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Eszopiclone: Drug information

Eszopiclone: Drug information
(For additional information see "Eszopiclone: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Complex sleep behaviors:

Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake, may occur following use of eszopiclone. Some of these events may result in serious injuries, including death. Discontinue eszopiclone immediately if a patient experiences a complex sleep behavior.

Brand Names: US
  • Lunesta
Brand Names: Canada
  • Lunesta
Pharmacologic Category
  • Hypnotic, Miscellaneous
Dosing: Adult

Note: Intended for short-term use (≤4 to 8 weeks), preferably in conjunction with nonpharmacologic therapies (ACP [Qaseem 2016]; ESRS [Riemann 2017]; Winkelman 2021). Limit long-term use to cases for which nonpharmacologic treatments are not available or not effective and benefits are felt to outweigh risks (AASM [Sateia 2017]).

Insomnia, sleep onset or sleep maintenance: Oral: Initial: 1 mg once daily immediately before bedtime, as needed; may increase to 2 or 3 mg based on response and tolerability (maximum dose: 3 mg/day).

Discontinuation of therapy: Reduce by ~25% of the original dose each week or every other week (eszopiclone can be reduced by 1 mg each week or every other week). For patients taking higher doses of eszopiclone (eg, 3 mg/day) for an extended period, tapering eszopiclone even more slowly in conjunction with cognitive behavioral therapy for insomnia is encouraged (Bélanger 2009).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

Mild to moderate impairment: No dosage adjustment necessary.

Severe impairment: Initial: 1 mg immediately before bedtime (maximum dose: 2 mg); use with caution; systemic exposure is doubled in severe impairment.

Dosing: Older Adult

Avoid use (Beers Criteria [AGS 2019]).

Insomnia, sleep onset or sleep maintenance: Oral: Initial: 1 mg once daily immediately before bedtime, as needed; may increase to 2 mg based on response and tolerability (maximum dose: 2 mg/day).

Discontinuation of therapy: Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Lunesta: 1 mg [contains fd&c blue #2 (indigotine)]

Lunesta: 2 mg

Lunesta: 3 mg [contains fd&c blue #2 (indigotine)]

Generic: 1 mg, 2 mg, 3 mg

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Lunesta: 1 mg [contains fd&c blue #2 (indigotine)]

Lunesta: 2 mg

Lunesta: 3 mg [contains fd&c blue #2 (indigotine)]

Controlled Substance

C-IV

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021476s038lbl.pdf#page=26, must be dispensed with this medication.

Administration: Adult

Because of the rapid onset of action, eszopiclone should be administered immediately prior to bedtime or after the patient has gone to bed and is having difficulty falling asleep. Do not take with, or immediately following, a high-fat meal (may delay onset).

Use: Labeled Indications

Insomnia, sleep onset or sleep maintenance: Treatment of insomnia.

Medication Safety Issues
Sound-alike/look-alike issues:

Lunesta may be confused with Neulasta

Geriatric Patients: High-Risk Medication:

Beers Criteria: Eszopiclone, a nonbenzodiazepine benzodiazepine-receptor agonist hypnotic, is identified in the Beers Criteria as a potentially inappropriate medication to be avoided in patients 65 years and older (independent of diagnosis or condition) due to adverse events similar to benzodiazepines in older adults (eg, delirium, falls, fractures) and an increase in emergency room visits, hospitalizations, and motor vehicle crashes. In addition, improvement in sleep latency and duration is minimal (Beers Criteria [AGS 2019]).

Pharmacy Quality Alliance (PQA): Eszopiclone (when cumulative day supply is >90 days) is identified as a high-risk medication in patients 65 years and older on the PQA’s Use of High-Risk Medications in the Elderly (HRM) performance measure, a safety measure used by the Centers for Medicare and Medicaid Services (CMS) for Medicare plans (PQA 2017).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Central nervous system: Headache (15% to 21%)

Gastrointestinal: Dysgeusia (8% to 34%)

1% to 10%:

Cardiovascular: Chest pain (≥1%), peripheral edema (≥1%)

Central nervous system: Drowsiness (8% to 10%), dizziness (5% to 7%), pain (4% to 5%), nervousness (≤5%), depression (1% to 4%), confusion (≤3%), neuralgia (≤3%), abnormal dreams (1% to 3%), anxiety (1% to 3%), hallucination (1% to 3%), migraine

Dermatologic: Skin rash (3% to 4%), pruritus (1% to 4%)

Endocrine & metabolic: Decreased libido (≤3%), gynecomastia (≤3%)

Gastrointestinal: Xerostomia (3% to 7%), dyspepsia (2% to 6%), nausea (4% to 5%), diarrhea (2% to 4%), vomiting (≤3%)

Genitourinary: Dysmenorrhea (≤3%), urinary tract infection (≤3%)

