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Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Sedative/Hypnotics

Status Drug PR PR-QL PR-AL ST M EX‡
P chloral hydrate          
P estazolam          
P flurazepam          
P lorazepam          
P phenobarbital          
P temazepam          
P triazolam          
P zolpidem   X      
P Ambien CR®  (zolpidem cr)   X   X X
FE Ambien®  (zolpidem)   X   X X
FE Doral®  (quazepam)         X
FE Lunesta™  (eszopiclone)   X   X X
FE Rozerem®  (ramelteon)   X   X X
FE Sonata®  (zaleplon)   X   X X
FE Strazepam pak ®  (temazepam cap/nutritional supplement cap pack)         X


Policy:

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

    According to the manufacturer, the sedative/hypnotics zolpidem, Ambien, Ambien CR, Lunesta, Rozerem and Sonata 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
    zolpidem, Ambien 10 mg/ once daily 5 mg Up to 60 tablets in 30 days
    zolpidem, Ambien 10 mg/ once daily 10 mg Up to 30 tablets in 30 days
    Ambien CR 12.5mg/ once daily 6.25 mg, 12.5 mg 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 8 mg Up to 30 tablets in 30 days
    Sonata 20 mg/ once daily 5 mg Up to 120 capsules in 30 days
    Sonata 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 Pharmacy Management Precertification Unit. Additional quantities of drug class/brand names will be considered medically necessary for those members who meet ANY of the following criteria:

    • Member requires a dose including half tablets (zolpidem/Ambien only)OR
    • Member's dose is being titrated by physician (3-month limit) OR 
    • Member has had failure to drug administered as a single dose at night (zolpidem/Ambien 10mg) and requires twice dosing at night (zolpidem/Ambien 5mg) OR
    • Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose.

     



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

    A documented trial of  7 days (one week) of the preferred generic alternative zolpidem.

    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. (See criteria under section III below.)

  5. Medical Exception Criteria
  6. Ambien,  Lunesta, Rozerem and Sonata are currently listed on the Aetna Formulary Exclusions and Step-Therapy lists.* Therefore, these drugs are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary or that require step-therapy criteria, unless a medical exception is granted. Aetna considers Ambien,  Lunesta, Rozerem and Sonata to be medically necessary for those members who meet the following criteria

    Ambien CR is listed on the Aetna Step-Therapy List.* Therefore, it is excluded from coverage for members enrolled in prescription drug benefit plans that require step-therapy criteria, unless a medical exception is granted.  Aetna considers Ambien CR  to be medically necessary for those members who meet the following criteria:

    For Ambien, Ambien CR, Lunesta, Rozerem and Sonata

    A.  A documented: 

    •  Intolerance to  preferred generic alternative zolpidem for sleep OR
    •  Contraindication to  preferred generic alternative zolpidem for sleep OR
    •  Allergy to preferred generic alternative zolpidem for sleep OR
    •  Failure of an adequate trial of 7 days (one week) of preferred generic alternative zolpidem for sleep OR
    •  History of substance abuse (for Rozerem only )

    Doral and  Strazepam pak are currently listed on the Aetna Formulary Exclusions List.* Therefore, they are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Doral and Strazepam pak to be medically necessary for those members who meet ANY of the following criteria:

    For Doral

    A.  A documented: 

    • Intolerance to two preferred alternatives for sleep OR
    • Contraindication to two preferred alternatives for sleep OR
    • Allergy to two preferred alternatives for sleep OR
    • Failure of an adequate trial of 7 days (one week) each of two preferred alternatives for sleep

    For Strazepam pak

    • Intolerance to two preferred alternatives for sleep (one of which should be temazepam) OR
    • Contraindication to two preferred alternatives for sleep (one of which should be temazepam)  OR
    • Allergy to two preferred alternatives for sleep (one of which should be temazepam)  OR
    • Failure of an adequate trial of 7 days (one week) each of 2 preferred alternatives for sleep (one of which should be temazepam)

     


Place of Service:

Outpatient

The above policy is based on the following references:
  1. St. Louis: J.B. Lippincott Company, 2006.
  2. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2006.
  3. McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2006.
  4. 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
  5. Nowell PD, Mazumdar S, Buysse DJ, et al. Benzodiazepines and Zolpidem for chronic insomnia. JAMA 1997;278:2170-7.
  6. Chesson A Jr, Anderson WM, Littner M, et al. Practice parameters for the nonpharmacologic treatment of chronic insomnia. An American Academy of Sleep Medicine report. Standards of Practice Committee of the American Academy of Sleep Medicine. Sleep 1999;22(8):1128-33
  7. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
  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. Morin CM, Culbert JP, Schwartz SM. Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy. Am J Psychiatry 1994;151:1172-80
  10. Danjou P, Paty I, Fruncillo R, et al. A comparison of the residual effects of zaleplon and zolpidem following administration 5 to 2 hours before awakening. Br J Clin Pharmacol 1999; 48(3): 367-74

 

Copyright 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.

October 15, 2007
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