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Medicines > classes : Research material or [[:Category:Sleep aids|Sleep aid]]

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generic:
brand:
None (130) · (none, never marketed) (1) · Ambien (IR), Ambien CR (biphasic-release), Edluar (sublingual), Intermezzo (low-dose sublingual for middle-of-night awakening), Zolpimist (oral spray) (1) · Benadryl (oral, injectable, topical), Banophen, Sominex (sleep aid), ZzzQuil, Aler-Dryl (1) · Desyrel (original IR), Oleptro (ER), Trittico (1) · Multiple OTC dietary supplement formulations (1) · O-DSMT (1)
classes: (Click arrow to add another value)
mechanism:
5-HT2A agonist (26) · Monoamine releasing agent (9) · GABAA positive allosteric modulator (8) · CB1/CB2 agonist (7) · Dopamine/norepinephrine reuptake inhibitor (5) · Potent 5-HT2A agonist (5) · LSD analogue; 5-HT2A agonist (4) · Prodrug of LSD; 5-HT2A agonist (4) · Serotonin/norepinephrine/dopamine releasing agent (3) · None (2) · Cathinone analogue; monoamine reuptake inhibitor (2) · Dopamine and norepinephrine reuptake inhibitor (2) · NMDA antagonist (2) · Prodrug of GHB (2)
uses:
None (131) · No approved medical problem. Encountered as a designer/research benzodiazepine and, increasingly, as an adulterant in illicit opioid supplies. (1) · '"`UNIQ--vote-00000017-QINU`"', '"`UNIQ--vote-00000018-QINU`"', '"`UNIQ--vote-00000019-QINU`"' (1) · '"`UNIQ--vote-00000019-QINU`"', '"`UNIQ--vote-0000001A-QINU`"', '"`UNIQ--vote-0000001B-QINU`"', '"`UNIQ--vote-0000001C-QINU`"' (1) · '"`UNIQ--vote-0000001B-QINU`"', '"`UNIQ--vote-0000001C-QINU`"', '"`UNIQ--vote-0000001D-QINU`"', '"`UNIQ--vote-0000001E-QINU`"', '"`UNIQ--vote-0000001F-QINU`"', '"`UNIQ--vote-00000020-QINU`"' (1) · '"`UNIQ--vote-00000020-QINU`"', '"`UNIQ--vote-00000021-QINU`"', '"`UNIQ--vote-00000022-QINU`"', '"`UNIQ--vote-00000023-QINU`"', '"`UNIQ--vote-00000024-QINU`"', '"`UNIQ--vote-00000025-QINU`"' (1)
starting dose:
None (131) · '''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 (1) · 0.5-3 mg PO 30-60 minutes before bedtime. Some patients respond to micro-doses (0.3 mg) without additional benefit at higher doses. For circadian phase shifting, timing relative to dim-light melatonin onset matters more than absolute dose (1) · Allergy: 25-50 mg PO every 4-6 hours. Insomnia: 25-50 mg PO at bedtime. IV (acute dystonia, severe allergic reaction): 25-50 mg slow IV push (1) · Insomnia (off-label): 25-50 mg PO at bedtime, titrate to effect. Depression: 150 mg/day divided BID-TID; titrate to 400 mg/day outpatient or 600 mg/day inpatient (1) · No medical dose. Active recreational doses reported in the 0.5–1.5 mg range (similar potency to alprazolam). (1)
preparations:
None (131) · Illicit tablets ("bars"), powders, blotter, occasionally solutions. No pharmaceutical product exists. (1) · IR tablets 5, 10 mg; CR tablets 6.25, 12.5 mg; SL tablets 1.75, 3.5, 5, 10 mg; oral spray (1) · IR tablets 50, 100, 150, 300 mg; Oleptro ER tablets 150, 300 mg (1) · OTC tablets, sublingual tablets, gummies, liquid, extended-release tablets and capsules; common strengths 0.5, 1, 3, 5, 10 mg (1) · Tablets 25, 50 mg; capsules; liquid; chewable; topical cream/gel; injection 50 mg/mL (1)
fda max:
