Lemborexant

Lemborexant is a prescription medicine used for adults who have trouble falling or staying asleep (insomnia).

• Lemborexant is available under the following different brand names: Dayvigo

Adult dosage

Tablet

• 5mg
• 10mg

Insomnia

Adult and geriatric dosage

• 5 mg orally no more than once per night, immediately before going to bed, with at least 7 hours remaining before the planned time of awakening
• May increase dose to a maximum of 10 mg based on clinical response and tolerability

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Lemborexant include:

• sleepiness,
• fatigue,
• headache, and
• nightmare or abnormal dreams.

Serious side effects of Lemborexant include:

• temporary inability to move or talk (sleep paralysis) for up to several minutes while going to sleep or waking up,
• temporary weakness in the 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 aware that may not be remembered the next morning, and 
• worsening depression and suicidal thoughts.

Rare side effects of Lemborexant include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Lemborexant has severe interactions with no other drugs.
• Lemborexant has serious interactions with at least 110 other drugs.
• Lemborexant has moderate interactions with at least 274 other drugs.
• Lemborexant has minor interactions with no other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Narcolepsy

Effects of drug abuse

• Addiction

Short-Term Effects

• See “What Are Side Effects Associated with Using Lemborexant?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Lemborexant?”

Cautions

• CNS depressant that can impair daytime wakefulness even when used as prescribed; CNS depression may persist and affect next-day tasks (eg, driving ability); CNS depression may persist in some patients for several days after discontinuing; Coadministration with other CNS depressants may increase risk
• Sleep paralysis, an inability to move or speak for up to several minutes during sleep-wake transitions, and hypnagogic/hypnopompic hallucinations, including vivid and disturbing perceptions, can occur; mild cataplexy can occur, with symptoms that include periods of leg weakness lasting from seconds to a few minutes
• Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake (eg, preparing and eating food, making phone calls, having sex), reported with hypnotic use
• Consider the effect on respiratory function if prescribed to patients with compromised respiratory function; has not been studied with moderate-to-severe obstructive sleep apnea or COPD
• In primarily depressed patients treated with hypnotics, worsening of depression and suicidal thoughts and actions (including completed suicides) have been reported; monitor for new behavioral signs or symptoms
• Evaluate for comorbid diagnoses where insomnia may be presenting manifestation of a medial and/or psychiatric disorder
• Drug interaction overview
• CNS depressants
  • Coadministration with other CNS depressants (eg, benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression, which can cause daytime impairment
• CYP3A inhibitors
  • Coadministration with a strong, moderate, or weak CYP3A inhibitor increases lemborexant AUC and peak plasma concentration which may increase the risk of lemborexant adverse reactions
• CYP3A inducers
  • Concomitant use with a strong or moderate CYP3A inducer decreases lemborexant exposure, which may reduce lemborexant efficacy
• CYP2B6 substrates
  • Coadministration decreases the AUC of CYP2B6 substrates
  • Check to prescribe information for CYP2B6 substrate for dosage recommendations if coadministered

Pregnancy and Lactation

• Data are not available on use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Clinicians are encouraged to register patients in the Dayvigo pregnancy registry by calling 1-888-274-2378
• Lactation
  • Data are not available on the presence of lemborexant in human milk, effects on breastfed infants, or effects on milk production
  • Lemborexant and its metabolites are present in the milk of lactating rats; when a drug is present in animal milk, the drug will likely be present in human milk
  • Monitor infants exposed through breastmilk for excessive sedation
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition