CurrentCignaPolicy N/A

Sedative Hypnotics Step Therapy Policy

Cigna national step therapy policy for sedative-hypnotic medications indicating Step 1 and Step 2 products, approval rules for progressing to Step 2, and special-case approvals (substance use disorder, age ≥65, swallowing difficulty). Applies to health benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicySedative Hypnotics Step Therapy Policy

Policy CodePolicy N/A

Change TypeAddition (zolpidem capsule) + annual reviews

Effective Date

Next Review Date

Key ActionAt point of service, require documentation of a trial of one Step 1 product before coverage of Step 2 products; provide documentation for exceptions (substance use disorder, age ≥65, or swallowing difficulty).

POLICY UPDATE CHANGES

Zolpidem capsule was added to the list of Step 2 medications (history notes).

Annual revisions on 09/04/2024 and 09/03/2025 noted but stated 'No criteria changes.'

2Approval exceptions (substance use disorder; age ≥65)

1 yearApproval duration

Step 1 → Step 2Required progression

Summary of changes and impact

Background: This step therapy policy covers sedative-hypnotic agents indicated for insomnia and establishes a two-step coverage framework: Step 1 (preferred first-line generics) and Step 2 (brand products and selected agents) to encourage use of Step 1 before Step 2. History: An early annual revision added zolpidem capsule to Step 2 (08/30/2023).

Coverage stance and step therapy overview

Overview: This is the Cigna national Step Therapy policy for sedative-hypnotics with a mixed coverage stance. The policy’s intent is to encourage trial of a Step 1 product before approving a Step 2 product; if the Step Therapy rule is not met at point of service coverage is determined by the stated criteria. Approvals for Step 2 products meeting criteria are provided for 1 year.

Step Therapy Approval Criteria

Step 2 products are covered as medically necessary when the following criteria are met. All approvals are for 1 year.

ALL of the following

If the patient has tried one Step 1 Product, approve a Step 2 Product.
Approval duration: 1 year.
Exceptions allowing Step 2 without Step 1
- If the patient has a documented history of substance use disorder, approve Silenor or generic doxepin 3 mg or 6 mg tablets.
  Approval duration: 1 year.
- If the patient is ≥ 65 years of age, approve Silenor or generic doxepin 3 mg or 6 mg tablets.
  Approval duration: 1 year.
- If the patient has difficulty swallowing or cannot swallow tablets/capsules, approve Edluar or Zolpimist.
  Approval duration: 1 year.

Step 1 and Step 2 product groups

Step 1 ProductsmixedCovered

	generic eszopiclone tablets
	generic ramelteon tablets
	generic zaleplon capsules
	generic zolpidem immediate-release tablets
	generic zolpidem extended-release tablets
	generic zolpidem sublingual tablets

Step 2 ProductsmixedCovered

	Ambien (zolpidem tablets - sanofi-aventis, generic)
	Ambien CR (zolpidem extended-release tablets - sanofi-aventis, generic)
	Belsomra (suvorexant tablets - Merck)
	Dayvigo (lemborexant tablets - Eisai)
	Edluar (zolpidem 5 and 10 mg sublingual tablets - Meda)
	Lunesta (eszopiclone tablets - Sepracor, generic)
	Quviviq (daridorexant tablets - Idorsia)
	Rozerem (ramelteon tablets - Takeda, generic)
	Silenor (doxepin 3 mg and 6 mg tablets - Currax, generic)
	generic doxepin 3 mg and 6 mg tablets

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1/2

What providers must do

Step Therapy

Step 1 requirement before Step 2

At point of service, coverage for Step 2 products requires a documented trial of one Step 1 product. If the Step Therapy rule is not met at point of service, coverage will be determined by the Step Therapy Approval Criteria (see criteria).

Step 1 trial required at point of service: one Step 1 product tried prior to Step 2
If not met, apply Step Therapy Approval Criteria to determine coverage

Documentation Required

Exceptions documentation

Document the specific exception to allow Step 2 without a prior Step 1 trial and indicate which Step 2 agents are approved for that exception.

Documented history of substance use disorder → approve Silenor or generic doxepin 3 mg or 6 mg tablets
Patient age ≥ 65 years → approve Silenor or generic doxepin 3 mg or 6 mg tablets
Difficulty swallowing or cannot swallow tablets/capsules → approve Edluar or Zolpimist

Billing Rule

Approval duration

All approvals are provided for 1 year in duration.

Clinical context and references

Policy details: The policy covers products indicated for insomnia and notes that many agents (eszopiclone, zaleplon, zolpidem, Edluar, Zolpimist, Belsomra, Dayvigo, Quviviq) are Schedule IV controlled substances, while ramelteon and doxepin are not. The policy highlights geriatric considerations: elderly patients may have increased sensitivity and require downward dosage adjustments for many agents, zolpidem capsules are not indicated in geriatric patients, and several insomnia agents appear on the 2023 AGS Beers Criteria as potentially inappropriate for persons aged ≥65. The program’s intent is to encourage use of Step 1 products prior to Step 2, with specified exceptions (e.g., substance use disorder, age ≥65, swallowing difficulty) that allow certain Step 2 agents without prior Step 1 trial.

Source	Reference
AASM guideline	2017 clinical practice guideline for pharmacologic treatment of chronic insomnia in adults
Beers list	2023 AGS Beers Criteria includes several insomnia agents as potentially inappropriate in ≥65

Policy change timeline

08/30/2023material change

Zolpidem capsule was added to the list of Step 2 medications (History entry: Early Annual Revision added zolpidem capsule; review date 08/30/2023).

09/04/2024annual revision

Policy reviewed with no criteria changes.

09/03/2025annual revisionLatest