Infection: Infection (5% to 10%), viral infection (3%)

Miscellaneous: Accidental injury (≤3%)

<1%, postmarketing, and/or case reports: Abnormal gait, abnormality in thinking, agitation, alopecia, altered sense of smell, amenorrhea, anaphylaxis, anemia, angioedema, anorexia, apathy, aphthous stomatitis, arthritis, asthma, ataxia, blepharoptosis, breast hypertrophy, breast neoplasm, bronchitis, bursitis, cholelithiasis, colitis, complex sleep-related disorder, conjunctivitis, contact dermatitis, cystitis, dehydration, diaphoresis, dry eye syndrome, dysphagia, dyspnea, dysuria, eczema, emotional lability, epistaxis, erythema multiforme, euphoria, facial edema, fever, gastric ulcer, gastritis, gout, halitosis, heatstroke, heavy menstrual bleeding, hematuria, hepatic disease, hepatitis, hepatomegaly, herpes zoster infection, hirsutism, hostility, hypercholesterolemia, hypersensitivity reaction, hypertension, hypokalemia, hyporeflexia, increased appetite, increased thirst, insomnia, laryngitis, lymphadenopathy, maculopapular rash, malaise, mastalgia, mastitis, melena, memory impairment, myasthenia, mydriasis, myopathy, neck stiffness, nephrolithiasis, neuritis, neuropathy, neurosis, nystagmus disorder, oliguria, paresthesia, photophobia, pyelonephritis, rectal hemorrhage, renal pain, skin discoloration, skin photosensitivity, swelling, thrombophlebitis, tinnitus, tongue edema, tremor, twitching, urethritis, urinary frequency, urinary incontinence, urticaria, uterine hemorrhage, vaginal hemorrhage, vaginitis, vertigo, vesiculobullous dermatitis, vestibular disturbance

Contraindications

Hypersensitivity to eszopiclone or any component of the formulation; patients who have experienced complex sleep behaviors after taking eszopiclone.

Warnings/Precautions

Concerns related to adverse effects:

• Abnormal thinking/behavioral changes: Hypnotics/sedatives have been associated with abnormal thinking and behavior changes, including decreased inhibition, aggression, bizarre behavior, agitation, hallucinations, and depersonalization. Amnesia and other neuropsychiatric symptoms may occur unpredictably and may indicate previously unrecognized psychiatric disorders; evaluate appropriately.

• CNS depression: Daytime function may be impaired in patients taking higher doses (2 or 3 mg), even if used as prescribed; caution patients taking 3 mg about performing tasks that require mental alertness (eg, operating machinery, driving) the day after use. The risk of next-day psychomotor impairment is increased if taken with less than a full night of sleep (7 to 8 hours); if a higher than recommended dose is taken; or if coadministered with other CNS depressants or other drugs that increase blood concentrations of eszopiclone. Dose adjustment may be necessary if taking concomitant CNS depressants; the use of concomitant sedative-hypnotics at bedtime or in the middle of the night is not recommended.

• Complex sleep behaviors: [US Boxed Warning]: Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake, may occur following the use of eszopiclone. Some of these events may result in serious injuries, including death. Other complex sleep behaviors (eg, preparing and eating food, making phone calls, having sex) while asleep have also been reported. Patients usually do not remember these events. May occur with first use and at recommended dosages with or without the use of alcohol or other CNS depressants. Discontinue immediately if a patient experiences a complex sleep behavior; use is contraindicated in patients who have experienced these events.

• Hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis as well as angioedema, have been reported, in some cases following initial dosing. Patients who develop severe reactions should not be rechallenged.

Disease-related concerns:

• Depression: Use with caution in patients with depression; worsening of depression, including suicidal ideation, has been reported with the use of hypnotics. Intentional overdose may be an issue in this population. The minimum dose that will effectively treat the individual patient should be used. Prescriptions should be written for the smallest quantity consistent with good patient care.

• Drug abuse: Use with caution in patients with a history of drug dependence.

• Hepatic impairment: Use with caution in patients with hepatic impairment; dosage adjustment required with severe impairment.

• Respiratory disease: Use with caution in patients with respiratory compromise, COPD or sleep apnea.

Special populations:

• Debilitated: Use with caution in debilitated patients; increased risk of impaired cognitive and/or motor performance. Dose adjustment recommended; monitor closely.

• Elderly: Increased risk of impaired cognitive and/or motor performance and falls; monitor closely.

Other warnings/precautions:

• Appropriate use: Symptomatic treatment of insomnia should be initiated only after careful evaluation of potential causes of sleep disturbance. Failure of sleep disturbance to resolve after 7-10 days may indicate psychiatric and/or medical illness.

• Duration of therapy: Tolerance, as assessed by sleep measurement, did not develop over 6 months of use.