None (131) · 10 mg/day (IR); 12.5 mg/day (CR) (1) · 300 mg/day (oral) (1) · 400 mg/day outpatient; 600 mg/day inpatient (1) · N/A (never approved) (1) · Not formally established (dietary supplement); doses above ~3-5 mg show no additional efficacy but increase next-day sedation risk (1)
routes:
None (131) · IM (1) · intranasal; rectal and IV reported. (1) · IV (1) · Oral (5) · oromucosal spray (1) · sublingual (3) · topical (1)
onset:
None (131) · 15-30 minutes (1) · 15-30 minutes (oral); 1-2 minutes (IV) (1) · 30-60 minutes (immediate-release oral) (1) · Sleep effect within 30-60 minutes; antidepressant effect over 1-2 weeks (1) · ~20–40 min PO; faster sublingual/intranasal. (1)
duration:
None (131) · 3-4 hours (1) · 4-6 hours (1) · 6-8 hours (IR); 8 hours (CR via biphasic release) (1) · 6–10 h subjective; full pharmacologic effect considerably longer. (1) · ~6-8 hours (IR); 24 hours (Oleptro ER) (1)
halflife:
None (131) · 30-50 minutes (short)'"`UNIQ--ref-00000021-QINU`"' (1) · 4-8 hours (longer in elderly, 9-13 hours)'"`UNIQ--ref-00000026-QINU`"' (1) · Biphasic: ~3-6 hours alpha, ~5-9 hours beta'"`UNIQ--ref-0000001D-QINU`"' (1) · Estimated ~12–17 h (some sources cite up to ~21 h); active metabolites prolong effect. (1) · ~2.5 hours'"`UNIQ--ref-0000001A-QINU`"' (1)
bioavailability:
None (131) · Not formally characterized in humans. (1) · ~15% (oral; highly variable due to extensive and variable first-pass metabolism)'"`UNIQ--ref-00000022-QINU`"' (1) · ~40-60% (oral, with significant first-pass)'"`UNIQ--ref-00000027-QINU`"' (1) · ~65% (oral)'"`UNIQ--ref-0000001E-QINU`"' (1) · ~70% (oral)'"`UNIQ--ref-0000001B-QINU`"' (1)
pregnancy:
None (131) · Avoid. Benzodiazepines are associated with neonatal sedation, floppy-infant syndrome, and withdrawal; teratogenic signal weak but non-zero. Designer benzo with no safety data, assume worst-case. (1) · Limited human data; case reports of neonatal sedation with late-pregnancy exposure.<sup class="pcp-cn" title="This claim needs a citation.">&#91;[[Pharmacopedia:Citation needed|citation&nbsp;needed]]&#93;</sup> (1) · Limited human data; endogenous hormone, but supplemental pharmacological doses are not well characterized in pregnancy.<sup class="pcp-cn" title="This claim needs a citation.">&#91;[[Pharmacopedia:Citation needed|citation&nbsp;needed]]&#93;</sup> (1) · Limited human data; observational signals inconclusive.<sup class="pcp-cn" title="This claim needs a citation.">&#91;[[Pharmacopedia:Citation needed|citation&nbsp;needed]]&#93;</sup> (1) · Older agent with substantial use experience; broadly considered safe in pregnancy'"`UNIQ--ref-00000028-QINU`"' (1)
legal:
None (132) · [[USLegal:Over-the-counter|OTC]] dietary supplement in the US ('''not FDA-regulated as a medicine'''; multiple studies show OTC products contain 50-470% of labeled melatonin content); [[USLegal:Prescription only|Rx-only]] in the EU and UK (1) · [[USLegal:Over-the-counter|OTC]] for most oral and topical formulations; [[USLegal:Prescription only|Rx-only]] for injectable (1) · [[USLegal:Prescription only|Rx-only]] in US. Carries the antidepressant '''Boxed Warning''' for suicidality in children, adolescents, and young adults'"`UNIQ--ref-0000001F-QINU`"' (1) · [[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'"`UNIQ--ref-0000001C-QINU`"' (1)

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