ONLY FDA-approved treatment for Restless Legs Syndrome that is strongly recommended by the AASM Clinical Practice Guidelines^†*

For adults living with moderate-to-severe primary Restless Legs Syndrome (RLS) or Postherpetic Neuralgia (PHN)¹

Symptom relief may be within reach

The gabapentin you take matters.

Choose the gabapentin specifically developed to:

Deliver 24-hour relief from symptoms²
Simplify the steps you take to get the right dose¹*
Be absorbed in the upper and lower intestine for extended release²

*Strong recommendation, moderate certainty of evidence based on 8 randomized controlled trials and 3 observational studies.

**Be sure to take the dose exactly as your doctor prescribes. The dose may be different based on your medical condition and for those with kidney or liver problems.¹

^†Winkelman JW, Berkowski JA, DelRosso LM, et al. Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. Published online September 26, 2024. doi:10.5664/jcsm.11390

AASM = American Academy of Sleep Medicine

See how Horizant® may help people living with moderate-to-severe primary Restless Legs Syndrome (RLS)

Learn about RLS

Learn more about Postherpetic Neuralgia (PHN) and how Horizant® can help people with nerve pain caused by shingles

Learn about PHN

How to save on Horizant®

Get the prescription treatment you need at a cost you can aﬀord with our range of savings programs. Reach your goals by ﬁnding the savings program that works for you

Horizant® savings

Eligibility requirements and terms & conditions may apply.

Tips and tools to help you stay on track with treatment

Horizant® resources

Important Safety Information for HORIZANT® (gabapentin enacarbil) Extended-Release Tablets

INDICATIONS

HORIZANT® (gabapentin enacarbil) is a prescription medicine used to:

treat adults with moderate to severe primary Restless Legs Syndrome (RLS). HORIZANT is not for people who need to sleep during the daytime and stay awake at night.

manage pain from damaged nerves (postherpetic neuralgia) that follows healing of shingles (a painful rash that comes after a herpes zoster infection) in adults.

IMPORTANT SAFETY INFORMATION

Do not drive after taking your dose of HORIZANT until you know how it affects you, including the morning after you take it. Do not operate heavy machinery or do other dangerous activities until you know how HORIZANT affects you. HORIZANT can cause sleepiness, dizziness, slow thinking, and can affect your coordination. Ask your healthcare provider when it is okay to do these activities.

Do not take other medicines that make you sleepy or dizzy while taking HORIZANT without talking to your healthcare provider. Taking HORIZANT with these other medicines may make your sleepiness or dizziness worse.

HORIZANT may cause suicidal thoughts or actions in a very small number of people (about 1 in 500). Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

thoughts or actions about suicide, self-harm, or dying; attempt to commit suicide
new or worsening depression or anxiety; or feeling agitated
new or worse restlessness or panic attacks
new or worse trouble sleeping (insomnia); or irritability
acting aggressive, being angry, or violent; acting on dangerous impulses
an extreme increase in activity or talking (mania); other unusual changes in mood or behavior

Serious breathing problems. Serious breathing problems can occur when HORIZANT is taken with other medicines that can cause severe sleepiness or decreased awareness, or when it is taken by someone who already has breathing problems. Watch for increased sleepiness or decreased breathing when starting HORIZANT or when the dose is increased. Get help right away if breathing problems occur.

Do not stop taking HORIZANT without first talking to your healthcare provider. Suicidal thoughts or actions can be caused by things other than medicines. If you have these thoughts or actions, your healthcare provider may check for other causes.

HORIZANT may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. You may or may not have a rash with these types of reactions. Call a healthcare provider right away if you have any of the following symptoms: skin rash, hives, fever, swollen glands that do not go away, swelling of your lips or tongue, yellowing of your skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, unexpected severe muscle pain, or frequent infections. These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking HORIZANT.

HORIZANT is not the same medicine as gabapentin [for example, NEURONTIN® (gabapentin) and GRALISE® (gabapentin)]. HORIZANT should not be used in their place. Do not take these or other gabapentin products while taking HORIZANT.

Before taking HORIZANT, tell your healthcare provider if you:

have or have had kidney problems or are on hemodialysis
have or have had depression, mood problems, or suicidal thoughts or behavior
have or have had seizures
have a history of drug abuse
have any other medical conditions
are pregnant or plan to become pregnant. It is not known if HORIZANT will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant while taking HORIZANT. You and your healthcare provider will decide if you should take HORIZANT while you are pregnant
are breastfeeding or plan to breastfeed. Your body turns HORIZANT into another drug (gabapentin) that passes into your milk. It is not known if this can harm your baby. You and your healthcare provider should decide if you will take HORIZANT or breastfeed
drink alcohol

Do not drink alcohol while taking HORIZANT because it may increase the risk of side effects.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking HORIZANT with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Do not stop taking HORIZANT without talking to your healthcare provider first. If you stop taking HORIZANT suddenly, you may develop side effects.

