Sleep-wake disorders:

Indications for: LUNESTA

Insomnia (decreased sleep latency and improved sleep maintenance).

Adult Dosage:

Use lowest effective dose. Effects delayed if taken with or after a heavy/high-fat meal. ≥18yrs: initially 1mg immediately before bedtime (with at least 7–8hrs remaining before planned time of awakening); may increase to 2–3mg if needed; max 3mg/dose. Elderly, debilitated, concomitant CYP3A4 inhibitors, or severe hepatic impairment: max 2mg/dose.

Children Dosage:

<18yrs: not established.

LUNESTA Contraindications:

Prior history of complex sleep behaviors with Lunesta.

Boxed Warning:

Complex sleep behaviors.

LUNESTA Warnings/Precautions:

Risk of complex sleep behaviors (eg, sleep-walking, sleep-driving, engaging in other activities while not fully awake); discontinue immediately if occur. Monitor for CNS depressant effects and next-day impairment. Evaluate for co-morbid diagnoses (eg, physical and/or psychiatric disorders) prior to treatment. Reevaluate if insomnia fails to remit after 7–10 days of use. Depression. Suicidal tendencies. Evaluate any new onset of behavioral changes. Compromised respiratory function. Conditions that affect metabolism or hemodynamic response. Drug or alcohol abuse. Hepatic impairment. Avoid abrupt cessation. Write ℞ for smallest practical amount. Elderly (higher risk of falls). Debilitated. Pregnancy. Nursing mothers.

LUNESTA Classification:

Pyrrolopyrazine hypnotic.

LUNESTA Interactions:

Concomitant other sedative-hypnotics at bedtime or middle of the night: not recommended. Potentiates CNS depression with alcohol, other CNS depressants; adjust dose. Potentiated by CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, nefazodone, troleandomycin, ritonavir, nelfinavir); see Adults. May be antagonized by CYP3A4 inducers (eg, rifampicin).

Adverse Reactions:

Unpleasant taste, headache, somnolence, dizziness, dry mouth, infection, rash, anxiety, hallucinations; abnormal thinking and behavioral changes; rare: anaphylaxis, angioedema (do not rechallenge).

Generic Drug Availability:


How Supplied:

Tabs 1mg—30; 2mg, 3mg—30, 100