Lemborexant

Lemborexant is a sleep medicine that helps treat insomnia (difficulty falling asleep or staying asleep).

Lemborexant may also be used for reasons not mentioned in this medication guide.

Follow the directions on your prescription label and read all medication guides. Never use lemborexant in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of lemborexant.

Lemborexant may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Take lemborexant only once per night, right before you get into bed.

Avoid taking the medicine shortly after eating a meal, or the medicine may take longer to work.

Lemborexant will make you fall asleep. Never take this medicine if you do not have 7 hours to sleep before being active again.

You may have trouble speaking or moving while you are falling asleep. It may take longer for you to wake up, speak, or move around when you wake up. You may feel like you are still dreaming for several minutes after waking.

Call your doctor if your insomnia symptoms do not improve, or if they get worse after using lemborexant for 7 to 10 nights in a row.

Store at room temperature away from moisture, heat, and light. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Take lemborexant right before you go to bed. Never take this medicine if you do not have 7 hours to sleep before you need to be active again.

Your reactions may be affected the morning after you take lemborexant. Do not drive or do anything that requires alertness. Drowsiness can lead to falls, accidents, or serious injuries.

You should not use lemborexant if you have:

• narcolepsy; or
• severe liver disease.

Tell your doctor if you have ever had:

• depression, mental illness, or thoughts about suicide;
• drug or alcohol abuse or addiction;
• breathing problems, sleep apnea (when breathing stops during sleep);
• liver or kidney disease;
• sudden muscle weakness;
• excessive sleepiness during normal waking hours; or
• if you have ever fallen asleep at unexpected times.

Tell your doctor if you are pregnant or breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of lemborexant on the baby.

Lemborexant is not approved for use by anyone younger than 18 years old.

Get emergency medical help if you notice signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people using lemborexant have done things while not fully awake and later had no memory of it. This may include walking, driving, eating, having sex, or making phone calls. If this happens to you, call your doctor right away.

Lemborexant may cause serious side effects. Call your doctor immediately if you have:

• trouble moving or talking when you first wake up;
• a weak feeling in your legs;
• unusual thoughts or behavior;
• anxiety, agitation, depression;
• memory problems;
• confusion, hallucinations; or
• worsening depression or thoughts about hurting yourself.

Older adults have a higher risk of falls due to drowsiness caused by lemborexant.

Common side effects of lemborexant may include:

• drowsiness during the day after taking lemborexant.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Insomnia:

5 mg orally once a day at bedtime-Maximum dose: 10 mg once at bedtimeUse: For the treatment of patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

Since lemborexant is taken only at bedtime if needed, you are not likely to miss a dose. Never take this medicine if you do not have 7 hours to sleep before being active again.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Your reactions may be impaired the morning after you take lemborexant. Do not drive or do anything that requires you to be alert. Drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects could occur.

Using lemborexant with other drugs that make you drowsy can increase this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Sometimes it is not safe to use certain medications at the same time. Some drugs can change the amount of other drugs in your blood, which may increase side effects or reduce how well the medications work.

Other drugs may affect lemborexant, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.