Consumer Information for: BELSOMRA

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

• have a history of depression, mental illness, or suicidal thoughts
• have a history of drug or alcohol abuse or addiction
• have had episodes of sleepwalking in the past or if there is a history of sleepwalking in your family
• have conditions known to affect your sleep or cause you to wake up often, such as
• sleep apnea
• Periodic Limb Movement Disorder (cramping or jerking of the legs during sleep)
• Restless Leg Syndrome (the need to move your legs)
• have a history of sudden muscle weakness (cataplexy)
• have a history of falling asleep often at unexpected times (narcolepsy) or daytime sleepiness
• have problems with your lungs or breathing problems
• have problems with your liver
• are pregnant or planning on becoming pregnant. It is not known if BELSOMRA can harm your unborn baby. Your doctor will decide whether giving you BELSOMRA outweighs the potential risk to the fetus.
• are breastfeeding or planning to breastfeed. It is not known whether BELSOMRA can pass into your breastmilk.
• have lactose intolerance

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 BELSOMRA™.

Talk to your doctor if after 7 to 10 days of taking BELSOMRA™ 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 problem.

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

It can 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 BELSOMRA™ affects you the next day.

You can feel less alert the next day:

• even if you take BELSOMRA™ 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 BELSOMRA™ 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 that affects your ability to do tasks that require clear thinking or attention, tell your doctor.

Abnormal thinking and behavioural changes: Taking hypnotics such as BELSOMRA™ can cause abnormal thinking and changes to your behaviour. These can include:

• memory loss (amnesia)
• anxiety
• seeing or hearing things that are not there (hallucinations)

Complex sleep-related behaviours: After taking hypnotics such as BELSOMRA™, you may get up out of bed while not being fully awake and do an activity 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 that you did anything during the night. You may have a greater chance for doing these activities while not fully awake if:

• you drink alcohol or
• take other medicines that make you sleepy with BELSOMRA™ or
• have other conditions that affect your sleep and cause you to wake up often during the night (for example, if you have sleep apnea, Periodic Limb Movement disorder or Restless Leg Syndrome)

You should let your family know that BELSOMRA™ can cause you to get out of bed while not being fully awake and do activities without knowing you are doing them.

If you find out that you have done any of these activities after taking BELSOMRA™, call your doctor.

Worsening depression and thoughts of suicide: Thoughts of suicide have been seen in people taking BELSOMRA™. Some people with depression who took hypnotic medications 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 have increased thoughts of suicide, call your doctor right away.

Sleep paralysis, muscle weakness and hallucinations: You may experience the following when taking BELSOMRA™:

• you are not able to move or talk for up to several minutes while you are going to sleep or waking up (sleep paralysis)
• sudden muscle weakness, commonly in the legs, that can last a few seconds to a few minutes. This can happen during the day or at night.
• hallucinations (seeing or hearing things that are not there) while falling asleep or when waking up

If you experience any of these symptoms, call your doctor.

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