Lunesta


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eszopiclone

Lunesta

Pharmacologic class: Nonbenzodi-azepine

Therapeutic class: Hypnotic Controlled substance schedule IV

Therapeutic class: Hypnotic Controlled substance schedule IV

Pregnancy risk category C

Action

Unclear. Effect may result from interaction with GABA-receptor complexes at binding domains near or allosterically coupled with benzodiazepine receptors.

Availability

Tablets: 1 mg, 2 mg, 3 mg

Indications and dosages

Insomnia

Nonelderly adults: 2 mg P.O. immediately before bedtime. Drug may be initiated at, or dosage may be increased to, 3 mg if indicated clinically. In patients also receiving potent CYP3A4 inhibitors, starting dosage shouldn't exceed 1 mg.

Elderly adults: 1 mg P.O. immediately before bedtime. Dosage may be increased to 2 mg if indicated clinically. If patient's chief complaint is difficulty staying asleep, recommended dosage is 2 mg P.O. immediately before bedtime.

Dosage adjustment

• Hepatic impairment
• Concomitant use of other CNS depressants

Contraindications

None

Precautions

Use cautiously in:
• hepatic impairment, respiratory compromise, depression
• pregnant or breastfeeding patients
• children younger than age 18 (safety and efficacy not established).

Administration

• Don't give with or immediately after a heavy, high-fat meal because this may slow drug absorption and reduce efficacy.

Adverse reactions

CNS: headache, anxiety, confusion, depression, dizziness, hallucinations, nervousness, abnormal dreams

CV: chest pain, peripheral edema

GI: nausea, vomiting, diarrhea, dyspepsia, cholelithiasis, dry mouth

GU: urinary tract infection, decreased libido, dysmenorrhea, gynecomastia (in males)

Respiratory: respiratory infection

Skin: rash, pruritus

Other: unpleasant taste, viral infection, neuralgia, facial edema, allergic reaction

Interactions

Drug-drug.CYP3A4 inhibitors (such as itraconazole, ketoconazole, ritonavir, troleandomycin): increased eszopiclone blood level

CYP3A4 inducers (such as rifampin): decreased eszopiclone blood level

Drug-food.Heavy, high-fat meal: slowed drug absorption and reduced efficacy

Drug-behaviors.Alcohol use: additive effects on psychomotor performance

Patient monitoring

• Before starting therapy, evaluate patient to help eliminate physical or psychiatric causes of insomnia.
• Know that after rapid dosage decrease or abrupt drug withdrawal, patient may experience signs and symptoms similar to those associated with withdrawal from other CNS depressants.

Patient teaching

• Instruct patient not to take drug with or immediately after a heavy, high-fat meal.
• Advise patient to take drug immediately before bedtime; otherwise, shortterm memory impairment, hallucinations, incoordination, dizziness, and light-headedness may occur.
• Caution patient not to engage in hazardous activities after taking drug.
• Tell patient drug may have some effect the next day; advise him to use extreme care when driving or performing other hazardous activities until drug effects are known.
• Caution patient not to take drug with other psychotropics, anticonvulsants, antihistamines, or other drugs that cause CNS depression.
• Advise patient not to take drug with alcohol.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, foods, and behaviors mentioned above.

eszopiclone

(es-zop-i-klone) ,

Lunesta

(trade name)

Classification

Therapeutic: sedative hypnotics
Pharmacologic: cyclopyrrolones
Pregnancy Category: C

Indications

Insomnia.

Action

Interacts with GABA-receptor complexes; not a benzodiazepine.

Therapeutic effects

Improved sleep with decreased latency and increased maintenance of sleep.

Pharmacokinetics

Absorption: Rapidly absorbed after oral administration.
Distribution: Unknown.
Metabolism and Excretion: Extensively metabolized by the liver (CYP3A4 and CYP2E1 enzyme systems); metabolites are renally excreted, <10% excreted unchanged in urine.
Half-life: 6 hr.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
POrapid1 hr6 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity.
Use Cautiously in: Debilitated patients may have ↓ metabolism or increased sensitivity; use lower initial dose;Conditions that may alter metabolic or hemodynamic function;Severe hepatic impairment (use lower initial dose); Obstetric / Pediatric: Safety not established ; Lactation: Occasional use while breast feeding an older infant should pose little risk (NIH); Geriatric: May impair motor and/or cognitive performance; see dosing guidelines.

Adverse Reactions/Side Effects

Central nervous system

  • abnormal thinking
  • behavior changes
  • depression
  • hallucinations
  • headache
  • sleep-driving

Cardiovascular

  • chest pain
  • peripheral edema

Gastrointestinal

  • dry mouth
  • unpleasant taste

Dermatologic

  • rash

Interactions

Drug-Drug interaction

↑ risk of CNS depression with other CNS depressants including antihistamines, antidepressants, opioids, sedative/hypnotics, and antipsychotics.↑ levels and risk of CNS depression with drugs that inhibit the CYP3A4 enzyme system, including ketoconazole, itraconazole, clarithromycin, nefazodone, ritonavir, and nelfinavir.Levels and effectiveness may be ↓ by drugs that induce the CYP3A4 enzyme system, including rifampin.

