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POST TIME: 6 January, 2020 00:00 00 AM
FDA approves Dayvigo (lemborexant) for Insomnia treatment
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FDA approves Dayvigo (lemborexant) for Insomnia treatment

Dayvigo is a prescription medicine for adults who have trouble falling or staying asleep (insomnia). It is not known if this medicine is safe and effective in children under the age of 18 years.

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.

have a history of drug or alcohol abuse or addiction.

have a history of a sudden onset of muscle weakness (cataplexy).

have a history of daytime sleepiness.

have lung problems or breathing problems, including sleep apnea.

have liver problems.

are pregnant or plan to become pregnant. It is not known if Dayvigo can harm your unborn baby.

Pregnancy Registry: There is a pregnancy registry for women who are exposed to Dayvigo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about the risk to your unborn baby if you take Dayvigo during pregnancy.

are breastfeeding or plan to breastfeed. It is not known if Dayvigo passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.

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.

Take Dayvigo exactly as your healthcare provider tells you to take it.

Only take Dayvigo one time each night, right before going to bed.

Only take Dayvigo when you can stay in bed for a full night (at least 7 hours).

Dayvigo may take longer to work if you take it with or soon after a meal.

Do not increase your dose without talking to your healthcare provider first. Call your healthcare provider if your insomnia (sleep problem) worsens or is not improved within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

If you take too much Dayvigo, call your healthcare provider or go to the nearest hospital emergency room right away.

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 do 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 side effects

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. Call your healthcare provider right away if you experience a complex sleep behavior.

worsening depression and suicidal thoughts have happened during treatment with Dayvigo. Call your healthcare provider right away if you have any worsening depression or thoughts of suicide or dying.

The most common side effect is sleepiness.