ModifiedmhnPolicy CP.PMN.209

Clinical Policy: Solriamfetol (Sunosi)

Defines medical necessity criteria, prescribing and documentation requirements, and approval durations for solriamfetol (Sunosi) to treat excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea across specified lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Solriamfetol (Sunosi)

Policy CodePolicy CP.PMN.209

Change TypeRevised approval durationadded narcolepsy diagnostic criteriaIL step therapy bypass

Effective DateMay 7, 2019

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, specialist involvement, required sleep testing (MSLT/PSG), prior stimulant and wake-promoting agent trials, and dose limits.

SourceLink

POLICY UPDATE CHANGES

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

Added criteria for documentation of MSLT with mean sleep latency ≤ 8 minutes with evidence of two or more SOREMPs or at least one SOREMP on MSLT and a SOREMP on the preceding overnight PSG, plus daily periods of irrepressible need to sleep or daytime lapses into sleep for at least 3 months, to align with narcolepsy with EDS criteria.

For narcolepsy, updated indication in initial approval criteria to FDA-approved indication of 'Narcolepsy with EDS' to align with prescriber information.

Updated description section to align with FDA labeling.

≥18minimum age

150 mg/daymax daily dose

12 monthsapproval duration

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2+ or 1+PSGSOREMP requirement

Coverage Criteria

Initial Approval — Narcolepsy with Excessive Daytime Sleepiness

Covered when ALL of the following are met:

Narcolepsy initial criteria

Diagnosis of narcolepsy with EDS
Prescribed by or in consultation with a neurologist or sleep medicine specialist
Age ≥ 18 years
ALL of the following
- (a) EDS confirmed by MSLT AND one of: (i) mean sleep latency ≤ 8 minutes with ≥2 SOREMPs OR (ii) ≥1 SOREMP on MSLT plus a SOREMP (<15 minutes) on the preceding overnight PSGMSLT/PSG criteria
- (b) Daily periods of irrepressible need to sleep or daytime lapses into sleep occurring for ≥3 months≥3 months
Failure of a 1-month trial of one generic CNS stimulant (amphetamine, dextroamphetamine, or methylphenidate) at up to maximally indicated doses, unless intolerant or contraindicated1 month
Prior authorization may be required for CNS stimulants; IL HIM exceptions per IL HB 5395
Failure of a 1-month trial of armodafinil or modafinil at up to maximally indicated doses, unless intolerant or contraindicated1 month
Prior authorization may be required
Dose does not exceed both: (a) 150 mg per day and (b) 1 tablet per day≤150 mg/day; 1 tablet/day

Initial Approval — Obstructive Sleep Apnea (OSA) with residual sleepiness

Covered when ALL of the following are met:

OSA initial criteria

Diagnosis of obstructive sleep apnea (OSA)
Age ≥ 18 years
Documented residual sleepiness despite compliant CPAP use as monotherapy for at least 1 monthCPAP ≥1 month
Underlying airway obstruction must be treated and treatment continued
Failure of a 1-month trial of armodafinil or modafinil at up to maximally indicated doses, unless intolerant or contraindicated1 month
Prior authorization may be required

Initial approval — Narcolepsy with EDS

Covered when ALL of the following are met for narcolepsy with EDS:

Narcolepsy with EDS initial approval: MSLT demonstrates mean sleep latency ≤ 8 minutes with either (a) ≥2 SOREMPs on MSLT, or (b) ≥1 SOREMP on MSLT and a SOREMP (<15 minutes) on the preceding overnight PSG; AND daily periods of irrepressible need to sleep or daytime lapses into sleep have occurred for at least 3 months; AND indication aligns with FDA-approved 'Narcolepsy with EDS'.see node text

Added to align with narcolepsy criteria and FDA labeling.

Continued Therapy (All Indications)

Continued coverage when ALL of the following are met:

Continued therapy criteria

Member currently receiving medication via Centene benefit OR member previously met initial approval criteria OR continuity of care applies
Refer to state addendums for continuity of care
Member is responding positively to therapy
If request is for a dose increase, new dose does not exceed both: (a) 150 mg per day and (b) 1 tablet per day≤150 mg/day; 1 tablet/day

Other/Off-label Uses

Other indications

If the drug label changed within the last 6 months and this policy is not updated, follow referenced formulary or non-formulary policies for the relevant line of business6 months
See CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16
If the requested use is not listed and criterion above does not apply, refer to off-label use policies
See CP.CPA.09, HIM.PA.154, CP.PMN.53

Non‑FDA approved indications that are not specifically addressed by this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid).

