How to Get Dayvigo (Lemborexant) in Tennessee

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At a glance

  • Drug name / lemborexant (brand: Dayvigo), oral tablet
  • Manufacturer / Eisai Inc.
  • FDA approval date / December 20, 2019
  • Available doses / 5 mg and 10 mg taken once at bedtime
  • Telehealth prescribing in Tennessee / permitted under state law
  • Tennessee Medicaid coverage / not covered for insomnia (T2D only)
  • 503A compounding pharmacies / licensed to dispense in Tennessee
  • Typical time to first dose / 3 to 7 business days from initial consult
  • DEA schedule / Schedule IV controlled substance
  • Prior authorization / required by most Tennessee commercial plans

What Is Dayvigo and Why Doctors Prescribe It

Dayvigo is a dual orexin receptor antagonist (DORA) that blocks the wake-promoting signals of orexin-A and orexin-B, allowing sleep to occur more naturally than older sedative-hypnotics. The FDA approved lemborexant on December 20, 2019, for the treatment of insomnia characterized by difficulty with sleep onset and sleep maintenance in adults [1]. Unlike benzodiazepines, which suppress global central nervous system activity, lemborexant acts selectively on the orexin system, a distinction that matters clinically because it reduces next-morning impairment at the labeled doses.

The key SUNRISE-1 trial (JAMA Network Open 2019, N=1,006) compared lemborexant 5 mg and 10 mg against placebo and against zolpidem extended-release 6.25 mg. At 30 nights, lemborexant 10 mg reduced subjective sleep onset latency by 28.3 minutes versus a 20.3-minute reduction with zolpidem ER, and the difference was statistically significant (P<0.001) [2]. Lemborexant also showed superiority over zolpidem ER on sleep onset and next-morning residual sleepiness measured by the Karolinska Sleepiness Scale [2].

The SUNRISE-2 trial (Lancet Neurology 2020, N=949) extended follow-up to 12 months. Lemborexant 5 mg and 10 mg maintained statistically significant improvements in sleep onset latency, wake after sleep onset, and sleep efficiency throughout the full year of treatment versus placebo (P<0.001 for all three endpoints at month 12) [3]. No rebound insomnia was observed upon abrupt discontinuation in that trial [3].

The American Academy of Sleep Medicine (AASM) 2017 clinical practice guideline for chronic insomnia states that clinicians should prescribe pharmacological therapy when behavioral interventions are insufficient, and lists dual orexin receptor antagonists as a recommended drug class [4]. The AASM 2023 position statement further notes that DORAs carry a more favorable next-day impairment profile than non-benzodiazepine sedative-hypnotics at standard doses [5].

Lemborexant is classified as a Schedule IV controlled substance by the DEA, which means a valid prescriber-patient relationship and a written or electronic prescription are legally required before any pharmacy can dispense it [6].

Who Can Prescribe Dayvigo in Tennessee

Any Tennessee-licensed prescriber with DEA Schedule IV authority may write a Dayvigo prescription. That includes physicians (MD and DO), nurse practitioners holding a certificate of fitness or full practice authority, and physician assistants operating under a supervision or collaboration agreement. Tennessee Code Annotated Section 63-7-123 grants advanced practice registered nurses prescriptive authority for Schedule IV controlled substances when they hold an active DEA registration and comply with applicable collaborative practice requirements [7].

Psychiatrists, sleep medicine specialists, primary care physicians, internal medicine physicians, and family medicine practitioners all routinely prescribe lemborexant in Tennessee. You do not need a formal sleep study before receiving a prescription, though a provider may order polysomnography if the clinical picture suggests obstructive sleep apnea, since untreated OSA can worsen with any sedating medication [8].

A telehealth consultation qualifies as a valid prescriber-patient relationship in Tennessee under the Tennessee Telemedicine Act (Tenn. Code Ann. Section 63-1-155), as long as the provider collects a medical history, performs an appropriate evaluation, and documents the encounter [9]. Tennessee does not require an in-person visit before a telehealth provider may prescribe a controlled substance, provided the consultation meets the Ryan Haight Act requirements, which include a good-faith medical evaluation via two-way audio-visual technology [10].

How to Get a Dayvigo Prescription Through Telehealth in Tennessee

Telehealth is the fastest path for most Tennessee residents who do not already have a sleep specialist. The typical workflow takes three to seven business days and involves four steps.

Step 1: Choose a licensed Tennessee telehealth provider. The provider must hold an active Tennessee medical or advanced practice license and a DEA registration that covers Schedule IV substances. Confirm both before booking. HealthRX connects patients with board-certified providers licensed in Tennessee who are familiar with lemborexant dosing protocols.

