Subject: Sedatives/Hypnotics

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	zaleplon			X
C	zolpidem			X
C	Ambien CR®  (zolpidem ER)			X		X	X
NC	Edluar®  (zolpidem)			X		X	X
NC	Sonata®  (zaleplon)			X		X	X
NC	Ambien®  (zolpidem)			X		X	X
NC	Lunesta®  (eszopiclone)			X		X	X
NC	Rozerem®  (ramelteon)			X		X	X

Policy:

1. Precertification Criteria

Under some plans, including plans that use an open or closed formulary, Ambien, Ambien CR, Edluar, Lunesta, Rozerem, Sonata, zaleplon and zolpidem are subject to precertification.  If precertification requirements apply Aetna considers Ambien, Ambien CR, Edluar, Lunesta, Rozerem, Sonata, zaleplon and zolpidem to be medically necessary for those members who meet the following precertification criteria:

A. Quantity limits: According to the manufacturer, the sedative/hypnotics Ambien, Ambien CR, Edluar, Lunesta, Rozerem, Sonata, zaleplon  and zolpidem can be dosed up to a maximum daily dose at the interval(s) as indicated in the table below. A quantity of each drug will be considered medically necessary as indicated in the table below:

Drug	Maximum Daily Dose/ Dosing Interval	Dosage Strength	Quantity Limits
Ambien, zolpidem	10 mg/ once daily	5 mg	Up to 60 tablets in 30 days
Ambien, zolpidem	10 mg/ once daily	10 mg	Up to 30 tablets in 30 days
Ambien CR	12.5 mg / once daily	6.25 mg, 12.5 mg	Up to 30 tablets in 30 days
Edluar	10 mg/once daily	5mg	Up to 60 tablets in 30 days
Edluar	10 mg/once daily	10mg	Up to 30 tablets in 30 days
Lunesta	3 mg/ once daily	1 mg, 2 mg, 3 mg	Up to 30 tablets in 30 days for all strengths
Rozerem	8 mg/ once daily	8mg	Up to 30 tablets in 30 days
Sonata, zaleplon	20 mg/ once daily	5 mg	Up to 120 capsules in 30 days
Sonata, zaleplon	20 mg/ once daily	10 mg	Up to 60 capsules in 30 days





For coverage of additional quantities, a member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit.  Additional quantities of the sedative/hypnotics will be considered medically necessary for those members who meet ANY of the following criteria:

• Member requires a dose including half tablets and cumulative daily dose falls within maximum daily dose limits OR
• Member's dose is being titrated by physician and cumulative daily dose falls within maximum daily dose limits (3-month limit) OR
• Member has had failure to drug administered as a single dose at night and requires twice dosing at night (zolpidem/Ambien 10mg ONLY - up to 20 mg/day) OR
• Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose
  



2. Step Therapy Criteria

Under some plans, including plans that use an open or closed formulary, Ambien, Ambien CR, Edluar, Lunesta, Rozerem and Sonata are subject to step-therapy.  Aetna considers Ambien, Ambien CR, Edluar, Lunesta, Rozerem and Sonata to be medically necessary for those members who meet the following step-therapy criteria:

A documented trial of 7 days of zaleplon or zolpidem - generic alternatives on the Aetna Medicare Preferred Drug List.

If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, the member's treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-800-414-2386. (See criteria under section III below.)


3. Medical Exception Criteria

Ambien, Ambien CR, Edluar, Lunesta, Rozerem and Sonata are currently listed on the Aetna Step-Therapy List.*  If it is medically necessary for a member to be treated initially with one of these medications subject to step-therapy, Aetna considers these drugs to be medically necessary for those members who meet the criteria specified below:

A.  A documented:

•  Intolerance to the preferred alternatives zaleplon or zolpidem OR
• Contraindication to the preferred alternatives zaleplon or zolpidem OR
• Allergy to the preferred alternatives zaleplon or zolpidem OR
• Failure of an adequate trial of 7 days of the preferred alternatives zaleplon or zolpidem OR
• Member has a history of substance abuse (Rozerem ONLY)

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.

July 02, 2009