Precautions

Important Precautions

• Daytime Impairment

Lemborexant, like other sleep-promoting drugs, may impair daytime wakefulness even when used as prescribed. Prescribers should advise patients about the potential for next-day somnolence. The risk of daytime impairment is increased if lemborexant is taken with less than a full night of sleep remaining, or if a higher than the recommended dose is taken. The use of lemborexant with other drugs to treat insomnia is not recommended.

• Effects on Ability to Drive and Use Machines

Although lemborexant at doses of 5 mg and 10 mg did not cause statistically significant impairment in next-morning driving performance in adult or elderly subjects (compared with placebo), driving ability was impaired in some subjects taking 10 mg lemborexant. Patients using the 10 mg dose should be cautioned about the potential for next-morning driving impairment because there is individual variation in sensitivity to lemborexant.

• Abuse

In an abuse liability study conducted in recreational sedative abusers (n=39), lemborexant (10, 20 and 30 mg) produced similar effects as zolpidem (30 mg) and suvorexant (40 mg) on subjective ratings of “drug liking”, “Overall Drug Liking,” “Take Drug Again,” and “Good Drug Effects” and other measures of subjective drug effects. Because individuals with a history of abuse or addiction to alcohol or other drugs may be at increased risk for abuse and addiction to lemborexant, follow such patients carefully.

• Dependence

In both 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.