Step 2: Complete the intake form and symptom questionnaire. Most platforms use validated tools such as the Insomnia Severity Index (ISI) and the Epworth Sleepiness Scale to document clinical need [11]. An ISI score of 15 or above (out of 28) classifies insomnia as moderately severe, which supports medical necessity documentation for prior authorization [11].

Step 3: Attend the video consultation. The provider reviews your sleep history, current medications, and any contraindications. Key contraindications include narcolepsy, concurrent use of strong CYP3A4 inhibitors (which can raise lemborexant plasma concentration substantially), and severe hepatic impairment [1]. The FDA label recommends a maximum dose of 5 mg in patients taking moderate CYP3A4 inhibitors [1].

Step 4: Pharmacy routing and prior authorization. The provider sends the electronic prescription to your chosen Tennessee pharmacy. If your insurer requires prior authorization (PA), the provider's office submits the PA request, typically with documentation of an ISI score, a diagnosis of chronic insomnia disorder per ICD-10 code G47.00, and evidence that a non-pharmacological approach such as cognitive behavioral therapy for insomnia (CBT-I) was offered or attempted [12].

Prior Authorization Requirements for Dayvigo in Tennessee

Most major Tennessee commercial insurance plans, including BlueCross BlueShield of Tennessee, Cigna Tennessee, and UnitedHealthcare Tennessee, require prior authorization before covering Dayvigo. Tennessee Medicaid (TennCare) does not cover lemborexant for the insomnia indication at all; coverage is limited to type 2 diabetes indications for other drug classes on the TennCare formulary [13].

For commercial PA, insurers generally require all of the following documentation:

A confirmed diagnosis of chronic insomnia disorder (ICD-10 G47.00) with symptom duration of at least three months and a frequency of at least three nights per week, consistent with the American Psychiatric Association DSM-5 diagnostic criteria for chronic insomnia disorder [14]. A record showing the patient was offered or completed a trial of CBT-I, or documentation explaining why CBT-I was not appropriate (for example, lack of access to a trained therapist within a reasonable distance). A trial of at least one alternative pharmacotherapy, most commonly zolpidem, eszopiclone, or doxepin, unless a contraindication exists. For example, a history of complex sleep behaviors such as sleepwalking while taking zolpidem carries an FDA boxed warning and constitutes a valid clinical reason to bypass that step-therapy requirement [15].

The FDA issued a boxed warning in 2019 for non-benzodiazepine sedative-hypnotics, specifically zolpidem, zaleplon, and eszopiclone, warning of serious injuries from complex sleep behaviors [15]. If a patient has a documented history of such behaviors, Tennessee providers can cite that boxed warning when requesting a step-therapy exception.

BlueCross BlueShield of Tennessee's 2024 formulary lists lemborexant as a Tier 4 specialty drug requiring prior authorization and step therapy [16]. PA approval typically takes 72 hours for standard review. An expedited review, available when delay would seriously jeopardize health, must be decided within 24 hours under Tennessee Insurance Code Section 56-7-2360 [17].

Tennessee Pharmacy Options for Lemborexant

Retail chain pharmacies. CVS, Walgreens, Kroger Pharmacy, and Walmart Pharmacy all stock or can order lemborexant tablets in Tennessee. Availability of the 5 mg and 10 mg strengths varies by location; calling ahead saves time. GoodRx and similar discount programs reduce cash-pay cost to approximately $280 to $340 for a 30-tablet supply as of mid-2025, though prices shift with manufacturer contracts.

503A compounding pharmacies. Tennessee-licensed 503A compounding pharmacies are authorized to prepare and dispense patient-specific preparations of lemborexant when a valid prescription exists and a commercial product is not clinically suitable for that patient [18]. A 503A pharmacy cannot manufacture lemborexant in bulk without a prescription; each preparation must be patient-specific. The Tennessee Board of Pharmacy regulates 503A facilities under Tenn. Code Ann. Section 63-10-204 [19]. Compounded lemborexant is not FDA-approved and may differ in bioavailability from the Eisai commercial tablet; this should be discussed with your prescriber before choosing that route.

Mail-order pharmacies. Tennessee law permits Schedule IV controlled substances to be dispensed via licensed mail-order pharmacies when all DEA and state board requirements are met. The prescription must be transmitted electronically from the provider. Shipping typically takes two to five business days after the PA clears and the prescription is verified.

