NUVIGIL, Wakefulness, and Shift Work Disorder
Do you work shifts and always feel sleepy or tired when you need to be awake? Does
this interfere with your life? If so, you may be suffering from a medical condition
called shift work disorder (SWD).
If you are suffering from excessive sleepiness (ES)
due to shift work disorder, NUVIGIL could help improve your wakefulness.1
NUVIGIL can help improve wakefulness in patients with excessive sleepiness due to
shift work disorder
NUVIGIL is a prescription medicine used to improve wakefulness in adults who are
very sleepy due to shift work disorder (SWD).
In a clinical trial, patients who took NUVIGIL experienced significant improvement
in wakefulness throughout the shift compared to patients taking a sugar pill (placebo).1
NUVIGIL was assessed using the Multiple Sleep Latency Test (MSLT),
four times throughout the patients’ night shift.
The MSLT is a measure of a person’s degree of sleepiness. The measures were averaged
between 2 AM and 8 AM.2-4
NUVIGIL could help you throughout your shift with improved wakefulness.
In an additional clinical trial, patients who took NUVIGIL experienced improvement
in their overall clinical condition compared to patients taking a sugar pill (placebo).5
- This improvement was reported late in the shift (4 AM to 8
AM), including the commute home
Patients should be cautioned about and, if appropriate, advised to avoid driving
or other hazardous activities.
NUVIGIL typically does not affect patients’ ability to sleep when they usually do1
Based on sleep studies that measure nighttime breathing and brain and muscle activity,
NUVIGIL typically does NOT affect a patient's ability to sleep when they need to
2% of patients in a shift work study taking NUVIGIL reported trouble sleeping vs
<1% of patients taking a sugar pill (placebo).2
NUVIGIL has an established safety profile1
In clinical studies:
- Most reported side effects were rated as mild to moderate
- Common side effects of NUVIGIL were headache, nausea, dizziness, and trouble sleeping1
- 7% of patients taking NUVIGIL stopped treatment due to side effects compared with
4% of patients taking a sugar pill (placebo)
NUVIGIL may cause serious side effects including a serious rash or a serious allergic
reaction that may affect parts of your body such as your liver or blood cells. Any
of these may need to be treated in a hospital and may be life-threatening.
Stop taking NUVIGIL and call your doctor right away or get emergency help if you
have any of these symptoms: skin rash, hives, sores in your mouth, or your
skin blisters and peels; swelling of your face, eyes, lips, tongue, or throat; trouble
swallowing or breathing; or fever, shortness of breath, swelling of the legs, yellowing
of the skin or whites of the eyes, or dark urine.
If you have a severe rash with NUVIGIL, stopping the medicine may not keep the rash
from becoming life-threatening or causing you to be permanently disabled or disfigured.
NUVIGIL is not approved for use in children for any medical condition. It
is not known if NUVIGIL is safe or if it works in children under the age of 17 years.
Does your doctor know what hours you work?
- If you are having difficulty staying awake when you need to be awake, it’s important
to discuss this with your doctor. Make sure your doctor is aware that you work shifts.
Doing so will help your doctor determine if you could have SWD and if NUVIGIL could
be right for you
- NUVIGIL is a federally controlled substance [C-IV] because it can be abused or lead
to dependence. Keep NUVIGIL in a safe place to prevent misuse and abuse. Selling
or giving away NUVIGIL may harm others, and is against the law.
- Talk to your doctor about whether you should avoid driving or using heavy machinery
while taking NUVIGIL
NUVIGIL does not replace sleep and may not stop your ES completely. Only you and
your doctor can decide if NUVIGIL is right for you, so make an appointment to see
your doctor today.
While NUVIGIL is used to improve wakefulness in patients with ES due to SWD, it
is not used to treat the sleep disorders themselves or their other symptoms or consequences.1