<p><strong>Severe anaphylactic/anaphylactoid reactions</strong>: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur.<br />
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<strong>Need to evaluate for co-morbid diagnoses</strong>: Reevaluate if insomnia persists after 7 to 10 days of treatment.<br />
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<strong>Abnormal thinking, behavioral changes, complex behaviors</strong>: May include &quot;sleep-driving&quot; and hallucinations. Immediately evaluate any new onset behavioral changes.<br />
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<strong>Depression</strong>: Worsening of depression or suicidal thinking may occur.<br />
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<strong>CNS effects</strong>: Potential impairment of activities requiring complete mental alertness such as operating machinery or driving a motor vehicle, after ingesting the drug.&nbsp;<br />
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<strong>Reproductive effects</strong>: Include decreased testosterone and increased prolactin levels. Effect on the reproductive axis in developing humans is unknown<br />
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<strong>Patients with severe sleep apnea</strong>: Rozerem is not recommended for use in this population.</p>