Solriamfetol (Sunosi) coverage
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Defines medical necessity, prior authorization, and coverage criteria for solriamfetol (Sunosi) for treatment of excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea for Delaware First Health lines of business.
For narcolepsy, initial approval criteria updated to the FDA-approved indication of 'Narcolepsy with EDS' and added requirement for documentation of MSLT with mean sleep latency criteria.
For OSA, requirement added that Sunosi be prescribed concurrently with continued use of positive airway pressure therapy (e.g., BiPAP).
For continued therapy, 'improvement in reported daytime wakefulness' was added as an example of positive response.
Coverage Criteria for Solriamfetol (Sunosi)
inv-01: Initial Therapy — Narcolepsy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Prescriber specialty, step therapy trials, and MSLT/PSG documentation required; Illinois HIM step therapy exception noted.
inv-02: Initial Therapy — Obstructive Sleep Apnea — Covered when ALL of the following are met
Covered when ALL of the following are met:
PAP compliance and concurrent continued PAP use required; Illinois HIM step therapy exception noted.
inv-03: Continued Therapy — Continuation therapy covered when ALL of the following are met
Continuation therapy covered when ALL of the following are met:
Evidence of clinical benefit required for renewal; PAP continuation required for OSA.
inv-04: Dosing-linked coverage conditions — Coverage tied to indication-specific criteria and required documentation
Coverage tied to indication-specific criteria and required documentation:
Initial approval criteria updated to 'Narcolepsy with EDS' and require MSLT documentation.
Coverage for OSA requires Sunosi be prescribed concurrently with continued positive airway pressure therapy (e.g., CPAP or BiPAP).
Non‑FDA approved indications that are not specifically addressed by this policy are not authorized for coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy. Refer to CP.CPA.09 (commercial), HIM.PA.154 (HIM/ICHRA), or CP.PMN.53 (Medicaid) as appropriate when requesting coverage for off‑label uses.
For Medicaid members, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any specific coverage rules that apply.
For obstructive sleep apnea (OSA), Sunosi must be prescribed while the member is continuing positive airway pressure therapy; use of Sunosi without concurrent continued PAP therapy may be considered not meeting the policy's coverage criteria and could result in denial.
Key Diagnostic Thresholds & Definitions
Initial Therapy Requirements and Dosing
inv-26: Initial therapy — criteria differ by indication (narcolepsy vs OSA); both require age 2 21, step therapy, and dose limits
Initial therapy criteria differ by indication; both require age ≥ 18 years, step therapy trials, and dose limits:
Illinois HIM step therapy bypass per IL HB 5395 noted where applicable.
MSLT requirement (mean sleep latency ≤ 8 minutes with SOREMPs or equivalent PSG/MSLT findings) is required to support narcolepsy diagnosis.
PAP compliance documentation required.
inv-27: Initial dosing — Dosing and titration per indication for initiation
Dosing and titration per indication for initiation:
Supports prior authorization dosing limits and aligns with narcolepsy indication updates.
Requires concurrent continued positive airway pressure therapy for OSA per policy update.
Criteria for Continued Therapy / Renewal
inv-28: Continuation therapy — Continuation therapy requirements
Continuation therapy requirements:
Approval durations specified per line of business; evidence of benefit required for renewal.
inv-29: Continued therapy evidence — Examples of acceptable evidence of continued benefit for renewal were updated
Examples of acceptable evidence of continued benefit for renewal (non-exhaustive):
Added as an example of acceptable evidence in the 2Q 2026 review.
Prior Authorization, Documentation & Operational Requirements
Prior authorization required; typical approval durations
Prior authorization is required for Sunosi; approval durations are typically 12 months for Medicaid/HIM/ICHRA and up to 12 months (or duration of request, whichever is less) for commercial requests.
Updated PA requirements: narcolepsy labeled as 'Narcolepsy with EDS' and OSA PAP concurrency
Verify that narcolepsy requests are for 'Narcolepsy with EDS' and include required evidence such as MSLT results; for OSA requests, confirm documentation shows Sunosi is prescribed concurrently with continued positive airway pressure therapy.