The most common side effects of HORIZANT include dizziness, sleepiness, and headache. Tell your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of HORIZANT. For more information, ask your healthcare provider or pharmacist.

To report a possible side effect, contact Azurity Pharmaceuticals, Inc by email or phone at aereports@azurity.com (Adverse Event Report Form)/1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

For more information, ask your healthcare provider or pharmacist, or consult the full Prescribing Information.

References:

1. Horizant [package insert] Woburn, MA: Azurity Pharmaceuticals, Inc.; 2022

2. Cundy KC, Sastry S, Luo W, et al. Clinical pharmacokinetics of XP13512, a novel transported prodrug of gabapentin. J Clin Pharmacol. 2008;48(12):1378-1388.

3. Lee DO, Ziman RB, Perkins AT, et al; XP053 Study Group. A randomized, double-blind, placebo-controlled study to assess the efficacy and tolerability of gabapentin enacarbil in subjects with restless legs syndrome. J Clin Sleep Med. 2011;7(3):282-292.

4. Zhang L, Rainka M, Freeman R, et al. A randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of gabapentin enacarbil in subjects with neuropathic pain associated with postherpetic neuralgia (PXN110748). J Pain. 2013;14(6):590-603.

5. Silber MH, Buchfuhrer MJ, Earley CJ, et al. The management of restless legs syndrome: an updated algorithm. Mayo Clin Proc. 2021;96(7):1921-1937.

6. Gralise [prescribing information]. Morristown, NJ: Almatica Pharma LLC.

7. Neurontin [prescribing information]. New York, NY: Parke-Davis Division of Pfizer Inc.

8. Restless Legs Syndrome. Mayo Clinic. Accessed January 20, 2023. https://www.mayoclinic.org/diseases-conditions/restless-legs-syndrome/symptoms-causes/syc-20377168

9. Allen RP, Walters AS, Montplaisir J, et al. Restless legs syndrome prevalence and impact: REST general population study. Arch Intern Med. 2005;165(11):1286-1292.

10. Restless Legs Syndrome Fact Sheet. National Institute of Neurological Disorders and Stroke. Accessed January 20, 2023. https://www.ninds.nih.gov/restless-legs-syndrome-fact-sheet

11. Restless Legs Syndrome (RLS). HelpGuide.org. Accessed January 20, 2023. https://www.helpguide.org/articles/sleep/restless-leg-syndrome-rls.htm

12. Postherpetic Neuralgia. Mayo Clinic. Accessed January 20, 2023. https://www.mayoclinic.org/diseases-conditions/postherpetic-neuralgia/symptoms-causes/syc-20376588

13. Sacks GM. Unmet need in the treatment of postherpetic neuralgia. Am J Manag Care. 2013;19(1 suppl):S207-S213.

14. Calkins AM, Gudin J, Gidal B, et al. Impact of data imputation methodology on pain assessment over 24 hours in a randomized, placebo-controlled study of gabapentin enacarbil in patients with neuropathic pain associated with postherpetic neuralgia. Pain Medicine. 2016;17(4):728-736.

15. Swearingen D, Aronoff GM, Ciric S, et al. Pharmacokinetics of immediate release, extended release, and gastric retentive gabapentin formulations in healthy adults. Int J Clin Pharmacol Ther. 2018;56(5):231-238.

16. Kanodia SK, Seth A, Dixit AM. Dose related efficacy of gabapentin in acute herpetic neuralgia among geriatric patients. Indian J Dermatol. 2012;57(5):362-365.

ONLY FDA-approved treatment for Restless Legs Syndrome that is strongly recommended by the AASM Clinical Practice Guidelines^†*

Symptom relief may be within reach

The gabapentin you take matters.

Horizant® helps put restless legs to rest^1,3

Horizant® helps ﬁght the nerve pain that remains after shingles⁴

How to save on Horizant®

Tips and tools to help you stay on track with treatment

Important Safety Information for HORIZANT® (gabapentin enacarbil) Extended-Release Tablets

INDICATIONS

IMPORTANT SAFETY INFORMATION

References:

Copay Savings Card program COMING SOON!

ONLY FDA-approved treatment for Restless Legs Syndrome that is strongly recommended by the AASM Clinical Practice Guidelines†*

Symptom relief may be within reach

The gabapentin you take matters.

Horizant® helps put restless legs to rest1,3

Horizant® helps ﬁght the nerve pain that remains after shingles4

How to save on Horizant®

Tips and tools to help you stay on track with treatment

Important Safety Information for HORIZANT® (gabapentin enacarbil) Extended-Release Tablets

INDICATIONS

IMPORTANT SAFETY INFORMATION

References:

ONLY FDA-approved treatment for Restless Legs Syndrome that is strongly recommended by the AASM Clinical Practice Guidelines^†*

Horizant® helps put restless legs to rest^1,3

Horizant® helps ﬁght the nerve pain that remains after shingles⁴