Zolpidem: Difference between revisions

(5 intermediate revisions by 2 users not shown)

Line 1:

{{MedTemplate

| generic = Zolpidem

| generic = Zolpidem (tartrate)

| brand = Ambien

| brand = Ambien (IR), Ambien CR (biphasic-release), Edluar (sublingual), Intermezzo (low-dose sublingual for middle-of-night awakening), Zolpimist (oral spray)

| structure =

| classes = Z-~~drug~~, ~~Sedative-Hypnotic~~

| classes = [[:Category:Non-benzodiazepine hypnotics|Non-benzodiazepine hypnotic]], [[:Category:Sleep aids|Sleep aid]], [[:Category:Schedule IV controlled substances|Schedule IV controlled substance]]

| ~~mechanism~~ = ~~GABAA positive allosteric modulator~~ (~~non~~-~~benzodiazepine~~)

| uses = <vote slug="insomnia-sleep-onset-use">Insomnia, sleep-onset type (FDA, short-term)</vote>, <vote slug="insomnia-sleep-maintenance-use">Insomnia, sleep-maintenance type (Ambien CR; FDA)</vote>, <vote slug="middle-of-night-awakening-use">Middle-of-night awakening with ≥4 hours sleep remaining (Intermezzo SL; FDA)</vote>

| ~~uses~~ =

| starting_dose = '''5 mg PO at bedtime for women, 5-10 mg for men''' (per FDA's 2013 sex-specific dose reduction for women due to slower clearance). Ambien CR 6.25 mg women / 6.25-12.5 mg men. Intermezzo SL 1.75 mg women / 3.5 mg men

| ~~starting_dose~~ =

| preparations = IR tablets 5, 10 mg; CR tablets 6.25, 12.5 mg; SL tablets 1.75, 3.5, 5, 10 mg; oral spray

| ~~preparations~~ =

| fda_max = 10 mg/day (IR); 12.5 mg/day (CR)

| ~~fda_max~~ =

| pill_id =

| routes =

| routes = Oral, sublingual, oromucosal spray

| onset =

| onset = 15-30 minutes

| duration =

| duration = 6-8 hours (IR); 8 hours (CR via biphasic release)

| halflife =

| halflife = ~2.5 hours<ref name="ambien-label">FDA Prescribing Information, Ambien (zolpidem tartrate), Sanofi, current revision. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019908s041lbl.pdf</ref>

~~| bioavailability =~~

| bioavailability = ~70% (oral)<ref name="ambien-label" />

~~| pregnancy~~ =

| pregnancy = Limited human data; case reports of neonatal sedation with late-pregnancy exposure.{{citation needed}}

~~| legal~~ =

| legal = [[USLegal:Schedule IV|Schedule IV controlled substance]] in US. Carries the FDA '''Boxed Warning''' for '''complex sleep behaviors''' (sleep-driving, sleep-walking, sleep-eating, other parasomnias) added in 2019<ref name="ambien-label" />

| ~~intro =~~

| mechanism = <vote slug="zolpidem-mech-claim">Selective positive allosteric modulator of the GABA-A receptor preferentially at α1-containing subtypes (the "sedation" subtypes), providing more sedation per unit anxiolysis and muscle relaxation than the non-selective benzodiazepines. The short half-life is the basis of less next-morning grogginess in most patients.</vote> The 2013 FDA dose reduction for women reflects slower clearance in women and higher rates of next-morning impaired driving; the 2019 Boxed Warning for complex sleep behaviors followed accumulated case reports. CYP3A4 substrate, so CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin) substantially raise plasma exposure<ref name="ambien-label" />.

~~| pharmacokinetics~~ =

~~| pharmacodynamics~~ =

| ~~indications~~ =

| ~~dosing~~ =

| ~~effects~~ =

| ~~interactions =~~

~~| pregnancy_details =~~

~~| monitoring~~ =

~~| counseling~~ =

~~| anecdotes =~~

~~| seealso =~~

~~| references~~ =

}}

[[Category:~~Sedative~~-~~Hypnotics~~]]

== References ==

[[Category:Non-benzodiazepine hypnotics]]

[[Category:Sleep aids]]

[[Category:Schedule IV controlled substances]]

MDElliottMD (talk | contribs)