Pharmacy Prior Authorization Criteria

Insomnia Agents

Indications for Prior Authorization

Edluar (zolpidem tartrate)

• For diagnosis of Insomnia
  Indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

  The clinical trials performed with zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.

Ambien (zolpidem tartrate)

• For diagnosis of Insomnia
  Indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

Ambien CR (zolpidem tartrate)

• For diagnosis of Insomnia
  Indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

Quviviq (daridorexant)

• For diagnosis of Insomnia
  Indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults.

Belsomra (suvorexant)

• For diagnosis of Insomnia
  Indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

Dayvigo (lemborexant)

• For diagnosis of Insomnia
  Indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

Zolpidem tartrate capsule

• For diagnosis of Insomnia
  Indicated for the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adults younger than 65 years of age.

Criteria

Ambien, Ambien CR, Brand Zolpidem capsules, Edluar

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30-day supply), or intolerance to one of the following:
• zolpidem
• zolpidem ER

Quviviq

*NOTE: Step Therapy (ST) requirements may apply for brand Belsomra and brand Dayvigo

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• ONE of the following:
• If the patient is less than 65 years of age, BOTH of the following:
• Trial and failure (of a minimum 30-day supply), contraindication, or intolerance to ONE of the following:
• Belsomra*
• Dayvigo*
AND
• Trial and failure (of a minimum 30-day supply), contraindication, or intolerance to TWO of the following:
• eszopiclone
• zaleplon
• zolpidem
• zolpidem ER
• triazolam
• temazepam
• generic ramelteon
• doxepin
OR
• If the patient is 65 years of age and older, trial and failure (of a minimum 30-day supply), contraindication, or intolerance to TWO of the following:
• generic ramelteon
• Belsomra*
• Dayvigo*
• doxepin

Belsomra, Dayvigo

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30-day supply), contraindication, or intolerance to one of the following:
• doxepin
• eszopiclone
• temazepam
• zaleplon
• zolpidem
• zolpidem ER

P & T Revisions

2024-05-20, 2023-09-22, 2023-09-22, 2023-06-06, 2023-04-05, 2022-09-08, 2021-08-14, 2021-05-19, 2020-08-18, 2019-09-05

References

1. Edluar Prescribing Information. Meda Pharmaceuticals Inc. Somerset, NJ. August 2022.
2. Ambien Prescribing Information. Sanofi-Aventis U.S. LLC. Bridgewater, NJ. February 2022.
3. Ambien CR Prescribing Information. Sanofi-Aventis U.S. LLC. Bridgewater, NJ. February 2022.
4. Quviviq Prescribing Information. Idorsia Pharmaceuticals US Inc. Radnor, PA. April 2023.
5. Belsomra Prescribing Information. Merck Sharp & Dohme LLC. Rahway, NJ. February 2023.
6. Dayvigo Prescribing Information. Eisai Inc. Nutley, NJ. May 2023.
7. The 2019 American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2019 Updated AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc 00:1-21, 2019. Available at https://www.uclahealth.org/geriatrics/workfiles/education/clinical-skills/handouts/Education-Updated-Beers-List-2019.pdf. Accessed August 7, 2023.
8. Sateia MJ, Buysse DJ, Krystal AD, Neubauer DN, Heald JL. Clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: An American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2017;13(2):307-349. Available at https://jcsm.aasm.org/doi/10.5664/jcsm.6470. Accessed August 7, 2023.
9. UpToDate. Overview of the Treatment of Insomnia in Adults. Available at https://www.uptodate.com/contents/overview-of-the-treatment-of-insomnia-in-adults?search=insomnia&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1. Accessed August 7, 2023.
10. Zolpidem Prescribing Information. Almatica Pharma LLC. Morristown, NJ. May 2023.

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Revision History

• 2024-05-20: 2024 Annual Review
• 2023-09-22: Background update (indications).
• 2023-09-22: Annual review: Removed Zolpimist as a target drug from guideline (no ST on drug) and updated background.
• 2023-06-06: update guideline
• 2023-04-05: update guideline
• 2022-09-08: Annual review: Updated criteria and background.
• 2021-08-14: 2021 UM Annual Review.
• 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
• 2020-08-18: Updated criteria to indicate 30 day supply trial of maintenance drugs.
• 2019-09-05: Guideline updated

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