CurrentHealth NetPolicy CP PMN.172

Clinical Policy: Zolpidem Tartrate (Edluar, Zolpimist)

Clinical coverage policy for zolpidem tartrate products (Edluar, zolpidem sublingual tablets 1.75 mg & 3.5 mg, Zolpimist) establishing initial and continued therapy medical necessity criteria, dose limits, age limits, contraindications, approval durations, formulary/redirection guidance, and references; applies to Commercial and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Zolpidem Tartrate (Edluar, Zolpimist)

Policy CodePolicy CP PMN.172

Change TypePeriodic revisions and formulary redirection updates

Effective DateDec 1, 2018

Next Review Date

Key ActionProvider must submit documentation demonstrating the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Initial policy created by splitting from CP.CPA.265 (non-benzodiazepine insomnia medications) and adding Medicaid line of business and age limit.

Increased initial approval duration for Medicaid to 6 months to align with other sleep agents.

Revised approval duration for Commercial line from length of benefit to 12 months or duration of request, whichever is less.

For brand Intermezzo requests, added requirement that member must use generic zolpidem sublingual tablet 1.75 mg or 3.5 mg (later removed when Intermezzo discontinued).

4Q annual reviews 2020-2023 noted (mostly references/template changes); 4Q2020 and 4Q2021: no significant changes; 4Q2023 removed Intermezzo as product discontinued and applied oral tablet redirection to sublingual tablet requests.

3Product formulations referenced

2Lines of business

Coverage Summary

Clinical coverage policy CP PMN.172 for Zolpidem Tartrate (Edluar, Zolpimist, zolpidem sublingual tablets 1.75 mg & 3.5 mg) applies to the Commercial and Medicaid lines of business and establishes initial and continued therapy medical necessity criteria, product-specific dose limits, age requirements, contraindications, approval durations, and formulary/redirection guidance.

Coverage stance: covered_with_criteria (approvable when the policy's initial or continued therapy criteria are met).

Surface thresholds

Minimum age>= 18 years

Zolpidem sublingual tablet (product-specific max)3.5 mg per day

Edluar and Zolpimist (product-specific max)10 mg per day

Initial approval duration - Medicaid6 months

Initial approval duration - Commercial12 months or duration of request, whichever is less

Continued therapy approval duration - Medicaid12 months

Continued therapy approval duration - Commercial12 months or duration of request, whichever is less

Initial Therapy Criteria

Initial Approval Criteria

Edluar, zolpidem sublingual tablet, and Zolpimist are medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of insomnia
Age 18 years or older>= 18 years
For zolpidem sublingual tablet 1.75 mg and 3.5 mg requests, member has a history of insomnia with difficulty returning to sleep after middle-of-the-night awakening
Failure of zolpidem oral tablets, unless contraindicated or clinically significant adverse effects are experienced

Other Diagnoses / Formulary Handling

Other Diagnoses/Indications (Non-standard uses / Formulary handling)

When the request does not meet the above, one of the following must be met:

ANY of the following

If drug is on the formulary (commercial/marketplace) or PDL (Medicaid), follow the no coverage criteria policy for the relevant line of business: CP.CPA.190 (commercial) or CP PMN.255 (Medicaid)
If drug is NOT on the formulary/PDL, follow the non-formulary policy for the relevant line of business: CP.CPA.190 (commercial) or CP.PMN.16 (Medicaid)
If the requested use (diagnosis, age, dosing) is not listed under section III and initial approval criteria do not apply, refer to off-label use policy: CP.CPA.09 (commercial) or CP PMN.53 (Medicaid)

Policy Reference Numbersmixed

CP PMN.172	Reference Number for this clinical policy
CP.CPA.190	No coverage criteria policy (commercial) referenced for other diagnoses/indications
CP PMN.255	No coverage criteria policy (Medicaid) referenced for other diagnoses/indications
CP.PMN.16	Non-formulary policy (Medicaid) referenced
CP.CPA.09	Off-label use policy (commercial) referenced
CP PMN.53	Off-label use policy (Medicaid) referenced

Continuation Therapy (Renewal) Criteria

Billing Rule

Approval duration differs by line of business

Medicaid initial approvals are for 6 months; Commercial initial approvals are for 12 months or the duration of the request, whichever is less. For continued therapy, Medicaid approvals are for 12 months; Commercial continued approvals are for 12 months or the duration of the request, whichever is less.

Diagnoses / Indications Not Authorized

Diagnoses/Indications NOT authorized

ALL of the following

Non-FDA approved indications that are not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety per applicable off-label use policies

Requests for off-label uses that are not addressed in this policy must follow the applicable off-label use policies referenced in the criteria: CP.CPA.09 for Commercial and CP PMN.53 for Medicaid.

Provider Actions & Requirements

Prior Authorization

Prior authorization required per policy

Requests must meet the initial or continued therapy criteria to be approved; non-formulary or off-label requests must follow referenced policies (see CP references).

Documentation Required

Submit supporting documentation

Provider must submit documentation (office chart notes, lab results, or other clinical information) demonstrating the member meets all approval criteria.

Clinical Evidence & References

Primary sources: Product prescribing information for Edluar; Zolpimist prescribing information; Zolpidem sublingual tablets prescribing information; and the clinical practice guideline Sateia MJ et al., J Clin Sleep Med. 2017.

Background

Zolpidem tartrate products (Edluar, zolpidem sublingual tablets, Zolpimist) are GABAA agonists approved for the short-term treatment of insomnia characterized by difficulties with sleep initiation. The zolpidem sublingual tablet formulation is indicated for as-needed middle-of-the-night awakenings with difficulty returning to sleep when there are at least 4 hours of bedtime remaining. This policy defines medical necessity criteria including diagnosis, minimum age (>= 18 years), requirement to try oral zolpidem unless contraindicated, and product-specific dosing limits to guide approval decisions.

Quick facts

Product formulations referenced3 (Edluar; zolpidem sublingual tablets 1.75 mg & 3.5 mg; Zolpimist)

Lines of business2 (Commercial, Medicaid)

Minimum age requirement>= 18 years

Definitions

Definitions: PDL = Preferred Drug List (Medicaid); SL = Sublingual.

Revision History

07.31.18; P&T Approval 11.18.18added

Initial policy created by splitting from CP.CPA.265 (non-benzodiazepine insomnia medications) and adding Medicaid line of business and age limit.

08.27.19; P&T Approval 11.19.19revised

Increased initial approval duration for Medicaid to 6 months to align with other sleep agents.

10.18.21; P&T Approval 02.22.22revised

Revised approval duration for Commercial line from length of benefit to 12 months or duration of request, whichever is less.