Zolpidem Tartrate (Edluar, Intermezzo, Zolpimist) Form

Zolpidem tartrate (Edluar®, Zolpimist®) is a gamma-aminobutyric acid (GABAA) agonist. FDA Approved Indication(s) Edluar and Zolpimist are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem sublingual tablet is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Limitation(s) of use: Zolpidem sublingual tablet is not indicated for the treatment of middle-of- the night awakening when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking.
Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Edluar, zolpidem sublingual tablet, and Zolpimist are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Insomnia (must meet all):

1. Diagnosis of insomnia;
2. Age ≥ 18 years;

3. Failure of zolpidem oral tablets, unless contraindicated or clinically significant adverse effects are experienced;

   4. For zolpidem sublingual tablet 1.75 mg and 3.5 mg requests, member has a history of insomnia with difficulty returning to sleep after middle of the night awakening;
   5. Dose does not exceed (a or b): a. Edluar, Zolpimist: 10 mg per day; b. Zolpidem sublingual tablet: 3.5 mg per day. Approval duration:
      Medicaid – 6 months Commercial – 12 months or duration of request, whichever is less Page 1 of 6

   CLINICAL POLICY Zolpidem Tartrate B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial and CP.PMN.16 for Medicaid; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Insomnia (must meet all):
   3. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
4. Member is responding positively to therapy;

5. If request is for a dose increase, new dose does not exceed (a or b): a. Edluar, Zolpimist: 10 mg per day; b. Zolpidem sublingual tablet: 3.5 mg per day. Approval duration:
   Medicaid – 12 months Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial and CP.PMN.16 for Medicaid; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial and CP.PMN.53 for Medicaid.
      Page 2 of 6

   CLINICAL POLICY Zolpidem Tartrate III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial and CP.PMN.53 for Medicaid, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   . Drug Name Dosing Regimen zolpidem tartrate (Ambien®) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Adults: 5-10 mg PO HS PRN Elderly: 5 mg PO HS PRN Dose Limit/ Maximum Dose 10 mg/day Appendix C: Contraindications/Boxed Warnings
   • Contraindication(s): known hypersensitivity to zolpidem • Boxed warning(s): none reported V. Dosage and Administration
   Drug Name Zolpidem tartrate (Edluar) Zolpidem tartrate sublingual tablets Zolpidem tartrate (Zolpimist) Dosing Regimen Adults: 5 mg SL for women and 5-10 mg for men SL HS PRN Elderly: 5 mg SL HS PRN Women: 1.75 mg SL HS PRN Men: 3.5 mg SL HS PRN Elderly: 1.75 mg SL HS PRN Adults: 5 mg for women and 5 or 10 mg for men PO HS PRN immediately before bedtime Elderly: 5 mg PO HS PRN immediately before bedtime Maximum Dose Adults: 10 mg/day Elderly: 5 mg/day 3.5 mg/day Adults: women – 5 mg/day, men – 10 mg/day Elderly: 5 mg/day VI. Product Availability
   Drug Name Zolpidem tartrate (Edluar) Zolpidem tartrate Availability Sublingual tablets: 5 mg, 10 mg Sublingual tablets: 1.75 mg, 3.5 mg Page 3 of 6

   CLINICAL POLICY Zolpidem Tartrate Drug Name Zolpidem tartrate (Zolpimist) Availability Oral spray: 5 mg per actuation VII.