ModifiedCignaPolicy CNF640

Wakefulness-Promoting Agents – Sunosi Prior Authorization with Step Therapy Policy - (CNF640)

Defines Cigna's prior authorization and step therapy requirements for Sunosi (solriamfetol) for treatment of excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea in adults, including required prior therapies, diagnostic confirmation, prescriber type, treatment duration of approval, and disallowed concomitant use.

Policy Summary

PayerCigna

PolicyWakefulness-Promoting Agents – Sunosi Prior Authorization with Step Therapy Policy - (CNF640)

Policy CodePolicy CNF640

Change TypeCriteria revised (step therapy expanded); exceptions added

Effective Date

Next Review DateSep 3, 2026

Key ActionPrescriptions for Sunosi require prior authorization and step therapy; approvals are for up to 1 year and require documentation of criteria (age, diagnostic testing, prescriber type, prior therapy or current Sunosi use).

SourceLink

POLICY UPDATE CHANGES

Narcolepsy criteria updated to include central nervous system (CNS) stimulants as an option for required prior therapy before Sunosi; previously only generic modafinil or armodafinil were required.

OSA criteria changed to require use in conjunction with positive airway pressure or inability to initiate/tolerate positive airway pressure (expanded language from continuous PAP).

Exceptions were added so patients currently receiving Sunosi do not need to have tried step therapy comparators.

Review date updated to 04/15/2026 with Early Annual Revision noting changes.

2Covered Indications

1 yrApproval Duration

2Contraindicated Concomitant Agents

Coverage Summary

Defines Cigna's prior authorization and step therapy requirements for Sunosi (solriamfetol) for treatment of excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea in adults: approvals are for 1 year and require the patient to be ≥ 18 years, with narcolepsy requiring diagnostic confirmation by polysomnography and a multiple sleep latency test and prescriber documentation that narcolepsy is confirmed, and medication prescribed by or in consultation with a sleep specialist or neurologist. Step therapy requires trial of at least one Step 1 product (generic modafinil, generic armodafinil, or a CNS stimulant where applicable) prior to Sunosi unless the patient is currently receiving Sunosi or qualifies for the brand Provigil/Nuvigil exception. For OSA, Sunosi must be used in conjunction with positive airway pressure therapy (CPAP, APAP, or BPAP) or the patient must be unable to initiate/tolerate PAP. Concomitant use of Sunosi with oxybate products or Wakix (pitolisant) is considered not medically necessary.

FDA-Approved Indication: Excessive Daytime Sleepiness Associated with Narcolepsy

Approve for 1 year if the patient meets ALL of the following (A, B, C, D, and E):

ALL of the following

Patient is ≥ 18 years of age
Patient has been evaluated using polysomnography and a multiple sleep latency test
According to the prescriber, diagnosis of narcolepsy has been confirmed
Medication is prescribed by or in consultation with a sleep specialist physician or a neurologist
E) ONE of the following
- Patient has tried at least ONE of the following treatments: a central nervous system (CNS) stimulant, generic modafinil, or generic armodafinil
  Examples of CNS stimulants include methylphenidate, dexmethylphenidate, and dextroamphetamine. An exception is allowed if the patient has previously tried brand Provigil or brand Nuvigil.
- Patient is currently receiving Sunosi

FDA-Approved Indication: Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea (OSA)

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

ALL of the following

A: Patient is ≥ 18 years of age
B) ONE of the following
- Sunosi will be used in conjunction with positive airway pressure therapy
- Patient is unable to initiate or tolerate positive airway pressure therapy
C) ONE of the following
- Patient has tried generic modafinil or generic armodafinil

Initial Therapy / Step Therapy Requirements

Step Therapy Component

When clinically appropriate, patient is directed to try one Step 1 product prior to Sunosi (Step 2).

ALL of the following

Step 1 Products: Step 1 Product(s): generic modafinil or generic armodafinil or a CNS stimulant (for narcolepsy per recent modification)
Examples of CNS stimulants include methylphenidate, dexmethylphenidate, and dextroamphetamine.
Step 2: Sunosi (solriamfetol) after Step 1 failure, intolerance, or if already receiving Sunosi
Exception: patients currently receiving Sunosi do not need to try Step 1 products.

Duration of Approval

All approvals are provided for the duration noted below:

Approvals for both narcolepsy and OSA indications: 1 year

Unproven / Exclusions

Conditions Not Covered / Not Medically Necessary

Sunosi is considered not medically necessary for any other use(s) including:

ANY of the following

Concomitant use of Sunosi with an oxybate product (Xyrem, Lumryz, Xywav)
Oxybate products include Xyrem, Lumryz, and Xywav.
Concomitant use of Sunosi with Wakix (pitolisant)

Applicable Codes

Drug (specified product covered with PA/step therapy)NDCCovered

Sunosi (solriamfetol) tablets - Jazz

Covered product (brand) subject to prior authorization and step therapy per policy

