Insomnia

Selecting a Treatment Regimen Table 7. Pharmaceutical Therapy Options Drug Dosage Form Recommended Dosage Indications/Specific Comments Benzodiazepine Receptor Agonistic Modulators [Schedule IV Controlled Substances] Nonbenzodiazepines cyclopyrrolones eszopiclone Lunesta® imidazopyridines zolpidem Ambien® Ambien CR® pyrazolopyrimidines zaleplon Sonata® Benzodiazepines estazolam ProSom® flurazepam Dalmane® quazepam Doral® temazepam Restoril® • 2-3 mg at bedtime • 1 mg at bedtime in elderly or debilitated; max 2 mg • 1 mg at bedtime in severe hepatic impairment; max 2 mg • 10 mg at bedtime; max 10 mg • 5 mg at bedtime in elderly, 5, 10 mg tablets debilitated, or hepatic impairment 6.25, 12.5 mg • 12.5 mg at bedtime tablets • 6.25 mg at bedtime in elderly, debilitated, or hepatic impairment • 10 mg at bedtime; max 20 mg • 5 mg at bedtime in elderly, 5, 10 mg capsule debilitated, mild to moderate hepatic impairment, or concomitant cimetidine 1, 2, 3 mg tablets 1, 2 mg tablets 15, 30 mg capsules 7.5 mg tablet • 1-2 mg at bedtime • 0.5 mg at bedtime in elderly or debilitated • 15-30 mg at bedtime • 15 mg at bedtime in elderly or debilitated • 7.5 mg at bedtime • 15-30 mg at bedtime • 7.5 mg at bedtime in elderly or 7.5, 15, 30 mg capsules debilitated • 0.25 mg at bedtime; triazolam ® Halcion 0.125, 0.25 mg max 0.5 mg • 0.125 mg at bedtime in elderly tablets or debilitated; max 0.25 mg Melatonin Receptor Agonists [Non-Scheduled] • 8 mg at bedtime ramelteon Rozerem® 8 mg tablet • Primarily used for sleep-onset and maintenance insomnia • Intermediate-acting • No short-term usage restriction • Primarily used for sleep-onset insomnia • Short- to intermediate-acting • Primarily used for sleep-onset and maintenance insomnia • Controlled release; swallow whole, not divided, crushedor chewed • Primarily used for sleep-onset insomnia • Short-acting • Short- to intermediate-acting • Long-acting • Risk of residual daytime drowsiness • Long-acting • Risk of residual daytime drowsiness • Short- to intermediate-acting • Short-acting • Primarily used for sleep-onset insomnia • Short-acting • No short-term usage restriction Histamine H1 Antagonist [Non-Scheduled] • Adults: 6 mg once daily; • Primarily indicated for sleep doxepin A 3 mg once daily dose may be maintenance insomnia Silenor® 3, 6 mg tablets appropriate for some patients, • The most common treatmentif clinically indicated emergent adverse reaction in the • Elderly (≥ 65 yrs old): starting placebo and each of the Silenor dose dose 3 mg once daily; The daily groups was somnolence/sedation dose can be increased to 6 mg, if clinically indicated Table partially constructed from individual drug Prescribing Information labeling. • See product labeling for complete prescribing information. • The FDA recently recommended that a warning be issued regarding adverse effects associated with BzRA hypnotics. These medications have been associated with reports of disruptive sleep related behaviors including sleepwalking, eating, driving, and sexual behavior. Patients should be cautioned about the potential for these adverse effects, and about the importance of allowing appropriate sleep time, using only prescribed doses and avoiding the combination of BzRA hypnotics with alcohol, other sedatives, and sleep restriction. • General comments about sedatives/hypnotics: ◉ Administration on an empty stomach is advised to maximize effectiveness. ◉ Not recommended during pregnancy or nursing. ◉ Caution is advised if signs/symptoms of depression, compromised respiratory function (eg, asthma, COPD, sleep apnea), or hepatic failure are present. ◉ Caution and downward dosage adjustment is advised in the elderly. ◉ Safety/effectiveness in patients < 18 years not established ◉ Additive effect on psychomotor performance with concomitant CNS-depressants and/or alcohol use. ◉ Rapid dose decrease or abrupt discontinuance of benzodiazepines can produce withdrawal symptoms, including rebound insomnia, similar to that of barbiturates and alcohol. • Certain antidepressants (amitriptyline, doxepin, mirtazapine, paroxetine, trazodone) are employed in lower than antidepressant therapeutic dosages for treatment of insomnia. These medications are not FDA approved for insomnia and their efficacy for this indication is not well established. • OTC sleep medications contain antihistamines as the primary agent; efficacy for treatment of insomnia is not well established, especially for long-term use.

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