March 27, 2017

Anxiety& Depression in Primary Care- a Pharmacology Primer. Lisa Deloris Slade, DNP, MSN, FNP-BC North Carolina NP Spring Symposium March 27, 2017 Anxiety& Depression in Primary Care- a Pharmacology Primer Lisa Deloris Slade, DNP, MSN, FNP-BC North Carolina NP Spring Symposium March 27, 2017 Objectives Describe pharmacology, treatment considerations,

More information

Benzodiazepines: Comparative Effectiveness and Strategies for Discontinuation. Ann M. Hamer, PharmD, BCPP Rural Oregon Academic Detailing Project

Benzodiazepines: Comparative Effectiveness and Strategies for Discontinuation. Ann M. Hamer, PharmD, BCPP Rural Oregon Academic Detailing Project Benzodiazepines: Comparative Effectiveness and Strategies for Discontinuation Ann M. Hamer, PharmD, BCPP Rural Oregon Academic Detailing Project This project is funded through a grant from the Pew Charitable

More information

You May Be at Risk. You are taking one of the following sedative-hypnotic medications: Diazepam (Valium ) Estazolam. Flurazepam.

You May Be at Risk. You are taking one of the following sedative-hypnotic medications: Diazepam (Valium ) Estazolam. Flurazepam. You May Be at Risk You are taking one of the following sedative-hypnotic medications: Alprazolam (Xanax ) Diazepam (Valium ) Temazepam (Restoril ) Chlorazepate Estazolam Triazolam (Halcion ) Chlordiazepoxide

More information

Sedative/Hypnotic Agents. Sedative/Hypnotic Agents. Central Nervous System Depressants. Sedative/Hypnotic Agents(cont d) Sleep

Sedative/Hypnotic Agents. Sedative/Hypnotic Agents. Central Nervous System Depressants. Sedative/Hypnotic Agents(cont d) Sleep Central Nervous System Depressants Sedative Drugs that have an inhibitory effect on the CNS to the degree that they reduce: Nervousness, excitability, irritability Without causing sleep Hypnotics Calm

More information

VI.2 Elements for a Public Summary

VI.2 Elements for a Public Summary VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Zolpidem is used for short-term treatment of serious sleep problems that incapacitate or cause people extreme distress. Zolpidem

More information

Core Safety Profile. Pharmaceutical form(s)/strength: Tablets 5 mg and 10 mg BE/H/PSUR/0002/002 Date of FAR:

Core Safety Profile. Pharmaceutical form(s)/strength: Tablets 5 mg and 10 mg BE/H/PSUR/0002/002 Date of FAR: Core Safety Profile Active substance: Clotiazepam Pharmaceutical form(s)/strength: Tablets 5 mg and 10 mg P-RMS: BE/H/PSUR/0002/002 Date of FAR: 16.06.2011 4.3 Contraindications is contraindicated

More information

Psychopharmacology in the Emergency Room. Michael D. Jibson, M.D., Ph.D. Professor of Psychiatry University of Michigan

Psychopharmacology in the Emergency Room. Michael D. Jibson, M.D., Ph.D. Professor of Psychiatry University of Michigan Psychopharmacology in the Emergency Room Michael D. Jibson, M.D., Ph.D. Professor of Psychiatry University of Michigan Pretest 1. Which of the following conditions is LEAST likely to benefit from emergency

More information

NEW ZEALAND DATA SHEET. HYPAM 0.125mg tablets are oval, flat, bevelled edged white tablets marked TZ on one side and scored on the other.

NEW ZEALAND DATA SHEET. HYPAM 0.125mg tablets are oval, flat, bevelled edged white tablets marked TZ on one side and scored on the other. NEW ZEALAND DATA SHEET HYPAM Triazolam Tablets 0.125mg, 0.25mg Presentation HYPAM 0.125mg tablets are oval, flat, bevelled edged white tablets marked TZ on one side and scored on the other. HYPAM 0.25mg

More information

Fact Sheet. Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII

Fact Sheet. Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII Fact Sheet Zohydro ER (hydrocodone bitartrate) Extended-Release Capsule, CII, is a long-acting (extendedrelease) type of pain medication

More information

Insomnia treatment in primary care

Insomnia treatment in primary care Insomnia treatment in primary care Daniel J. Buysse, MD UPMC Professor of Sleep Medicine Professor of Psychiatry and Clinical and Translational Science University of Pittsburgh School of Medicine buyssedj@upmc.edu

More information

A Pharmacist s Guide to Intermezzo

A Pharmacist s Guide to Intermezzo A Pharmacist s Guide to Intermezzo Intermezzo (zolpidem tartrate) is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to

