CurrentCentenePolicy CP PMN.209

Solriamfetol (Sunosi) coverage policy

Defines medical necessity criteria, prior authorization requirements, allowed indications (narcolepsy with EDS and OSA-related residual sleepiness), dosing limits, step therapy exceptions, approval durations, and documentation requirements for solriamfetol (Sunosi) across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicySolriamfetol (Sunosi) coverage policy

Policy CodePolicy CP PMN.209

Change TypeCriteria added and wording updated

Effective DateMay 7, 2019

Next Review Date

Key ActionProvider must submit office chart notes, lab results, or other clinical information supporting member has met all approval criteria, including MSLT/PSG results, CPAP compliance documentation, and prior trial documentation.

SourceLink

POLICY UPDATE CHANGES

Added specific MSLT/MSLT+PSG documentation criteria for narcolepsy with EDS (mean latency < 8 minutes with ≥2 SOREMPs OR ≥1 SOREMP on MSLT plus SOREMP <15 min on preceding PSG) and requirement of daily irrepressible sleep periods for ≥3 months.

Updated description section to align with FDA labeling and updated narcolepsy indication wording to 'Narcolepsy with EDS'.

Clarified approval duration for Commercial to 12 months or duration of request, whichever is less.

2Covered Indications

150 mgMax Daily Dose

12 monthsApproval Duration

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Coverage Summary

coverage_stance: Covered with criteria for adults with narcolepsy with EDS and for adults with OSA and residual sleepiness when all policy criteria are met. (See prior authorization and documentation requirements.)

covered indications: Narcolepsy with EDS and Obstructive Sleep Apnea (OSA) with residual daytime sleepiness.

dosing limits: Maximum 150 mg per day; 1 tablet per day (tablets available 75 mg and 150 mg).

approval durations: Medicaid/HIM: 12 months; Commercial: 12 months or duration of request, whichever is less.

scope_summary: Defines medical necessity criteria, prior authorization and documentation requirements (MSLT/PSG and CPAP compliance where applicable), step-therapy for stimulant and modafinil/armodafinil trials (with Illinois HIM bypass per IL HB 5395), dose limits, and continued-therapy requirements for solriamfetol (Sunosi) across Commercial, HIM, and Medicaid lines of business.

thresholds (quick view): MSLT mean sleep latency: < 8 minutes with ≥2 SOREMPs; OR SOREMP on MSLT + PSG: ≥1 SOREMP on MSLT and a SOREMP on preceding overnight PSG < 15 minutes; CPAP trial for OSA: ≥ 1 month of compliant CPAP monotherapy prior to initiating Sunosi; Failed trial duration for stimulants/modafinil/armodafinil: 1 month at up to maximally indicated doses; Maximum daily dose: 150 mg/day.

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization requirement

Prior authorization is required. Approval is contingent on documentation that the member meets the policy's initial or continued therapy criteria (diagnosis, required testing, prescriber, step therapy unless exempted, and dose limits) and that the requested dose does not exceed 150 mg/day and one tablet per day.

Documentation Required

Submit supporting documentation

Submit clinical documentation supporting that the member meets all approval criteria. Required documentation includes MSLT and/or PSG results meeting narcolepsy thresholds, documentation of CPAP use and compliance for OSA-related requests, and records of prior stimulant/modafinil trials (including duration and doses).

MSLT results (mean sleep latency < 8 minutes with ≥2 SOREMPs OR ≥1 SOREMP on MSLT plus a SOREMP < 15 minutes on preceding PSG)
Overnight PSG report when relevant
CPAP compliance documentation showing ≥1 month of compliant CPAP monotherapy for OSA
Documentation of prior trials of generic stimulants and armodafinil/modafinil (1 month at up to maximally indicated doses)

Step Therapy

Step therapy requirement with statewide exception

Step therapy requires failure of specified stimulant agents (one 1-month trial of a generic central nervous system stimulant at up to maximally indicated doses) and a 1-month trial of armodafinil or modafinil at up to maximally indicated doses, unless contraindicated or intolerant. For Illinois HIM requests, these step therapy requirements do not apply as of 2026-01-01 per IL HB 5395.

Failure of a 1-month trial of one generic CNS stimulant (amphetamine, dextroamphetamine, or methylphenidate) at up to maximally indicated doses
Failure of a 1-month trial of armodafinil or modafinil at up to maximally indicated doses
Illinois HIM step therapy exemption effective 2026-01-01 per IL HB 5395

Billing Rule

Approval duration

Approval durations: Medicaid and HIM approvals are for 12 months. Commercial approvals are for 12 months or the duration of the request, whichever is less.

Denial Risk

Denial risk for non-FDA or unsupported indications

Requests for non-FDA approved indications that are not addressed in this policy require sufficient documentation of efficacy and safety per the applicable off-label use policy or will not be authorized.

Clinical Evidence & References

evidence: Prescribing information reference: Sunosi Prescribing Information, Jazz Pharmaceuticals, June 2023 (accessed Jan 14, 2025).

The policy evidence and criteria were updated to align with FDA labeling and to add specific objective testing documentation for narcolepsy with EDS (MSLT thresholds and PSG/SOREMP combination) and to add an IL HIM step-therapy bypass per IL HB 5395. Annual reviews and reference updates are documented in the revision history.

Background

background: Solriamfetol (Sunosi) is a dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adults with excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA).

It is not indicated to treat the underlying airway obstruction in OSA; modalities to treat airway obstruction (e.g., CPAP) must be used for at least one month prior to initiating Sunosi and should be continued during treatment, as Sunosi is not a substitute for these therapies.

Dosage/administration highlights from labeling: initiation regimens differ by indication and the maximum recommended dose is 150 mg/day.

definitions: MSLT — Multiple sleep latency test: an objective sleep test used to confirm narcolepsy (policy requires MSLT documentation per narcolepsy criteria).

definitions: PSG — Polysomnography (overnight sleep study): used preceding MSLT when required to document SOREMP within <15 minutes.

definitions: SOREMP — Sleep-onset rapid eye movement period: policy requires ≥2 SOREMPs on MSLT or combination of MSLT and PSG SOREMP findings for narcolepsy documentation.

definitions: EDS — Excessive daytime sleepiness: clinical requirement includes daily periods of irrepressible need to sleep or daytime lapses into sleep occurring for ≥3 months as part of narcolepsy criteria.

Revision History

material_changeLatest

05.25revised

Multiple annual reviews with reference updates; P&T approval dates noted (annual review activity documented 2021-2025). Updated description section to align with FDA labeling and updated narcolepsy indication wording to 'Narcolepsy with EDS'.

02.22clarified

Clarified approval duration for Commercial to 12 months or duration of request, whichever is less.

Policy Summary

PayerCentene

PolicySolriamfetol (Sunosi) coverage policy

Policy CodePolicy CP PMN.209

Change TypeCriteria added and wording updated

Effective DateMay 7, 2019

Next Review Date

SourceLink

On This Page

OpenPayer

Solriamfetol (Sunosi) coverage policy

Coverage Summary

Initial Therapy Criteria — Narcolepsy with EDS

Initial Therapy Criteria — Obstructive Sleep Apnea (OSA)

Continuation Therapy Criteria

Other Diagnoses / Exclusions

Provider Actions / Prior Authorization

Applicable Codes

Clinical Evidence & References

Background

Key Thresholds & Parameters

Revision History