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Table 15: Hypnotics


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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

Drug
Notes

daridorexant Quviviq PA  
doxepin tablet PA   A90
eszopiclone Lunesta PA   - < 6 years and PA > 1 unit/day #
lemborexant Dayvigo PA  
ramelteon Rozerem PA   - > 1 unit/day BP, A90
suvorexant Belsomra PA  
zaleplon PA   - < 6 years and PA > 1 unit/day
zolpidem 1.75 mg, 3.5 mg sublingual tablet PA  
zolpidem 10 mg tablet Ambien PA   - < 6 years and PA > 1 unit/day #
zolpidem 5 mg tablet Ambien PA   - < 6 years and PA > 1.5 units/day #
zolpidem 5 mg, 10 mg sublingual tablet Edluar PA  
zolpidem 7.5 mg capsule PA  
zolpidem extended-release tablet Ambien CR PA   - < 6 years and PA > 1 unit/day #

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. For additional information regarding hypnotic benzodiazepines (estazolam, flurazepam, 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. PA 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.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 

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.
  • Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply.
  • 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). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

 

 

Belsomra, Dayvigo, and Quviviq

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two 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 ≤ one unit/day; or
      • medical necessity for > one unit/day; and
    • for Dayvigo, an inadequate response, adverse reaction or contraindication to Belsomra; and
    • for Quviviq, an inadequate response, adverse reaction, or contraindication to both of the following: Belsomra and Dayvigo.

 

doxepin tablet

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two or contraindication to all of the following: Belsomra, Dayvigo or Quviviq, doxepin capsule or liquid, eszopiclone, ramelteon, zaleplon, zolpidem immediate-release or extended-release; and
    • one of the following:
      • requested quantity is ≤ one unit/day; or
      • medical necessity for > one unit/day.

 

Edluar

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical necessity for a sublingual formulation as noted by one of the following:
      • member utilizes tube feeding (G-tube/J-tube); or
      • member has a swallowing disorder or condition affecting ability to swallow; and 
    • one of the following:
      • requested quantity is ≤ one unit/day; or
      • medical necessity for > one unit/day.

 

eszopiclone, ramelteon, zaleplon, zolpidem 10 mg tablet, and zolpidem extended-release tablet (quantities > one unit/day)

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • requested dose is consolidated; and 
    • one of the following:
      • requested dose is once daily at bedtime; or
      • clinical rationale for requiring more than once daily bedtime dosing; and
    • all of the following:
      • inadequate response to established quantity limit; and
      • trial of a higher dose was effective in alleviating symptoms; and
      • inadequate response or adverse reaction to two of the following other alternatives for sleep (one must be a non-benzodiazepine hypnotic): doxepin, eszopiclone, an orexin receptor antagonist (Belsomra, Dayvigo, Quviviq), ramelteon or melatonin, zaleplon, zolpidem or zolpidem ER.

 

 

zolpidem 1.75 mg, 3.5 mg sublingual tablet

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • medical necessity for a sublingual formulation as noted by one of the following:
        • member utilizes tube feeding (G-tube/J-tube); or
        • member has a swallowing disorder or condition affecting ability to swallow; or
      • 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 ≤ one unit/day; or
      • medical necessity for > one unit/day.

 

zolpidem 5 mg tablet (quantities > 1.5 units/day)

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • requested dose is consolidated; and 
    • one of the following:
      • requested dose is once daily at bedtime; or
      • clinical rationale for requiring more than once daily bedtime dosing; and
    • all of the following:
      • inadequate response to established quantity limit; and
      • trial of a higher dose was effective in alleviating symptoms; and
      • inadequate response or adverse reaction to two of the following other alternatives for sleep (one must be a non-benzodiazepine hypnotic): doxepin, eszopiclone, an orexin receptor antagonist (Belsomra, Dayvigo, Quviviq), ramelteon or melatonin, zaleplon, zolpidem or zolpidem ER.

   

zolpidem 7.5 mg capsule

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to both of the following: zolpidem 5 mg tablet, zolpidem 10 mg tablet; and 
    • medical necessity for 7.5 mg capsule instead of formulations available without PA; and 
    • requested quantity is ≤ one unit/day.

    

Brand-name Ambien CR

  • Documentation of all of the following is required:
    • appropriate diagnosis; and 
    • 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 ≤ one unit/day; or
      • medical necessity for > one unit/day.

 

Hypnotic Polypharmacy (overlapping pharmacy claims for two or more hypnotics [including benzodiazepine hypnotics (estazolam, flurazepam, quazepam, temazepam, and triazolam) and non-benzodiazepine hypnotics] for at least 60 days within a 90-day period)

  • For all requests, individual drug PA criteria must be met first where applicable within established quantity limits for the individual drug.
  • Documentation of all of the following is required:
    • diagnosis of insomnia (acute or chronic); and
    • clear treatment plan; and
    • severity of sleep diagnosis; and
    • prescriber is a neurologist, sleep medicine specialist, or psychiatrist, or consultation notes from a specialist are provided; and
    • one of the following:
      • inadequate response or adverse reaction to all of the following alternative hypnotics indicated for diagnosis: an orexin receptor antagonist (Belsomra, Dayvigo, Quviviq), doxepin capsules or doxepin tablets, eszopiclone, ramelteon, zaleplon, zolpidem or zolpidem ER; or
      • contraindication to all alternative hypnotics indicated for the diagnosis; and
    • one of the following:
      • the hypnotic regimen includes two agents with different mechanisms of action; or
      • for concomitant zolpidem IR and ER, total dose requested does not exceed FDA-approved dosing of individual agents (not to exceed 12.5 mg/day).

 

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 four or more behavioral health medications [i.e., alpha2 agonists, antidepressants, antipsychotics, armodafinil, atomoxetine, benzodiazepines, buspirone, cerebral stimulants, donepezil, hypnotic agents, memantine, modafinil, mood stabilizers (agents considered to be used only for seizure diagnoses are not included), naltrexone, and viloxazine] within a 45-day period) for members < 18 years of age

  • For all requests, individual drug PA criteria must be met first where applicable.
  • For regimens including ≤ two 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 ≥ three 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, with or without seizure 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), with or without seizure diagnosis, and 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), with or without seizure diagnosis, and 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.

 

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

  • 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, Dayvigo, doxepin tablet, Edluar, and zolpidem 1.75 mg, 3.5 mg sublingual tablet) for members < six years of age

  • 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: 03/2024


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Last updated 05/16/24

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