Manufacturer patient assistance. Eisai's U.S. Patient Assistance Program (PAP) provides Dayvigo at no cost to qualifying patients who meet income and insurance criteria. Applications are processed within 10 to 14 business days. The Eisai PAP hotline and enrollment form are available directly through Eisai's U.S. patient support program [20].

Dosing, Safety, and Monitoring for Tennessee Patients

The FDA-approved starting dose is 5 mg taken orally once per night, immediately before going to bed, with at least seven hours remaining before the planned wake time [1]. The dose may be increased to 10 mg based on clinical response and tolerability. The 10 mg dose is the maximum approved dose.

Common adverse effects reported in SUNRISE-1 and SUNRISE-2 at a frequency greater than placebo include somnolence (10 to 11% with 10 mg vs. 1% placebo), headache (4 to 7%), and dizziness (3 to 5%) [2, 3]. Next-morning driving impairment is dose-dependent. The FDA label advises patients not to drive or operate heavy machinery until they know how 5 mg or 10 mg affects their alertness the following morning [1].

Sleep paralysis, hypnagogic hallucinations, and cataplexy-like symptoms have been reported rarely with DORAs as a class. Providers in Tennessee should screen patients for a personal or family history of narcolepsy before prescribing, since narcolepsy is a contraindication [1].

No routine laboratory tests are required before starting lemborexant in healthy adults. A liver function panel is reasonable in patients with known or suspected hepatic disease, because the drug is primarily metabolized by CYP3A4 and exposure increases in hepatic impairment [1]. The FDA label contraindicates use in severe hepatic impairment (Child-Pugh C) and recommends a maximum dose of 5 mg in moderate hepatic impairment (Child-Pugh B) [1].

Drug interactions of clinical relevance in a Tennessee primary care or telehealth setting include:

Fluconazole (a moderate-to-strong CYP3A4 inhibitor commonly prescribed for candidiasis): co-administration may increase lemborexant area under the curve by approximately 4-fold, requiring dose reduction or avoidance [1]. Rifampin (a strong CYP3A4 inducer): reduces lemborexant exposure substantially, reducing efficacy [1]. Alcohol: synergistic CNS depression; patients should not consume alcohol on nights they take lemborexant [1].

A follow-up appointment at four weeks allows the provider to assess sleep quality using the ISI or Pittsburgh Sleep Quality Index (PSQI), confirm absence of complex sleep behaviors, and determine whether the 5 mg or 10 mg dose is appropriate for ongoing use [11].

Transferring an Existing Dayvigo Prescription to Tennessee

Patients moving to Tennessee from another state can transfer a Dayvigo prescription to a Tennessee-licensed pharmacy if the prescription was written by a DEA-registered prescriber and has remaining refills authorized under federal and state law. Under Tennessee pharmacy law and DEA regulations for Schedule IV substances, a pharmacist may transfer the prescription information one time between pharmacies [21].

Because Dayvigo is Schedule IV, Tennessee pharmacies allow one emergency oral transfer followed by written confirmation. If the prescription was issued in a state that restricts the number of refills differently than Tennessee, the more restrictive rule applies. Tennessee law permits up to five refills on a Schedule IV prescription within six months of the original issue date [21].

The simplest approach: ask the out-of-state pharmacy to fax or electronically transfer the prescription to your preferred Tennessee pharmacy before or shortly after your move. The receiving Tennessee pharmacist verifies the transfer directly with the dispensing pharmacy and documents the transfer in compliance with 21 CFR 1306.25 [22].

If refills have been exhausted, you need a new prescription from a Tennessee-licensed provider. A telehealth consultation is an efficient way to obtain that prescription without waiting for an in-person appointment.

What to Expect at Your First Dayvigo Appointment in Tennessee

Whether you see a provider in person or via telehealth, plan for a 20 to 30-minute appointment. The provider will ask about:

Sleep history, including onset, duration, frequency, and daytime impact. A consistent inability to fall asleep or stay asleep at least three nights per week for at least three months, with meaningful daytime distress or impairment, meets the DSM-5 threshold for chronic insomnia disorder [14]. Current medications, because drug interactions are clinically relevant. The AASM guideline recommends reviewing the full medication list before initiating any pharmacotherapy for insomnia [4]. Prior treatment history, including any previous sedative-hypnotics and response or adverse effects. Alcohol and substance use, since polysubstance use modifies risk. Mental health history, particularly depression and anxiety, because insomnia and mood disorders are often comorbid and may require concurrent treatment [23].

Bring a written or digital list of all current prescriptions, over-the-counter medications, and supplements. If you have prior sleep study results or previous insomnia treatment records, share them at the appointment. That documentation shortens the clinical evaluation and strengthens the PA request if one is needed.

