Cigna sedative-hypnotics quantity limits Policy Update

Coverage Criteria and Quantity Limits

Per-product Quantity Limits

Quantity limits apply per listed product; exceptions are covered as medically necessary when the specific criteria are met; otherwise not medically necessary.

Per-product quantity limits: Each listed sedative-hypnotic has a retail and home-delivery maximum quantity per prescription as specified in the Drug Quantity Limits section (examples: many agents retail = 30 tablets, home delivery = 90 tablets; certain benzodiazepines and older hypnotics have retail and home delivery limits of 15).see product-specific entries

See chunks 9-12 for per-product exact limits

Drug- and indication-specific exception criteria

Exceptions to the stated quantity limits are considered medically necessary when the listed criteria for the specific drug and clinical scenario are met.

Zaleplon 10 mg approval

A) Acute Insomnia (one-time override): Approve a one-time override for 30 capsules/tablets if ALL: i) patient has received nightly therapy with the requested drug for <60 days; ii) insomnia expected to persist >15 of next 30 days per prescriber; iii) insomnia not amenable to intermittent therapy per prescriber; iv) patient has tried at least one form of behavioral therapy; v) patient has been evaluated for underlying psychiatric/medical conditions and, if necessary, those conditions are being addressed.one-time 30 days
Authorization beyond 60 days for acute insomnia is not recommended.
B) Chronic Insomnia: Initial therapy: approve 30 capsules per dispensing (retail) or 90 per dispensing (home delivery) for 6 months if patient requires nightly therapy AND either (a) is being followed by or consulted with a sleep specialist OR (b) meets all: 1) tried at least one behavioral therapy; 2) not currently taking non-prescription and/or prescription stimulants if medically appropriate; 3) evaluated for underlying psychiatric/medical conditions and those are being addressed. Continuation: approve 30 retail/90 home delivery per dispensing for 1 year if patient has received nightly therapy ≥6 months and the drug remains effective per prescriber.30 retail/90 home delivery initial; 1 year continuation
Chronic insomnia = >4 nights/week for >3 months.
C) Major Depressive Disorder, Bipolar Disorder, or Generalized Anxiety Disorder: Initial therapy: approve 30 capsules per dispensing (retail) or 90 per dispensing (home delivery) for 3 months if patient is receiving drug therapy to treat MDD, bipolar disorder, or GAD. Continuation: approve 30 retail/90 home delivery per dispensing for 1 year if ALL: a) patient is receiving drug therapy for the psychiatric disorder; b) has received nightly therapy ≥3 months; c) has diagnosis of chronic insomnia requiring nightly therapy; d) has tried at least one behavioral therapy; e) is not currently taking non-prescription and/or prescription stimulants if medically appropriate.30 retail/90 home delivery initial; 1 year continuation
See chunks 14-17 for details.

Standard per-dispensing quantity coverage

Covered when dispensed at or below the specified per-dispensing limits (retail and home delivery) unless a clinical override is approved.

Standard quantity limits: Dispensing quantity must be less than or equal to the specified limit for the agent (examples include 15 tablets/capsules per dispensing for certain benzodiazepines/older hypnotics and 30/90 for many agents at retail/home delivery).<= specified product limit (e.g., <=15 or <=30 retail/<=90 home delivery)

Clinical override allowed when exception criteria are met

Zaleplon dispensing limits

Zaleplon 10 mg capsule dispensing limits differ by channel.

Zaleplon limits: Dispensing quantity must be <=30 capsules at retail OR <=90 capsules at home delivery. Exceptions above these limits may be approved only when the specific exception criteria (A, B, or C) and prior inadequate response to zaleplon 10 mg once daily are documented.<=30 retail; <=90 home delivery

Clinical override criteria apply; see detailed criteria for zaleplon in chunks 14-17

Exceptions to the quantity limits in this policy are explicitly permitted only when the listed clinical criteria are met. Any other exception is considered not medically necessary.