• Rapid onset: Because of the rapid onset of action, administer immediately prior to bedtime or after the patient has gone to bed and is having difficulty falling asleep.

• Rebound insomnia: Following withdrawal of therapy, transient insomnia may recur accompanied by other reactions, including restlessness, anxiety, and mood changes.

• Withdrawal: A longer sleep-onset latency and increased awakenings during sleep may occur for 1 to 2 days following the discontinuation of GABA-mediated (GABAergic) medications. A more severe withdrawal syndrome may rarely occur following abrupt discontinuation or large decreases in dose after sustained use, and is characterized by abdominal pain, anxiety, confusion, delirium, disorientation, euphoria, hypertension, insomnia, irritability, restlessness, speech difficulties, seizures, and tremor. This withdrawal syndrome is generally mild and infrequent and resolves within weeks or upon re-initiation of the GABAergic medication. Intermittent dosing may reduce the risk of withdrawal symptoms (BAP [Wilson 2019]; Schifano 2019).

Metabolism/Transport Effects

Substrate of CYP2E1 (minor), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy

Alizapride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Azelastine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Management: Use caution if coadministering blonanserin and CNS depressants; dose reduction of the other CNS depressant may be required. Strong CNS depressants should not be coadministered with blonanserin. Risk D: Consider therapy modification

Brexanolone: CNS Depressants may enhance the CNS depressant effect of Brexanolone. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromopride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants. Risk D: Consider therapy modification

Cannabinoid-Containing Products: CNS Depressants may enhance the CNS depressant effect of Cannabinoid-Containing Products. Risk C: Monitor therapy

Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider therapy modification

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of Eszopiclone. Risk C: Monitor therapy

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Eszopiclone. Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Eszopiclone. Management: Limit the eszopiclone dose to 2 mg daily when combined with strong CYP3A4 inhibitors and monitor for increased eszopiclone effects and toxicities (eg, somnolence, drowsiness, CNS depression). Risk D: Consider therapy modification

Daridorexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dose reduction of daridorexant and/or any other CNS depressant may be necessary. Use of daridorexant with alcohol is not recommended, and the use of daridorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modification

Difelikefalin: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Risk C: Monitor therapy

Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Risk D: Consider therapy modification

Erdafitinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Esketamine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Management: Reduce the dose of CNS depressants when combined with flunitrazepam and monitor patients for evidence of CNS depression (eg, sedation, respiratory depression). Use non-CNS depressant alternatives when available. Risk D: Consider therapy modification

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Kava Kava: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Kratom: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Lemborexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Risk D: Consider therapy modification

Lisuride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Melatonin: May enhance the sedative effect of Hypnotics (Nonbenzodiazepine). Risk C: Monitor therapy

Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce the usual dose of CNS depressants by 50% if starting methotrimeprazine until the dose of methotrimeprazine is stable. Monitor patient closely for evidence of CNS depression. Risk D: Consider therapy modification

Metoclopramide: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Risk C: Monitor therapy

Minocycline (Systemic): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Olopatadine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Opioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Risk X: Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Oxybate Salt Products: Hypnotics (Nonbenzodiazepine) may enhance the CNS depressant effect of Oxybate Salt Products. Risk X: Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Risk X: Avoid combination

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Risk C: Monitor therapy

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Risk C: Monitor therapy

Ropeginterferon Alfa-2b: CNS Depressants may enhance the adverse/toxic effect of Ropeginterferon Alfa-2b. Specifically, the risk of neuropsychiatric adverse effects may be increased. Management: Avoid coadministration of ropeginterferon alfa-2b and other CNS depressants. If this combination cannot be avoided, monitor patients for neuropsychiatric adverse effects (eg, depression, suicidal ideation, aggression, mania). Risk D: Consider therapy modification

ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Risk C: Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Risk C: Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Risk C: Monitor therapy

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modification

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Risk X: Avoid combination

Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Valerian: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider therapy modification

Food Interactions

Onset of action may be reduced if taken with or immediately after a heavy meal. Management: Take immediately prior to bedtime, not with or immediately after a heavy or high-fat meal.

Pregnancy Considerations

Eszopiclone is the S-isomer of the racemic derivative zopiclone. Available data related to zopiclone (not available in the United States) and similar medications note the potential for preterm birth, low birth weight, and/or small for gestational age infants following maternal use.

Long-term use of medications in this class is not recommended during pregnancy and a planned discontinuation should be done to prevent rebound insomnia (Okun 2015).

Breastfeeding Considerations

It is not known if eszopiclone is present in breast milk.

Eszopiclone is the S-isomer of the racemic derivative zopiclone. Zopiclone is excreted in human milk (Matheson 1990).

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Dietary Considerations

Avoid taking after a heavy meal; may delay onset.