More information

Using Benzodiazepines in Primary Care

Using Benzodiazepines in Primary Care Using Benzodiazepines in Primary Care Spencer A. Tighe MD, FRCPC Saturday, Feb. 16, 2008 Overview Historical context Drug information Indications Side effects Abuse vs. physical dependence Clinical practice

More information

Disclosure. Sleep Medications in Primary Care: How to choose, what to avoid

Disclosure. Sleep Medications in Primary Care: How to choose, what to avoid Sleep Medications in Primary Care: How to choose, what to avoid Margaret A. Fitzgerald, DNP, FNP-BC, NP-C, FAANP, CSP, FAAN, DCC, FNAP President, Fitzgerald Health Education Associates, North Andover,

More information

An algorithm for medication in the treatment of Complex PTSD

An algorithm for medication in the treatment of Complex PTSD An algorithm for medication in the treatment of Complex PTSD Andreas Laddis, M.D. aladdis@gmail.com ESTD Conference Bern November 10, 2017 The purpose for the presentation Algorithm for medication: My

More information

You May Be at Risk. You are taking one of the following sedative-hypnotic medications:

You May Be at Risk. You are taking one of the following sedative-hypnotic medications: You May Be at Risk You are taking one of the following sedative-hypnotic medications: Alprazolam (Xanax ) Bromazepam (Lectopam ) Chlorazepate Chlordiazepoxideamitriptyline Clidinium-chlordiazepoxide Clobazam

More information

LORAZEPAM. THERAPEUTICS Brands Ativan see index for additional brand names. Generic? Yes

LORAZEPAM. THERAPEUTICS Brands Ativan see index for additional brand names. Generic? Yes LORAZEPAM THERAPEUTICS Brands Ativan see index for additional brand names Generic? Yes Class Neuroscience-based Nomenclature: GABA positive allosteric modulator (GABA-PAM) Benzodiazepine (anxiolytic, anticonvulsant)

More information

Core Safety Profile: Midazolam Route of Administration Tablets Procedure: FR/H/PSUR/0026/001 Decemebr 2011

Core Safety Profile: Midazolam Route of Administration Tablets Procedure: FR/H/PSUR/0026/001 Decemebr 2011 Core Safety Profile: Midazolam Route of Administration Tablets Procedure: FR/H/PSUR/0026/001 Decemebr 2011 4.2 Posology and method of administration Duration of treatment should be as short as possible.

More information

Can you take sleeping pills with ativan

Can you take sleeping pills with ativan Cari untuk: Cari Cari Can you take sleeping pills with ativan 30-5-2015 Can 't sleep? Consumer Reports Best Buy Drugs explains why the Best Insomnia Treatment Is Not A Drug. 2-3-2018 Sleeping Pills: What

More information

Sleep Science: better sleep for you and your patients CHUNBAI ZHANG, MD MPH UW MEDICINE VALLEY MEDICAL CENTER

Sleep Science: better sleep for you and your patients CHUNBAI ZHANG, MD MPH UW MEDICINE VALLEY MEDICAL CENTER Sleep Science: better sleep for you and your patients CHUNBAI ZHANG, MD MPH UW MEDICINE VALLEY MEDICAL CENTER Disclosure: Financial - none Non-Financial - none Selected Topics Sleep epidemiology Sleep

More information

Ruby Williams, M.D. Drugs, Alcohol and Sleep February 24, 2018

Ruby Williams, M.D. Drugs, Alcohol and Sleep February 24, 2018 Ruby Williams, M.D. Drugs, Alcohol and Sleep February 24, 2018 Objectives Describe pharmacology of commonly prescribed drugs for stimulants and hypnotics Brief review of common drugs that affect sleep

More information

Sleep Disorders: Assessment and Therapeutic Options

Sleep Disorders: Assessment and Therapeutic Options Sleep Disorders: Assessment and Therapeutic Options John W. Winkelman MD, PhD Chief, Sleep Disorders Clinical Research Program Departments of Psychiatry and Neurology Massachusetts General Hospital Professor

More information

SYSTEMATIC REVIEW. Introduction. L. Citrome

SYSTEMATIC REVIEW. Introduction. L. Citrome SYSTEMATIC REVIEW for insomnia: a systematic review of the efficacy and safety profile for this newly approved hypnotic what is the number needed to treat, number needed to harm and likelihood to be helped

More information

MISCELLANEOUS AGENTS - ALPHA-AGONISTS

MISCELLANEOUS AGENTS - ALPHA-AGONISTS Documentation A. FDA Approved Indications ADHD (Clonidine, Guanfacine) Documentation B. Non-FDA approved, commonly used psychiatric indications 1. Alcohol and opiate dependence 2. Opioid withdrawal 3.

