Potential Pharmacokinetic Basis for Zolpidem Dosing in Children With Sleep Difficulties

Jl, Blumer; Reed,; Steinberg, Frank; O’Riordan, MaryAnn; Rosen, CL; Springer, MA; Christensen, Michael L.; Glaze, Daniel G.

doi:10.1038/sj.clpt.6100380

Cited by 32 publications

(17 citation statements)

References 36 publications

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“…Zolpidem (brand name Ambien) is an imidazopyridine agent that is an agonist to the benzodiazepine receptor component of the γ‐aminobutyric acid A receptor complex which is commonly used as a hypnotic/sedative agent . It has a very rapid onset of action, can be orally administered, and is rapidly metabolized and eliminated . Additionally, one study has demonstrated utility of zolpidem as oral premedication in adults prior to general anesthesia .…”

Section: Introductionmentioning

confidence: 99%

A comparison of midazolam and zolpidem as oral premedication in children, a prospective randomized double‐blinded clinical trial

Hanna

Ramsingh

Sullivan-Lewis

et al. 2018

Pediatric Anesthesia

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Summary Background Anxiety associated with pediatric surgery can be stressful. Midazolam is a well‐accepted anxiolytic in this setting. However, there are cases in which this medication is not effective. Zolpidem is a short‐acting nonbenzodiazepine hypnotic drug that is administered orally and has quick onset of action (~15 minutes), and 2‐3 hour duration. Aims Based on the theory that impaired perception following oral zolpidem administration would suppress the development of anxiety, we sought to compare zolpidem to midazolam for pediatric preoperative anxiety. Methods This prospective randomized double‐blinded clinical trial was designed to compare the effectiveness of oral midazolam and zolpidem for anxiety premedication. Eighty ASA class I‐II pediatric patients between 2 and 9 years old, surgery >2 hours, and at least 23 hours postoperative admission were included in the study. Randomization was done with 0.5 mg/kg midazolam or 0.25 mg/kg zolpidem administered orally. The primary outcome measure was between group difference in patient anxiety at the time of separation using the Modified Yale Preoperative Anxiety Scale. Secondary outcomes included emergence delirium and mask acceptance at induction. Results There was no significant difference in Modified Yale Preoperative Anxiety Scale scores at separation between midazolam (median/interquartile range = 26.7/23.3‐36.6) and zolpidem (median/interquartile range = 30.0/23.3‐56.6) groups, difference 0.01 (95% CI −3E−5, 3E−2; P = 0.07). Mask acceptance score was significantly better in the midazolam group. There was no significant difference in emergence delirium scores between groups. Conclusion This study demonstrates that zolpidem, as dosed, was similar to midazolam with regard to anxiety scoring, and inferior with regard to mask acceptance scores.

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Section: Introductionmentioning

confidence: 99%

A comparison of midazolam and zolpidem as oral premedication in children, a prospective randomized double‐blinded clinical trial

Hanna

Ramsingh

Sullivan-Lewis

et al. 2018

Pediatric Anesthesia

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“…23 The only other pediatric zolpidem pharmacokinetic study was conducted by Blumer et al, 24 which used a single dose escalation design to evaluate 3 zolpidem dosage regimens (0.125, 0.25, and 0.5 mg/kg) among otherwise healthy children with insomnia. 23 The only other pediatric zolpidem pharmacokinetic study was conducted by Blumer et al, 24 which used a single dose escalation design to evaluate 3 zolpidem dosage regimens (0.125, 0.25, and 0.5 mg/kg) among otherwise healthy children with insomnia.…”

Section: Discussionmentioning

confidence: 99%

“…In the previously mentioned study conducted by Blumer et al, 24 the pharmacokinetics of zolpidem were evaluated among otherwise healthy children suffering from insomnia. Age was found to significantly influence the zolpidem area under the concentration-time curve, half-life, and mean residence time.…”

Section: Discussionmentioning

confidence: 99%

Preliminary Assessment of Zolpidem Pharmacokinetics in Pediatric Burn Patients

Stockmann

Sherwin

Buterbaugh

et al. 2014

Therapeutic Drug Monitoring

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A population pharmacokinetic model has been developed that reliably characterized the pharmacokinetic parameters of zolpidem when used as a sleep-enhancing agent among pediatric burn patients. Additional studies are needed to link this pharmacokinetic model with pharmacodynamic data, which may include an assessment of the effects of higher zolpidem doses and/or more frequent administration upon sleep architecture.

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“…These medications only have FDA approval for use in patients older than 18 years old, and therefore, the use of these medications in children is considered Boff-label.^They may also be difficult to administer in children as none of these medications are offered in liquid or dissolvable wafer form [26]. There are reports of zolpidem abuse among adolescents [27,28].…”

Section: Benzodiazepinesmentioning

confidence: 99%

Pharmacotherapy of Insomnia in Children

Pelayo

Huseni

2016

Curr Sleep Medicine Rep

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Insomnia is defined as the inability to fall asleep and/or the inability to maintain sleep to the point that it has a negative impact on time awake. Insomnia in adults may lead to daytime fatigue and sleepiness but in children, the lack of quality sleep may lead to daytime behavioral problems such as hyperactivity and academic difficulty. The pharmacological treatment of insomnia in children is a challenging problem for clinicians since there is paucity of Food and Drug Administration (FDA) approved. Parents often seek medical attention for their children when their own or other members of the family's sleep schedule has been disrupted. The clinician has to take into account the entire family when evaluating a child and making therapeutic recommendations. When evaluating a child with insomnia, it is not only important to take a thorough history of the child's sleep schedule but it also involves getting a detailed evaluation of the other family member's sleep history. The pharmacological management of insomnia is dependent on the child's age. The primary healthcare physician may have limited training in pediatric sleep disorders. Although the mainstay treatment for insomnia in children is behavioral therapy, in this chapter, we will provide a review of the medications that may be used as an adjunct treatment for pediatric insomnia.

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Potential Pharmacokinetic Basis for Zolpidem Dosing in Children With Sleep Difficulties

Cited by 32 publications

References 36 publications

A comparison of midazolam and zolpidem as oral premedication in children, a prospective randomized double‐blinded clinical trial

A comparison of midazolam and zolpidem as oral premedication in children, a prospective randomized double‐blinded clinical trial

Preliminary Assessment of Zolpidem Pharmacokinetics in Pediatric Burn Patients

Pharmacotherapy of Insomnia in Children

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