Dayvigo (lemborexant)

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

Dayvigo is a federally controlled substance (CIV) because it can be abused or cause dependence. Keep Dayvigo in a safe place to prevent misuse and abuse. Selling or giving away Dayvigo may harm others and is against the law. Tell your doctor if you have ever abused or have been dependent on alcohol, prescription medicines or street drugs.

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 of Dayvigo is sleepiness.

These are not all of the possible side effects of Dayvigo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Drug Abuse And Dependence

Controlled Substance

Dayvigo contains lemborexant, a Schedule IV controlled substance.

Abuse

• Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects.
• In a human abuse potential study conducted in recreational sedative abusers (n=29), lemborexant 10 mg, 20 mg (two times the maximum recommended dose), and 30 mg (three times the maximum recommended dose) produced responses on positive subjective measures such as “Drug Liking,” “Overall Drug Liking,” “Take Drug Again,” and “Good Drug Effects” that were statistically similar to those produced by the sedatives zolpidem (30 mg) and suvorexant (40 mg), and statistically greater than the responses on these measures that were produced by placebo.
• Because individuals with a history of abuse or addiction to alcohol or other drugs may be at increased risk for abuse and addiction to Dayvigo, follow such patients carefully.

Dependence

• Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.
• In animal studies and clinical trials evaluating physical dependence, chronic administration of lemborexant did not produce withdrawal signs or symptoms upon drug discontinuation. This suggests that lemborexant does not produce physical dependence.

Dosing Information

The recommended dosage of Dayvigo is 5 mg taken no more than once per night, immediately before going to bed, with at least 7 hours remaining before the planned time of awakening. The dose may be increased to the maximum recommended dose of 10 mg based on clinical response and tolerability. Time to sleep onset may be delayed if taken with or soon after a meal.

Dosage Recommendations For Concomitant Use With CYP3A Inhibitors Or CYP3A Inducers

Co-Administration With Strong Or Moderate CYP3A Inhibitors

• Avoid concomitant use of Dayvigo with strong or moderate CYP3A inhibitors.

Co-Administration With Weak CYP3A Inhibitors

• The maximum recommended dosage of Dayvigo is 5 mg no more than once per night when co-administered with weak CYP3A inhibitors.

Co-Administration With Strong Or Moderate CYP3A Inducers

• Avoid concomitant use of Dayvigo with strong or moderate CYP3A inducers.

Dosage Recommendations For Patients With Hepatic Impairment

• The maximum recommended dose of Dayvigo is 5 mg no more than once per night in patients with moderate hepatic impairment.
• Dayvigo is not recommended in patients with severe hepatic impairment.

Drugs Having Clinically Important Interactions With Dayvigo

Table 2: Clinically Important Drug Interactions with Dayvigo

• There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to Dayvigo during pregnancy.
• Healthcare providers are encouraged to register patients in the Dayvigo pregnancy registry by calling 1-888-274-2378.
• There are no data on the presence of lemborexant in human milk, the effects on the breastfed infant, or the effects on milk production. Lemborexant and its metabolites are present in the milk of lactating rats.
• When a drug is present in animal milk, it is likely that the drug will be present in human milk.
• Infants exposed to Dayvigo through breastmilk should be monitored for excessive sedation.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Dayvigo and any potential adverse effects on the breastfed infant from Dayvigo or from the underlying maternal condition.