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Drug Category: Central Nervous System (CNS)

Medication Class/Individual Agents: Hypnotics

I. Prior-Authorization Requirements

 Hypnotics

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

doxepin tablet-Silenor Silenor PA  
eszopiclone Lunesta # PA   - < 6 years and PA > 30 units/month
ramelteon Rozerem BP PA   - > 30 units/month
suvorexant Belsomra PA  
zaleplon PA   - < 6 years and PA > 30 units/month
zolpidem 1.75 mg, 3.5 mg sublingual tablet Intermezzo PA  
zolpidem 10 mg tablet Ambien # PA   - < 6 years and PA > 30 units/month
zolpidem 5 mg tablet Ambien # PA   - < 6 years and PA > 45 units/month
zolpidem 5 mg, 10 mg sublingual tablet Edluar PA  
zolpidem extended-release tablet Ambien CR # PA   - < 6 years and PA > 30 units/month
zolpidem oral spray Zolpimist PA  

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

 

Please note: Concurrent therapy with two or more hypnotics (including hypnotic benzodiazepines) will also require PA if there are at least two 30 day fills of separate hypnotics in the past 45 days. For additional information regarding hypnotic benzodiazepines (estazolam, flurazepam, midazolam, temazepam, triazolam), please see: Table 69 - Barbiturates, Benzodiazepines and Miscellaneous Antianxiety Agents.

  • Nonpharmacologic treatments, such as practicing good sleep hygiene, relaxation training, and cognitive therapy may be more effective than medications in some individuals. See “10 Tips for a Good Night's Sleep.”
  • There is limited medical evidence on the safety and efficacy of prolonged use of hypnotics.
  • To avoid tolerance and dependence, use the lowest dose, intermittently, and for the shortest possible duration.
  • Recommended hypnotic dosages are generally lower in the elderly.
 
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Acute insomnia
  • Chronic insomnia
  • Insomnia characterized by middle of the night awakenings with difficulty falling back asleep

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • Documentation of the following is required:
    • All PA requests must include clinical diagnosis, drug name, dose, and frequency; and
    • Member’s current medications.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply depending upon diagnosis and/or requested medication (see below).

 

 

Belsomra

  • Documentation of all of the following is required: 
    • an appropriate diagnosis; and
    • an inadequate response or adverse reaction to two of the following, or a contraindication to all of the following: eszopiclone, ramelteon, zaleplon, zolpidem immediate-release or extended-release; and
    • one of the following:
      • requested quantity is ≤ 30 units/month; or
      • medical necessity for > 30 units per month.

 

 Edluar

  • Documentation of all of the following is required:
    • an appropriate diagnosis; and
    • clinical rationale for a sublingual formulation; and
    • one of the following:
      • requested quantity is ≤ 30 units/month; or
      • medical necessity for > 30 units per month.

 

eszopiclone, ramelteon, zaleplon, zolpidem 10 mg tablet, and zolpidem extended-release tablet (quantities > 30 units/month)

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical necessity for exceeding the quantity limit.

   

Silenor

  • Documentation of all of the following is required:
    • an appropriate diagnosis; and
    • an inadequate response or adverse reaction to one of the following, or a contraindication to all of the following: doxepin capsule or liquid, eszopiclone, ramelteon, zaleplon, zolpidem immediate-release or extended-release; and
    • one of the following:
      • requested quantity is ≤ 30 units/month; or
      • medical necessity for > 30 units per month.

  

zolpidem 1.75 mg, 3.5 mg sublingual tablet

  • Documentation of all of the following is required:
    • an appropriate diagnosis; and
    • one of the following:
      • clinical rationale for a sublingual formulation; or
      • an inadequate response or adverse reaction to three of the following: eszopiclone, zaleplon, zolpidem immediate-release, zolpidem extended-release; and
    • one of the following:
      • requested quantity is ≤ 30 units/month; or
      • medical necessity for > 30 units per month.

  

zolpidem 5 mg tablet (quantities > 45 units/month)

  • Documentation of all of the following is required:
    • an appropriate diagnosis; and
    • medical necessity for exceeding the quantity limit.

  

Zolpimist

  • Documentation of all of the following is required:
    • an appropriate diagnosis; and
    • requested dose and frequency does not exceed one canister/month; and
    • one of the following:
      • an inadequate response, adverse reaction, or contraindication to all of the following: Belsomra, doxepin capsule, liquid, or tablet, eszopiclone, ramelteon, zaleplon, zolpidem immediate-release or extended-release; or
      • both of the following:
        • clinical rationale for a non-tablet dosage form; and
        • medical necessity for use of the requested agent instead of zolpidem sublingual tablets.

