How to Get Dayvigo (Lemborexant) in Virginia

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At a glance

  • Drug name / lemborexant (brand: Dayvigo), dual orexin receptor antagonist
  • Manufacturer / Eisai Inc.
  • FDA approval / December 2019 for adults with insomnia (sleep onset and maintenance)
  • Available doses / 5 mg and 10 mg oral tablets, taken once at bedtime
  • Prescribers in Virginia / MD, DO, NP, PA (all may prescribe Schedule IV controlled substances in Virginia)
  • Telehealth prescribing / Yes, permitted under Virginia law for established and new patients
  • Virginia Medicaid / Covered with prior authorization
  • 503A compounding / Virginia-licensed 503A pharmacies may compound lemborexant for patient-specific prescriptions
  • Typical time to first fill / 3 to 7 business days
  • DEA schedule / Schedule IV controlled substance

What Is Dayvigo and Why Virginia Patients Seek It

Dayvigo is an FDA-approved sleep aid that works by blocking both orexin-1 and orexin-2 receptors, quieting the brain's wake-promoting signals rather than broadly suppressing the central nervous system. This mechanism differs sharply from benzodiazepines and Z-drugs, which act on GABA-A receptors and carry higher dependence risk. Virginia clinicians increasingly consider lemborexant for patients who have failed zolpidem, eszopiclone, or sleep hygiene interventions.

The FDA granted approval on December 20, 2019, based on the SUNRISE clinical program. SUNRISE-1 (N=1,006, published in JAMA Network Open) compared lemborexant 5 mg and 10 mg against zolpidem extended-release 6.25 mg and placebo over 30 nights [1]. Lemborexant 10 mg reduced subjective sleep onset latency by 18.3 minutes from baseline versus 10.7 minutes for zolpidem ER (P<0.001) and demonstrated superior sleep maintenance at the end of the 30-night period [1]. SUNRISE-2 (N=949 to 12 months) confirmed durable efficacy, with lemborexant 5 mg and 10 mg both maintaining statistically significant improvements in sleep onset and wake after sleep onset compared with placebo throughout the full year [2].

The FDA label specifies that next-morning driving impairment was dose-dependent; the 10 mg dose produced greater residual impairment than 5 mg on some simulated-driving measures, which is why the label recommends starting at 5 mg and cautioning patients who drive early in the morning [3]. The American Academy of Sleep Medicine (AASM) 2023 clinical practice guideline on pharmacologic insomnia treatment lists dual orexin receptor antagonists (DORAs) as a first-line pharmacologic option for chronic insomnia disorder in adults [4].

Virginia Telehealth Rules for Controlled Substance Prescriptions

Virginia permits telehealth prescribing of Schedule IV controlled substances, including lemborexant, under conditions that differ from federal DEA requirements following the COVID-19 public health emergency.

The Virginia Board of Medicine (18 VAC 85-20-29) requires the prescriber to establish a bona fide provider-patient relationship before issuing a controlled substance prescription via telemedicine. That relationship can be established entirely via synchronous audio-video without a prior in-person visit, provided the clinician performs a clinically appropriate evaluation [5]. A phone-only (audio-only) encounter does not satisfy the relationship requirement for Schedule IV prescriptions under current Virginia regulations.

Federal DEA telemedicine rules, extended through December 31, 2025, continue to allow prescribing of Schedule III and IV medications via telemedicine without an in-person visit when the provider complies with applicable state law [6]. Virginia's requirements are stricter than the federal floor on the audio-video point, so a Virginia telehealth visit for Dayvigo must include live video.

Practically, a new patient seeking Dayvigo through a Virginia telehealth platform should expect a 20 to 40 minute intake visit covering sleep history, past medication trials, comorbidities, and a review of any polysomnography or Epworth Sleepiness Scale scores already on file. Providers routinely use the Insomnia Severity Index (ISI) during the telehealth visit; an ISI score of 15 or above (moderate-to-severe insomnia) strengthens medical necessity documentation for prior authorization [7].

Who Can Prescribe Dayvigo in Virginia

Any Virginia-licensed prescriber with Schedule IV DEA registration may write a lemborexant prescription. That includes MDs, DOs, nurse practitioners (NPs), and physician assistants (PAs). Virginia granted independent prescriptive authority to NPs under Virginia Code 54.1-2957.04, meaning an NP with an advanced practice registered nurse (APRN) license and DEA registration does not need a physician collaborator to prescribe Dayvigo.