No additional explicit items are listed in this section beyond the product-specific limits and exception criteria already provided.

Requests that exceed the stated per-dispensing quantity limits and that do not meet the specified exception criteria are not medically necessary and are not eligible for coverage.

Although not spelled out as a separate line item, the policy change notes make clear that dispensing above the established per-dispensing limits without an approved clinical override will fail to meet coverage rules and therefore will not be approved.

Product-Specific Quantity Limits

Multiple (see list) — overview

ScopeQuantity limits vary by product and are applied per prescription; examples include many agents with Retail=30 / Home delivery=90, while some older benzodiazepine agents have lower limits.

Examples (retail/home delivery)Ambien (zolpidem): Retail 30 / Home delivery 90; Ambien CR: Retail 30 / Home delivery 90; Lunesta: Retail 30 / Home delivery 90.

Lower-limit examplesDoral (quazepam), Estazolam, Flurazepam, Triazolam (Halcion), Temazepam (Restoril): Retail 15 / Home delivery 15 per dispensing.

Zaleplon example (channel-specific)Zaleplon 10 mg capsules have channel-specific limits (see product entry): retail and home delivery limits differ from many other agents.

ExceptionsExceptions to listed quantity limits are considered medically necessary only when the specific criteria in the policy are met; otherwise requests exceeding limits are not medically necessary.

Provider / Pharmacist Actions and Documentation

Denial Risk

Quantity limit enforcement and denial risk

Quantity limits are enforced at point-of-service. If the Drug Quantity Management rule is not met for the requested medication at the time of dispensing, coverage will be determined by the clinical criteria. Requests that exceed established quantity limits without meeting exception criteria may be denied.

Point-of-service enforcement — clinical criteria required for exceptions
Denial risk when Drug Quantity Management rule not met

Prior Authorization

Quantity limits and one-time approvals

One-time approvals are provided for 30 days in duration. Routine quantity limit overrides require documentation that meets the applicable clinical criteria; single 30-day one-time overrides do not waive the need to meet criteria for longer-term supplies.

'One-time' approvals = 30 days

Initial Therapy — Medical Necessity Criteria

Initial therapy criteria

Covered when ALL of the following apply for the relevant insomnia scenario.

B.i Initial therapy for chronic insomnia: Approve 30 capsules (retail) / 90 capsules (home delivery) per dispensing for 6 months if patient requires nightly therapy AND either is followed by or has consulted with a sleep specialist OR meets all: tried at least one behavioral therapy; not currently taking stimulants if appropriate; evaluated for underlying psychiatric/medical conditions and they are being addressed.

A Acute insomnia (one-time): Approve a one-time override for 30 capsules/tablets if ALL: patient has received nightly therapy with the requested drug for <60 days; insomnia expected to persist >15 of the next 30 days; insomnia not amenable to intermittent therapy; patient has tried at least one form of behavioral therapy; patient has been evaluated for underlying psychiatric/medical conditions and they are being addressed.

C Initial therapy for MDD/Bipolar/GAD: Approve 30 capsules (retail) / 90 capsules (home delivery) per dispensing for 3 months if patient is receiving drug therapy to treat major depressive disorder, bipolar disorder, or generalized anxiety disorder.

Continuation Therapy Rules

Continuation therapy rules

Continuation therapy is covered when the prescriber documents ongoing nightly benefit and the patient meets the duration and maintenance requirements for the scenario.

Continuation for chronic insomnia: Approve 30 capsules (retail) / 90 capsules (home delivery) per dispensing for 1 year if the patient has received nightly therapy with the requested drug for at least 6 months and the drug remains effective, per prescriber.

Continuation for MDD/Bipolar/GAD: Approve 30 capsules (retail) / 90 capsules (home delivery) per dispensing for 1 year if ALL: patient is receiving drug therapy for the psychiatric disorder; patient has received nightly therapy ≥3 months; patient has a diagnosis of chronic insomnia requiring nightly therapy; patient has tried at least one behavioral therapy; and patient is not currently taking non-prescription and/or prescription stimulants if medically appropriate.

