Renal Dose Adjustment (Based on CrCl)
- <10 mL/min: Decrease dose by 50%
Hepatic Dose Adjustment
- Hepatic impairment: Caution advised; dose adjustments not defined
See Supplemental Patient Information
- Safety and efficacy of doxylamine as a nighttime sleep aid in children <12 years of age have not been established
- Children are more prone than adults to get paradoxically CNS stimulation rather than sedation when antihistamines are used as night time sleep aids
- Doxylamine may cause CNS depression, which may impair physical or mental abilities; caution patients against performing tasks which require mental alertness (eg, operating machinery or driving)
- May increase the effect of alcohol
- Assess potential for interactions with other prescription, OTC medications, or herbal products, which the patient may be using
- Assess therapeutic effectiveness and adverse reactions on a regular basis throughout therapy
Cautions: Use cautiously in
- Hepatic impairment
- Prostatic hypertrophy
- Cardiovascular disease
- Hypertension
- Diabetes
- Bronchial asthma
- Stenosing peptic ulcer
- Angle-closure glaucoma
- Pyloroduodenal obstruction
- Bladder neck obstruction
- Thyroid dysfunction
- Increased intraocular pressure
- Hyperthyroidism
- Concomitant use with CNS depressant drug
Supplemental Patient Information
- If sleeplessness persists for >2 weeks, consult healthcare provider
- Avoid concomitant use of CNS depressants, including alcohol
Pregnancy Category:B
Breastfeeding: Probably unsafe.