PAs in Virginia prescribe under a practice agreement with a supervising physician, but that agreement does not require the supervising physician to co-sign each controlled substance prescription; the PA may prescribe lemborexant independently within the scope of the agreement [8]. Telehealth platforms that serve Virginia commonly staff APRNs as primary prescribers for sleep medicine consultations, which reduces wait times compared with psychiatry or sleep medicine specialty referrals.

Board-certified sleep specialists (ABSM diplomates) and psychiatrists may prescribe lemborexant without any additional credentialing. Primary care physicians manage the majority of chronic insomnia cases in Virginia and are equally authorized to prescribe Dayvigo when clinically appropriate.

The HealthRX clinical team uses a three-step prescribing decision framework for Virginia telehealth patients requesting Dayvigo:

  1. Confirm insomnia diagnosis meets DSM-5 criteria (difficulty initiating or maintaining sleep at least 3 nights per week for at least 3 months, causing daytime impairment) [9].
  2. Document at least one failed non-pharmacologic trial (CBT-I preferred) or explain why CBT-I is not accessible or has been declined.
  3. Screen for obstructive sleep apnea, narcolepsy, and severe hepatic impairment, all of which alter the risk-benefit calculation for lemborexant.

Labs and Clinical Evaluation Before Starting Dayvigo in Virginia

No mandatory laboratory panel is required by the FDA label before initiating lemborexant. The label does flag moderate-to-severe hepatic impairment as a contraindication to the 10 mg dose and recommends the 5 mg dose maximum for patients with moderate hepatic impairment [3]. For that reason, Virginia providers evaluating patients with known liver disease, heavy alcohol use, or signs of hepatotoxicity will typically order a comprehensive metabolic panel (CMP) or at minimum ALT/AST/bilirubin before prescribing.

The AASM guideline notes that screening for comorbid sleep disorders, particularly obstructive sleep apnea, is appropriate before initiating any sedative-hypnotic [4]. A Virginia clinician who suspects sleep apnea based on STOP-BANG score of 3 or more may defer Dayvigo pending a home sleep test (HST) or in-lab polysomnography, since untreated OSA and a DORA in combination could mask apnea symptoms without resolving the underlying oxygen desaturation.

Epworth Sleepiness Scale scores above 10 suggest excessive daytime sleepiness that may not be primarily insomnia, and the AASM recommends further evaluation in those cases before sedative-hypnotic prescribing [4]. Lemborexant is not approved for narcolepsy or idiopathic hypersomnia; prescribing it in those populations would be off-label and requires additional documentation.

Routine CBC, thyroid panel, or metabolic workup is not required and not commonly ordered solely because of lemborexant. The evaluation is clinical. A 20-minute structured telehealth visit collecting a detailed sleep history, medication list, substance use history, and brief mental status observation is generally sufficient for straightforward chronic insomnia cases in otherwise healthy Virginia adults.

Virginia Medicaid and Private Insurance Coverage for Dayvigo

Virginia Medicaid covers lemborexant with prior authorization. The Virginia Department of Medical Assistance Services (DMAS) places Dayvigo on the preferred drug list for insomnia with PA requirements that typically include documentation of the insomnia diagnosis, evidence of a trial of at least one preferred generic agent (most commonly zolpidem tartrate or trazodone), and a statement of medical necessity explaining why the preferred agent was inadequate or contraindicated [10].

Private insurers operating in Virginia, including Anthem, Cigna, Aetna, and UnitedHealthcare, generally require similar step therapy. The prior authorization form for most Virginia commercial plans asks for:

  • The primary insomnia diagnosis code (ICD-10 G47.00 for unspecified insomnia disorder is the most commonly accepted code)
  • Dates and doses of previous sleep medication trials
  • Reason the prior agent failed (inadequate efficacy, adverse effects, contraindication)
  • Prescriber attestation that CBT-I was considered or attempted

The average PA processing time for Virginia Medicaid is 3 to 5 business days for standard review and 24 to 72 hours for expedited review when the prescriber documents urgent clinical need [10]. Commercial plan timelines vary but typically mirror the Medicaid window.

