CurrentCignaPolicy N/A

Sedative Hypnotics Step Therapy Policy

Defines Cigna's step therapy requirements for coverage of sedative-hypnotic medications (various zolpidem products, zaleplon, eszopiclone, ramelteon, doxepin low-dose, orexin receptor antagonists, and others) for insured members under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicySedative Hypnotics Step Therapy Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateSep 4, 2024

Key ActionA Step 1 product must be used prior to a Step 2 product unless a specified clinical exception applies; approvals are provided for 1 year when criteria are satisfied.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2step levels

1 yearapproval duration

≥65age threshold

Schedule IVscheduling

Coverage and Medical Necessity Criteria

Step Therapy Criteria

Covered when ALL of the following step therapy criteria are met (with listed exceptions):

Step therapy general rule

Step 1 products: generic eszopiclone tablets OR generic ramelteon tablets OR generic zaleplon capsules OR generic zolpidem immediate-release tablets OR generic zolpidem extended-release tablets OR generic zolpidem sublingual tablets
These are the preferred first-line agents per policy

Exceptions allowing Step 2 without Step 1: Documented history of substance use disorder (approve Silenor or generic doxepin 3 mg/6 mg), age ≥ 65 years (approve Silenor or generic doxepin 3 mg/6 mg), or difficulty swallowing/unable to swallow tablets/capsules (approve Edluar or Zolpimist)

Policy explicitly permits these pathways to Step 2 products

Covered when the Step Therapy criteria are satisfied. Any product use not meeting the step therapy criteria or listed exceptions is considered not medically necessary. Approvals for products that meet the criteria are provided for 1 year in duration.

Policy Summary

PayerCigna

PolicySedative Hypnotics Step Therapy Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateSep 4, 2024

Key ActionA Step 1 product must be used prior to a Step 2 product unless a specified clinical exception applies; approvals are provided for 1 year when criteria are satisfied.

SourceLink

On This Page

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Step Therapy Rules and Product Lists

Requirement	Coverage status / notes
Patient must try one Step 1 product prior to a Step 2 product	covered when requirement met (approvals provided for 1 year).
Exception — Documented history of substance use disorder: Silenor (doxepin 3 mg or 6 mg) or generic low‑dose doxepin may be approved without prior Step 1 trial	Exception — Age ≥ 65 years: Silenor (doxepin 3 mg or 6 mg) or generic low‑dose doxepin may be approved without prior Step 1 trial
Exception — Difficulty swallowing or unable to swallow tablets/capsules: approve Edluar or Zolpimist without prior Step 1 trial	If the Step Therapy rule is not met at point of service and no exception applies, use is considered not medically necessary

Step 2 product	Coverage status / notes
Ambien (zolpidem tablets)	Requires prior trial of one Step 1 product unless an allowed exception applies; approvals are provided for 1 year when criteria met.
Ambien CR (zolpidem extended‑release)	Requires prior trial of one Step 1 product unless an allowed exception applies; approvals are provided for 1 year when criteria met.
Belsomra (suvorexant)	Requires prior trial of one Step 1 product unless an allowed exception applies; approvals are provided for 1 year when criteria met.
Dayvigo (lemborexant)	Requires prior trial of one Step 1 product unless an allowed exception applies; approvals are provided for 1 year when criteria met.
Edluar (zolpidem sublingual)	May be approved without Step 1 trial for patients with difficulty swallowing; otherwise requires Step 1 first.
Intermezzo (zolpidem sublingual for middle‑of‑the‑night awakenings)	Requires prior trial of one Step 1 product unless an allowed exception applies; approvals are provided for 1 year when criteria met.
Lunesta (eszopiclone)	Requires prior trial of one Step 1 product unless an allowed exception applies; approvals are provided for 1 year when criteria met.
Quviviq (daridorexant)	Requires prior trial of one Step 1 product unless an allowed exception applies; approvals are provided for 1 year when criteria met.
Rozerem (ramelteon)	Requires prior trial of one Step 1 product unless an allowed exception applies; approvals are provided for 1 year when criteria met.
Silenor (doxepin 3 mg and 6 mg) / generic low‑dose doxepin	May be approved without Step 1 trial for patients with documented substance use disorder or age ≥ 65 years; otherwise requires Step 1 first.
Sonata (zaleplon)	Requires prior trial of one Step 1 product unless an allowed exception applies; approvals are provided for 1 year when criteria met.
zolpidem 7.5 mg capsules (branded generic)	Requires prior trial of one Step 1 product unless an allowed exception applies; approvals are provided for 1 year when criteria met.
Zolpimist (zolpidem oral spray)	May be approved without Step 1 trial for patients with difficulty swallowing; otherwise requires Step 1 first. Note: product listed in policy product list.