Referenced alternative products (step 1 comparators / exceptions)mixed

modafinil (generic / Provigil)	Step 1 comparator; exception notes for brand Provigil
armodafinil (generic / Nuvigil)	Step 1 comparator; exception notes for brand Nuvigil
CNS stimulants (examples)	Examples include methylphenidate, dexmethylphenidate, and dextroamphetamine; acceptable Step 1 option per narcolepsy criteria
Xyrem / Lumryz / Xywav	Oxybate products referenced as contraindicated for concomitant use
Wakix (pitolisant)	Referenced as contraindicated for concomitant use

Clinical Evidence & Definitions

Sunosi (solriamfetol) is a dopamine and norepinephrine reuptake inhibitor indicated to improve wakefulness in adults with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea; it is a Schedule IV controlled substance. Related wakefulness-promoting agents include modafinil and armodafinil (also Schedule IV), and pitolisant (Wakix). Oxybate products (Xyrem, Lumryz, Xywav) are used in narcolepsy for cataplexy and disease severity but are not studied or recommended for concomitant use with Sunosi.

Evidence includes the Sunosi prescribing information (Axsome Therapeutics; June 2023) and the AASM clinical practice guideline for central disorders of hypersomnolence (2021). The AASM guideline gives strong recommendations for modafinil, Wakix (pitolisant), sodium oxybate, and Sunosi as effective treatments for daytime sleepiness due to narcolepsy; it also notes recommendations for modafinil in residual OSA sleepiness when PAP is effective. The Sunosi prescribing information is cited for drug-specific prescribing details.

Positive airway pressure (PAP)Includes continuous positive airway pressure (CPAP), auto-titrating positive airway pressure (APAP), or bilevel positive airway pressure (BPAP).

CNS stimulantExamples include methylphenidate, dexmethylphenidate, and dextroamphetamine (per policy note).

Revision History

2024-09-04review

Early Annual Revision: Narcolepsy criteria updated to include CNS stimulants as an option for required prior therapy before Sunosi; examples of CNS stimulants were added to the note.

2025-09-03review

Annual Revision: OSA criteria changed to require use in conjunction with positive airway pressure or inability to initiate/tolerate positive airway pressure; note added that positive airway pressure can include CPAP, APAP, or BPAP.

2026-04-15reviewLatest

Policy Summary

PayerCigna

PolicyWakefulness-Promoting Agents – Sunosi Prior Authorization with Step Therapy Policy - (CNF640)

Policy CodePolicy CNF640

Change TypeCriteria revised (step therapy expanded); exceptions added

Effective Date

Next Review DateSep 3, 2026

SourceLink

On This Page

Patient is currently receiving Sunosi

Prior Authorization

Prior authorization required for Sunosi

Prescriptions for Sunosi require prior authorization and step therapy. Approvals are for up to 1 year. Approval requires documentation that the patient meets the applicable criteria including age (≥18), diagnostic testing, prescriber type, and prior therapy or current Sunosi use.

Approvals provided for 1 year
Documentation must show age (≥18)
Documentation must show required diagnostic testing (per indication)
Documentation must show prescriber specialty or consultation
Documentation must show prior therapy trial (Step 1) or that patient is currently receiving Sunosi

Step Therapy

Step therapy enforcement

Step therapy is enforced: when clinically appropriate, patients should try a Step 1 product prior to Sunosi. Step 1 options include generic modafinil, generic armodafinil, or a CNS stimulant (for narcolepsy per recent modification). Exceptions apply for patients who are currently receiving Sunosi and for patients with prior use of brand Provigil or brand Nuvigil.

Step 1: generic modafinil, generic armodafinil, or a CNS stimulant (examples added in policy)
Step 2: Sunosi after Step 1 failure, intolerance, or if the patient is already receiving Sunosi
Exception: prior brand Provigil or brand Nuvigil use may qualify for exception
Exception: patients currently receiving Sunosi do not need to try Step 1

Documentation Required

Diagnostic documentation required for narcolepsy

For the narcolepsy indication, approval requires documentation that the patient has been evaluated with polysomnography and a multiple sleep latency test and that the prescriber has confirmed the diagnosis of narcolepsy.

Polysomnography (PSG) results must be provided
Multiple Sleep Latency Test (MSLT) results must be provided
Prescriber confirmation of narcolepsy diagnosis is required

Documentation Required

Prescriber specialty requirement

For the narcolepsy indication, the medication must be prescribed by or in consultation with a sleep specialist physician or a neurologist; documentation of the prescriber specialty or consultation is required.

Prescribed by a sleep specialist or neurologist, or
Prescribed in consultation with a sleep specialist or neurologist (document consultation)

Denial Risk

Not covered concomitant use

Requests for concomitant use of Sunosi with oxybate products (Xyrem, Lumryz, Xywav) or with pitolisant (Wakix) are considered not medically necessary and should be denied.

Do not approve Sunosi in combination with any oxybate product (Xyrem, Lumryz, Xywav)
Do not approve Sunosi in combination with Wakix (pitolisant)

Early Annual Revision: Exceptions added so patients currently receiving Sunosi do not need to have tried step therapy comparators (narcolepsy and OSA); review date updated to 04/15/2026.

2026-04-15changeLatest

Review date updated to 04/15/2026 with Early Annual Revision noting the addition of exceptions for patients currently receiving Sunosi.