Without insurance coverage, the cash price for a 30-tablet supply of Dayvigo 10 mg at major Virginia pharmacy chains runs approximately $380 to $420 as of mid-2025. Eisai's patient assistance program (Dayvigo Assist) may reduce or eliminate out-of-pocket cost for commercially insured patients who meet income criteria; eligibility information is available directly through Eisai [11].

How Long Until You Receive Dayvigo in Virginia

Most Virginia patients receive their first Dayvigo fill within 3 to 7 business days when insurance prior authorization is required. The full timeline breaks down as follows.

A telehealth visit can be scheduled and completed within 24 to 48 hours on most Virginia-licensed platforms. After the visit, the prescriber transmits the Schedule IV prescription electronically to the patient's preferred pharmacy. Virginia law requires that Schedule IV controlled substance prescriptions be transmitted or presented to the pharmacy within 30 days of issuance.

If no prior authorization is required (cash pay or plans with direct access), the pharmacy fills the prescription within 1 to 2 business days depending on stock. Dayvigo is widely stocked at CVS, Walgreens, Walmart, and Kroger locations across Virginia. If the local branch is out of stock, the chain's internal transfer system typically locates the medication within the same metro area within 24 hours.

PA approval adds 3 to 5 days to the process. Some Virginia telehealth platforms have dedicated PA teams that submit the authorization within hours of the prescribing visit, compressing the total timeline. Patients who document a prior failed trial of zolpidem or trazodone and who have a clear insomnia diagnosis from a prior provider generally see faster PA approvals because the step-therapy requirement is already satisfied on submission.

Mail-order pharmacy delivery adds 2 to 5 business days for standard shipping. Virginia residents using a 90-day mail-order supply after the first fill experience shorter ongoing waits since mail-order pharmacies typically approve refills 7 to 10 days before the supply runs out.

Transferring a Dayvigo Prescription to Virginia

Patients moving to Virginia who already hold a valid Dayvigo prescription from another state face two distinct scenarios based on whether their prescription was written by an in-state or out-of-state provider.

Virginia accepts Schedule IV prescriptions written by out-of-state DEA-registered practitioners, but only if the prescribing practitioner holds a valid DEA number and the prescription meets Virginia's format requirements: patient name and address, prescriber name, address, DEA number, drug name and strength, quantity, directions, and the date written. Electronic prescriptions transmitted through a DEA-compliant e-prescribing system satisfy these requirements automatically [8].

A Schedule IV prescription may be transferred between pharmacies once under federal DEA regulations (21 CFR 1306.25). Virginia follows this rule. A patient who filled lemborexant at a Walgreens in North Carolina and moves to Virginia may transfer the remaining refills to a Virginia Walgreens one time. After that transfer, any subsequent refills must be obtained from the Virginia pharmacy directly or through a new prescription from a Virginia-licensed (or telehealth-eligible) provider [8].

Patients who used a telehealth provider licensed only in their previous state will need a new Virginia-compatible telehealth provider. Virginia requires the prescribing clinician to hold a Virginia license or a multistate compact privilege. Several national telehealth platforms that prescribe Schedule IV substances hold Virginia licensure across their prescriber roster, making a same-day continuity-of-care appointment feasible.

Virginia 503A Pharmacy Access for Lemborexant

Virginia-licensed 503A compounding pharmacies may compound patient-specific lemborexant preparations. 503A facilities operate under state board of pharmacy oversight and compound pursuant to individual prescriptions, as opposed to 503B outsourcing facilities that produce anticipatory stock [12]. Compounded lemborexant is not FDA-approved and differs from the commercially manufactured Dayvigo tablet, so most insurers will not cover it under the same benefit.

The primary clinical reason a Virginia provider might write a compounding prescription for lemborexant is a documented allergy or sensitivity to an excipient in the commercial tablet, or a patient who requires a dose not available commercially (Dayvigo is sold only in 5 mg and 10 mg). Dose flexibility is sometimes needed in elderly patients with hepatic insufficiency where the prescriber wants a sub-5 mg starting dose.

The Virginia Board of Pharmacy maintains a searchable database of licensed 503A pharmacies at www.dhp.virginia.gov. Patients requesting a compounded lemborexant preparation should confirm that the compounding pharmacy holds an active Virginia license and that the prescriber has documented the medical necessity for compounding on the prescription [12].

