ph-1049
print Print Back Back

Insomnia Agents Step Therapy and Quantity Limit Program Summary

Policy Number: PH-1049


 

Step Therapy will only apply to members that have a benefit including the Enhanced Step Therapy Package.

program applies to BCBS AL and Blue Partner

Insomnia Agents Step Therapy and Quantity Limit

TARGET AGENTS

Ambien® (zolpidem)a

Ambien CR® (zolpidem)a

Belsomra® (suvorexant)

Edluar® (zolpidem)

Intermezzo® (zolpidem)a

Lunesta® (eszopiclone)a

Rozerem® (ramelteon)b

Silenor® (doxepin)

Sonata® (zaleplon)a

Zolpimist (zolpidem)

a – generic available that is a prerequisite agent for step therapy program

b – generic available

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Brand Insomnia Agents will be approved when ONE of the following is met:

  1. The patient’s medication history includes the use of a generic nonbenzodiazepine hypnotic agent in the past 90 days

OR

  1. There is documentation that the patient is currently being treated with the requested agent

OR

  1. The prescriber states the patient is currently being treated with the requested agent AND is at risk if therapy is changed

OR

  1. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to the available generic nonbenzodiazepine hypnotic agents

OR

  1. The patient requires therapy with a non-controlled agent, Rozerem or Silenor

Length of approval: 12 months

NOTE: If Quantity Limit program also applies, please refer to Quantity Limit documents.

FDA APPROVED INDICATIONS AND DOSAGE1-10

Agent

Indication

Dosing and Administration

 
 

Ambien® (zolpidem)ab

tablets

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

Initial dose:

  • Women: 5 mg once nightly
  • Men: 5-10 mg once nightly

Max daily dose: 10 mg once nightly

Compared to lower doses, zolpidem 10 mg (immediate release) is more likely to impair next-morning activities requiring alertness (e.g. driving).

 

Ambien CR® (zolpidem CR)ab

tablets

Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance

Initial dose:

  • Women: 6.25 mg once nightly
  • Men: 6.25-12.5 mg once nightly

Max daily dose: 12.5 mg once nightly

Compared to lower doses, zolpidem 12.5 mg (extended release) is more likely to impair next-morning activities requiring alertness (e.g. driving).

 

Belsomra®

(suvorexant)

tablets

Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance

Initial dose: 10 mg once nightly

Max daily dose: 20 mg once nightly

 

Edluar®

(zolpidem)a

sublingual tablets

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

Initial dose:

  • Women: 5 mg once nightly
  • Men: 5-10 mg once nightly

Max daily dose: 10 mg once nightly

Compared to lower doses, zolpidem 10 mg (immediate release) is more likely to impair next-morning activities requiring alertness (e.g. driving).

 

Intermezzo® (zolpidem)ab

sublingual tablet

For use as needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep

Max daily dose:

  • Women: 1.75 mg once nightly

Men: 3.5 mg once nightly

 

Lunesta® (eszopiclone)ab

tablet

Treatment of insomnia

Initial Dose: 1 mg once nightly

Max daily dose: 3 mg once nightly

Compared to lower doses, eszopiclone 2 mg and 3 mg increase the risk of next day impairment of driving and other activities that require full alertness.

 

Rozerem® (ramelteon)

tablet

Treatment of insomnia characterized by difficulty with sleep onset

Initial dose: 8 mg once nightly

Max daily dose: 8 mg once nightly

 

Silenor®

(doxepin)

tablet

Treatment of insomnia characterized by difficulty with sleep maintenance

Initial dose: 6 mg once nightly. 3 mg once nighty may be appropriate for some patients.

Max daily dose: 6 mg once nightly

 

Sonata® (zaleplon)ab

capsule

Short-term treatment of insomnia

Initial Dose: 10 mg once nightly

Max daily dose: 20 mg once nightly

 

Zolpimist™

(zolpidem)a

oral spray

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

Initial dose:

  • Women: 5 mg once nightly
  • Men: 5-10 mg once nightly

Max daily dose: 10 mg once nightly

Compared to lower doses, zolpidem 10 mg (immediate release) is more likely to impair next-morning activities requiring alertness (e.g. driving).