Provider Responsibilities, Prior Authorization, and Billing

Prior Authorization

Prior Authorization Required — Step Therapy Applies

Step therapy prior authorization is required for Step 2 products. This program encourages use of a Step 1 product before a Step 2 product. All approvals are provided for 1 year when the step therapy criteria are satisfied. If the Step Therapy rule is not met at the point of service, coverage for a Step 2 product may be denied and will be determined by the step therapy criteria below.

Step 1 products include: generic eszopiclone, generic ramelteon, generic zaleplon, generic zolpidem IR, generic zolpidem ER, generic zolpidem sublingual.
Step 2 products include: Ambien, Ambien CR, Belsomra, Dayvigo, Edluar, Intermezzo, Lunesta, Quviviq, Rozerem, Silenor, generic doxepin 3 mg/6 mg, Sonata, zolpidem 7.5 mg capsules, Zolpimist.

Step Therapy

Provider Step Therapy Actions

Providers must follow the Step Therapy actions below when requesting coverage for Sedative Hypnotics Step Therapy Policy products. A Step 1 product should be used prior to a Step 2 product unless a clinical exception below applies.

Approve a Step 2 product when the patient has tried one Step 1 product.
If patient has documented history of substance use disorder, Silenor or generic doxepin (3 mg or 6 mg) may be approved without prior Step 1 use.
If patient is ≥ 65 years of age, Silenor or generic doxepin (3 mg or 6 mg) may be approved without prior Step 1 use.
If patient has difficulty swallowing or cannot swallow tablets/capsules, Edluar or Zolpimist may be approved without prior Step 1 use.

Documentation Required

Billing and Claims Documentation Requirements

When submitting claims, providers must use the most appropriate diagnosis and procedure codes as of the date of service. Claims submitted for services that are not accompanied by covered diagnosis/procedure codes under the applicable coverage policy will be denied as not covered.

Ensure the submitted codes correspond to covered services under this policy.
Use current CPT/HCPCS/ICD-10/NDC codes applicable to the medication or service being billed.

Denial Risk

Step Therapy Enforcement and Denial Risk

Coverage for Step 2 products will be determined by the step therapy criteria. If step therapy requirements are not met at point of service, there is a risk of denial; providers should document prior Step 1 use or an applicable exception to reduce denial risk.

Denial risk exists if Step 1 has not been tried and no exception applies.
Document clinical rationale and applicable clinical exceptions (age ≥65, substance use disorder, swallowing difficulty) in the medical record and on the prior authorization request.

Key Definitions

Insomnia — definition and policy relevance

DefinitionInsomnia — difficulty initiating or maintaining sleep as treated by the sedative‑hypnotic agents listed in this policy (e.g., zolpidem IR/ER, zaleplon, eszopiclone, ramelteon, low‑dose doxepin, orexin receptor antagonists).

Typical presentationsSleep onset insomnia (difficulty initiating sleep), sleep maintenance insomnia (difficulty maintaining sleep), and middle‑of‑the‑night awakenings with difficulty returning to sleep — agent choice depends on labeled indication.

Agent labeling notesZolpidem IR/ER, zaleplon, and zolpidem sublingual (Edluar) are indicated for short‑term use; eszopiclone, ramelteon, and low‑dose doxepin do not have a specific short‑term limitation in labeling.

Clinical implication for this policyStep therapy requires trial of a Step 1 preferred agent prior to Step 2 agents for treatment of insomnia unless an exception applies.

Schedule IV status of selected hypnotics

Controlled substance scheduleMany non‑benzodiazepine hypnotics included in this policy (eszopiclone, zaleplon, zolpidem products, zolpidem sublingual/Edluar, Zolpimist, and the orexin receptor antagonists Belsomra, Dayvigo, Quviviq) are classified as Schedule IV controlled substances.

ExceptionsRamelteon (Rozerem) and doxepin (Silenor/low‑dose) are not controlled substances per product labeling.

Policy relevanceControlled substance status may affect prescribing, dispensing, and monitoring considerations when selecting insomnia therapy under the step therapy rules.

Clinical Background

The policy applies to sedative-hypnotic agents indicated for the treatment of insomnia. The policy’s Step 1 list consists of preferred generics (generic eszopiclone, generic ramelteon, generic zaleplon, and generic zolpidem in immediate-, extended-release, or sublingual forms), while Step 2 includes a broader set of branded and other products (for example, Ambien/Ambien CR, Belsomra, Dayvigo, Edluar, Lunesta, Rozerem, Silenor, and orexin receptor antagonists). Certain agents (such as zolpidem immediate- and extended-release and zaleplon) are noted for short-term use in product labeling, and many of the nonbenzodiazepine hypnotics are classified as Schedule IV controlled substances.

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