When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual for any state‑specific coverage requirements.

Requests for indications not covered by this policy that lack adequate supporting evidence will not be authorized. Such requests must meet the documentation standards and evidentiary requirements specified in the referenced off‑label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for HIM, CP.PMN.53 for Medicaid) to be considered for approval.

For Commercial line of business, the policy approval duration has been revised: prior authorizations are limited to 12 months or the duration of request, whichever is less. Requests that seek durations beyond this revised Commercial approval limit may be considered not medically necessary and are subject to denial under plan rules.

Diagnostic Thresholds & Coding-Adjacent Criteria

MSLT mean sleep latency — narcolepsy confirmation

MSLT mean sleep latency (narcolepsy confirmatory)Mean sleep latency ≤ 8 minutes with evidence of ≥2 SOREMPs

Alternative MSLT/PSG combinationAt least one SOREMP on MSLT plus a SOREMP (<15 minutes) on the preceding overnight PSG

PurposeUsed to confirm excessive daytime sleepiness associated with narcolepsy via objective sleep-onset measures (SOREMPs)

Narcolepsy daily symptom duration

Required symptom durationDaily periods of irrepressible need to sleep or daytime lapses into sleep for ≥3 months

Symptom characterizationSymptoms must be daily and include irrepressible sleepiness or daytime lapses into sleep

Provider Requirements and Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Solriamfetol (Sunosi). Provider must include key documentation with the request and involve appropriate specialists for initial approvals where indicated.

Prior authorization required for commercial, Medicaid/HIM per plan rules
Prescribed by or in consultation with a neurologist or sleep medicine specialist for narcolepsy indication
Include documentation listed below to avoid denial

Prior Authorization

Prior Authorization and Approval Duration

Commercial approvals are limited to 12 months or the duration of the request, whichever is less. Medicaid/HIM approvals are 12 months.

Commercial: 12 months or duration of request, whichever is less
Medicaid/HIM: 12 months

Background

Solriamfetol is a dopamine and norepinephrine reuptake inhibitor approved to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. For narcolepsy, diagnosis should align with FDA‑approved description of "Narcolepsy with EDS" and objective testing (e.g., MSLT/PSG) is used to confirm excessive daytime sleepiness. For OSA, underlying airway obstruction should be treated (for example, with CPAP) and continued while treating residual sleepiness with solriamfetol.

Definitions

MSLT — definition and role

DefinitionMultiple Sleep Latency Test (MSLT): a diagnostic sleep test used to confirm excessive daytime sleepiness and identify sleep-onset REM periods (SOREMPs)

RoleProvides objective measurement of mean sleep latency and number/timing of SOREMPs to support narcolepsy diagnosis

Typical usePerformed following an overnight polysomnography (PSG) to assess daytime sleep propensity and REM onset

PSG — definition and diagnostic role

DefinitionPolysomnography (PSG): an overnight sleep study used to document sleep architecture and SOREMPs

Role in narcolepsy workupPSG documents nocturnal SOREMPs and supports interpretation of subsequent MSLT findings (e.g., SOREMP <15 min on PSG)

Revision History

2025-04-07annual_review/updateLatest

Updated initial narcolepsy indication to align with FDA-approved 'Narcolepsy with EDS' in the initial approval criteria (2Q 2025 annual review).

2021-09-28policy_revision

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

2024-01-12annual_review/update

Policy Summary

Payermhn

PolicyClinical Policy: Solriamfetol (Sunosi)

Policy CodePolicy CP.PMN.209

Change TypeRevised approval durationadded narcolepsy diagnostic criteriaIL step therapy bypass

Effective DateMay 7, 2019

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, specialist involvement, required sleep testing (MSLT/PSG), prior stimulant and wake-promoting agent trials, and dose limits.