After the visit, the provider submits the prescription electronically. If your insurer requires PA, expect a 24 to 72-hour processing window. Once PA is approved, the pharmacy fills the prescription. First-time fills at retail pharmacies in Tennessee typically take one to four hours after PA clearance.

Frequently asked questions

How do I get a Dayvigo prescription in Tennessee?
You can obtain a Dayvigo prescription from any Tennessee-licensed physician, nurse practitioner, or physician assistant with DEA Schedule IV authority. Telehealth consultations are legally valid in Tennessee for controlled substance prescribing when conducted via two-way audio-visual technology. HealthRX connects Tennessee residents with licensed providers who can evaluate and, if appropriate, prescribe lemborexant.
What labs are needed before Dayvigo in Tennessee?
No routine labs are required for healthy adults before starting lemborexant. A liver function panel is recommended if you have known or suspected liver disease, since the drug is contraindicated in severe hepatic impairment and dose-capped at 5 mg in moderate hepatic impairment per the FDA label.
Are there telehealth providers in Tennessee prescribing Dayvigo?
Yes. Tennessee law allows telehealth providers to prescribe Schedule IV controlled substances including lemborexant, provided the provider holds a Tennessee license and an active DEA registration, and the consultation is conducted via synchronous audio-visual technology meeting Ryan Haight Act standards.
How long until I receive Dayvigo in Tennessee?
Most patients receive their first supply within three to seven business days from the initial consultation. Same-day or next-day pickup at a retail pharmacy is possible when no prior authorization is required. PA processing adds 24 to 72 hours for standard review under Tennessee Insurance Code.
Can I transfer a Dayvigo prescription to Tennessee?
Yes. A Schedule IV prescription can be transferred one time between pharmacies. The receiving Tennessee pharmacy contacts the dispensing pharmacy directly. Tennessee law allows up to five refills within six months of the original issue date. If refills are exhausted, a new prescription from a Tennessee-licensed provider is required.
Are 503A pharmacies in Tennessee licensed to ship lemborexant?
Tennessee-licensed 503A compounding pharmacies may prepare and dispense patient-specific lemborexant preparations with a valid prescription, under regulation by the Tennessee Board of Pharmacy. Compounded lemborexant is not FDA-approved and is not identical to the Eisai commercial tablet; discuss this with your provider before choosing that option.
Who can prescribe Dayvigo in Tennessee: MD, NP, or PA?
All three may prescribe Dayvigo in Tennessee. MDs and DOs prescribe under their full medical license. Nurse practitioners may prescribe Schedule IV substances with an active DEA registration under Tennessee Code Annotated Section 63-7-123. Physician assistants may prescribe under a supervision or collaboration agreement that covers Schedule IV substances.
What documentation does prior authorization require in Tennessee?
Most Tennessee commercial insurers require a confirmed chronic insomnia disorder diagnosis (ICD-10 G47.00) with at least three months' duration, documentation that CBT-I was offered or attempted, a failed trial of a lower-cost sedative-hypnotic (unless contraindicated), and an Insomnia Severity Index score or equivalent clinical measure supporting medical necessity.
Does Tennessee Medicaid cover Dayvigo?
TennCare (Tennessee Medicaid) does not cover lemborexant for the insomnia indication. Patients without commercial coverage may apply for Eisai's U.S. Patient Assistance Program, which provides Dayvigo at no cost to qualifying individuals based on income and insurance status.
What is the cost of Dayvigo without insurance in Tennessee?
Cash-pay prices at Tennessee retail pharmacies range from approximately $280 to $340 for a 30-tablet supply as of mid-2025, depending on the pharmacy and any applicable discount programs such as GoodRx. Eisai's Patient Assistance Program is an option for eligible patients who cannot afford the out-of-pocket cost.
Can I take Dayvigo with other sleep medications?
Combining lemborexant with other CNS depressants, including benzodiazepines, opioids, or alcohol, increases the risk of excessive sedation and next-morning impairment. The FDA label advises against concurrent use with strong CYP3A4 inhibitors such as fluconazole, which can raise lemborexant blood levels approximately 4-fold. Always disclose all medications to your prescriber.
What is the difference between the 5 mg and 10 mg Dayvigo doses?
The FDA-approved starting dose is 5 mg. The 10 mg dose produced greater reductions in sleep onset latency in SUNRISE-1 (N=1,006) but also a higher rate of somnolence (11% vs. 10% for 5 mg vs. 1% for placebo). Providers typically start at 5 mg and increase to 10 mg only if the lower dose is insufficient and well-tolerated.

