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09. Insomnia in Pregnancy and Older Adults: Choosing the Safer Agent

Published on August 5, 2026 Certification expiration date: August 5, 2029

Bhanu Prakash Kolla, M.D.

Professor of Psychiatry - Mayo Clinic

Key Points

In pregnancy, consider doxylamine as a first-line pharmacologic option when non-pharmacological strategies fail.
For older adults with insomnia, doxepin, mirtazapine, DORAs, and trazodone are all reasonable first-line options. If these are ineffective, consider half doses of zolpidem ER or eszopiclone.
Eszopiclone, low-dose doxepin, and DORAs all carry FDA approval for long-term use in insomnia, with no specified duration limit.

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Slides and Transcript

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In this section, we will talk about treating insomnia in pregnancy, older adults and long-term use of hypnotic medication.

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Sleep disturbance is very common in pregnancy. Both Z-drugs and benzodiazepines cross the placental barrier but also could be associated with preterm birth and low birth weight. Doxylamine is commonly used for nausea and multiple reviews have found that it is safe and not associated with birth defects. Ultimately, treatment selection should be based on shared decision making in pregnancy and should involve a careful risk versus benefit analysis.

References:

Tu, X., Junna, M. R., & Kolla, B. P. (2025). How do you Zzz during pregnancy? A brief review of Z-drug use and management of insomnia during pregnancy. *Journal of Clinical Sleep Medicine*, *21*(8), 1499–1502. https://doi.org/10.5664/jcsm.11740

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Slide 3 of 8

Doxylamine remains first-line choice for insomnia in pregnancy that has not responded to non-pharmacological strategies. Among other medications, trazodone, doxepin, ramelteon are potential low-risk options. Continuation of previously effective hypnotic after careful risk-benefit discussion is ideal as compared to starting a new medication during pregnancy.

References:

Tu, X., Junna, M. R., & Kolla, B. P. (2025). How do you Zzz during pregnancy? A brief review of Z-drug use and management of insomnia during pregnancy. *Journal of Clinical Sleep Medicine*, *21*(8), 1499–1502. https://doi.org/10.5664/jcsm.11740

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In older adults, effective pharmacotherapy for insomnia is complicated by several factors. In older adults, there could be increased sensitivity to side effects of medications, interference with multiple comorbidities that are more likely, decreased drug metabolism and clearance, medication interactions. In addition, in older adults, benzodiazepines can potentially increase the risk of falls, confusion and cognitive issues.

References:

León-Barriera, R., Chaplin, M. M., Kaur, J., & Modesto-Lowe, V. (2025). Insomnia in older adults: A review of treatment options. *Cleveland Clinic Journal of Medicine*, *92*(1), 43–50. https://doi.org/10.3949/ccjm.92a.24073

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For the treatment of insomnia in the elderly in clinical practice, doxepin, mirtazapine, dual orexin receptor antagonists and trazodone are reasonable first-line options in older adults. If these are ineffective, Zolpidem extended release at 6.25 mg and eszopiclone at 1 to 2 mg are considered next options.

References:

Richardson, G. S., Zammit, G., Wang-Weigand, S., & Zhang, J. (2009). Safety and subjective sleep effects of ramelteon administration in adults and older adults with chronic primary insomnia: a 1-year, open-label study. *The Journal of Clinical Psychiatry*, *70*(4), 467–476. https://doi.org/10.4088/jcp.07m03834
León-Barriera, R., Chaplin, M. M., Kaur, J., & Modesto-Lowe, V. (2025). Insomnia in older adults: A review of treatment options. *Cleveland Clinic Journal of Medicine*, *92*(1), 43–50. https://doi.org/10.3949/ccjm.92a.24073

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In terms of the duration of treatment or long-term use of hypnotics, while insomnia is a chronic condition, guidelines for the treatment previously recommended only short-term medication use. Eszopiclone is unique in that its FDA label does not specify a limited duration of use. Low-dose doxepin and dual orexin receptor antagonists are also approved without any duration limits. Ramelteon also has data supporting long-term efficacy.

References:

Qaseem, A., Kansagara, D., Forciea, M. A., Cooke, M., & Denberg, T. D. (2016). Management of chronic insomnia disorder in adults: A clinical practice guideline from the American College of Physicians. *Annals of Internal Medicine*, *165*(2). https://doi.org/10.7326/M15-2175
Zee, P. C., Bertisch, S. M., Morin, C. M., Pelayo, R., Watson, N. F., Winkelman, J. W., & Krystal, A. D. (2023). Long-term use of insomnia medications: An appraisal of the current clinical and scientific evidence. *Journal of Clinical Medicine*, *12*(4), 1629. https://doi.org/10.3390/jcm12041629

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The key points for this section include: Sleep disturbances during pregnancy are extremely common. Behavioral strategies are the first-line treatment for insomnia in this population. Doxylamine is the safest pharmacological agent to use to treat sleep problems during pregnancy. Doxepin, mirtazapine, DORAs and trazodone are reasonable first-line options in older adults.

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Insomnia is a chronic condition. Therefore, many patients may require long-term treatment. Data indicate that eszopiclone, doxepin, DORAs and ramelteon continue to remain effective with long-term use.

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Next Section

10. Clinical Case: Eszopiclone for Perimenopausal Insomnia

Learning Objectives:

Describe the diagnostic criteria for chronic insomnia disorder and apply the Insomnia Severity Index to screen patients and monitor treatment response.
Compare the efficacy, dosing, and safety profiles of FDA-approved and off-label agents for insomnia, including dual orexin receptor antagonists, Z-drugs, benzodiazepines, melatonin agonists, and sedating antidepressants.
Select appropriate pharmacotherapy for insomnia in special populations, including pregnancy, older adults, patients receiving opioids or with comorbid substance use disorder, and patients requiring long-term treatment.

Original Release Date: August 05, 2026
Expiration Date: August 05, 2029

Faculty: Bhanu Kolla, M.D.
Medical Editor: Tomás Abudarham, M.D.

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None of the faculty, planners, and reviewers for this educational activity has relevant financial relationships to disclose during the last 24 months with ineligible companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

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