 

a – Hypnotics classified as Schedule IV controlled substances

b – Generics available

CLINICAL RATIONALE

Insomnia is the most prevalent sleep disorder and can be associated with numerous adverse effects on function, health, and quality of life.11,13 The American Academy of Sleep Medicine and the American Academy of Family Physicians created clinical guidelines for the management (psychological/behavioral and pharmacological).11,12,13 The guidelines list psychological/behavioral interventions are first line and as effective as pharmacologic therapies.11,12 Short-term hypnotic therapy should be supplemented with behavioral and cognitive therapies. The guidelines recommend these general sequence of medication trials for patients with primary insomnia:11

  • Short-intermediate acting benzodiazepine receptor ago­nists (BZD or newer BzRAs) or ramelteon: examples of these medications include zolpidem, eszopiclone, zale­plon, and temazepam

• Alternate short-intermediate acting BzRAs or ramelt­eon if the initial agent has been unsuccessful

• Sedating antidepressants, especially when used in con­junction with treating comorbid depression/anxiety: examples of these include trazodone, amitriptyline, doxepin, and mirtazapine

• Combined BzRA or ramelteon and sedating antide­pressant

• Other sedating agents: examples include anti-epilepsy medications (gabapentin, tiagabine) and atypical an­tipsychotics (quetiapine and olanzapine)

The guidelines also provide recommendations regarding the management of chronic insomnia with all prescription medications:11

  • Pharmacological treatment should be accompanied by patient education regarding: (1) treatment goals and expectations; (2) safety concerns; (3) potential side effects and drug interactions; (4) other treatment mo­dalities (cognitive and behavioral treatments); (5) po­tential for dosage escalation; (6) rebound insomnia.
  • Patients should be followed on a regular basis, every few weeks in the initial period of treatment when pos­sible, to assess for effectiveness, possible side effects, and the need for ongoing medication.
  • Efforts should be made to employ the lowest effective maintenance dosage of medication and to taper medi­cation when conditions allow.
    • Medication tapering and discontinuation are fa­cilitated by cognitive behavioral therapy for insomnia.
  • Chronic hypnotic medication may be indicated for long-term use in those with severe or refractory insomnia or chronic comorbid illness. Whenever possible, patients should receive an adequate trial of cognitive behavioral treatment during long-term pharmacotherapy.
    • Long-term prescribing should be accompanied by consistent follow-up, ongoing assessment of ef­fectiveness, monitoring for adverse effects, and evaluation for new onset or exacerbation of exist­ing comorbid disorders
    • Long-term administration may be nightly, intermit­tent (e.g. three nights per week), or as needed.

Use in the Elderly

Zolpidem, zaleplon, and eszopiclone are all included in the list of Potentially Inappropriate Medications (for use in the elderly) in the Beers List published by the American Geriatrics Society.14 Benzodiazepine-receptor agonists have adverse events similar to those of benzodiazepines in older adults (e.g., delirium, falls, fractures); increased emergency department visits and hospitalizations; motor vehicle crashes; minimal improvement in sleep latency and duration. Beers provides a strong recommendation that these drugs be avoided in the elderly.14

For additional clinical information see Prime Therapeutics Formulary Chapters 9.4D: Hypnotics: Non-Benzodiazepine GABA-Receptor Modulators; and 9.4E: Selective Melatonin Receptor Agonist.

REFERENCES

  1. Rozerem prescribing information. Takeda Pharmaceuticals America, Inc. November 2010.
  2. Lunesta prescribing information. Sunovian Pharmaceuticals, Inc. November 2018.
  3. Sonata prescribing information. Pfizer Pharmaceuticals, Inc. November 2016.
  4. Ambien prescribing information. Sanofi-Aventis U.S. LLC. September 2018.
  5. Ambien CR prescribing information. Sanofi-Aventis U.S. LLC. September 2018.
  6. Edluar prescribing information. Meda Pharmaceuticals Inc. October 2018.
  7. Zolpimist prescribing information. Magna Pharmaceuticals. March 2016.
  8. Silenor prescribing information. Pernix Therapeutics, Inc. January 2018.
  9. Intermezzo prescribing information. Transcept Pharmaceuticals, Inc. September 2015.
  • 10. Belsomra prescribing information. Merck & Co., Inc. July 2018.
  • 11. Schutte-Rodin S, Broch L, Buysse D, et al. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008;4(5): 487-504.
  • 12. Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD, for the Clinical Guidelines Committee of the American College of Physicians. Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016;165:125-133. doi: 10.7326/M15-2175
  • 13. Sateia, Michael J, MD, et al. Clinical Practice Guidelines for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline. Journal of Clinical Sleep Medicine. 2017. 13 (2): 307-349.
  • 14. American Geriatrics Society 2018 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc 2018:1-53.

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

ALBP_PS_Insomnia_Agents_ST_QL_ProgSum_AR0419_r0719