PATIENT SUPPORT

IMPORTANT SAFETY INFORMATION

DAYVIGO may cause serious side effects including:

• decreased awareness and alertness. The morning after you take DAYVIGO, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day. Do not take more DAYVIGO than prescribed. Do not take DAYVIGO unless you are able to stay in bed for a full night (at least 7 hours) before you must be active again. Take DAYVIGO right before going to bed.

Do not take DAYVIGO if you fall asleep often at unexpected times (narcolepsy).

DAYVIGO is a federally controlled substance because it can be abused or cause dependence.

Before taking DAYVIGO, tell your healthcare provider about all of your medical conditions, including if you:

• have a history of depression, mental illness, or suicidal thoughts; drug or alcohol abuse or addiction; a sudden onset of muscle weakness (cataplexy); daytime sleepiness

• have lung problems or breathing problems

• have liver problems

• are pregnant or plan to become pregnant

• are breastfeeding or plan to breastfeed. DAYVIGO passes into your breastmilk

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

• Taking DAYVIGO with certain other medicines can cause serious side effects. DAYVIGO may affect the way other medicines work and other medicines may affect the way DAYVIGO works.

• Do not take DAYVIGO with other medicines that can make you sleepy unless your healthcare provider tells you to.

What should I avoid while taking DAYVIGO?

• Do not drink alcohol while taking DAYVIGO. It can increase your chances of getting serious side effects.

• Do not drive, operate heavy machinery, do anything dangerous, or other activities that require clear thinking if you take DAYVIGO and have had less than a full night of sleep (at least 7 hours) or if you have taken more DAYVIGO than prescribed by your healthcare provider.

• You may still feel drowsy the next day after taking DAYVIGO. Do not drive or do other dangerous activities until you feel fully awake.

DAYVIGO may cause serious side effects, including:

• temporary inability to move or talk (sleep paralysis) for up to several minutes while you are going to sleep or waking up

• temporary weakness in your legs that can happen during the day or at night

• complex sleep behaviors such as sleep-walking, sleep-driving, preparing and eating food, making phone calls, having sex or doing other activities while not fully awake that you may not remember the next morning.

• worsening depression and suicidal thoughts have happened during treatment with DAYVIGO.

The most common side effect of DAYVIGO is sleepiness.

These are not all of the possible side effects of DAYVIGO. Call your doctor for medical advice and if you have any new or worsening side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-10881-800-FDA-1088.

Please read the accompanying Medication Guide for DAYVIGO and discuss it with your doctor