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Insomnia Agents Quantity Limit Program Summary
Policy Number: PH-1049
This program applies to Commercial, Blue Partner, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
7/1/2023 |
|
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Ambien® (zolpidem)*^ Tablet |
Short-term treatment of insomnia characterized by difficulties with sleep initiation
|
*- Hypnotics classified as Schedule IV controlled substances ^- Generics available |
2 |
Ambien CR® (zolpidem CR)*^ Tablet |
Short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance
|
*- Hypnotics classified as Schedule IV controlled substances ^- Generics available |
1 |
Belsomra® (suvorexant)* Tablet |
Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance
|
*- Hypnotics classified as Schedule IV controlled substances |
3 |
Dayvigo® (lemborexant)* Tablet |
Treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance
|
*- Hypnotics classified as Schedule IV controlled substances
|
13 |
Edular® (zolpidem)* Sublingual tablet |
Short-term treatment of insomnia characterized by difficulties with sleep initiation
|
*- Hypnotics classified as Schedule IV controlled substances |
4 |
Intermezzo® (zolpidem)*^ 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
|
*- Hypnotics classified as Schedule IV controlled substances ^- Generics available |
5 |
Lunesta® (eszopiclone)*^ Tablet |
Treatment of insomnia
|
*- Hypnotics classified as Schedule IV controlled substances ^- Generics available |
6 |
Quviviq™ (daridorexant)* Tablet |
Treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance |
*- Hypnotics classified as Schedule IV controlled substances
|
14 |
Rozerem (ramelteon)^ Tablet |
Treatment of insomnia characterized by difficulty with sleep onset
|
^- Generics available |
7 |
Silenor® (doxepin)^ Tablet |
Treatment of insomnia characterized by difficulty with sleep maintenance
|
^- Generics available |
8 |
Zolpimist (zolpidem)* Oral spray |
Short-term treatment of insomnia characterized by difficulties with sleep initiation
|
*- Hypnotics classified as Schedule IV controlled substances |
9 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Insomnia |
Insomnia is the most prevalent sleep disorder and can be associated with numerous adverse effects on function, health, and quality of life. (10,11) The American Academy of Sleep Medicine and the American College of Physicians created clinical guidelines for the management (psychological/behavioral and pharmacological).(10,11,15) The guidelines indicate psychological/behavioral interventions are first line and as effective as pharmacologic therapies. Initial approaches to treatment should include at least one behavioral intervention such as stimulus control therapy or relaxation therapy, or the combination of cognitive therapy, stimulus control therapy, sleep restriction therapy with or without relaxation therapy—otherwise known as cognitive behavioral therapy for insomnia (CBT-I). Short-term hypnotic therapy should be supplemented with behavioral and cognitive therapies.(10,15) The guidelines recommend these general sequence of medication trials for patients with primary insomnia:(15)
The guidelines also provide recommendations regarding the management of chronic insomnia with all prescription medications:(15)
Over-the-counter antihistamine or antihistamine/analgesic type drugs (OTC “sleep aids”) as well as herbal and nutritional substances (e.g., valerian and melatonin) are not recommended in the treatment of chronic insomnia due to the relative lack of efficacy and safety data.(15) |
Safety(1-9,13,14) |
Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist are contraindicated in the following:
Belsomra, Dayvigo, and Quviviq are contraindicated in patients with narcolepsy Lunesta is contraindicated in the following:
Rozerem is contraindicated in the following:
Silenor is contraindication in the following:
|
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.(12) Benzodiazepine-receptor agonist hypnotics (i.e., Z drugs) have adverse events similar to those of benzodiazepines in older adults (e.g., delirium, falls, fractures); increased emergency room 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.(12) |
REFERENCES
Number |
Reference |
1 |
Ambien CR prescribing information. Sanofi-Aventis U.S. LLC. February 2022. |
2 |
Ambien prescribing information. Sanofi-Aventis U.S. LLC. February 2022. |
3 |
Belsomra prescribing information. Merck & Co., Inc. May 2022. |
4 |
Edluar prescribing information. Meda Pharmaceuticals Inc. August 2019. |
5 |
Intermezzo prescribing information. Transcept Pharmaceuticals, Inc. August 2019. |
6 |
Lunesta prescribing information. Sunovian Pharmaceuticals, Inc. August 2019. |
7 |
Rozerem prescribing information. Takeda Pharmaceuticals America, Inc. November 2021. |
8 |
Silenor prescribing information. Pernix Therapeutics, Inc. October 2020. |
9 |
Zolpimist prescribing information. Magna Pharmaceuticals. August 2019. |
10 |
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 |
11 |
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. |
12 |
American Geriatrics Society 2019 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc 2019:1-21. |
13 |
Dayvigo prescribing information. Eisai Inc. June 2022. |
14 |
Quviviq prescribing information. Idorsia Pharmaceuticals LTD. October 2022. |
15 |
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. |
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
|
zaleplon cap |
10 MG ; 5 MG |
30 |
Capsules |
30 |
DAYS |
|
|
|
|
Zolpidem Tartrate SL Tab 1.75 MG |
1.75 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
|
Zolpidem Tartrate SL Tab 3.5 MG |
3.5 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Ambien |
zolpidem tartrate tab |
10 ; 10 MG ; 5 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Ambien cr |
zolpidem tartrate tab er |
12.5 MG ; 6.25 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Belsomra |
suvorexant tab |
10 MG ; 15 MG ; 20 MG ; 5 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Dayvigo |
lemborexant tab |
10 MG ; 5 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Edluar |
Zolpidem Tartrate SL Tab 10 MG |
10 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Edluar |
Zolpidem Tartrate SL Tab 5 MG |
5 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Lunesta |
Eszopiclone Tab ; eszopiclone tab |
1 MG ; 2 ; 2 MG ; 3 ; 3 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Quviviq |
daridorexant hcl tab |
25 MG ; 50 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Rozerem |
ramelteon tab |
8 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Silenor |
doxepin hcl (sleep) tab |
3 MG ; 6 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Zolpimist |
zolpidem tartrate oral spray |
5 MG/ACT |
1 |
Inhaler |
30 |
DAYS |
|
|
|
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
|
zaleplon cap |
10 MG ; 5 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
Zolpidem Tartrate SL Tab 1.75 MG |
1.75 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
Zolpidem Tartrate SL Tab 3.5 MG |
3.5 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Ambien |
zolpidem tartrate tab |
10 ; 10 MG ; 5 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Ambien cr |
zolpidem tartrate tab er |
12.5 MG ; 6.25 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Belsomra |
suvorexant tab |
10 MG ; 15 MG ; 20 MG ; 5 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Dayvigo |
lemborexant tab |
10 MG ; 5 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Edluar |
Zolpidem Tartrate SL Tab 10 MG |
10 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Edluar |
Zolpidem Tartrate SL Tab 5 MG |
5 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Lunesta |
Eszopiclone Tab ; eszopiclone tab |
1 MG ; 2 ; 2 MG ; 3 ; 3 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Quviviq |
daridorexant hcl tab |
25 MG ; 50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Rozerem |
ramelteon tab |
8 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Silenor |
doxepin hcl (sleep) tab |
3 MG ; 6 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Zolpimist |
zolpidem tartrate oral spray |
5 MG/ACT |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: up to 12 months |
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 Blue Cross and Blue Shield of Alabama’s 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.
Commercial _ PS _ Insomnia Agents Quantity Limit _ProgSum_ 7/1/2023