Step Therapy / Prior Trial Requirements

Step	Requirement	Coverage
{"text":"1","status":""}\|{"text":"Prior inadequate response to zaleplon 10 mg once daily (i.e., patient did not respond adequately to zaleplon 10 mg once daily).","status":""}\|{"text":"covered_with_criteria","status":"covered"}

References and Coding Notes

Referenced Prescribing Information and Clinical Referencesmixed

Ambien (zolpidem) PI Feb 2022	sanofi-aventis Ambien tablets prescribing information, Bridgewater, NJ; Feb 2022.
Ambien CR PI Feb 2022	sanofi-aventis Ambien CR extended-release tablets prescribing information; Feb 2022.
Zolpidem 7.5 mg PI May 2023	Almatica zolpidem 7.5 mg capsules prescribing information; May 2023.
Zolpimist PI Aug 2019	Aytu Zolpimist oral spray prescribing information; Aug 2019.
Edluar PI Aug 2019	Meda Edluar sublingual tablets prescribing information; Aug 2019.
Sonata (zaleplon) PI Aug 2019	Pfizer Sonata capsules prescribing information; Aug 2019.
Restoril (temazepam) PI Jan 2023	Mallinckrodt Restoril capsules prescribing information; Jan 2023.
Halcion (triazolam) PI Jan 2023	Pfizer Halcion tablets prescribing information; Jan 2023.
Doral (quazepam) PI Jan 2023	Galt Doral tablets prescribing information; Jan 2023.
Flurazepam PI Dec 2023	Chartwell flurazepam capsules prescribing information; Dec 2023.

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Per-dispensing quantity limits — common retail/home delivery limits

Retail per-dispensing limitMost benzodiazepine and related sedative-hypnotic tablets/capsules: 15 units per dispensing (exceptions apply); Zaleplon: 30 capsules per retail dispensing.

Home delivery per-dispensing limitMost benzodiazepine and related sedative-hypnotic tablets/capsules: 15 units per dispensing (exceptions apply); Zaleplon: 90 capsules per home delivery dispensing.

Exceptions / notesClinical override criteria may allow different quantities; one-time approvals are provided for 30 days' supply when applicable. Policy history lists specific products with new limits (Doral/quazepam, Estazolam, Flurazepam, Halcion/triazolam, Restoril/temazepam, Zaleplon).

Definitions and Guideline References

Chronic insomnia definition

Chronic insomnia definitionChronic insomnia is defined as insomnia that occurs greater than 4 nights weekly for greater than 3 months in duration.

ContextDefinition is used to determine eligibility for initial and continuation therapy criteria in the policy.

SourcePolicy text providing chronic insomnia definition and related approval criteria.

Acute insomnia contextual note

Acute insomnia causes (contextual)Acute insomnia may be due to stress (bereavement or traumatic event), incurable progressive medical conditions (e.g., cancer), or chronic pain.

Authorization recommendationAuthorization beyond 60 days for acute insomnia is NOT recommended; the policy provides a one-time override for up to 30 days when criteria are met.

Background

Sedative-hypnotic agents covered by this policy are used to treat insomnia with differing indications for sleep onset and/or maintenance depending on the agent. The policy establishes per-prescription quantity limits by product and channel (retail vs home delivery) and permits clinical overrides only when prespecified exception criteria are met. Recent updates introduced new 15 tablets/capsules per dispensing limits for several older benzodiazepine and related hypnotic agents and revised zaleplon 10 mg limits to 30 capsules per retail dispensing and 90 capsules per home-delivery dispensing. One-time approvals are provided for 30 days when allowed by the criteria.

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Sedative Hypnotics Drug Quantity Management Policy - Per Rx