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Prior Authorization Protocol
BELSOMRAR (suvorexant), EDLUARR, INTERMEZZOR(zolpidem sublingual tablets), LUNESTAR (eszopiclone), ROZEREMR (ramelteon), SILENORR (doxepin), SONATAR (zaleplon), ZOLPIMISTR(zolpidem spray), AMBIEN CR (zolpidem CR)


HNMC
Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    Zolpimist
    • Short-term treatment of insomnia characterized by difficulties with sleep initiation

    Edluar

    • Short-term treatment of insomnia characterized by difficulties with sleep initiation

    Intermezzo
    • Treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep

    Lunesta

    • Treatment of insomnia

    Rozerem

    • Treatment of insomnia characterized by difficulties with sleep onset

    Sonata

    • Short-term treatment of insomnia
    Silenor
    • Treatment of insomnia characterized by difficulties with sleep maintenance
    Ambien CR
    • Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance
    Belsomra
    • Treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance

  2. Health Net Approved Indications and Usage Guidelines:

    Ambien CR, Belsomra, Lunesta, Sonata, Silenor

    • Diagnosis of insomnia

    AND

    • Failure or clinically significant adverse effects to zolpidem

    Intermezzo

    • Diagnosis of insomnia
    AND
    • History of insomnia with difficulty returning to sleep after middle of the night awakening

    Edluar, Zolpimist

    • Diagnosis of insomnia

    AND

    • Trial of zolpidem unless contraindicated

    Rozerem

    • Diagnosis of insomnia

    AND

    • Failure or clinically significant adverse effects to zolpidem

    OR

    • Patient has a previous history of substance abuse
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    • Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient.
    • Rozerem is a melatonin receptor agonist, Silenor is a histamine H1 receptor antagonist, and Belsomra is an orexin receptor agonist. These three agents do not work through the GABA-A receptors, as do the other available agents in this class.
    • Silenor is not a scheduled controlled substance.
    • Zolpidem has a Micromedex Class IIa indication for improving sleep in patients with SSRI-induced insomnia. The insomnia had been ongoing for two weeks while on the SSRI.
    • The recommended initial doses for women and men are different because zolpidem clearance is lower in women.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    flurazepam (DalmaneR)

    Adults:
    15 - 30 mg PO QHS
    Elderly**:
    15 mg PO QHS
    **Generally not recommended in the elderly due to long half-life of active metabolite

    30 mg/day

    temazepam (RestorilR)

    Adults:
    15 - 30 mg PO QHS
    Elderly:
    7.5 - 15 mg PO QHS

    30 mg/day

    triazolam (HalcionR)
    Adults:
    0.125 - 0.5 mg PO QHS
    Elderly:
    0.125 - 0.25 mg PO QHS

    0.5 mg/day

    trazodone (DesyrelR)

    Adults:
    50 - 100 mg PO QHS
    Elderly:
    25 - 100 mg PO QHS

    Up to 600 mg/day for depression.

    Lower doses are used for insomnia.

    zolpidem (AmbienR)
    Adults:
    5 - 10 mg PO QHS
    Elderly:
    5 mg PO QHS

    10 mg/day

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Rozerem

    Adults:
    8 mg PO QHS
    Length of Benefit

    Sonata

    Adults:
    10 mg (max 20 mg) PO QHS
    Elderly:
    5 mg - 10 mg PO QHS
    Length of Benefit

    Edluar

    Women:
    5 mg SL QHS
    Men:
    5 or 10 mg SL QHS
    Elderly:
    5 mg PO QHS
    Length of Benefit

    Zolpimist

    Women:
    5 mg PO QHS
    Men:
    5-10 mg PO QHS immediately before bedtime
    Elderly:
    5 mg PO QHS immediately before bedtime
    Length of Benefit

    Intermezzo

    Women:
    1.75 mg SL QD PRN
    Men:
    3.5 mg SL QD PRN
    Elderly:
    1.75 mg SL QD PRN
    Length of Benefit

    Silenor

    Adults:
    6 mg PO QHS (max 6 mg)
    Elderly:
    3 mg PO QHS
    Length of Benefit

    Zolpidem CR

    Women: 6.25 mg PO QHS
    Men: 6.25 mg or 12.5 mg PO QHS
    Elderly: 6.25 mg PO QHS
    Length of Benefit

    Lunesta

    Adults: 1-2 mg PO QHS (max 3 mg)
    Elderly: 1 - 2 mg PO QHS

    Length of Benefit

    Belsomra

    10 mg PO QHS
    If the 10 mg dose is well-tolerated but not effective, the dose can be increased, not to exceed 20 mg once daily.

    Length of Benefit

  7. Product Availability:
    Edluar sublingual tablets (not scored): 5 mg, 10 mg
    Intermezzo sublingual tablets: 1.75 mg, 3.5 mg
    Lunesta tablets: 1 mg, 2 mg, 3 mg
    Rozerem tablets: 8 mg
    Silenor tablets (not scored): 3 mg, 6 mg
    Sonata capsules: 5 mg, 10 mg
    Zolpimist oral spray: 5 mg per actuation
    Zolpidem CR extended-release tablets: 6.25 mg, 12.5 mg
    Belsomra tablets: 5 mg, 10 mg, 15 mg, 20 mg
  8. References:
    1. Edluar [Prescribing Information] Somerset, NJ: Meda Pharmaceuticals, Inc.; October 2014.
    2. Lunesta [Prescribing Information] Marlborough, MA: Sunovion Pharmaceuticals Inc; May 2014.
    3. Rozerem [Prescribing Information] Deerfield, IL: Takeda Pharmaceuticals Inc. March 2012.
    4. Silenor [Prescribing Information] San Diego, CA: Somaxon Pharmaceuticals, Inc. March 2010.
    5. Sonata [Prescribing Information] Bristol, TN: King Pharmaceuticals, Inc. April 2013.
    6. Zolpimist [Prescribing Information] Richmond, VA:ECR Pharmaceuticals. September 2011.
    7. Intermezzo [Prescribing Information] Stamford, CT: Purdue Pharma L.P. February 2013.
    8. Zolpidem CR [Prescribing Information] Bridgewater, NJ: Sanofi-Aventis U.S. LLC. October 2014.
    9. Belsomra [Prescribing Information} Whitehouse Station, NJ: Merck & Co, Inc.; August 2014.
    10. MicromedexR Healthcare Series (Internet Database). Greenwood Village, CO: Thompson Healthcare. Updated periodically. Accessed June 2015.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.