Route/Dosage

Oral (Adults) 2 mg immediately before bedtime, may be ↑ to 3 mg if needed (3-mg dose is more effective for sleep maintenance); Geriatric patients—1 mg immediately before bedtime for patients with difficulty falling asleep, 2 mg for patients with difficulty staying asleep; Concurrent use of CYP3A4 inhibitors—1 mg immediately before bedtime, may be ↑ to 2 mg if needed.

Hepatic Impairment

Oral (Adults) Severe hepatic impairment—1 mg immediately before bedtime.

Availability (generic available)

Tablets: 1 mg, 2 mg, 3 mg Cost: 1 mg $338.76 / 30, 2 mg $300.85 / 30, 3 mg $300.85 / 30

Nursing implications

Nursing assessment

  • Assess sleep patterns prior to and during administration. Continued insomnia after 7–10 days of therapy may indicate primary psychiatric or mental illness.
  • Assess mental status and potential for abuse prior to administration. Prolonged use of >7–10 days may lead to physical and psychological dependence. Limit amount of drug available to the patient.

Potential Nursing Diagnoses

 (Indications)

Implementation

  • Do not confuse Lunesta with Neulasta.
  • Oral: Onset is rapid. Administer immediately before going to bed or after patient has gone to bed and has experienced difficulty falling asleep, only on nights when patient is able to get 8 or more hours of sleep before being active again.
    • Swallow tablet whole; do not break, crush, or chew.
    • Eszopiclone is more effective if not taken with or before a high-fat, heavy meal.

Patient/Family Teaching

  • Instruct patient to take eszopiclone immediately before going to bed, as directed. May result in short-term memory impairment, hallucinations, impaired coordination, and dizziness. Do not increase dose or discontinue without notifying health care professional. Dose may need to be decreased gradually to minimize withdrawal symptoms. Rebound insomnia may occur upon discontinuation and usually resolves within 1–2 nights.
  • May cause daytime drowsiness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any other Rx, OTC, or herbal products.
  • Caution patient to avoid concurrent use of alcohol or other CNS depressants.
  • Advise patient to notify health care professional if pregnancy is planned or suspected.

Evaluation/Desired Outcomes

  • Decreased sleep latency and improved sleep maintenance.

Lunesta

(lo͞o-nĕs′tə)
A trademark for the drug eszopiclone.

Lunesta

a trademark for eszopiclone.
References in periodicals archive ?
Patients currently taking the 2 mg and 3 mg doses of Lunesta should contact their health care professional to ask for instructions on how to continue to take their medicine safely at a dose that is best for them.
Marketed in the United States since April 2005, Lunesta was approved as the first insomnia treatment not to have restrictions placed on its length of use, and is widely used by individuals suffering from insomnia and is not typically taken by patients concomitantly with other insomnia treatments.
Lunesta is also the single most heavily advertised drug of the past two years, according to TNS Media Intelligence, which estimates that Sepracor has spent more than $400 million on ads so far .
Data from LUNESTA Phase IIIB/IV studies were also presented at the American Psychiatric Association annual meeting and the SLEEP 2006 20th Anniversary Meeting of the Associated Professional Sleep Societies in May and June.
Sepracor (Monte McCrary) and I have worked since October to allow APN's in Tennessee to even receive SRx of Lunesta.
Sepracor will market Lunesta on its own, but Neurocrine's drug will be marketed by Pfizer, and Pfizer will be responsible for marketing and promotional expenses in this market, where consumer advertising costs can top $200 million in the first year of launch.
Incidence (%) of treatment-emergent adverse events in a 6-week placebo-controlled study in non-elderly adults with Lunesta * Placebo Lunesta 2 mg Lunesta 3 mg Adverse event (n = 99) (n =104) (n =105) Body as a whole Headache 13 21 17 Viral infection 1 3 3 Digestive system Dry mouth 3 5 7 Dyspepsia 4 4 5 Nausea 4 5 4 Vomiting 1 3 0 Nervous system Anxiety 0 3 1 Confusion 0 0 3 Depression 0 4 1 Dizziness 4 5 7 Hallucinations 0 1 3 Libido decreased 0 0 3 Nervousness 3 5 0 Somnolence 3 10 8 Respiratory system Infection 3 5 10 Skin and appendages Rash 1 3 4 Special senses Unpleasant taste 3 17 34 Urogenital system Dysmenorrhea ([dagger]) 0 3 0 Gynecomastia ([double 0 3 0 dagger]) * Reprinted with permission from reference 6.
In addition to the novel drug Rozerem (ramelteon), the Food and Drug Administration approved the hypnotic drugs Lunesta (eszopiclone) and a new, slow-release formulation of zolpidem called Ambien CR.
Lunesta and Suvorexant: Based on clinical data and the opinions of interviewed thought leaders, suvorexant (Merck & Co.
has gained another six months to sell the sleep drug Lunesta in the United States before generic versions hit the market.
Sunovion has now gained an additional six months of United States market exclusivity for LUNESTA, which will expire on May 31, 2014.
Ltd announced today that it received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) on January 18, 2012 to market Lunesta (eszopiclone), a product the company has been developing in Japan, as a treatment for insomnia.