SourceLink

On This Page

Dose does not exceed both: (a) 150 mg per day and (b) 1 tablet per day≤150 mg/day; 1 tablet/day

Documentation linkageSymptom duration must be documented alongside MSLT/PSG findings to support narcolepsy with EDS diagnosis

OSA CPAP trial duration

CPAP trial durationCompliant CPAP use as monotherapy for ≥1 month

ContextRequired for OSA patients to demonstrate residual sleepiness despite airway obstruction treatment

ContinuationAirway obstruction treatment should be continued during solriamfetol therapy

MSLT mean sleep latency (alternate index)

MSLT mean sleep latency (alternate index)Mean sleep latency ≤ 8 minutes

Usage noteThreshold reiterated to align with narcolepsy diagnostic criteria and documentation requirements

Relation to SOREMPsMSLT ≤8 min is interpreted in context of SOREMP findings (see SOREMP criteria)

Duration of symptoms

Diagnostic duration thresholdSymptoms present for ≥3 months

Applies toNarcolepsy with EDS (daily irrepressible need to sleep or daytime lapses into sleep)

Documentation requirementDuration must be documented in clinical records submitted for prior authorization

Step Therapy

Step Therapy Requirements

Step therapy requirements must be documented for applicable indications unless an exception applies (see IL bypass). Providers must document trials and reasons for failure or intolerance.

Narcolepsy: Failure of a 1-month trial of a generic CNS stimulant (amphetamine, dextroamphetamine, or methylphenidate) at up to maximally indicated doses unless contraindicated or not tolerated
Narcolepsy and OSA: Failure of a 1-month trial of armodafinil or modafinil at up to maximally indicated doses unless contraindicated or not tolerated
Note: Prior authorization may also be required for the stimulant agents and modafinil/armodafinil

Note

IL Step Therapy Bypass

Illinois (HIM) step therapy bypass: per IL HB 5395 (effective 1/1/2026), the step therapy requirements do not apply for Illinois HIM requests. Indicate state and product on the request to enable applicable bypass/continuity rules.

IL HIM: Step therapy requirements do not apply as of 1/1/2026 per IL HB 5395

Documentation Required

Providers must submit complete clinical documentation to support that the member meets all approval criteria. Failure to provide required documentation may result in denial or delay.

Office chart notes documenting diagnosis, symptom history, medication trials, and response
Relevant test results (MSLT, PSG, sleep study reports, CPAP compliance evidence)
Medication history including dates, doses, durations, and reasons for discontinuation or intolerance
Specialist consultation notes when required (neurologist or sleep medicine specialist for narcolepsy)

Documentation Required

Narcolepsy Diagnostic Documentation

For narcolepsy with excessive daytime sleepiness, document objective diagnostic testing and symptom duration as specified below.

MSLT documentation showing mean sleep latency ≤ 8 minutes with evidence of two or more SOREMPs, OR at least one SOREMP on MSLT plus a SOREMP (<15 minutes) on the preceding overnight PSG
Daily periods of irrepressible need to sleep or daytime lapses into sleep occurring for at least 3 months (daily symptom documentation)
If requested, include raw sleep study reports and interpreting clinician notes

Denial Risk

Approval Duration Limit

Approval requests exceeding the revised Commercial approval duration (greater than 12 months or longer than the duration of request) may be denied. Ensure requested duration aligns with plan limits.

Do not request durations for Commercial members that exceed 12 months or the duration of request, whichever is less

Use caseA PSG is performed before MSLT when required to confirm REM-related findings referenced in narcolepsy criteria

MSLT / SOREMP narcolepsy criteria

Primary narcolepsy criteriaMSLT demonstrating mean sleep latency ≤ 8 minutes with either (a) ≥2 SOREMPs on MSLT or (b) ≥1 SOREMP on MSLT plus a SOREMP (<15 minutes) on the preceding overnight PSG

Symptom requirementAND daily periods of irrepressible need to sleep or daytime lapses into sleep for ≥3 months

Clinical alignmentCriteria align with FDA-approved 'Narcolepsy with EDS' indication and must be documented for prior authorization

Updated description section to align with FDA labeling (2Q 2024 annual review).

criteria_addition

Added criteria for documentation of MSLT with mean sleep latency ≤ 8 minutes with SOREMP requirements and ≥3 months of daily irrepressible sleepiness, and added an IL HIM step therapy bypass per IL HB 5395.