More information

Addressing the Multiple Causes and Lifestyle Impacts of Insomnia: A Guide for Patient Counseling

Addressing the Multiple Causes and Lifestyle Impacts of Insomnia: A Guide for Patient Counseling Addressing the Multiple Causes and Lifestyle Impacts of Insomnia: A Guide for Patient Counseling Educational Objectives: At the completion of this knowledge-based activity, participants will be able to:

More information

Sedative-Hypnotics. Sedative Agents (General Considerations)

Sedative-Hypnotics. Sedative Agents (General Considerations) Sedative Agents (General Considerations) No best sedative agent Any agent given in sufficient dosage can produce any level of sedation Intravenous dosing is more predictable then intramuscular or oral

More information

ANTIANXIETY DRUGS: BENZODIAZEPINES

ANTIANXIETY DRUGS: BENZODIAZEPINES Margaret Gnegy Professor of Pharmacology pgnegy@umich.edu 1 ANTIANXIETY DRUGS: BENZODIAZEPINES Sedatives and hypnotics M. Gnegy, Ph.D. 1 2 Reading: Goodman & Gilman, 11th ed. Chapter 16, pp. 401-427. Drug

More information

8.6 Chronic Obstructive Pulmonary Disease 8.7 Sleep Apnea 1 INDICATIONS AND USAGE

8.6 Chronic Obstructive Pulmonary Disease 8.7 Sleep Apnea 1 INDICATIONS AND USAGE Page 1 of 18 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ROZEREM safely and effectively. See full prescribing information for ROZEREM. ROZEREM

More information

Benzodiazepine Toolbox

Benzodiazepine Toolbox PL Detail-Document #300806 This PL Detail-Document gives subscribers additional insight related to the Recommendations published in PHARMACIST S LETTER / PRESCRIBER S LETTER August 2014 Benzodiazepine

More information

Sleep Clinic Case: History. Insomnia in Patients with Comorbid Psychiatric Disorders: Shared Neurobiology and Clinical Solutions

Sleep Clinic Case: History. Insomnia in Patients with Comorbid Psychiatric Disorders: Shared Neurobiology and Clinical Solutions Sleep Clinic Case: History Insomnia in Patients with Comorbid Psychiatric Disorders: Shared Neurobiology and Clinical Solutions David N. Neubauer, MD Associate Professor Johns Hopkins University School

More information

Drug Class Review on Newer Drugs for Insomnia

Drug Class Review on Newer Drugs for Insomnia Drug Class Review on Newer Drugs for Insomnia Final Report July 00 The Agency for Healthcare Research and Quality has not yet seen or approved this report The purpose of this report is to make available

More information

Migraleve, Migraleve Pink and Migraleve Yellow Product Information

Migraleve, Migraleve Pink and Migraleve Yellow Product Information Migraleve, Migraleve Pink and Migraleve Yellow Product Information Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard Adverse events should also

More information

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

2 QUALITATIVE AND QUANTITATIVE COMPOSITION SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT STILNOCT 10mg/ZOLPIDEM TARTRATE 10MG TABLETS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Stilnoct 10mg Tablets: White to off-white film-coated

More information

Dsuvia (sufentanil) NEW PRODUCT SLIDESHOW

Dsuvia (sufentanil) NEW PRODUCT SLIDESHOW Dsuvia (sufentanil) NEW PRODUCT SLIDESHOW Introduction Brand name: Dsuvia Generic name: Sufentanil Pharmacological class: Opioid agonist Strength and Formulation: 30mcg; sublingual tabs (housed in a disposable,

More information

Cetirizine Proposed Core Safety Profile

Cetirizine Proposed Core Safety Profile Cetirizine Proposed Core Safety Profile Posology and method of administration Elderly subjects: data do not suggest that the dose needs to be reduced in elderly subjects provided that the renal function

More information

Stilnoct 10mg Tablets: White to off-white film-coated oblong tablet, scored and engraved SN 10 on one side, containing 10mg zolpidem tartrate.

Stilnoct 10mg Tablets: White to off-white film-coated oblong tablet, scored and engraved SN 10 on one side, containing 10mg zolpidem tartrate. 1. NAME OF THE MEDICINAL PRODUCT Stilnoct 5mg Stilnoct 10mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Stilnoct 5mg Tablets: Round white film coated tablets containing 5mg zolpidem tartrate. Stilnoct

More information

Chapter 7. Depressants and Inhalants. Depressants & Inhalants. History: Before Barbiturates 10/1/2012

Chapter 7. Depressants and Inhalants. Depressants & Inhalants. History: Before Barbiturates 10/1/2012 Chapter 7 Depressants and Inhalants Depressants & Inhalants Depressants = drugs that slow activity in the central nervous system Include prescription drugs that treat anxiety (sedatives) and insomnia (hypnotics)