 

Brand-name Ambien CR

  • Documentation of all of the following is required:
    • an appropriate diagnosis; and 
    • an inadequate response (defined as ≥ 30 days of therapy) or adverse reaction to eszopiclone; and
    • medical records documenting an inadequate response or adverse reaction to generic zolpidem extended-release tablet; and
    • one of the following:
      • requested quantity is ≤ 30 units/month; or
      • medical necessity for > 30 units/month.

  

In addition to individual drug PA criteria where applicable, some behavioral health medications are subject to additional polypharmacy and age limit restrictions.

 

Behavioral Health Medication Polypharmacy (pharmacy claims for any combination of 4 or more behavioral health medications [i.e., alpha2 agonists, antidepressants, antipsychotics, atomoxetine, benzodiazepines, buspirone, cerebral stimulants, hypnotic agents, and mood stabilizers] within a 45-day period) for members < 18 years old

  • For all requests, individual drug PA criteria must be met first where applicable.
  • For regimens including ≤ 2 mood stabilizers (also includes regimens that do not include a mood stabilizer), documentation of the following is required:
    • one of the following:
      • member had a recent psychiatric hospitalization (within the last three months); or
      • member has a history of severe risk of harm to self or others; or
    • all of the following:
      • appropriate diagnoses and
      • treatment plan including names of current behavioral health medications and corresponding diagnoses; and
      • prescriber is a specialist (e.g.,  psychiatrist, neurologist) or consult is provided.

 

  • For regimens including ≥ 3 mood stabilizers, documentation of the following is required:
    • one of the following:
      • member had a recent psychiatric hospitalization (within the last three months); or
      • member has a history of severe risk of harm to self or others; or
    • all of the following:
      • appropriate diagnoses; and
      • treatment plan including names of current behavioral health medications and corresponding diagnoses; and
      • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided; and
      • one of the following:
        • member has a seizure diagnosis only; or
        • member has an appropriate psychiatric diagnosis and one of the following:
          • Cross-titration/taper of mood stabilizer therapy; or
          • Inadequate response or adverse reaction to two monotherapy trials and/or multiple combination therapy trials as clinically appropriate; or
        • member has a diagnosis in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain)  and documentation that other clinically appropriate therapies have been tried and failed; therefore, multiple mood stabilizers are needed; or
        • member has  psychiatric and comorbid diagnosis in which mood stabilizers may be clinically appropriate  (e.g., migraine, neuropathic pain) and documentation that other clinically relevant therapies have been tried and failed; therefore, multiple mood stabilizers are needed, and one of the following:
          • Cross-titration/taper of mood stabilizer therapy; or
          • Inadequate response or adverse reaction to two monotherapy trials and/or multiple combination therapy trials as clinically appropriate.

SmartPA: Claims will usually process at the pharmacy without a PA request if the member is < 18 years of age, has a history of MassHealth medical claims for seizure, and has a history of paid MassHealth pharmacy claims for four or less behavioral health medications within the past 60 days and one mood stabilizer agent is identified as being used for seizure only.

 

eszopiclone, zaleplon, zolpidem tablet, and zolpidem extended-release tablet for members < six years old

  • For all requests, individual drug PA criteria must be met first where applicable.
  • Documentation of the following is required for members with a diagnosis of insomnia with other behavioral health comorbidities excluding ADHD:
    • treatment plan including name of current hypnotic agent and corresponding diagnosis; and
    • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided.

 

  • Documentation of the following is required for members with a diagnosis of insomnia without behavioral health comorbidities:
    • treatment plan including name of current hypnotic agent and corresponding diagnosis; and
    • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided; and
    • inadequate response (defined by ≥ 10 days of therapy), adverse reaction, or contraindication to melatonin.

 

  • Documentation of the following is required for members with a diagnosis of insomnia with comorbid ADHD:
    • treatment plan including name of current hypnotic agent and corresponding diagnosis; and
    • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided; and
    • inadequate response (defined by ≥ 10 days of therapy), adverse reaction, or contraindication to melatonin; and
    • inadequate response (defined by ≥ 10 days of therapy), adverse reaction, or contraindication to clonidine.

 

Other hypnotic agents (Belsomra, Edluar, Silenor, zolpidem 1.75 mg, 3.5 mg sublingual tablet, and Zolpimist) for members < six years old

  • For all requests, individual drug PA criteria must be met first where applicable.
  • Documentation of the following is required:
    • treatment plan including name of current hypnotic agent and corresponding diagnosis; and
    • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult was provided.

 

†Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 02/2005

Last Revised Date: 08/2019


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Last updated 11/25/19