Step therapy: required trials of stimulants and armodafinil/modafinil
For both narcolepsy and OSA, the member must have failed a 1-month trial of a generic CNS stimulant (amphetamine, dextroamphetamine, or methylphenidate) and a 1-month trial of armodafinil or modafinil at maximally indicated doses, unless contraindicated or intolerant.
- Trials are 1 month each at up to maximally indicated doses.
- Exceptions apply for clinical intolerance, contraindication, or Illinois HIM per IL HB 5395.
Illinois-specific step therapy bypass (IL HB 5395)
Illinois HIM requests are exempt from the step therapy requirement per IL HB 5395; document applicability when submitting PA for Illinois HIM members.
- Step therapy does not apply for Illinois HIM requests as of 1/1/2026 per IL HB 5395.
Required supporting documentation (office notes, labs, sleep studies)
Submit supporting documentation with the PA request, such as office chart notes, laboratory results, and sleep study reports, to demonstrate the member meets all approval criteria.
- Include evidence of prior stimulant and modafinil/armodafinil trials when applicable.
- For OSA, include documentation of PAP compliance (e.g., device reports) showing at least 1 month of use.
MSLT documentation required to support narcolepsy (mean sleep latency and SOREMPs)
Provide MSLT results that meet the policy thresholds to support narcolepsy requests: mean sleep latency ≤ 8 minutes with either ≥2 SOREMPs or at least one SOREMP on MSLT plus a SOREMP on the preceding overnight PSG, and documentation of daily irrepressible sleep or lapses for ≥3 months.
- MSLT report must include mean sleep latency and SOREMP findings.
- Document symptom duration of at least 3 months.
Incomplete documentation or unmet criteria may lead to denial
Requests missing required documentation (office notes, lab results, sleep study reports) or that do not meet the diagnostic criteria or step therapy requirements may be denied.
- Denials may result if MSLT/PSG evidence, stimulant/modafinil trial documentation, or PAP compliance is not provided.
- Ensure all criteria (age, dosing limits, prescriber specialty where required) are documented.
Document concurrent use of positive airway pressure for OSA
For OSA, include documentation that Sunosi is prescribed concurrently with continued positive airway pressure therapy (e.g., CPAP or BiPAP); lack of this documentation may result in non-coverage.
- Provide evidence of continued PAP use at the time Sunosi is prescribed.
- Document prior PAP monotherapy for at least 1 month with residual sleepiness.
Step Therapy Requirements and Exceptions
| Step | Requirement | Duration / Notes |
|---|---|---|
| 1 | ||
| Failure of a 1-month trial of a generic central nervous system stimulant (amphetamine, dextroamphetamine, or methylphenidate) at up to maximally indicated doses unless clinically significant adverse effects are experienced or all are contraindicated | ||
| 1 month; prior authorization may be required for CNS stimulants; therapeutic alternatives listed in Appendix B (see policy). |
| Step | Requirement / Bypass | State-specific note |
|---|---|---|
| 2 | ||
| Failure of a 1-month trial of armodafinil or modafinil at up to maximally indicated doses unless clinically significant side effects are experienced or both are contraindicated | ||
| 1 month; prior authorization may be required for armodafinil and modafinil; for Illinois HIM requests the step therapy requirement (both stimulant and modafinil/armodafinil trials) does not apply as of 1/1/2026 per IL HB 5395 (step therapy bypass) |
Quantity Limits and Product Details
Background
Solriamfetol (Sunosi) is a wakefulness‑promoting agent classified as a dopamine and norepinephrine reuptake inhibitor (DNRI). It is indicated to improve wakefulness in adults with excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea. Dosing recommendations in the policy align with the product information: for narcolepsy initiate at 75 mg once daily (titrate as allowed up to a maximum of 150 mg/day), and for OSA initiate at 37.5 mg once daily (titrate as allowed up to a maximum of 150 mg/day). The policy emphasizes that Sunosi is not a substitute for therapies that treat airway obstruction; for OSA, underlying airway support (e.g., CPAP or BiPAP) must be used and continued during treatment.
Definitions
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