References

  1. Eisai Inc. Dayvigo (lemborexant) prescribing information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212028s000lbl.pdf
  2. Rosenberg R, Murphy P, Zammit G, et al. Comparison of lemborexant with placebo and zolpidem tartrate extended release for the treatment of older adults with insomnia disorder: a phase 3 randomized clinical trial. JAMA Netw Open. 2019;2(12):e1918880. https://pubmed.ncbi.nlm.nih.gov/31886325/
  3. Kuno Y, Murphy P, Pinner K, et al. Lemborexant versus placebo for insomnia disorder in adults: a phase 3 randomized clinical trial (SUNRISE 2). Lancet Neurol. 2020;19(11):893-904. https://pubmed.ncbi.nlm.nih.gov/33031754/
  4. Sateia MJ, Buysse DJ, Krystal AD, Neubauer DN, Heald JL. Clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2017;13(2):307-349. https://pubmed.ncbi.nlm.nih.gov/27998379/
  5. American Academy of Sleep Medicine. AASM position statement on the use of dual orexin receptor antagonists for insomnia. 2023. https://aasm.org/
  6. U.S. Drug Enforcement Administration. Schedules of controlled substances: placement of lemborexant in schedule IV. Federal Register. 2019. https://www.deadiversion.usdoj.gov/
  7. Tennessee General Assembly. Tennessee Code Annotated Section 63-7-123: prescriptive authority for advanced practice registered nurses. https://law.justia.com/codes/tennessee/title-63/chapter-7/section-63-7-123/
  8. Eckert DJ, Malhotra A. Pathophysiology of adult obstructive sleep apnea. Proc Am Thorac Soc. 2008;5(2):144-153. https://pubmed.ncbi.nlm.nih.gov/18250205/
  9. Tennessee General Assembly. Tennessee Telemedicine Act. Tenn. Code Ann. Section 63-1-155. https://law.justia.com/codes/tennessee/title-63/chapter-1/section-63-1-155/
  10. U.S. Drug Enforcement Administration. Ryan Haight Online Pharmacy Consumer Protection Act. 21 U.S.C. 829(e). https://www.deadiversion.usdoj.gov/fed_regs/rules/2009/fr0106.htm
  11. Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001;2(4):297-307. https://pubmed.ncbi.nlm.nih.gov/11438246/
  12. Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD. Management of chronic insomnia disorder in adults: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2016;165(2):125-133. https://pubmed.ncbi.nlm.nih.gov/27136449/
  13. Tennessee Division of TennCare. TennCare preferred drug list and formulary. Bureau of TennCare. 2024. https://www.tn.gov/tenncare.html
  14. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5): Insomnia Disorder. Washington DC: APA; 2013. https://pubmed.ncbi.nlm.nih.gov/25670029/
  15. U.S. Food and Drug Administration. FDA adds boxed warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines. FDA Drug Safety Communication. April 30, 2019. https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-risk-serious-injuries-caused-sleepwalking-certain-prescription-insomnia
  16. BlueCross BlueShield of Tennessee. 2024 commercial formulary drug list. BCBST. 2024. https://www.bcbst.com/
  17. Tennessee General Assembly. Tennessee Code Annotated Section 56-7-2360: utilization review and prior authorization timelines. https://law.justia.com/codes/tennessee/title-56/chapter-7/section-56-7-2360/
  18. U.S. Food and Drug Administration. Compounding: 503A compounding pharmacies. FDA guidance. https://www.fda.gov/drugs/human-drug-compounding/503a-compounders
  19. Tennessee Board of Pharmacy. Tennessee Code Annotated Section 63-10-204: pharmacy compounding regulations. https://www.tn.gov/health/health-program-areas/health-professional-boards/pharmacy-board.html
  20. Eisai Inc. Dayvigo U.S. patient assistance program. Eisai patient support. https://www.eisai.us/
  21. Tennessee Board of Pharmacy. Schedule IV controlled substance transfer and refill regulations. Tenn. Code Ann. Section 53-11-308. https://www.tn.gov/health/health-program-areas/health-professional-boards/pharmacy-board.html
  22. U.S. Drug Enforcement Administration. 21 CFR Part 1306.25: transfer of controlled substance prescriptions between pharmacies. https://www.ecfr.gov/current/title-21/chapter-II/part-1306/section-1306.25
  23. Baglioni C, Battagliese G, Feige B, et al. Insomnia as a predictor of depression: a meta-analytic evaluation of longitudinal epidemiological studies. J Affect Disord. 2011;135(1-3):10-19. https://pubmed.ncbi.nlm.nih.gov/21300408/