CurrentCignaPolicy IP0102

Wakefulness-Promoting Agents - Sunosi

Defines Cigna's prior authorization, step therapy, and medical necessity criteria for coverage of Sunosi (solriamfetol) for adults with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyWakefulness-Promoting Agents - Sunosi

Policy CodePolicy IP0102

Change TypeRevised criteria and documentation

Effective Date

Next Review DateMar 1, 2025

Key ActionObtain prior authorization and document prior trial of a Step 1 agent (generic modafinil, generic armodafinil, or a CNS stimulant) and required diagnostic testing as applicable.

SourceLink

POLICY UPDATE CHANGES

Added central nervous system (CNS) stimulants as an alternative Step 1 product option; patients must try a CNS stimulant, generic modafinil, or generic armodafinil prior to Sunosi.

Narcolepsy criteria updated to require documentation that the patient has been evaluated using polysomnography and MSLT and that the diagnosis is documented.

OSA criteria revised to require either use with positive airway pressure (PAP) therapy (CPAP/APAP/BPAP) or documentation the patient is unable to initiate or tolerate PAP therapy, and require documentation of prior trial of generic modafinil or armodafinil.

Documentation requirements were clarified throughout (marked as [Documentation Required]).

2FDA-approved indications covered (narcolepsy; OSA)

1 yearTypical approval duration for covered indications

Policy Summary

PayerCigna

PolicyWakefulness-Promoting Agents - Sunosi

Policy CodePolicy IP0102

Change TypeRevised criteria and documentation

Effective Date

Next Review DateMar 1, 2025

Key ActionObtain prior authorization and document prior trial of a Step 1 agent (generic modafinil, generic armodafinil, or a CNS stimulant) and required diagnostic testing as applicable.

SourceLink

On This Page

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Coverage criteria for Sunosi (solriamfetol)

Initial therapy (FDA-approved uses)

Covered when ALL of the following are met for each indication as specified below.

Narcolepsy - approval for 1 year: Patient is ≥ 18 years of age; AND documentation that the patient has been evaluated using polysomnography and a multiple sleep latency test [Documentation Required]; AND documented diagnosis of narcolepsy [Documentation Required]; AND medication is prescribed by or in consultation with a sleep specialist physician or a neurologist; AND patient has tried at least ONE of the following: a central nervous system (CNS) stimulant, generic modafinil, or generic armodafinil [Documentation Required] (exception if the patient has previously tried brand Provigil or brand Nuvigil).

Approvals are for 1 year.

Obstructive Sleep Apnea (OSA) - approval for 1 year: Patient is ≥ 18 years of age; AND patient meets ONE of: (i) Sunosi will be used in conjunction with positive airway pressure therapy (CPAP, APAP, or BPAP); OR (ii) documentation that the patient is unable to initiate or tolerate positive airway pressure therapy [Documentation Required]; AND patient has tried generic modafinil or generic armodafinil [Documentation Required] (exception if the patient has previously tried brand Provigil or brand Nuvigil).

Approvals are for 1 year.

Concomitant use of Sunosi (solriamfetol) with any oxybate product (including Xyrem, Lumryz, or Xywav) and/or Wakix (pitolisant) is considered not medically necessary. Oxybate products contain the same active ingredient (oxybate), are central nervous system depressants, and have not been studied in combination or as alternating therapy with Sunosi. Similarly, Wakix has not been studied in combination with Sunosi. Because there are no published studies evaluating these combination uses, coverage for Sunosi when prescribed concomitantly with an oxybate product and/or Wakix is not supported.

Use of Sunosi for any indication other than excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea is considered not medically necessary. The policy’s list of conditions not covered reflects the lack of evidence for other indications and will be updated if new published data become available.

Coding and diagnostic thresholds

Policy-level coding guidancemixed

No codes listed

MSLT threshold and details

MSLT mean sleep latency thresholdMean sleep latency ≤ 8 minutes (average across five naps)

MSLT nap protocolFive short naps separated by 2 hours, performed the day after an overnight PSG

MSLT diagnostic significanceMean sleep latency < 8 minutes indicates excessive daytime sleepiness; presence of SOREMPs (REM within 15 minutes on ≥2 naps or night study) supports narcolepsy diagnosis

What providers must do

Prior Authorization

Prior Authorization Required

Prior authorization is required for Sunosi. Approvals are provided for the durations noted in the FDA‑approved indications when all criteria are met. Documentation is required where noted in the criteria as [Documentation Required]; documentation may include chart notes, laboratory tests, claims records, and/or other information.

Prior Authorization required for Sunosi
Approvals provided for 1 year when criteria are met

Note

Approval Duration

For both FDA‑approved indications (narcolepsy and obstructive sleep apnea), approval duration is 1 year if the patient meets the applicable criteria.

Approval duration: 1 year for covered indications

Key definitions

PSG and MSLT (definitions)

Polysomnogram (PSG)Overnight recording of brain and physiologic measures including brain and muscle activity, breathing, and eye movements

Multiple Sleep Latency Test (MSLT)Daytime test performed the day after PSG consisting of five naps to measure how quickly a person falls asleep and whether they enter REM sleep

Diagnostic useBoth PSG and MSLT are required to establish a diagnosis of narcolepsy

Positive airway pressure (PAP) definitions and notes

Positive airway pressure (PAP)Therapies used to treat obstructive sleep apnea including continuous positive airway pressure (CPAP), auto‑titrating positive airway pressure (APAP), and bilevel positive airway pressure (BPAP)

PAP role in OSA managementUnderlying airway obstruction should be treated (e.g., with CPAP) for at least 1 month prior to initiating wakefulness‑promoting therapy and continued during treatment

Background on Sunosi

Sunosi (solriamfetol) is a dopamine and norepinephrine reuptake inhibitor indicated to improve wakefulness in adults with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA). It is a Schedule IV controlled substance. For narcolepsy, diagnosis typically requires specialized testing (polysomnography and multiple sleep latency testing); for OSA, treatment of the underlying airway obstruction with positive airway pressure therapy should be optimized before or during pharmacologic wake‑promoting therapy. Prior authorization and step‑therapy requirements apply as described in the coverage criteria and provider actions sections.

Documentation Required

Documentation Required — Condition Specific

Condition‑specific documentation must be provided as noted in the criteria. For narcolepsy, documentation must include evidence that the patient was evaluated with polysomnography and a multiple sleep latency test and that the diagnosis of narcolepsy has been confirmed. For obstructive sleep apnea, documentation is required to show use of positive airway pressure therapy when applicable or documentation supporting inability to initiate or tolerate positive airway pressure; and documentation that the patient has tried generic modafinil or generic armodafinil (unless exception applies).

Narcolepsy: polysomnography and multiple sleep latency test documentation required; documented diagnosis of narcolepsy required
Obstructive sleep apnea: documentation of positive airway pressure use or documentation of inability to initiate/tolerate PAP required
For OSA and narcolepsy: documentation that patient tried generic modafinil or generic armodafinil (or exception if previously tried brand Provigil/Nuvigil)