Mechanism of Action

May interact with GABA-receptor complexes at binding domains located close to or allosterically coupled to benzodiazepine receptors.

Pharmacokinetics

Absorption: Rapid; high-fat/heavy meal may delay absorption

Protein binding: 52% to 59%

Metabolism: Hepatic via oxidation and demethylation (CYP2E1, 3A4); (S)-N-desmethyl zopiclone metabolite has less activity than parent compound

Half-life elimination: ~6 hours; Elderly (≥65 years): ~9 hours

Time to peak, plasma: ~1 hour

Excretion: Urine (up to 75%, primarily as metabolites; <10% as parent drug)

Pharmacokinetics: Additional Considerations

Hepatic function impairment: Systemic exposure is doubled in severe hepatic impairment with no change in Cmax or Tmax.

Geriatric: Subjects ≥65 years of age had a 41% increase in total exposure (AUC) and a 50% increase in elimination half-life.

Pricing: US

Tablets (Eszopiclone Oral)

1 mg (per each): $11.66 - $12.16

2 mg (per each): $11.66 - $12.16

3 mg (per each): $11.66 - $12.16

Tablets (Lunesta Oral)

1 mg (per each): $18.82

2 mg (per each): $18.82

3 mg (per each): $18.82

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • 8 Horas (AR);
  • Eszop (CL);
  • Fresom (BD);
  • Fulnite (IN);
  • Inductal (AR, LB);
  • Isoklon (CO);
  • Lunesta (JP);
  • Lunox 2 (UY);
  • Magicpiclone (EG);
  • Miapax (AR);
  • Neogaival (EC, UY);
  • Night Calm (EG);
  • Nirvan (CL);
  • Noptic (CL);
  • Orizon (PY);
  • Sleepez (EG);
  • Sleepil (BD);
  • Sominex 1 (BD);
  • Sominex 2 (BD);
  • Sono (BD);
  • Valnoc (PE);
  • Wen Fei (CN)


For country abbreviations used in Lexicomp (show table)

REFERENCES

  1. 2019 American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2019 Updated AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2019;67(4):674-694. doi: 10.1111/jgs.15767. [PubMed 30693946]
  2. Bélanger L, Belleville G, Morin C. Management of hypnotic discontinuation in chronic insomnia. Sleep Med Clin. 2009;4(4):583-592. doi:10.1016/j.jsmc.2009.07.011 [PubMed 20607118]
  3. FDA Safety Alert. MedWatch. FDA adds Boxed Warnings for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines. Food and Drug administration website. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-risk-serious-injuries-caused-sleepwalking-certain-prescription-insomnia. Accessed May 3, 2019.
  4. Krystal AD, Walsh JK, Laska E, et al. Sustained Efficacy of Eszopiclone Over 6 Months of Nightly Treatment: Results of a Randomized, Double-Blind, Placebo-Controlled Study in Adults With Chronic Insomnia. Sleep. 2003;26(7):793-799. [PubMed 14655910]
  5. Lunesta (eszopiclone) [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc; August 2019.
  6. Matheson I, Sande HA, Gaillot J. The excretion of zopiclone into breast milk. Br J Clin Pharmacol. 1990;30(2):267-271. [PubMed 2206788]
  7. Okun ML, Ebert R, Saini B. A review of sleep-promoting medications used in pregnancy. Am J Obstet Gynecol. 2015;212(4):428-441. [PubMed 25448509]
  8. Pharmacy Quality Alliance. Use of high-risk medications in the elderly (2017 update) (HRM-2017). https://www.pqaalliance.org/medication-safety. Published 2017. Accessed March 21, 2019.
  9. Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Management of chronic insomnia disorder in adults: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2016;165(2):125-133. doi:10.7326/M15-2175 [PubMed 27136449]
  10. Riemann D, Baglioni C, Bassetti C, et al. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017;26(6):675-700. doi:10.1111/jsr.12594 [PubMed 28875581]
  11. Sateia MJ, Buysse DJ, Krystal AD, Neubauer DN, Heald JL. Clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2017;13(2):307-349. doi:10.5664/jcsm.6470 [PubMed 27998379]
  12. Schifano F, Chiappini S, Corkery JM, Guirguis A. An insight into Z-drug abuse and dependence: an examination of reports to the European Medicines Agency database of suspected adverse drug reactions. Int J Neuropsychopharmacol. 2019;22(4):270-277. doi:10.1093/ijnp/pyz007 [PubMed 30722037]
  13. Wilson S, Anderson K, Baldwin D, et al. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders: an update. J Psychopharmacol. 2019;33(8):923-947. doi:10.1177/0269881119855343 [PubMed 31271339]
  14. Winkelman JW. Overview of the treatment of insomnia in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed September 10, 2021.
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