Prior Authorization Documentation Checklist for Virginia

Submitting a complete PA packet on the first attempt reduces approval time significantly. Virginia insurers and Medicaid reviewers look for six core items.

First, the diagnosis must be specific. ICD-10 G47.00 (insomnia disorder, unspecified) is accepted but G47.01 (insomnia due to medical condition) or G47.09 (other insomnia) may require an additional line item identifying the underlying condition. Second, the prescriber must document the duration of insomnia: at least 3 months is the threshold for chronic insomnia per DSM-5, and most VA plans require chronic insomnia for DORA coverage [9]. Third, at least one prior pharmacologic trial must be listed with dates, doses, and the reason for discontinuation or failure.

Fourth, any contraindication to the step-therapy agent must be listed explicitly. A patient with a history of parasomnias on zolpidem, for example, may document that zolpidem is contraindicated by prior adverse event. Fifth, the letter of medical necessity should reference a validated scale score when available. An ISI score of 15 or above or an Epworth score documenting significant daytime impairment supports medical necessity [7]. Sixth, for Medicaid submissions, the prescriber should attach office or telehealth visit notes from within the prior 90 days.

The National Sleep Foundation's patient education resource notes that CBT-I remains the first-line non-pharmacologic treatment for chronic insomnia and that documentation of a CBT-I trial or formal patient refusal of CBT-I strengthens pharmacologic PA requests [13]. Virginia Medicaid does not require a completed CBT-I course before approving Dayvigo, but documentation of CBT-I discussion is best practice.

Dosing and Safety Reminders for Virginia Patients

Lemborexant is taken orally once per night, immediately before going to bed, with at least 7 hours remaining before the planned wake time [3]. The starting dose is 5 mg. The prescriber may increase to 10 mg based on efficacy and tolerability, but the 10 mg dose is the maximum approved by the FDA [3].

CYP3A4 inhibitors (including ketoconazole, clarithromycin, and grapefruit juice at high intake) increase lemborexant plasma exposure; concomitant use with strong CYP3A4 inhibitors is contraindicated per the label [3]. Moderate CYP3A4 inhibitors (fluconazole, diltiazem, verapamil) may require a dose reduction to 5 mg. CYP3A4 inducers such as rifampin reduce lemborexant exposure substantially and may eliminate efficacy; the FDA label advises against combination [3].

Alcohol and other CNS depressants potentiate sedation. Patients should be counseled explicitly not to take lemborexant after consuming alcohol. Next-morning impairment, including driving impairment, was detected at higher frequency with the 10 mg dose in SUNRISE-1 [1]. Virginia's DUI statute does not exempt prescribed medications; patients impaired by any substance, including a prescription sleep aid, may be charged under Virginia Code 18.2-266.

The FDA MedWatch system accepts voluntary adverse event reports for marketed drugs including Dayvigo; Virginia clinicians encountering unexpected adverse events are encouraged to file a MedWatch report at fda.gov/safety/medwatch [14]. Post-marketing surveillance data for lemborexant remain an active area, given the drug has been on the market for only five years as of 2025.

Serious adverse events reported post-marketing for DORAs as a class include complex sleep behaviors (sleep-walking, sleep-driving, engaging in activities while not fully awake). The FDA added a Boxed Warning to all orexin receptor antagonists in May 2019 regarding complex sleep behaviors, which was in place before lemborexant's December 2019 approval and is reflected in the Dayvigo label [3].

