Category: Central Nervous System

Class: Sedative Hypnotics

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX	TOC	NSO
C	ZOLPIDEM TARTRATE			X
C	ZALEPLON			X
C	AMBIEN CR  (ZOLPIDEM TARTRATE TABLET CR)			X		X
NC	AMBIEN  (ZOLPIDEM TARTRATE)			X		X	X
NC	EDLUAR SUB  (ZOLPIDEM TARTRATE SL)			X		X	X
NC	LUNESTA  (ESZOPICLONE)			X		X	X
NC	ROZEREM  (RAMELTEON)			X		X	X
NC	SONATA  (ZALEPLON )			X		X	X

Policy:

1. Precertification Criteria:

Under some plans, including plans that use an open or closed formulary, precertifcation criteria may apply.  If precertification requirements apply Aetna considers the drugs below to be medically necessary for those members who meet the following precertification criteria:

1. Quantity Limitations

According to the manufacturer labeling, a quantity of each drug will be considered medically necessary as indicated in the table below:

Drug Name	Dosage Form	Strength	Qty	Day(s)
AMBIEN	TABLET	5mg	2	Per Day	Max Daily Dose 10 mg/ once daily
AMBIEN	TABLET	10mg	1	Per Day	Max Daily Dose 10 mg/ once daily
AMBIEN CR	TABLET CR	6.25mg	1	Per Day	Max Daily Dose 12.5 mg/ once daily
AMBIEN CR	TABLET CR	12.5mg	1	Per Day	Max Daily Dose 12.5 mg/ once daily
EDLUAR SUB	TABLET SL	5mg	2	Per Day	Max Daily Dose 10 mg/ once daily
EDLUAR SUB	TABLET SL	10mg	1	Per Day	Max Daily Dose 10 mg/ once daily
LUNESTA	TABLET	1mg	1	Per Day	Max Daily Dose 3 mg/ once daily
LUNESTA	TABLET	2mg	1	Per Day	Max Daily Dose 3 mg/ once daily
LUNESTA	TABLET	3mg	1	Per Day	Max Daily Dose 3 mg/ once daily
ROZEREM	TABLET	8mg	1	Per Day	Max Daily Dose 8 mg/ once daily
SONATA	CAPSULE	5mg	3	Per Day	Max Daily Dose 20 mg/ once daily
SONATA	CAPSULE	10mg	2	Per Day	Max Daily Dose 20 mg/ once daily
ZALEPLON	CAPSULE	5mg	3	Per Day	Max Daily Dose 20 mg/ once daily
ZALEPLON	CAPSULE	10mg	2	Per Day	Max Daily Dose 20 mg/ once daily
ZOLPIDEM	TABLET	5mg	2	Per Day	Max Daily Dose 10 mg/ once daily
ZOLPIDEM	TABLET	10mg	1	Per Day	Max Daily Dose 10 mg/ once daily





Quantity Limit Exceptions

For coverage of additional quantities, the member, a person appointed to manage the member’s care, or the member's treating physician may contact the Aetna Pharmacy Management Precertification Unit at 1-800-414-2386. Additional quantities will be considered medically necessary for those members who meet the following criteria.


• Member requires a dose including half tablets OR
• Member's dose is being titrated by physician (3-month limit) OR
• Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose

Quantity Limit Coverage Duration

Aetna considers the following Maximum length of approval for the drug(s) that meet quantity limits criteria.
 
30 Days





2. Step Therapy Criteria




Under some plans, including plans that use an open or closed formulary, step-therapy criteria may apply. If step-therapy requirements apply Aetna considers the drugs below to be medically necessary for those members who meet the following step-therapy criteria.

For Ambien, Ambien CR, Edluar Sub, Lunesta, Rozerem and Sonata

• A documented trial of 7 days of generic zaleplon or zolpidem
  
  
1. Step Therapy Medical Exception




If it is medically necessary for a member to be treated initially with one of these medications subject to step-therapy, the member, a person appointed to manage the member’s care, or the member’s treating physician may contact the Aetna Pharmacy Management Precertification Unit at 1-800-414-2386 to request coverage as a medical exception. Aetna considers these drugs to be medically necessary for those members who meet the criteria specified below.