More information

Tranquilizers & Sedative-Hypnotics

Tranquilizers & Sedative-Hypnotics Tranquilizers & Sedative-Hypnotics 1 Tranquilizer or anxiolytic: Drugs used therapeutically to treat agitation or anxiety Sedative-Hypnotic: drugs used to sedate and aid in sleep Original sedatives (before

More information

4.4 Special warnings and precautions for use

4.4 Special warnings and precautions for use SUMMARY OF PRODUCT CHARACTERISTICS 4.3 Contraindications Durogesic is contraindicated in patients with known hypersensitivity to fentanyl or to the excipients present in the patch. Acute or postoperative

More information

Insomnia: habits, help, and hazards

Insomnia: habits, help, and hazards Insomnia: habits, help, and hazards Balanced data about medications www.rxfacts.org Copyright 2010 by The Alosa Foundation www.rxfacts.org November 2010 2 www.rxfacts.org Author: Leslie Jackowski, B.Sc.,

More information

Figure 1: Quantity Dispensed/100 Members (Ambien and Sonata on left axis)

Figure 1: Quantity Dispensed/100 Members (Ambien and Sonata on left axis) Sedative Hypnotic Quantity Limit Policy Impact Analysis Effective 12/6/2 OMAP implemented a 15 tablet per 3 day quantity limit on non-barbiturate sedative hypnotics for FFS patients. This policy was made

More information

Pharmacological Treatment of Insomnia

Pharmacological Treatment of Insomnia Janette D. Lie, PharmD, BCACP; Kristie N. Tu, PharmD, BCPS, CGP; Diana D. Shen, PharmD Candidate; and Bonnie M. Wong, PharmD Candidate INTRODUCTION People experience two forms of sleep: rapid eye movement

More information

Psychopharmacology of Sleep Disorders

Psychopharmacology of Sleep Disorders Psychopharmacology of Sleep Disorders John W. Winkelman MD, PhD Chief, Sleep Disorders Clinical Research Program Departments of Psychiatry and Neurology Massachusetts General Hospital Professor of Psychiatry

More information

Learning Objectives. Management of Insomnia. Impact of Chronic Insomnia. Insomnia: Definitions. Measurement of Goals. Goals of Therapy 9/29/2017

Learning Objectives. Management of Insomnia. Impact of Chronic Insomnia. Insomnia: Definitions. Measurement of Goals. Goals of Therapy 9/29/2017 Learning Objectives Characterize insomnia and its negative effects Management of Insomnia Discuss the goals of treatment Summarize guidelines of management of insomnia including non-pharmacologic and pharmacologic

More information

Zopiclone Orion. Date: , Version 1.2 PUBLIC SUMMARY OF THE RISK MANAGEMENT PLAN

Zopiclone Orion. Date: , Version 1.2 PUBLIC SUMMARY OF THE RISK MANAGEMENT PLAN Zopiclone Orion Date: 16-11-2016, Version 1.2 PUBLIC SUMMARY OF THE RISK MANAGEMENT PLAN VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Insomnia (i.e. sleeplessness) is a common

More information

LOFLAZEPATE. THERAPEUTICS Brands Meilax see index for additional brand names. Generic? No. Class Benzodiazepine (anxiolytic)

LOFLAZEPATE. THERAPEUTICS Brands Meilax see index for additional brand names. Generic? No. Class Benzodiazepine (anxiolytic) LOFLAZEPATE THERAPEUTICS Brands Meilax see index for additional brand names Generic? No Class Benzodiazepine (anxiolytic) Commonly Prescribed for (bold for FDA approved) Anxiety, tension, depression, or

More information

Lorazepam Tablets, USP

Lorazepam Tablets, USP Lorazepam Tablets, USP DESCRIPTION: Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H -1,4-benzodiazepin-2-one: Cl H N N O Cl OH It is a white

More information

Benzodiazepines. Benzodiazepines

Benzodiazepines. Benzodiazepines : History 1950s - Invented by Swiss chemists who identified its sedative effects 1950s 60s - Chlordiazepoxide (Librium) marketed as a safer alternative to barbiturates; along with newer benzodiazepines

More information

Sedative / Hypnotics

Sedative / Hypnotics Sedative / Hypnotics David H. Rubin, MD Executive Director, Massachusetts General Hospital Psychiatry Academy Director of Child and Adolescent Psychiatry Residency Training Massachusetts General Hospital

More information

What is sleep? o Sleep is a body s rest cycle.

What is sleep? o Sleep is a body s rest cycle. What is sleep? o Sleep is a state when our senses and motor actvity are relatively suspended; there is a total or partial unconsciousness and all voluntary muscles are inactive. o Sleep is a body s rest

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS MUTUAL RECOGNITION PROCEDURE Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT, syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of syrup contains 1 mg loratadine.

More information