Details for: DAYVIGO

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DAYVIGO. Talk about any health conditions or problems you may have, including if you:

• have a history of drug or alcohol abuse or addiction.
• have a history of falling asleep often at unexpected times (narcolepsy) or feeling sleepy during the day.
• have breathing problems (such as sleep apnea).
• have liver problems.
• are pregnant or plan to become pregnant. It is not known if DAYVIGO can harm your unborn baby. Your doctor will decide whether prescribing DAYVIGO to you outweighs the risk to your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if DAYVIGO passes into your breast milk.
• are lactose intolerant

Other warnings you should know about

Need to check for other existing medical conditions: Sleep problems can be a sign of many physical and mental disorders. Your doctor will need to check your medical history before you start taking DAYVIGO.

Talk to your doctor if after 7 to 10 days of taking DAYVIGO your sleep problems:

• do not stop or do not get better
• get worse or you develop new abnormal thinking or behaviour

This may mean that there is another condition such as a physical or mental illness causing your sleep problems.

Abnormal thinking and behavioural changes: When using hypnotics such as DAYVIGO you may experience abnormal thinking and changes to your behaviour. These can include:

• memory loss (amnesia) for events that occur when you are not fully awake
• anxiety
• seeing or hearing things that are not there (hallucinations) when falling asleep or waking up

Complex sleep-related behaviours: While taking hypnotic medicines such as DAYVIGO, you may get out of bed while not being fully awake and do activities that you do not know you are doing, such as:

• sleep-walking
• driving a car (“sleep-driving”)
• eating
• making phone calls
• having sex

The next morning you may not remember what you did during the night. If someone tells you about events you do not remember doing, or you think you may have done things in your sleep you do not remember doing, stop taking DAYVIGO and call your doctor.

You increase your risk of doing activities while not fully awake if you:

• drink alcohol
• take other medicines that make you feel sleepy
• have other conditions that affect your sleep that can cause you to wake up often during the night (such as sleep apnea, Periodic Limb Movement Disorder or Restless Leg Syndrome)

Worsening depression and thoughts of suicide: Thoughts of suicide have been reported in people taking DAYVIGO. Some people with depression who took hypnotic medicines saw their depression get worse. They also had increased thoughts of suicide and actions. If you, your caregiver or your family members notice that your depression is getting worse or that you are having thoughts of suicide call your doctor right away.

Sleep paralysis, muscle weakness (cataplexy) and hallucinations: You may experience the following when taking DAYVIGO:

• you are not able to move or talk for up to several minutes while you are going to sleep or waking up (“sleep paralysis”)
• have sudden muscle weakness, commonly in the legs, that can last a few seconds to a few minutes (cataplexy-like symptoms). This can happen during the day or at night and may not be associated with an identified triggering event (e.g. laughter or surprise)
• seeing or hearing things that are not there (hallucinations) while falling asleep or when you wake up

If you experience any of these, talk to your doctor.

Mental alertness, driving and using machines: DAYVIGO may affect your ability to be alert the next day.

It may affect how well you drive and you may be at an increased risk of falling asleep while you drive. Do NOT drive or use dangerous machinery until you know how taking DAYVIGO affects you the next day.

You can feel less alert:

• even if you take DAYVIGO as exactly as prescribed
• for several days after you stop taking it

You increase the risk of being less alert the next day if:

• you do NOT get a full night of sleep (at least 7 hours)
• take DAYVIGO with other medicines that make you sleepy
• are taking a higher dose

If you notice that you are feeling more sleepy or drowsy during the day and it is affecting your ability to do tasks that require clear thinking or attention, talk to your doctor.

Falls: Since DAYVIGO can cause you to feel drowsy, patients, especially the elderly, may be at a higher risk of falls.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Do NOT:

• drink alcohol while taking DAYVIGO. It can increase your chances of getting serious side effects or
• take other medicines that can make you sleepy (sedatives). Examples of these types of medicines are:
  • prescription and over the counter sleep products
  • opioids (used to treat pain)
  • certain antidepressants (used to treat depression)