For Ambien, Ambien CR, Edluar Sub, Lunesta, Rozerem and Sonata

• Contraindication or Intolerance or Allergy or Failure of 7 days of generic zaleplon or zolpidem
  
  
2. Step Therapy Coverage Duration




Aetna considers the following Maximum length of approval for the drug(s) that meet step therapy criteria.

Through End Of Plan Contract Year



3. Not Covered Drug Criteria




Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan  are excluded from coverage for members enrolled in prescription drug benefits plans that use a closed formulary, unless a medical exception is granted.  Aetna considers the drugs below to be medically necessary for those members who meet the following criteria.

For All Not Covered (NC) Drugs

• Contraindication or Intolerance or Allergy or Failure of 7 days each of three covered (C) alternatives, both generics, zolpidem and zaleplon AND Ambien CR.
  
  
1. Not Covered Drug Coverage Duration




Aetna considers the following Maximum length of approval for the drug(s) that meet criteria for not covered drugs.

Through End of Plan Contract Year

Place of Service:

Outpatient

The above policy is based on the following references:

1. DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
2. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
3. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
4. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
5. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
6. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
7. Chesson A Jr, Hartse K, Anderson WM, et al. Practice parameters for the evaluation of chronic insomnia. An American Academy of Sleep Medicine report. Standards of Practice Committee of the American Academy of Sleep Medicine. Sleep 2000;23(2):237-41.
8. Roth T, Hajak G, Ustun TB. Consensus for the pharmacological management of insomnia in the new millennium. Int J Clin Pract 2001;55(1):42-52.
9. Nowell PD, Mazumdar S, Buysse DJ, et al. Benzodiazepines and Zolpidem for chronic insomnia. JAMA 1997;278:2170-7.
10. Weitzel KW, Wickman JM, Augustin SG, and Strom JG. Zaleplon: A pyrazolopyrimidine sedative-hypnotic agent for the treatment of insomnia. Clin Ther. 2000;22:1254-67.
11. Zammit GK, McNabb LJ, Caron J, et al.  Efficacy and safety of eszopiclone across 6-weeks of treatment for primary insomnia.  Curr Med Res Opin 2004;20(12):1979-1991.
12. Krystal AD, Walsh JK, Laska E, et al.  Sustained efficacy of eszopiclone over 6 months of nightly treatment: Results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia.  Sleep 2003;26(7): 793-799.
13. Scharf M, Erman M, Rosenberg R, et al.  A 2-week efficacy and safety study of eszopiclone in elderly patients with primary insomnia.  Sleep 2005;28(6):720-727.
14. Erman M, Seiden D, Zammit G, et al.  An efficacy, safety, and dose-response study of ramelteon in patients with chronic primary insomnia.  Sleep Med 2006; 7(1):17-24.
15. Roth T, Stubbs, Walsh JK.  Ramelteon (TAK-375), a selective MT1/MT2-receptor agonist, reduces latency to persistent sleep in a model of transient insomnia related to a novel sleep environment.  Sleep 2005;28(3):303-307).
16. Zammit G, Roth T, Erman M, et al.  Double-blind, placebo-controlled polysomnography and outpatient trial to evaluate the efficacy and safety of ramelteon in adult patients wth chronic insomnia. Sleep 2005;28(suppl):A229.
17. Owens JA, Babcock D, Blumer J, et al. The use of pharmacotherapy in the treatment of pediatric insomnia in primary care: rational approaches. A consensus meeting summary. J Clin Sleep Med. 2005 Jan 15;1(1):49-59.
18. Wilson S, Nutt D. Management of insomnia: treatments and mechanisms. Br J Psychiatry. 2007;191:195-7.
19. Buscemi N, Vandermeer B, Friesen C, et al. The efficacy and safety of drug treatments for chronic insomnia in adults: a meta-analysis of RCTs. J Gen Intern Med. 2007 Sep;22(9):1335-50.

Property of Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

Original Policy Date: January 01, 2010

Effective Date: January 01, 2010