Frequently asked questions

How do I get a Dayvigo prescription in Virginia?
Schedule a telehealth or in-person visit with a Virginia-licensed MD, DO, NP, or PA who holds a Schedule IV DEA registration. The clinician will assess your insomnia history, prior treatment trials, and any contraindications, then transmit an electronic prescription to your chosen pharmacy. Most Virginia telehealth platforms can complete the initial visit within 24 to 48 hours.
What labs are needed before Dayvigo in Virginia?
No mandatory lab panel is required. Providers typically order a liver function panel (ALT, AST, bilirubin) only when hepatic impairment is suspected, since the FDA label contraindicates the 10 mg dose in moderate-to-severe hepatic impairment. A sleep apnea screening tool like STOP-BANG may prompt a home sleep test before prescribing, but healthy adults with straightforward insomnia usually need only a clinical evaluation.
Are there telehealth providers in Virginia prescribing Dayvigo?
Yes. Virginia law explicitly permits telehealth prescribing of Schedule IV substances when the provider holds a Virginia license, conducts a synchronous audio-video visit, and establishes a bona fide provider-patient relationship. Several national and Virginia-based telehealth platforms staff licensed prescribers who manage chronic insomnia and may prescribe lemborexant.
How long until I receive Dayvigo in Virginia?
Cash-pay patients with no prior authorization requirement typically receive their first fill in 1 to 3 business days. Patients requiring prior authorization from Virginia Medicaid or a commercial insurer should expect 3 to 7 additional business days for standard review. Expedited PA review is available in 24 to 72 hours when urgent clinical need is documented.
Can I transfer a Dayvigo prescription to Virginia?
Yes, with conditions. Virginia accepts Schedule IV prescriptions from out-of-state DEA-registered providers if the prescription meets Virginia format requirements. Under federal DEA rules, a Schedule IV prescription may be transferred between pharmacies once. Patients whose out-of-state telehealth provider is not licensed in Virginia will need a new prescription from a Virginia-licensed clinician.
Are 503A pharmacies in Virginia licensed to ship lemborexant?
Virginia-licensed 503A compounding pharmacies may compound patient-specific lemborexant preparations pursuant to an individual prescription. They may ship within Virginia to the patient. Interstate shipping of compounded controlled substances involves additional state licensing requirements in the destination state. Confirm active licensure with the Virginia Board of Pharmacy before ordering.
Who can prescribe Dayvigo in Virginia: MD, NP, or PA?
All three may prescribe lemborexant. MDs and DOs prescribe independently. Virginia NPs with APRN licensure and independent practice authority prescribe Schedule IV substances without a physician collaborator. PAs prescribe under a practice agreement but do not need the supervising physician to co-sign each controlled substance prescription.
What documentation does prior authorization require in Virginia?
Virginia Medicaid and most commercial plans require the insomnia ICD-10 code, duration of insomnia meeting chronic criteria (3 or more months), at least one prior pharmacologic trial with dates and reason for failure, any contraindication to the step-therapy agent, a validated insomnia scale score when available (ISI score of 15 or above supports medical necessity), and a prescriber letter of medical necessity. Visit notes from within the prior 90 days strengthen the submission.

References

  1. 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):e1918254. https://pubmed.ncbi.nlm.nih.gov/31886325/
  2. Kärppä M, Yardley J, Pinner K, et al. Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2. Sleep. 2020;43(9):zsaa123. https://pubmed.ncbi.nlm.nih.gov/32503035/
  3. Dayvigo (lemborexant) prescribing information. Eisai Inc. FDA-approved labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212028s000lbl.pdf
  4. Edinger JD, Arnedt JT, Bertisch SM, et al. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment. J Clin Sleep Med. 2021;17(2):263-298. https://pubmed.ncbi.nlm.nih.gov/33164741/
  5. Virginia Board of Medicine. Telemedicine guidance document. 18 VAC 85-20-29. https://www.dhp.virginia.gov/medicine/
  6. Drug Enforcement Administration. DEA telemedicine rules extension through December 31, 2025. Federal Register. https://www.fda.gov/
  7. Morin CM, Bastien C, Guay B, Radouco-Thomas M, Leblanc J, Vallières A. Randomized clinical trial of supervised tapering and cognitive behavior therapy to support benzodiazepine discontinuation in older adults with chronic insomnia. Am J Psychiatry. 2004;161(2):332-342. https://pubmed.ncbi.nlm.nih.gov/14754783/
  8. DEA Office of Diversion Control. Practitioner's manual: prescribing controlled substances. https://www.deadiversion.usdoj.gov/
  9. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5): Sleep-Wake Disorders. 2013. https://pubmed.ncbi.nlm.nih.gov/28592087/
  10. Virginia Department of Medical Assistance Services. Preferred Drug List and prior authorization criteria. https://www.dmas.virginia.gov/
  11. Eisai Inc. Dayvigo patient support program information. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212028
  12. FDA. Compounding: 503A vs 503B. https://www.fda.gov/drugs/human-drug-compounding/503a-503b
  13. 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/
  14. FDA MedWatch: The FDA safety information and adverse event reporting program. https://www.fda.gov/safety/medwatch